Composite Nanocoatings
                                            Eric Loth
                                            Principal Investigator
Team 21       http://youtu.be/sk45p1mpWe8

              http://vimeo.com/6552419

                                            Adam Steele
                                            Entrepreneurial Lead




                                            Bob Hergenrother
                                            I-Corps Mentor

Ultra-low friction
nanocomposite coatings that
are durable and low-cost
                                            Joram Slager
       # of customer meetings               Mentor & Coating Expert
            during I-Corps
                 106
Composite Nanocoatings




Example - anti-wetting nanocomposite coating

http://tmblr.co/Z0i3WyB7sDP
Day     Month   Ye




                                                                                                                                                                                                                                                                                                                                                                                                           No.




Who are our Key Partners?                                           What Key Activities do our Value Propositions require?    What value do we deliver to the customer?                                                 What type of relationship does each of our Customer                                                        For whom are we creating value?

Surmodics                                                           Supplying know-how                                       Reduce icing on aircraft                                                                 Collaborative
Who are our key suppliers?                                          Our Distribution Channels?                                Which one of our customer’s problems are we helping to solve?                             Segments expect us to establish and maintain with them?                                                    Who are our most important customers?
Which Key Resources are we acquiring from partners?                 Customer Relationships?                                   What bundles of products and services are we offering to each Customer Segment?           Which ones have we established?
Which Key Activities do partners perform?                           Revenue streams?                                          Which customer needs are we satisfying?                                                   How are they integrated with the rest of our business model?
                                                                                                                                                                                                                                                                                                                                   Medical catheter
                                                                    & other pre-license                                      and wind turbines                                                                        relationship
                                                                                                                                                                                                                        How costly are they?

                                                                                                                                                                                                                                                                                                                                   companies using
UVA Patent                                                          implementation help
                                                                                                                             Reduce drag in fluid                                                                                                                                                                                  Teflon inner liners
Foundation                                                                                                                                                                                                            Possible training for
                                                                                                                             lines
                                                                    Providing a simple                                                                                                                                coating application
                                                                                                                                                                                                                                                                                                                                   Ship buildings
UI Office of Tech.                                                   and efficient license                                     Reduce insect fouling on
Management                                                                                                                   airplane wings
                                                                                                                                                                                                                                                                                                                                   Aircraft
                                                                                                                             Reduce drag on marine                                                                                                                                                                                 companies
                                                                    What Key Resources do our Value Propositions require?
                                                                                                                             vehicles                                                                                   Through which Channels do our Customer Segments
                                                                    Our Distribution Channels? Customer Relationships?
                                                                                                                                                                                                                      Licensenow? coating
                                                                                                                                                                                                                      How are we reaching them to
                                                                                                                                                                                                                      want to be reached?
                                                                    Coating engineers
                                                                    Revenue Streams?
                                                                                                                                                                                                                      How are our Channels integrated?
                                                                                                                             Reduce ear wax fouling                                                                   companies and
                                                                                                                                                                                                                      Which ones work best?
                                                                                                                                                                                                                      Which ones are most cost-efficient?

                                                                                                                             on hearing aids
                                                                                                                                                                                                                      How are we integrating them with customer routines?
                                                                                                                                                                                                                      device companies
                                                                    PI with university
                                                                                                                                                                                                                      directly
                                                                    tech transfer depts.                                     Preventing liquid films
                                                                                                                             on heat xfer elements
                                                                                                                                                                                                                      Direct sales: materials
                                                                    Biomed labs at
                                                                                                                             …                                                                                        & equipment
                                                                    Surmodics



Most important current cost is time and salary                                                                                                                         Materials and coating equipment sales for immediate
What are the most important costs inherent in our business model?                                                                                                        For what value are our customers really willing to pay?
Which Key Resources are most expensive?                                                                                                                                 For what do they currently pay?
Which Key Activities are most expensive?                                                                                                                                How are they currently paying?
                                                                                                                                                                        How would they prefer to pay?
                                                                                                                                                                       revenue during customers’ build-test stage
                                                                                                                                                                        How much does each Revenue Stream contribute to overall revenues?


R&D to obtain know-how
                                                                                                                                                                       A licensing model based on a combination of IP and
Licensing fees from IP consolidation                                                                                                                                   know-how for sustainable revenue

                                                                                                                                                                                                                                                                                                This work is licensed under the Creative Commons Attribution-Share Alike 3.0 Unported License.
                                                                                                                                                                                                                                                                                                              To view a copy of this license, visit http://creativecommons.org/licenses/by-sa/3.0/
                                                                                                                                                                                                                                                                                       or send a letter to Creative Commons, 171 Second Street, Suite 300, San Francisco, California, 94105, USA.
Composite Nanocoatings




                         Anti-fouling & anti-icing coatings on off-
                         shore wind turbine blades




$300K from AREVA
Composite Nanocoatings




                         Lubricious coatings on medical catheters
                         for easy device deployment
Composite Nanocoatings



Customer Discovery
                                                                   Maturity

                         Rolls Royce :: icing on aircraft inlets   3-4 yrs away
Anti-icing                                                         high speed impact
                         AREVA :: icing wind turbine blades

                         Gates :: fluid power lines
                                                                   4-6 yrs away
Less ΔP                                                            high pressure
                         Nitta :: fluid transfer tubes

                         Boeing :: insect fouling
                                                                   3-5 yrs away
Anti-fouling             Navy :: salt water bio-fouling
                                                                   high variability
                         Starkey :: hearing aid wax buildup

                         Lightsail :: preventing liquid films       2-3 yrs away
Anti-wetting                                                       longevity
                         SIPS :: moisture on structural panels

                         West Pharm :: lubricious syringes         < 1 yr away
Lubricity                                                          bio-compatibility
                         Surmodics :: lubricious med. devices
Composite Nanocoatings


                            No major fundamental
Customer Focus              breakthroughs needed
                                                                   Maturity

                         Rolls Royce :: icing on aircraft inlets   3-4 yrs away
Anti-icing                                                         high speed impact
                         AREVA :: icing wind turbine blades

                         Gates :: fluid power lines
                                                                   4-6 yrs away
Less ΔP                                                            high pressure
                         Nitta :: fluid transfer tubes

                         Boeing :: insect fouling
                                                                   3-5 yrs away
Anti-fouling             Navy :: salt water bio-fouling
                                                                   high variability
                         Starkey :: hearing aid wax buildup

                         Lightsail :: preventing liquid films       2-3 yrs away
Anti-wetting                                                       longevity
                         SIPS :: moisture on structural panels

                         West Pharm :: lubricious syringes         < 1 yr away
Lubricity                                                          bio-compatibility
                         Surmodics :: lubricious med. devices
Lubricity - medical devices
                                                                                                                                                                                                                                                                                                                                                                                                Day     Mont




                                                                                                                                                                                                                                                                                                                                                                                                      No.




Who are our Key Partners?                                           What Key Activities do our Value Propositions require?   What value do we deliver to the customer?                                             What type of relationship does each of our Customer                                                        For whom are we creating value?

Surmodics
Who are our key suppliers?
Which Key Resources are we acquiring from partners?
Which Key Activities do partners perform?
                                                                    Consolidate the
                                                                    Our Distribution Channels?
                                                                    Customer Relationships?
                                                                    Revenue streams?
                                                                                                                             Added dry lubricity to
                                                                                                                             Which one of our customer’s problems are we helping to solve?
                                                                                                                             What bundles of products and services are we offering to each Customer Segment?
                                                                                                                             Which customer needs are we satisfying?
                                                                                                                                                                                                                   Collaborative
                                                                                                                                                                                                                   Segments expect us to establish and maintain with them?
                                                                                                                                                                                                                   Which ones have we established?
                                                                                                                                                                                                                   How are they integrated with the rest of our business model?
                                                                                                                                                                                                                                                                                                                          Medical catheter
                                                                                                                                                                                                                                                                                                                              Who are our most important customers?



                                                                    university IP and                                        inner lumen of                                                                        relationship                                                                                           companies
                                                                                                                                                                                                                   How costly are they?



UVA Medical Center                                                  determine strength                                       catheters for easy
                                                                                                                             device deployment                                                                     Possible training for                                                                                  Medical stent
UVA Patent                                                          Solidify know-how                                                                                                                              coating application                                                                                    companies
Foundation                                                          of applying coating                                      Added wet lubricity to
                                                                                                                             outer surface of
                                                                                                                                                  Guessed at the                                                                                                                                                          Laparoscopic
                                                                                                                             catheters for smooth value props                                                                                                                                                             device
                                                                                                                             introduction                                                                                                                                                                                 companies
                                                                    What Key Resources do our Value Propositions require?                                                                                          Through which Channels do our Customer Segments

                                                                    Coating engineers
                                                                    Our Distribution Channels? Customer Relationships?
                                                                    Revenue Streams?
                                                                                                                             Improved                                                                              Conferences and
                                                                                                                                                                                                                   want to be reached?
                                                                                                                                                                                                                   How are we reaching them now?
                                                                                                                                                                                                                   How are our Channels integrated?                                                                       Satellite
                                                                                                                                                                                                                   expos
                                                                                                                                                                                                                   Which ones work best?

                                                                                                                             hemocompatibility for
                                                                                                                                                                                                                   Which ones are most cost-efficient?
                                                                                                                                                                                                                   How are we integrating them with customer routines?                                                    companies
                                                                    PI with university                                       extended duration of
                                                                    tech transfer depts.                                     devices                                                                               Professional                                                                                           Artistic effects
                                                                                                                                                                                                                   network
                                                                                                                             Simplified university                                                                                                                                                                         Exterior paint
                                                                                                                             license                                                                                                                                                                                      companies



What are the most important costs inherent in our business model?                                                                                                       For what value are our customers really willing to pay?

