1. A division of
How Outsourcing ensures Medical Device Startups make the
Right Product in addition to making the Product Right
Advanced Medical Operations
3. 3
Advanced Medical
Operations
Business Plans often fall terribly short
• Reasons are numerous but
seldom have to do with product
execution
– Lack of “real world” experience
– Not focusing on must haves
versus nice to haves
– Falling into common pitfalls
particularly dealing with FDA
regulatory requirements
– Missing key technical hurdles
upfront that are expensive to
resolve later
• Outsourcing can provide an
insurance policy for early stage
business plans
Source: Gerry Langeler. OVP Venture Partners
4. 4
Advanced Medical
Operations
Utilizing Outsourcing to enhance business
plan development
• Outsourcing companies have traditionally only become involved
after a business plan is complete and the company is funded
• The trend is to utilize outsourcing much earlier
• Outsourcing companies bring a wealth of “real world” experience
that can prevent Startups from making commons mistakes
– Improves time to market
– Helps identify issues that may be expensive to correct after
development begins
– Anticipates FDA and other regulatory issues
• Product development and introduction proceeds smoothly and
efficiently
– Outsource company is “up to speed” from the start
– Technical relationships speed issue resolution
5. 5
Advanced Medical
Operations
Outsourcing Provides Upfront Resources
• Demonstrate that the concept has the technical feasibility to enable
it to serve a large, rapidly growing opportunity
– Provides real world experience from the start
– Identifies significant technical hurdles
• Help to identify elements that are truly differentiable in a sustainable
way
– Brings focus to “must have” versus “nice to have”
– Broad view of the market helps identify true differentiators
• Provide a strong understanding of the competition
– Often have experience with the direct competition
– Can bring an understanding of other forces competing for the same
customer budget dollars
6. 6
Advanced Medical
Operations
Outsourcing helps all phases of business
plan development
• Initial phase of business plan development
– Clarification of the compelling market need
– Identify key technical areas requiring research
• Companies seeking funding
– Incorporate concepts developed from initial discussions with potential
customers
– Modify the plan based on comments from Venture Capitalists
• Funded companies
– Accelerate development product requirements
– Identify critical development concerns
8. 8
Advanced Medical
Operations
Business Plan Review
• Not consulting
• Puts highly motivated, talented, technical people together to discuss
state of the art technology
• A framework where new and exciting concepts and insights emerge
• Begins with development of “elevator speech” focusing Startup on
the customer and benefits
• Encourages Startup to identify market segments that the product
has the potential to dominate
• The concept is discussed with a view to whether a broader potential
exists which might make it easier to obtain funding
9. 9
Advanced Medical
Operations
Technical Feasibility
• Begins the process of developing a comprehensive list of product
requirements
– Identifying Must Haves rather than not Nice to Haves
– Identifying design unknowns
– Identifying required prototyping
– Developing a critical requirements list
– Developing a risk control measures list
• Goal is to identify key requirements and issues early in the process
when the impact is low
– Entire process is outside of FDA review
• The process is completed within a complete Best-Path Program
10. 10
Advanced Medical
Operations
Differentiation
• Startups must understand that their concept must address not just a
need, but a compelling need
• Helps avoid “gee whiz” features that are not compelling
differentiators
• Helps identify technology that is better acquired than developed
• Example: HEI Embedded Processor Development Framework
– A Processor Family and Development Environment
– Software Modules
– Connectivity Modules
– DSP Modules
11. 11
Advanced Medical
Operations
Competition
• Outsourcing companies are unique in seeing new design concepts
across the medical device market
• Competition is not just other medical device companies but anything
or anyone that competes for precious budget dollars and the staff
needed to evaluate, recommend, and utilize the product.
• Encourages a dialog about who the client believes is the likely
competition and how their concept can win in the market
• Process brings competitive depth to a Startup’s business plan
– Startups often lack the