Most important current cost is time and salary
Which Key Resources are most expensive?
Which Key Activities are most expensive?                                                                                                                                A licensing model based on a combination of IP and
                                                                                                                                                                        For what do they currently pay?
                                                                                                                                                                        How are they currently paying?
                                                                                                                                                                        How would they prefer to pay?

                                                                                                                                                                        know-how
                                                                                                                                                                        How much does each Revenue Stream contribute to overall revenues?



R&D to obtain know-how
                                                                                                                                                                        Additional materials and coating equipment sale
Licensing fees from IP consolidation
                                                                                                                                                                                                                                                                                           This work is licensed under the Creative Commons Attribution-Share Alike 3.0 Unported License.
                                                                                                                                                                                                                                                                                                         To view a copy of this license, visit http://creativecommons.org/licenses/by-sa/3.0/
                                                                                                                                                                                                                                                                                  or send a letter to Creative Commons, 171 Second Street, Suite 300, San Francisco, California, 94105, USA.
IP @ U. of Illinois              IP @ U. of Virginia
                                        IP


                       Composite Nanocoatings
        !                     product              product


                         Medical Device             Medical Coatings
                         Company                    Company

Health Insurance          product
Company

                              Hospital
             $
                           services



                         Medical Doctor
Composite Nanocoatings


 Customer Archetype

 Acutely aware of cost

 Ease of fabrication extremely important

 Want to use a cool tech to differentiate

 Need a reliable process

 Sensitive to FDA and regulation

 Happy with friction performance of PTFE

 Very focused on their particular device

 2 main hubs - Minneapolis and Bay Area
Lubricity - medical devices
                                                                                                                                                                                                                                                                                                                                                                                                    Day     Month   Ye




                                                                                                                                                                                                                                                                                                                                                                                                          No.




Who are our Key Partners?                                           What Key Activities do our Value Propositions require?   What value do we deliver to the customer?                                                 What type of relationship does each of our Customer                                                        For whom are we creating value?

Surmodics                                                           Supplying know-how                                       A Composite              Collaborative
Who are our key suppliers?                                          Our Distribution Channels?                               Which one of our customer’s problems are we helping to solve?                             Segments expect us to establish and maintain with them?                                                    Who are our most important customers?
Which Key Resources are we acquiring from partners?                 Customer Relationships?                                  What bundles of products and services are we offering to each Customer Segment?           Which ones have we established?
Which Key Activities do partners perform?                           Revenue streams?                                         Which customer needs are we satisfying?                                                   How are they integrated with the rest of our business model?
                                                                                                                                                                                                                                                                                                                                  Medical catheter
                                                                    & other pre-license                                      Nanocoating is a cheaper relationship                                                     How costly are they?


                                                                                                                             and easier-to-use                                                                                                                                                                                    companies using
UVA Patent                                                          implementation help
                                                                                                                             alternative to Teflon                                                                                                                                                                                Teflon inner liners
Foundation                                                                                                                                            Possible training for
                                                                                                                             catheter liners
                                                                    Providing a simple                                                                                                                               coating application
UI Office of Tech.                                                   and efficient license
Management                                                                                                                                    “Teflon liners are 25% of our
                                                                                                                                              cost and are a pain to use”
                                                                                                                                                                                                                     How are AdvancedCath
                                                                                                                                                                                                                      - we reaching them to                                                                            Technologies
                                                                    What Key Resources do our Value Propositions require?                                                                                              Through which Channels do our Customer Segments
                                                                    Our Distribution Channels? Customer Relationships?
                                                                                                                                                                                                                     Licensenow? coating
                                                                                                                                                                                                                     want to be reached?
                                                                    Coating engineers
                                                                    Revenue Streams?
                                                                                                                                                                                                                     How are our Channels integrated?
                                                                                                                                                                                                                     companies and
                                                                                                                                                                                                                     Which ones work best?
                                                                                                                                                                                                                     Which ones are most cost-efficient?
                                                                                                                                                                                                                     How are we integrating them with customer routines?
                                                                                                                                                                                                                     device companies
                                                                    PI with university
                                                                                                                                                                                                                     directly
                                                                    tech transfer depts.

                                                                                                                                                                                                                     Direct sales: materials
                                                                    Biomed labs at
                                                                                                                                                                                                                     & equipment
                                                                    Surmodics



Most important current cost is time and salary                                                                                                                        Materials and coating equipment sales for immediate
What are the most important costs inherent in our business model?                                                                                                       For what value are our customers really willing to pay?
Which Key Resources are most expensive?                                                                                                                                For what do they currently pay?
Which Key Activities are most expensive?                                                                                                                               How are they currently paying?
                                                                                                                                                                       How would they prefer to pay?
                                                                                                                                                                      revenue during customers’ build-test stage
                                                                                                                                                                       How much does each Revenue Stream contribute to overall revenues?


R&D to obtain know-how
                                                                                                                                                                      A licensing model based on a combination of IP and
Licensing fees from IP consolidation                                                                                                                                  know-how for sustainable revenue

                                                                                                                                                                                                                                                                                               This work is licensed under the Creative Commons Attribution-Share Alike 3.0 Unported License.
                                                                                                                                                                                                                                                                                                             To view a copy of this license, visit http://creativecommons.org/licenses/by-sa/3.0/
                                                                                                                                                                                                                                                                                      or send a letter to Creative Commons, 171 Second Street, Suite 300, San Francisco, California, 94105, USA.
Composite Nanocoatings



              $21.2B Total Market
              Catheters (Global)




                          $9.6B Market
                          Cardiovascular Catheters (Global)




                                              $900M
                                        Addressable Market
                                         Cardiovascular catheter
                                               inner liners
Composite Nanocoatings   Push a rod through a catheter tube
                         Preliminary data showed equivalency to Teflon
                         Teflon = $12 vs. Coating $0.10
Exclusive Partnership
                Medical Devices                                          Wind Turbines

                      Corpus Medical                                         AREVA
Advanced Cath                           Stryker
                                                                   GE                    Vestas
Technologies                            Neurovascular



                                                             $
                     Surmodics                                               PPG

                                $
                                                                         $
                $
                                                Composite Nanocoatings
                                                                                     $
                                    $


                      Sherwin

                                                         $
                                         Crowley
Horizon Lines
                                         Maritime
                    Matson Navigation
                        Company



                Marine Vehicles
Expansion
                Medical Devices                                              Wind Turbines

                      Corpus Medical                                             AREVA
Advanced Cath                           Stryker
                                                                     GE                        Vestas
Technologies                            Neurovascular



                                                             $
                     Surmodics                                                   PPG

                                 $                                           $
                $
                                                Composite Nanocoatings
                                                                                         $
                                   $


                      Sherwin
                                                                 Growing Customers
                                                         $       leverage existing expertise & channels
                                         Crowley
Horizon Lines
                    Matson Navigation    Maritime                attack other markets as technology matures
                        Company                                  focused customer portfolios

                Marine Vehicles
Backup
Composite Nanocoatings   Push a rod through a catheter tube
                         Show that coating has similar performance
                         Show how much cheaper and easier it is




Demo
Composite Nanocoatings




Anti-icing coatings on airplane wings &
engine inlets



                                          $50K from Rolls Royce
Composite Nanocoatings



Competition...or potential partners


    * by far the biggest

    Seem unaware of price
    and ease of use issue
                                                   Etch only and do not sell
                                                   the liners themselves




                     Need prototype to gauge
                     the potential of partnering
Lubricity - medical devices
                                                                                                                                                                                                                                                                                                                                                                                                 Day     Mont




                                                                                                                                                                                                                                                                                                                                                                                                       No.



                                                                                                                                                                                                                       Need to focus due



                                                                                                                                                                                                                                                                                                                                          ✘
                                                                                                                                                                                                                       to varying needs
Who are our Key Partners?                                             Consolidate univ. IP &
                                                                     What Key Activities do our Value Propositions require?   What value do we deliver to the customer?                                             What type of relationship does each of our Customer
                                                                                                                                                                                                                                                                                                                           Medicalvalue?
                                                                                                                                                                                                                                                                                                                            Who are our most important catheter
                                                                                                                                                                                                                                                                                                                            For whom are we creating

Surmodics
Who are our key suppliers?                                           Our Distribution Channels?
                                                                                                                              Teflon liners are
                                                                                                                              Which one of our customer’s problems are we helping to solve?
                                                                                                                                                                                                                    Collaborative
                                                                                                                                                                                                                    Segments expect us to establish and maintain with them?                                                                            customers?

                                                                      determine strength -
Which Key Resources are we acquiring from partners?                  Customer Relationships?                                  What bundles of products and services are we offering to each Customer Segment?       Which ones have we established?
Which Key Activities do partners perform?                            Revenue streams?                                         Which customer needs are we satisfying?
                                                                                                                              expensive and
                                                                                                                                                                                                                    How are they integrated with the rest of our business model?
                                                                                                                                                                                                                                                                                                                           companies
                                                                                                                                                                                                                    relationship
                                                                                                                                                                                                                    How costly are they?

                                                                      no license deal                                         monopolized. We have a
UVA Medical Center
                                                                      possible without                                        better alternative:                                                                                                                                                                          Endoscopic
                                                                                                                                                                                                                    Possible training for
                                                                      crystal clear IP                                        inexpensive, easier-to-                                                                                                                                                                      catheter
UVA Patent                                                                                                                                                                                                          coating application
                                                                                                                              use, same-or-better                                                                                                                                                                          companies
Foundation
                                                                      Solidify know-how of                                    performance
                                                                      applying coating                                                                                                                                                                                                                                     Pacemaker-lead
                                                                                                                              Endoscopic catheters                                                                                                                                                                         catheter
                                                                                                                              cause pain for patients
                                                                                                                                                                                                                                                                                                                           companies
                                                                     What Key Resources do our Value Propositions require?    and require an extra                                                                  Through which Channels do our Customer Segments

                                                                     Coating engineers
                                                                     Our Distribution Channels? Customer Relationships?
                                                                     Revenue Streams?
                                                                                                                              doctor to lubricate; we                                                               Conferences and
                                                                                                                                                                                                                    want to be reached?
                                                                                                                                                                                                                    How are we reaching them now?
                                                                                                                                                                                                                    How are our Channels integrated?

                                                                                                                                                                                                                    expos
                                                                                                                                                                                                                    Which ones work best?
                                                                                                                                                                                                                                                                                                                           Non-stick
                                                                                                                              can simplify the                                                                      Which ones are most cost-efficient?
                                                                                                                                                                                                                    How are we integrating them with customer routines?

                                                                     PI with university                                       procedure.                                                                                                                                                                                   cookware
                                                                                                                                                                                                                                                                                                                           companies




                                                                                                                                 ✘
                                                                     tech transfer depts.                                                                                                                           Professional
                                                                                                                              No license deal possible                                                              network
                                                                                                                              without crystal clean IP...                                                                                                                                                                  Medical stent &
                                                                    Not a value prop                                          Composite Nanocoatings                                                                                                                                                                       laparoscopic
                                                                                                                              will provide licensable IP                                                                                                                                                                   device companies


What are the most important costs inherent in our business model?                                                                                                        For what value are our customers really willing to pay?

Most important current cost is time and salary
Which Key Resources are most expensive?
Which Key Activities are most expensive?                                                                                                                                 A licensing model based on a combination of IP and
                                                                                                                                                                         For what do they currently pay?
                                                                                                                                                                         How are they currently paying?
                                                                                                                                                                         How would they prefer to pay?

                                                                                                                                                                         know-how
                                                                                                                                                                         How much does each Revenue Stream contribute to overall revenues?



R&D to obtain know-how
                                                                                                                                                                         Additional materials and coating equipment sale
Licensing fees from IP consolidation
                                                                                                                                                                                                                                                                                            This work is licensed under the Creative Commons Attribution-Share Alike 3.0 Unported License.
                                                                                                                                                                                                                                                                                                          To view a copy of this license, visit http://creativecommons.org/licenses/by-sa/3.0/
                                                                                                                                                                                                                                                                                   or send a letter to Creative Commons, 171 Second Street, Suite 300, San Francisco, California, 94105, USA.
Lubricity - medical devices
                                                                                                                                                                                                                                                                                                                                                                                                 Day     Mont




                                                                                                                                                                                                                                                                                                                                                                                                       No.




Who are our Key Partners?                                           Consolidate univ. IP &
                                                                    What Key Activities do our Value Propositions require?    What value do we deliver to the customer?                                             What type of relationship does each of our Customer
                                                                                                                                                                                                                                                                                                                           Endoscopic
                                                                                                                                                                                                                                                                                                                            For whom are we creating value?




                                                                                                                              ✘
Surmodics
Who are our key suppliers?                                          Our Distribution Channels?
                                                                                                                             Teflon liners are
                                                                                                                              Which one of our customer’s problems are we helping to solve?
                                                                                                                                                                                                                    Collaborative
                                                                                                                                                                                                                    Segments expect us to establish and maintain with them?                                                 Who are our most important customers?

                                                                    determine strength -
Which Key Resources are we acquiring from partners?                 Customer Relationships?                                   What bundles of products and services are we offering to each Customer Segment?       Which ones have we established?
Which Key Activities do partners perform?                           Revenue streams?                                          Which customer needs are we satisfying?
                                                                                                                             expensive and
                                                                                                                                                                                                                    How are they integrated with the rest of our business model?
                                                                                                                                                                                                                                                                                                                           catheter
                                                                                                                                                                                                                    relationship
                                                                                                                                                                                                                    How costly are they?

                                                                    no license deal                                          monopolized. We have a                                                                                                                                                                        companies
UVA Medical Center
                                                                    possible without                                         better alternative:                                                                    Possible training for
                                                                    crystal clear IP                                         inexpensive, easier-to-                                                                                                                                                                       Pacemaker-lead
UVA Patent                                                                                                                                                                                                          coating application
                                                                                                                             use, same-or-better                                                                                                                                                                           catheter
Foundation
                                                                    Solidify know-how of                                     performance                                                                                                                                                                                   companies
                                                                    applying coating




                                                                                                                              ✘ ✘
                                                                                                                             Endoscopic catheters
                                                                                                                             cause pain for patients
                                                                    What Key Resources do our Value Propositions require?    and require an extra                                                                   Through which Channels do our Customer Segments

                                                                    Coating engineers
                                                                    Our Distribution Channels? Customer Relationships?
                                                                    Revenue Streams?
                                                                                                                             doctor to lubricate; we                                                               Conferences and
                                                                                                                                                                                                                    want to be reached?
                                                                                                                                                                                                                    How are we reaching them now?
                                                                                                                                                                                                                    How are our Channels integrated?

                                                                                                                                                                                                                   Expos
                                                                                                                                                                                                                    Which ones work best?

                                                                                                                             can simplify the                                                                       Which ones are most cost-efficient?
                                                                                                                                                                                                                    How are we integrating them with customer routines?

                                                                    PI with university                                       procedure.
                                                                    tech transfer depts.                                                                                                                           Professional
                                                                                                                                                                                                                   network                                                Not channels
                                                                                                                             Not value props



What are the most important costs inherent in our business model?

Most important current cost is time and salary
Which Key Resources are most expensive?
Which Key Activities are most expensive?




                                                                                                                                ✘                                        For what value are our customers really willing to pay?

                                                                                                                                                                         A licensing model based on a combination of IP and
                                                                                                                                                                         For what do they currently pay?
                                                                                                                                                                         How are they currently paying?




                                                                                                                                                                                                                                                                             ✘
                                                                                                                                                                         How would they prefer to pay?

                                                                                                                                                                         know-how
                                                                                                                                                                         How much does each Revenue Stream contribute to overall revenues?



R&D to obtain know-how
                                                                                                                                                                         Additional materials and coating equipment sale
Licensing fees from IP consolidation
                                                                                                                                                                                                                                                                                            This work is licensed under the Creative Commons Attribution-Share Alike 3.0 Unported License.
                                                                                                                                                                                                                                                                                                          To view a copy of this license, visit http://creativecommons.org/licenses/by-sa/3.0/
                                                                                                                                                                                                                                                                                   or send a letter to Creative Commons, 171 Second Street, Suite 300, San Francisco, California, 94105, USA.
Lubricity - medical devices
                                                                                                                                                                                                                                                                                                                                                                                                Day     Mont




                                                                                                                                                                                                                                                                                                                                                                                                      No.




Surmodics



           ✘ ✘
Who are our Key Partners?
Who are our key suppliers?
Which Key Resources are we acquiring from partners?
Which Key Activities do partners perform?




UVA Medical Center
                                                                    Consolidate univ. IP &
                                                                    What Key Activities do our Value Propositions require?
                                                                    Our Distribution Channels?

                                                                    determine strength -
                                                                    Customer Relationships?
                                                                    Revenue streams?


                                                                    no license deal
                                                                    possible without
                                                                                                                             What value do we deliver to the customer?
                                                                                                                             A Composite
                                                                                                                             Which one of our customer’s problems are we helping to solve?
                                                                                                                             What bundles of products and services are we offering to each Customer Segment?
                                                                                                                             Which customer needs are we satisfying?
                                                                                                                             Nanocoating is a cheaper
                                                                                                                             and easier-to-use
                                                                                                                             alternative to Teflon
                                                                                                                                                                                                                   What type of relationship does each of our Customer

                                                                                                                                                                                                                   Collaborative
                                                                                                                                                                                                                   Segments expect us to establish and maintain with them?
                                                                                                                                                                                                                   Which ones have we established?
                                                                                                                                                                                                                   How are they integrated with the rest of our business model?

                                                                                                                                                                                                                   relationship
                                                                                                                                                                                                                   How costly are they?
                                                                                                                                                                                                                                                                                                                          Medicalvalue?
                                                                                                                                                                                                                                                                                                                           Who are our most important catheter
                                                                                                                                                                                                                                                                                                                           For whom are we creating



                                                                                                                                                                                                                                                                                                                          companies using
                                                                                                                                                                                                                                                                                                                          Teflon inner liners
                                                                                                                                                                                                                                                                                                                                                      customers?




             ✘
                                                                                                                                                                                                                   Possible training for
                                                                    crystal clear IP                                         catheter liners                                                                                                                                                                              Pacemaker-lead
UVA Patent                                                                                                                                                                                                         coating application
                                                                                                                                                                                                                                                                                                                          catheter
Foundation
                                                                    Build prototype!                                         A Composite Nanocoating                                                                                                                                                                      companies
                                                                                                                             can make implant lead
Should be long-                                                                                                              extraction much less                                                                                                                                                                         Medical implant
term activities                                                                                                              dangerous                                                                                                                                                                                    companies
                                                                    What Key Resources do our Value Propositions require?

                                                                    Coating engineers
                                                                    Our Distribution Channels? Customer Relationships?
                                                                    Revenue Streams?
                                                                                                                                                                                                                  Licensenow?Customer Segments
                                                                                                                                                                                                                  Through which Channels do our
                                                                                                                                                                                                                  want to be reached?
                                                                                                                                                                                                                  How are we reaching them
                                                                                                                                                                                                                                                to coating
                                                                                                                                                                                                                  companies and
                                                                                                                                                                                                                  How are our Channels integrated?
                                                                                                                                                                                                                  Which ones work best?
                                                                                                                                                                                                                  Which ones are most cost-efficient?

                                                                                                                                                                                                                  device companies
                                                                                                                                                                                                                  How are we integrating them with customer routines?

                                                                    PI with university
                                                                    tech transfer depts.                                                                                                                          directly

                                                                    Biomed labs at                                                                                                                                Direct sales: materials
                                                                    Surmodics                                                                                                                                     & equipment



What are the most important costs inherent in our business model?                                                                                                       For what value are our customers really willing to pay?

Most important current cost is time and salary
Which Key Resources are most expensive?
Which Key Activities are most expensive?                                                                                                                                Materials and coating equipment sales for immediate
                                                                                                                                                                        For what do they currently pay?
                                                                                                                                                                        How are they currently paying?
                                                                                                                                                                        How would they prefer to pay?

                                                                                                                                                                        revenue during build-test stage
                                                                                                                                                                        How much does each Revenue Stream contribute to overall revenues?



R&D to obtain know-how
                                                                                                                                                                        A licensing model based on a combination of IP and
Licensing fees from IP consolidation                                                                                                                                    know-how for sustainable revenue
                                                                                                                                                                                                                                                                                           This work is licensed under the Creative Commons Attribution-Share Alike 3.0 Unported License.
                                                                                                                                                                                                                                                                                                         To view a copy of this license, visit http://creativecommons.org/licenses/by-sa/3.0/
                                                                                                                                                                                                                                                                                  or send a letter to Creative Commons, 171 Second Street, Suite 300, San Francisco, California, 94105, USA.
Lubricity - medical devices
                                                                                                                                                                                                                                                                                                                                                                                                      Day     Month   Ye




                                                                                                                                                                                                                                                                                                                                                                                                            No.




Who are our Key Partners?                                           What Key Activities do our Value Propositions require?     What value do we deliver to the customer?                                                 What type of relationship does each of our Customer                                                        For whom are we creating value?

Surmodics                                                           Supplying know-how                                        A Composite              Collaborative
Who are our key suppliers?                                          Our Distribution Channels?                                 Which one of our customer’s problems are we helping to solve?                             Segments expect us to establish and maintain with them?                                                    Who are our most important customers?
Which Key Resources are we acquiring from partners?                 Customer Relationships?                                    What bundles of products and services are we offering to each Customer Segment?           Which ones have we established?
Which Key Activities do partners perform?                           Revenue streams?                                           Which customer needs are we satisfying?                                                   How are they integrated with the rest of our business model?
                                                                                                                                                                                                                                                                                                                                    Medical catheter
                                                                    & other pre-license                                       Nanocoating is a cheaper relationship                                                      How costly are they?


                                                                                                                              and easier-to-use                                                                                                                                                                                     companies using
UVA Patent                                                          implementation help




                                                                                                                                                                                                                                                                                                                                         ✘
                                                                                                                              alternative to Teflon                                                                                                                                                                                 Teflon inner liners
Foundation                                                                                                                                             Possible training for
                                                                                                                              catheter liners
                                                                    Providing a simple                                                                                                                                 coating application




                                                                                                                                       ✘
                                                                                                                                                                                                                                                                                                                                    Active medical
UI Office of Tech.                                                   and efficient license                                                                                                                                                                                                                                            implant companies
                                                                                                                              A Composite Nanocoating
Management




                                                                                                                                                                                                                                                                                                                                         ✘
                                                                                                                              can make implant lead
                                                                                                                              extraction much less                                                                                                                                                                                  Pacemaker-lead
                                                                                                                              dangerous                                                                                                                                                                                             catheter
                                                                    What Key Resources do our Value Propositions require?
                                                                    Our Distribution Channels? Customer Relationships?
                                                                                                                                                                                                                         Through which Channels do our Customer Segments
                                                                                                                                                                                                                       Licensenow? coating
                                                                                                                                                                                                                       How are we reaching them to
                                                                                                                                                                                                                       want to be reached?                                                                                          companies
                                                                    Coating engineers
                                                                    Revenue Streams?

                                                                                                                             This is a big                                                                             How are our Channels integrated?
                                                                                                                                                                                                                       companies and
                                                                                                                                                                                                                       Which ones work best?
                                                                                                                                                                                                                       Which ones are most cost-efficient?
                                                                                                                                                                                                                       How are we integrating them with customer routines?


                                                                    PI with university                                       problem but tech                                                                          device companies
                                                                                                                                                                                                                       directly
                                                                    tech transfer depts.                                     years away
                                                                                                                                                                                                                       Direct sales: materials
                                                                    Biomed labs at
                                                                                                                                                                                                                       & equipment
                                                                    Surmodics



Most important current cost is time and salary                                                                                                                          Materials and coating equipment sales for immediate
What are the most important costs inherent in our business model?                                                                                                         For what value are our customers really willing to pay?
Which Key Resources are most expensive?                                                                                                                                  For what do they currently pay?
Which Key Activities are most expensive?                                                                                                                                 How are they currently paying?
                                                                                                                                                                         How would they prefer to pay?
                                                                                                                                                                        revenue during customers’ build-test stage
                                                                                                                                                                         How much does each Revenue Stream contribute to overall revenues?


R&D to obtain know-how
                                                                                                                                                                        A licensing model based on a combination of IP and
Licensing fees from IP consolidation                                                                                                                                    know-how for sustainable revenue

                                                                                                                                                                                                                                                                                                 This work is licensed under the Creative Commons Attribution-Share Alike 3.0 Unported License.
                                                                                                                                                                                                                                                                                                               To view a copy of this license, visit http://creativecommons.org/licenses/by-sa/3.0/
                                                                                                                                                                                                                                                                                        or send a letter to Creative Commons, 171 Second Street, Suite 300, San Francisco, California, 94105, USA.
Lubricity - medical devices
                                                                                                                                                                                                                                                                                                                                                                                                 Day     Mont




                                                                                                                                                                                                                                                                                                                                                                                                       No.




Who are our Key Partners?                                           Consolidate univ. IP &
                                                                    What Key Activities do our Value Propositions require?    What value do we deliver to the customer?                                             What type of relationship does each of our Customer
                                                                                                                                                                                                                                                                                                                           Medicalvalue?
                                                                                                                                                                                                                                                                                                                            Who are our most important catheter
                                                                                                                                                                                                                                                                                                                            For whom are we creating

Surmodics
Who are our key suppliers?                                          Our Distribution Channels?
                                                                                                                             A Composite
                                                                                                                              Which one of our customer’s problems are we helping to solve?
                                                                                                                                                                                                                    Collaborative
                                                                                                                                                                                                                    Segments expect us to establish and maintain with them?                                                                            customers?

                                                                    determine strength -
Which Key Resources are we acquiring from partners?                 Customer Relationships?                                   What bundles of products and services are we offering to each Customer Segment?       Which ones have we established?
Which Key Activities do partners perform?                           Revenue streams?                                          Which customer needs are we satisfying?
                                                                                                                             Nanocoating is a cheaper
                                                                                                                                                                                                                    How are they integrated with the rest of our business model?
                                                                                                                                                                                                                                                                                                                           companies using
                                                                                                                                                                                                                    relationship
                                                                                                                                                                                                                    How costly are they?

                                                                    no license deal                                          and easier-to-use                                                                                                                                                                             Teflon inner liners
UVA Medical Center




                                                                                                                                                                                                                                                                                                                                   ✘
                                                                    possible without                                         alternative to Teflon                                                                  Possible training for
                                                                    crystal clear IP                                         catheter liners                                                                                                                                                                               GI endoscopic
UVA Patent                                                                                                                                                                                                          coating application
                                                                                                                                                                                                                                                                                                                           catheter
Foundation




                                                                                                                                   ✘
                                                                    Solidify know-how of                                     A Composite          Learned not a big                                                                                                                                                        companies
                                                                    applying coating                                         Nanocoating reduces
                                                                                                                             cost and improves
                                                                                                                                                  enough problem
                                                                                                                                                                                                                                                                                                                           Pacemaker-lead
                                                                                                                             patient comfort in GI
                                                                                                                                                                                                                                                                                                                           catheter
                                                                    What Key Resources do our Value Propositions require?    endoscopic procedures     Licensenow?Customer Segments
                                                                                                                                                       Through which Channels do our
                                                                                                                                                                                    to coating
                                                                    Coating engineers
                                                                    Our Distribution Channels? Customer Relationships?                                 want to be reached?
                                                                                                                                                                                                                                                                                                                           companies
                                                                                                                             using catheters
                                                                    Revenue Streams?                                                                   How are we reaching them

                                                                                                                                                       companies and
                                                                                                                                                       How are our Channels integrated?
                                                                                                                                                       Which ones work best?
                                                                                                                                                                                                                    Which ones are most cost-efficient?

                                                                                                                                                                                                                   device companies
                                                                                                                                                                                                                    How are we integrating them with customer routines?

                                                                    PI with university                                       A Composite                                                                                                                                                                                   Implant
                                                                    tech transfer depts.                                                                                                                           directly                                                                                                companies lead
                                                                                                                             Nanocoating can make
                                                                                                                             implant lead extraction                                                                                                                                                                       extraction
                                                                                                                             much less dangerous                                                                   Direct sales: materials
                                                                                                                                                                                                                   & equipment



What are the most important costs inherent in our business model?                                                                                                        For what value are our customers really willing to pay?

Most important current cost is time and salary
Which Key Resources are most expensive?
Which Key Activities are most expensive?                                                                                                                                 Materials and coating equipment sales for immediate
                                                                                                                                                                         For what do they currently pay?
                                                                                                                                                                         How are they currently paying?
                                                                                                                                                                         How would they prefer to pay?

                                                                                                                                                                         revenue during build-test stage
                                                                                                                                                                         How much does each Revenue Stream contribute to overall revenues?



R&D to obtain know-how
                                                                                                                                                                         A licensing model based on a combination of IP and
Licensing fees from IP consolidation                                                                                                                                     know-how for sustainable revenue
                                                                                                                                                                                                                                                                                            This work is licensed under the Creative Commons Attribution-Share Alike 3.0 Unported License.
                                                                                                                                                                                                                                                                                                          To view a copy of this license, visit http://creativecommons.org/licenses/by-sa/3.0/
                                                                                                                                                                                                                                                                                   or send a letter to Creative Commons, 171 Second Street, Suite 300, San Francisco, California, 94105, USA.
Lubricity - medical devices
                                                                                                                                                                                                                                                                                                                                                                                                Day     Mont




                                                                                                                                                                                                                                                                                                                                                                                                      No.




                                                                                                                                             ✘
Who are our Key Partners?                                           What Key Activities do our Value Propositions require?   What value do we deliver to the customer?                                             What type of relationship does each of our Customer                                                        For whom are we creating value?

Surmodics
Who are our key suppliers?
Which Key Resources are we acquiring from partners?
Which Key Activities do partners perform?
                                                                    Consolidate the
                                                                    Our Distribution Channels?
                                                                    Customer Relationships?
                                                                    Revenue streams?
                                                                                                                             Added dry lubricity to
                                                                                                                             Which one of our customer’s problems are we helping to solve?
                                                                                                                             What bundles of products and services are we offering to each Customer Segment?
                                                                                                                             Which customer needs are we satisfying?
                                                                                                                                                                                                                   Collaborative
                                                                                                                                                                                                                   Segments expect us to establish and maintain with them?
                                                                                                                                                                                                                   Which ones have we established?
                                                                                                                                                                                                                   How are they integrated with the rest of our business model?
                                                                                                                                                                                                                                                                                                                          Medical catheter
                                                                                                                                                                                                                                                                                                                              Who are our most important customers?



                                                                    university IP and                                        inner lumen of                                                                        relationship                                                                                           companies
                                                                                                                                                                                                                   How costly are they?



UVA Medical Center                                                  determine strength                                       catheters for easy
                                                                                                                             device deployment                                                                     Possible training for                                                                                  Medical stent




                                                                                                                                             ✘
UVA Patent                                                          Solidify know-how                                                                                                                              coating application                                                                                    companies
Foundation                                                          of applying coating                                      Added wet lubricity to
                                                                                                                             outer surface of
                                                                                                                                                   Learned we don’t                                                                                                                                                       Laparoscopic
                                                                                                                             catheters for smooth need super                                                                                                                                                              device
                                                                                                                             introduction          performance                                                                                                                                                            companies




                                                                                                                                             ✘
                                                                    What Key Resources do our Value Propositions require?                                                                                          Through which Channels do our Customer Segments

                                                                    Coating engineers
                                                                    Our Distribution Channels? Customer Relationships?
                                                                    Revenue Streams?
                                                                                                                             Improved                                                                              Conferences and
                                                                                                                                                                                                                   want to be reached?
                                                                                                                                                                                                                   How are we reaching them now?
                                                                                                                                                                                                                   How are our Channels integrated?

                                                                                                                                                                                                                   expos
                                                                                                                                                                                                                   Which ones work best?

                                                                                                                             hemocompatibility for
                                                                                                                                                                                                                   Which ones are most cost-efficient?
                                                                                                                                                                                                                   How are we integrating them with customer routines?

                                                                    PI with university                                       extended duration of




                                                                                                                                             ✘
                                                                    tech transfer depts.                                     devices                                                                               Professional
                                                                                                                                                                                                                   network
                                                                                                                             Simplified university
                                                                                                                             license


What are the most important costs inherent in our business model?                                                                                                       For what value are our customers really willing to pay?

Most important current cost is time and salary
Which Key Resources are most expensive?
Which Key Activities are most expensive?                                                                                                                                A licensing model based on a combination of IP and
                                                                                                                                                                        For what do they currently pay?
                                                                                                                                                                        How are they currently paying?
                                                                                                                                                                        How would they prefer to pay?

                                                                                                                                                                        know-how
                                                                                                                                                                        How much does each Revenue Stream contribute to overall revenues?



R&D to obtain know-how
                                                                                                                                                                        Additional materials and coating equipment sale
Licensing fees from IP consolidation
                                                                                                                                                                                                                                                                                           This work is licensed under the Creative Commons Attribution-Share Alike 3.0 Unported License.
                                                                                                                                                                                                                                                                                                         To view a copy of this license, visit http://creativecommons.org/licenses/by-sa/3.0/
                                                                                                                                                                                                                                                                                  or send a letter to Creative Commons, 171 Second Street, Suite 300, San Francisco, California, 94105, USA.
Composite Nanocoatings



Key Partners




We need expertise in      We need to license the IP      We need to license the
medical device coatings   with reasonable terms,         IP with reasonable terms,
and established           preferably with a tiered       preferably consolidating
channels                  structure                      IP into UVA

They need new revenue     They need to see the           They need new revenue
sources to grow           details of the business        sources to grow
                          model and plan in order to
The cost is an extra      determine specific terms        The cost is the royalty
middle-man taking a cut                                  rate (3-8%) and the time
                          The cost is the royalty rate   to inform them
                          (3-8%) and the time to
                          inform them
Composite Nanocoatings



Competition...or potential partners




We need established        We need established           We need established
channel to most medical    channel to some medical       channel to some medical
companies that need        companies that need teflon     companies that have
teflon liners               liners                        teflon liners etched

They need new revenue      They need new revenue         They need new revenue
sources to grow            sources to grow               sources to grow

The cost is the cut they   The cost is the cut they      The cost is the cut they
take to be the middle-     take to be the middle-man     take to be the middle-
man                                                      man
                           Need prototype to gauge
Seem unaware of price      the potential of partnering   Etch only and do not sell
and ease of use issue                                    the liners themselves
Composite Nanocoatings



 Hypothesis
 A Composite Nanocoating is a cheaper and easier-to-use alternative to Teflon
 catheter inner liners



 Experiment
 Catheter companies must consistently tell us that this is one of their top issues
 and they are eager to use an alternative right away



 Results
 Four companies have identified this as a major issue, and two described it as nice-
 to-have.




 Iterate
 Complete new coating formulation to replace Teflon liners
Non-Exclusive


                 Composite Nanocoatings
                                                                         $
           $                         $                          $
Advanced Cath                                            Stryker
                           Corpus Medical
Technologies                                             Neurovascular


        Advantages
        no middle-man to take an extra cut
        closer relationship to end customer


        Disadvantages
        can’t leverage established channels
        loss of existing expertise from an established coating company
        more relationships to maintain
Composite Nanocoatings




 Customer acquisition cost
 10 feasibility studies per 1 license

 $10K per feasibility study

 $100K cost per customer




 Customer lifetime value
 $1M per year per customer
Composite Nanocoatings



 Most important metric
 for business model is the cost to produce alternative coating




 Pricing tests
 Catheter companies currently pay $8-12 per device for PTFE liners and will buy an
 alternative coating if cheaper




 Pricing tactics
 If coating is easier to use, maybe we can charge more?




 Iterate
 Develop prototype
Composite Nanocoatings


 Hypothesis
 Need to supply equipment, materials, and know-how + training in addition to
 licensing



 Experiment
 Coating and surface modification company interviews



 Results
 Both Hoowaki Inc and Surmodics Inc. have described that this is a critical part of a
 licensing model because the licensees do not have the know-how or desire to
 implement the tech from scratch




 Iterate
 No
Composite Nanocoatings




 Hypothesis
 Medical device coatings may take too long to deploy and earn revenue, which
 could make it extremely difficult to start a new business


 Experiment
 Talk to medical coating and device companies and understand the ecosystem and
 the different options


 Results
 Discovered that the time to revenue varies widely depending on the medical device
 and the country




 Iterate
 Once market niche selected, must select the appropriate options from the following
 diagram
Composite Nanocoatings



                         Class I - common low risk devices, e.g. bandages, gloves, surgical instruments
Determine device         Class II - higher risk devices, e.g. wheelchairs, infusion pumps, surgical drapes
class                    Class III - highest risk devices, e.g. implants, pulse generators, HIV diagnostics




                         Class I - most exempt from pre-market submission
Classification selects    Class II - special controls, pre-market notification (510k)
marketing process        Class III - comprehensive data needed, pre-market application (PMA)




                         Seek approval in the U.S. first - long FDA approval
Select regulatory        Seek approval overseas first - fast CE Mark in E.U.
strategy                 Start approval process in the U.S. and overseas in tandem - most resources




Develop data for             Materials and equipment sales
required applications        for build-test stage
PTFE Extrusion
                       Supplier

                            $
                       Medical Catheter
                       Company

                            $
Payment flows diagram      Hospital

                            $
                       Health Insurance
                       Company

                            $
                           Patients
PTFE Extrusion
  Composite Nanocoatings   Supplier

                                $
                           Medical Catheter
                           Company

                                $
Payment flows diagram          Hospital

                                $
                           Health Insurance
                           Company

                                $
                               Patients
Composite Nanocoatings                                         SAM
                                                               Medical Device Coatings - $5B




               Total Market
               Coatings (Global) - $87B




                              Addressable Market
                              Dry+Wet Lubricious Medical Device Coatings - $170M

                              (Based on a multiple of Surmodics’ current estimated market share)
Composite Nanocoatings


 Teflon liners

Composite Nanocoatings NSF FInal Presentation

  • 1.
    Composite Nanocoatings Eric Loth Principal Investigator Team 21 http://youtu.be/sk45p1mpWe8 http://vimeo.com/6552419 Adam Steele Entrepreneurial Lead Bob Hergenrother I-Corps Mentor Ultra-low friction nanocomposite coatings that are durable and low-cost Joram Slager # of customer meetings Mentor & Coating Expert during I-Corps 106
  • 3.
    Composite Nanocoatings Example -anti-wetting nanocomposite coating http://tmblr.co/Z0i3WyB7sDP
  • 4.
    Day Month Ye No. Who are our Key Partners? What Key Activities do our Value Propositions require? What value do we deliver to the customer? What type of relationship does each of our Customer For whom are we creating value? Surmodics Supplying know-how Reduce icing on aircraft Collaborative Who are our key suppliers? Our Distribution Channels? Which one of our customer’s problems are we helping to solve? Segments expect us to establish and maintain with them? Who are our most important customers? Which Key Resources are we acquiring from partners? Customer Relationships? What bundles of products and services are we offering to each Customer Segment? Which ones have we established? Which Key Activities do partners perform? Revenue streams? Which customer needs are we satisfying? How are they integrated with the rest of our business model? Medical catheter & other pre-license and wind turbines relationship How costly are they? companies using UVA Patent implementation help Reduce drag in fluid Teflon inner liners Foundation Possible training for lines Providing a simple coating application Ship buildings UI Office of Tech. and efficient license Reduce insect fouling on Management airplane wings Aircraft Reduce drag on marine companies What Key Resources do our Value Propositions require? vehicles Through which Channels do our Customer Segments Our Distribution Channels? Customer Relationships? Licensenow? coating How are we reaching them to want to be reached? Coating engineers Revenue Streams? How are our Channels integrated? Reduce ear wax fouling companies and Which ones work best? Which ones are most cost-efficient? on hearing aids How are we integrating them with customer routines? device companies PI with university directly tech transfer depts. Preventing liquid films on heat xfer elements Direct sales: materials Biomed labs at … & equipment Surmodics Most important current cost is time and salary Materials and coating equipment sales for immediate What are the most important costs inherent in our business model? For what value are our customers really willing to pay? Which Key Resources are most expensive? For what do they currently pay? Which Key Activities are most expensive? How are they currently paying? How would they prefer to pay? revenue during customers’ build-test stage How much does each Revenue Stream contribute to overall revenues? R&D to obtain know-how A licensing model based on a combination of IP and Licensing fees from IP consolidation know-how for sustainable revenue This work is licensed under the Creative Commons Attribution-Share Alike 3.0 Unported License. To view a copy of this license, visit http://creativecommons.org/licenses/by-sa/3.0/ or send a letter to Creative Commons, 171 Second Street, Suite 300, San Francisco, California, 94105, USA.
  • 5.
    Composite Nanocoatings Anti-fouling & anti-icing coatings on off- shore wind turbine blades $300K from AREVA
  • 6.
    Composite Nanocoatings Lubricious coatings on medical catheters for easy device deployment
  • 7.
    Composite Nanocoatings Customer Discovery Maturity Rolls Royce :: icing on aircraft inlets 3-4 yrs away Anti-icing high speed impact AREVA :: icing wind turbine blades Gates :: fluid power lines 4-6 yrs away Less ΔP high pressure Nitta :: fluid transfer tubes Boeing :: insect fouling 3-5 yrs away Anti-fouling Navy :: salt water bio-fouling high variability Starkey :: hearing aid wax buildup Lightsail :: preventing liquid films 2-3 yrs away Anti-wetting longevity SIPS :: moisture on structural panels West Pharm :: lubricious syringes < 1 yr away Lubricity bio-compatibility Surmodics :: lubricious med. devices
  • 8.
    Composite Nanocoatings No major fundamental Customer Focus breakthroughs needed Maturity Rolls Royce :: icing on aircraft inlets 3-4 yrs away Anti-icing high speed impact AREVA :: icing wind turbine blades Gates :: fluid power lines 4-6 yrs away Less ΔP high pressure Nitta :: fluid transfer tubes Boeing :: insect fouling 3-5 yrs away Anti-fouling Navy :: salt water bio-fouling high variability Starkey :: hearing aid wax buildup Lightsail :: preventing liquid films 2-3 yrs away Anti-wetting longevity SIPS :: moisture on structural panels West Pharm :: lubricious syringes < 1 yr away Lubricity bio-compatibility Surmodics :: lubricious med. devices
  • 9.
    Lubricity - medicaldevices Day Mont No. Who are our Key Partners? What Key Activities do our Value Propositions require? What value do we deliver to the customer? What type of relationship does each of our Customer For whom are we creating value? Surmodics Who are our key suppliers? Which Key Resources are we acquiring from partners? Which Key Activities do partners perform? Consolidate the Our Distribution Channels? Customer Relationships? Revenue streams? Added dry lubricity to Which one of our customer’s problems are we helping to solve? What bundles of products and services are we offering to each Customer Segment? Which customer needs are we satisfying? Collaborative Segments expect us to establish and maintain with them? Which ones have we established? How are they integrated with the rest of our business model? Medical catheter Who are our most important customers? university IP and inner lumen of relationship companies How costly are they? UVA Medical Center determine strength catheters for easy device deployment Possible training for Medical stent UVA Patent Solidify know-how coating application companies Foundation of applying coating Added wet lubricity to outer surface of Guessed at the Laparoscopic catheters for smooth value props device introduction companies What Key Resources do our Value Propositions require? Through which Channels do our Customer Segments Coating engineers Our Distribution Channels? Customer Relationships? Revenue Streams? Improved Conferences and want to be reached? How are we reaching them now? How are our Channels integrated? Satellite expos Which ones work best? hemocompatibility for Which ones are most cost-efficient? How are we integrating them with customer routines? companies PI with university extended duration of tech transfer depts. devices Professional Artistic effects network Simplified university Exterior paint license companies What are the most important costs inherent in our business model? For what value are our customers really willing to pay? Most important current cost is time and salary Which Key Resources are most expensive? Which Key Activities are most expensive? A licensing model based on a combination of IP and For what do they currently pay? How are they currently paying? How would they prefer to pay? know-how How much does each Revenue Stream contribute to overall revenues? R&D to obtain know-how Additional materials and coating equipment sale Licensing fees from IP consolidation This work is licensed under the Creative Commons Attribution-Share Alike 3.0 Unported License. To view a copy of this license, visit http://creativecommons.org/licenses/by-sa/3.0/ or send a letter to Creative Commons, 171 Second Street, Suite 300, San Francisco, California, 94105, USA.
  • 10.
    IP @ U.of Illinois IP @ U. of Virginia IP Composite Nanocoatings ! product product Medical Device Medical Coatings Company Company Health Insurance product Company Hospital $ services Medical Doctor
  • 11.
    Composite Nanocoatings CustomerArchetype Acutely aware of cost Ease of fabrication extremely important Want to use a cool tech to differentiate Need a reliable process Sensitive to FDA and regulation Happy with friction performance of PTFE Very focused on their particular device 2 main hubs - Minneapolis and Bay Area
  • 12.
    Lubricity - medicaldevices Day Month Ye No. Who are our Key Partners? What Key Activities do our Value Propositions require? What value do we deliver to the customer? What type of relationship does each of our Customer For whom are we creating value? Surmodics Supplying know-how A Composite Collaborative Who are our key suppliers? Our Distribution Channels? Which one of our customer’s problems are we helping to solve? Segments expect us to establish and maintain with them? Who are our most important customers? Which Key Resources are we acquiring from partners? Customer Relationships? What bundles of products and services are we offering to each Customer Segment? Which ones have we established? Which Key Activities do partners perform? Revenue streams? Which customer needs are we satisfying? How are they integrated with the rest of our business model? Medical catheter & other pre-license Nanocoating is a cheaper relationship How costly are they? and easier-to-use companies using UVA Patent implementation help alternative to Teflon Teflon inner liners Foundation Possible training for catheter liners Providing a simple coating application UI Office of Tech. and efficient license Management “Teflon liners are 25% of our cost and are a pain to use” How are AdvancedCath - we reaching them to Technologies What Key Resources do our Value Propositions require? Through which Channels do our Customer Segments Our Distribution Channels? Customer Relationships? Licensenow? coating want to be reached? Coating engineers Revenue Streams? How are our Channels integrated? companies and Which ones work best? Which ones are most cost-efficient? How are we integrating them with customer routines? device companies PI with university directly tech transfer depts. Direct sales: materials Biomed labs at & equipment Surmodics Most important current cost is time and salary Materials and coating equipment sales for immediate What are the most important costs inherent in our business model? For what value are our customers really willing to pay? Which Key Resources are most expensive? For what do they currently pay? Which Key Activities are most expensive? How are they currently paying? How would they prefer to pay? revenue during customers’ build-test stage How much does each Revenue Stream contribute to overall revenues? R&D to obtain know-how A licensing model based on a combination of IP and Licensing fees from IP consolidation know-how for sustainable revenue This work is licensed under the Creative Commons Attribution-Share Alike 3.0 Unported License. To view a copy of this license, visit http://creativecommons.org/licenses/by-sa/3.0/ or send a letter to Creative Commons, 171 Second Street, Suite 300, San Francisco, California, 94105, USA.
  • 13.
    Composite Nanocoatings $21.2B Total Market Catheters (Global) $9.6B Market Cardiovascular Catheters (Global) $900M Addressable Market Cardiovascular catheter inner liners
  • 14.
    Composite Nanocoatings Push a rod through a catheter tube Preliminary data showed equivalency to Teflon Teflon = $12 vs. Coating $0.10
  • 15.
    Exclusive Partnership Medical Devices Wind Turbines Corpus Medical AREVA Advanced Cath Stryker GE Vestas Technologies Neurovascular $ Surmodics PPG $ $ $ Composite Nanocoatings $ $ Sherwin $ Crowley Horizon Lines Maritime Matson Navigation Company Marine Vehicles
  • 16.
    Expansion Medical Devices Wind Turbines Corpus Medical AREVA Advanced Cath Stryker GE Vestas Technologies Neurovascular $ Surmodics PPG $ $ $ Composite Nanocoatings $ $ Sherwin Growing Customers $ leverage existing expertise & channels Crowley Horizon Lines Matson Navigation Maritime attack other markets as technology matures Company focused customer portfolios Marine Vehicles
  • 17.
  • 18.
    Composite Nanocoatings Push a rod through a catheter tube Show that coating has similar performance Show how much cheaper and easier it is Demo
  • 19.
    Composite Nanocoatings Anti-icing coatingson airplane wings & engine inlets $50K from Rolls Royce
  • 20.
    Composite Nanocoatings Competition...or potentialpartners * by far the biggest Seem unaware of price and ease of use issue Etch only and do not sell the liners themselves Need prototype to gauge the potential of partnering
  • 21.
    Lubricity - medicaldevices Day Mont No. Need to focus due ✘ to varying needs Who are our Key Partners? Consolidate univ. IP & What Key Activities do our Value Propositions require? What value do we deliver to the customer? What type of relationship does each of our Customer Medicalvalue? Who are our most important catheter For whom are we creating Surmodics Who are our key suppliers? Our Distribution Channels? Teflon liners are Which one of our customer’s problems are we helping to solve? Collaborative Segments expect us to establish and maintain with them? customers? determine strength - Which Key Resources are we acquiring from partners? Customer Relationships? What bundles of products and services are we offering to each Customer Segment? Which ones have we established? Which Key Activities do partners perform? Revenue streams? Which customer needs are we satisfying? expensive and How are they integrated with the rest of our business model? companies relationship How costly are they? no license deal monopolized. We have a UVA Medical Center possible without better alternative: Endoscopic Possible training for crystal clear IP inexpensive, easier-to- catheter UVA Patent coating application use, same-or-better companies Foundation Solidify know-how of performance applying coating Pacemaker-lead Endoscopic catheters catheter cause pain for patients companies What Key Resources do our Value Propositions require? and require an extra Through which Channels do our Customer Segments Coating engineers Our Distribution Channels? Customer Relationships? Revenue Streams? doctor to lubricate; we Conferences and want to be reached? How are we reaching them now? How are our Channels integrated? expos Which ones work best? Non-stick can simplify the Which ones are most cost-efficient? How are we integrating them with customer routines? PI with university procedure. cookware companies ✘ tech transfer depts. Professional No license deal possible network without crystal clean IP... Medical stent & Not a value prop Composite Nanocoatings laparoscopic will provide licensable IP device companies What are the most important costs inherent in our business model? For what value are our customers really willing to pay? Most important current cost is time and salary Which Key Resources are most expensive? Which Key Activities are most expensive? A licensing model based on a combination of IP and For what do they currently pay? How are they currently paying? How would they prefer to pay? know-how How much does each Revenue Stream contribute to overall revenues? R&D to obtain know-how Additional materials and coating equipment sale Licensing fees from IP consolidation This work is licensed under the Creative Commons Attribution-Share Alike 3.0 Unported License. To view a copy of this license, visit http://creativecommons.org/licenses/by-sa/3.0/ or send a letter to Creative Commons, 171 Second Street, Suite 300, San Francisco, California, 94105, USA.
  • 22.
    Lubricity - medicaldevices Day Mont No. Who are our Key Partners? Consolidate univ. IP & What Key Activities do our Value Propositions require? What value do we deliver to the customer? What type of relationship does each of our Customer Endoscopic For whom are we creating value? ✘ Surmodics Who are our key suppliers? Our Distribution Channels? Teflon liners are Which one of our customer’s problems are we helping to solve? Collaborative Segments expect us to establish and maintain with them? Who are our most important customers? determine strength - Which Key Resources are we acquiring from partners? Customer Relationships? What bundles of products and services are we offering to each Customer Segment? Which ones have we established? Which Key Activities do partners perform? Revenue streams? Which customer needs are we satisfying? expensive and How are they integrated with the rest of our business model? catheter relationship How costly are they? no license deal monopolized. We have a companies UVA Medical Center possible without better alternative: Possible training for crystal clear IP inexpensive, easier-to- Pacemaker-lead UVA Patent coating application use, same-or-better catheter Foundation Solidify know-how of performance companies applying coating ✘ ✘ Endoscopic catheters cause pain for patients What Key Resources do our Value Propositions require? and require an extra Through which Channels do our Customer Segments Coating engineers Our Distribution Channels? Customer Relationships? Revenue Streams? doctor to lubricate; we Conferences and want to be reached? How are we reaching them now? How are our Channels integrated? Expos Which ones work best? can simplify the Which ones are most cost-efficient? How are we integrating them with customer routines? PI with university procedure. tech transfer depts. Professional network Not channels Not value props What are the most important costs inherent in our business model? Most important current cost is time and salary Which Key Resources are most expensive? Which Key Activities are most expensive? ✘ For what value are our customers really willing to pay? A licensing model based on a combination of IP and For what do they currently pay? How are they currently paying? ✘ How would they prefer to pay? know-how How much does each Revenue Stream contribute to overall revenues? R&D to obtain know-how Additional materials and coating equipment sale Licensing fees from IP consolidation This work is licensed under the Creative Commons Attribution-Share Alike 3.0 Unported License. To view a copy of this license, visit http://creativecommons.org/licenses/by-sa/3.0/ or send a letter to Creative Commons, 171 Second Street, Suite 300, San Francisco, California, 94105, USA.
  • 23.
    Lubricity - medicaldevices Day Mont No. Surmodics ✘ ✘ Who are our Key Partners? Who are our key suppliers? Which Key Resources are we acquiring from partners? Which Key Activities do partners perform? UVA Medical Center Consolidate univ. IP & What Key Activities do our Value Propositions require? Our Distribution Channels? determine strength - Customer Relationships? Revenue streams? no license deal possible without What value do we deliver to the customer? A Composite Which one of our customer’s problems are we helping to solve? What bundles of products and services are we offering to each Customer Segment? Which customer needs are we satisfying? Nanocoating is a cheaper and easier-to-use alternative to Teflon What type of relationship does each of our Customer Collaborative Segments expect us to establish and maintain with them? Which ones have we established? How are they integrated with the rest of our business model? relationship How costly are they? Medicalvalue? Who are our most important catheter For whom are we creating companies using Teflon inner liners customers? ✘ Possible training for crystal clear IP catheter liners Pacemaker-lead UVA Patent coating application catheter Foundation Build prototype! A Composite Nanocoating companies can make implant lead Should be long- extraction much less Medical implant term activities dangerous companies What Key Resources do our Value Propositions require? Coating engineers Our Distribution Channels? Customer Relationships? Revenue Streams? Licensenow?Customer Segments Through which Channels do our want to be reached? How are we reaching them to coating companies and How are our Channels integrated? Which ones work best? Which ones are most cost-efficient? device companies How are we integrating them with customer routines? PI with university tech transfer depts. directly Biomed labs at Direct sales: materials Surmodics & equipment What are the most important costs inherent in our business model? For what value are our customers really willing to pay? Most important current cost is time and salary Which Key Resources are most expensive? Which Key Activities are most expensive? Materials and coating equipment sales for immediate For what do they currently pay? How are they currently paying? How would they prefer to pay? revenue during build-test stage How much does each Revenue Stream contribute to overall revenues? R&D to obtain know-how A licensing model based on a combination of IP and Licensing fees from IP consolidation know-how for sustainable revenue This work is licensed under the Creative Commons Attribution-Share Alike 3.0 Unported License. To view a copy of this license, visit http://creativecommons.org/licenses/by-sa/3.0/ or send a letter to Creative Commons, 171 Second Street, Suite 300, San Francisco, California, 94105, USA.
  • 24.
    Lubricity - medicaldevices Day Month Ye No. Who are our Key Partners? What Key Activities do our Value Propositions require? What value do we deliver to the customer? What type of relationship does each of our Customer For whom are we creating value? Surmodics Supplying know-how A Composite Collaborative Who are our key suppliers? Our Distribution Channels? Which one of our customer’s problems are we helping to solve? Segments expect us to establish and maintain with them? Who are our most important customers? Which Key Resources are we acquiring from partners? Customer Relationships? What bundles of products and services are we offering to each Customer Segment? Which ones have we established? Which Key Activities do partners perform? Revenue streams? Which customer needs are we satisfying? How are they integrated with the rest of our business model? Medical catheter & other pre-license Nanocoating is a cheaper relationship How costly are they? and easier-to-use companies using UVA Patent implementation help ✘ alternative to Teflon Teflon inner liners Foundation Possible training for catheter liners Providing a simple coating application ✘ Active medical UI Office of Tech. and efficient license implant companies A Composite Nanocoating Management ✘ can make implant lead extraction much less Pacemaker-lead dangerous catheter What Key Resources do our Value Propositions require? Our Distribution Channels? Customer Relationships? Through which Channels do our Customer Segments Licensenow? coating How are we reaching them to want to be reached? companies Coating engineers Revenue Streams? This is a big How are our Channels integrated? companies and Which ones work best? Which ones are most cost-efficient? How are we integrating them with customer routines? PI with university problem but tech device companies directly tech transfer depts. years away Direct sales: materials Biomed labs at & equipment Surmodics Most important current cost is time and salary Materials and coating equipment sales for immediate What are the most important costs inherent in our business model? For what value are our customers really willing to pay? Which Key Resources are most expensive? For what do they currently pay? Which Key Activities are most expensive? How are they currently paying? How would they prefer to pay? revenue during customers’ build-test stage How much does each Revenue Stream contribute to overall revenues? R&D to obtain know-how A licensing model based on a combination of IP and Licensing fees from IP consolidation know-how for sustainable revenue This work is licensed under the Creative Commons Attribution-Share Alike 3.0 Unported License. To view a copy of this license, visit http://creativecommons.org/licenses/by-sa/3.0/ or send a letter to Creative Commons, 171 Second Street, Suite 300, San Francisco, California, 94105, USA.
  • 25.
    Lubricity - medicaldevices Day Mont No. Who are our Key Partners? Consolidate univ. IP & What Key Activities do our Value Propositions require? What value do we deliver to the customer? What type of relationship does each of our Customer Medicalvalue? Who are our most important catheter For whom are we creating Surmodics Who are our key suppliers? Our Distribution Channels? A Composite Which one of our customer’s problems are we helping to solve? Collaborative Segments expect us to establish and maintain with them? customers? determine strength - Which Key Resources are we acquiring from partners? Customer Relationships? What bundles of products and services are we offering to each Customer Segment? Which ones have we established? Which Key Activities do partners perform? Revenue streams? Which customer needs are we satisfying? Nanocoating is a cheaper How are they integrated with the rest of our business model? companies using relationship How costly are they? no license deal and easier-to-use Teflon inner liners UVA Medical Center ✘ possible without alternative to Teflon Possible training for crystal clear IP catheter liners GI endoscopic UVA Patent coating application catheter Foundation ✘ Solidify know-how of A Composite Learned not a big companies applying coating Nanocoating reduces cost and improves enough problem Pacemaker-lead patient comfort in GI catheter What Key Resources do our Value Propositions require? endoscopic procedures Licensenow?Customer Segments Through which Channels do our to coating Coating engineers Our Distribution Channels? Customer Relationships? want to be reached? companies using catheters Revenue Streams? How are we reaching them companies and How are our Channels integrated? Which ones work best? Which ones are most cost-efficient? device companies How are we integrating them with customer routines? PI with university A Composite Implant tech transfer depts. directly companies lead Nanocoating can make implant lead extraction extraction much less dangerous Direct sales: materials & equipment What are the most important costs inherent in our business model? For what value are our customers really willing to pay? Most important current cost is time and salary Which Key Resources are most expensive? Which Key Activities are most expensive? Materials and coating equipment sales for immediate For what do they currently pay? How are they currently paying? How would they prefer to pay? revenue during build-test stage How much does each Revenue Stream contribute to overall revenues? R&D to obtain know-how A licensing model based on a combination of IP and Licensing fees from IP consolidation know-how for sustainable revenue This work is licensed under the Creative Commons Attribution-Share Alike 3.0 Unported License. To view a copy of this license, visit http://creativecommons.org/licenses/by-sa/3.0/ or send a letter to Creative Commons, 171 Second Street, Suite 300, San Francisco, California, 94105, USA.
  • 26.
    Lubricity - medicaldevices Day Mont No. ✘ Who are our Key Partners? What Key Activities do our Value Propositions require? What value do we deliver to the customer? What type of relationship does each of our Customer For whom are we creating value? Surmodics Who are our key suppliers? Which Key Resources are we acquiring from partners? Which Key Activities do partners perform? Consolidate the Our Distribution Channels? Customer Relationships? Revenue streams? Added dry lubricity to Which one of our customer’s problems are we helping to solve? What bundles of products and services are we offering to each Customer Segment? Which customer needs are we satisfying? Collaborative Segments expect us to establish and maintain with them? Which ones have we established? How are they integrated with the rest of our business model? Medical catheter Who are our most important customers? university IP and inner lumen of relationship companies How costly are they? UVA Medical Center determine strength catheters for easy device deployment Possible training for Medical stent ✘ UVA Patent Solidify know-how coating application companies Foundation of applying coating Added wet lubricity to outer surface of Learned we don’t Laparoscopic catheters for smooth need super device introduction performance companies ✘ What Key Resources do our Value Propositions require? Through which Channels do our Customer Segments Coating engineers Our Distribution Channels? Customer Relationships? Revenue Streams? Improved Conferences and want to be reached? How are we reaching them now? How are our Channels integrated? expos Which ones work best? hemocompatibility for Which ones are most cost-efficient? How are we integrating them with customer routines? PI with university extended duration of ✘ tech transfer depts. devices Professional network Simplified university license What are the most important costs inherent in our business model? For what value are our customers really willing to pay? Most important current cost is time and salary Which Key Resources are most expensive? Which Key Activities are most expensive? A licensing model based on a combination of IP and For what do they currently pay? How are they currently paying? How would they prefer to pay? know-how How much does each Revenue Stream contribute to overall revenues? R&D to obtain know-how Additional materials and coating equipment sale Licensing fees from IP consolidation This work is licensed under the Creative Commons Attribution-Share Alike 3.0 Unported License. To view a copy of this license, visit http://creativecommons.org/licenses/by-sa/3.0/ or send a letter to Creative Commons, 171 Second Street, Suite 300, San Francisco, California, 94105, USA.
  • 27.
    Composite Nanocoatings Key Partners Weneed expertise in We need to license the IP We need to license the medical device coatings with reasonable terms, IP with reasonable terms, and established preferably with a tiered preferably consolidating channels structure IP into UVA They need new revenue They need to see the They need new revenue sources to grow details of the business sources to grow model and plan in order to The cost is an extra determine specific terms The cost is the royalty middle-man taking a cut rate (3-8%) and the time The cost is the royalty rate to inform them (3-8%) and the time to inform them
  • 28.
    Composite Nanocoatings Competition...or potentialpartners We need established We need established We need established channel to most medical channel to some medical channel to some medical companies that need companies that need teflon companies that have teflon liners liners teflon liners etched They need new revenue They need new revenue They need new revenue sources to grow sources to grow sources to grow The cost is the cut they The cost is the cut they The cost is the cut they take to be the middle- take to be the middle-man take to be the middle- man man Need prototype to gauge Seem unaware of price the potential of partnering Etch only and do not sell and ease of use issue the liners themselves
  • 29.
    Composite Nanocoatings Hypothesis A Composite Nanocoating is a cheaper and easier-to-use alternative to Teflon catheter inner liners Experiment Catheter companies must consistently tell us that this is one of their top issues and they are eager to use an alternative right away Results Four companies have identified this as a major issue, and two described it as nice- to-have. Iterate Complete new coating formulation to replace Teflon liners
  • 30.
    Non-Exclusive Composite Nanocoatings $ $ $ $ Advanced Cath Stryker Corpus Medical Technologies Neurovascular Advantages no middle-man to take an extra cut closer relationship to end customer Disadvantages can’t leverage established channels loss of existing expertise from an established coating company more relationships to maintain
  • 31.
    Composite Nanocoatings Customeracquisition cost 10 feasibility studies per 1 license $10K per feasibility study $100K cost per customer Customer lifetime value $1M per year per customer
  • 32.
    Composite Nanocoatings Mostimportant metric for business model is the cost to produce alternative coating Pricing tests Catheter companies currently pay $8-12 per device for PTFE liners and will buy an alternative coating if cheaper Pricing tactics If coating is easier to use, maybe we can charge more? Iterate Develop prototype
  • 33.
    Composite Nanocoatings Hypothesis Need to supply equipment, materials, and know-how + training in addition to licensing Experiment Coating and surface modification company interviews Results Both Hoowaki Inc and Surmodics Inc. have described that this is a critical part of a licensing model because the licensees do not have the know-how or desire to implement the tech from scratch Iterate No
  • 34.
    Composite Nanocoatings Hypothesis Medical device coatings may take too long to deploy and earn revenue, which could make it extremely difficult to start a new business Experiment Talk to medical coating and device companies and understand the ecosystem and the different options Results Discovered that the time to revenue varies widely depending on the medical device and the country Iterate Once market niche selected, must select the appropriate options from the following diagram
  • 35.
    Composite Nanocoatings Class I - common low risk devices, e.g. bandages, gloves, surgical instruments Determine device Class II - higher risk devices, e.g. wheelchairs, infusion pumps, surgical drapes class Class III - highest risk devices, e.g. implants, pulse generators, HIV diagnostics Class I - most exempt from pre-market submission Classification selects Class II - special controls, pre-market notification (510k) marketing process Class III - comprehensive data needed, pre-market application (PMA) Seek approval in the U.S. first - long FDA approval Select regulatory Seek approval overseas first - fast CE Mark in E.U. strategy Start approval process in the U.S. and overseas in tandem - most resources Develop data for Materials and equipment sales required applications for build-test stage
  • 36.
    PTFE Extrusion Supplier $ Medical Catheter Company $ Payment flows diagram Hospital $ Health Insurance Company $ Patients
  • 37.
    PTFE Extrusion Composite Nanocoatings Supplier $ Medical Catheter Company $ Payment flows diagram Hospital $ Health Insurance Company $ Patients
  • 38.
    Composite Nanocoatings SAM Medical Device Coatings - $5B Total Market Coatings (Global) - $87B Addressable Market Dry+Wet Lubricious Medical Device Coatings - $170M (Based on a multiple of Surmodics’ current estimated market share)
  • 39.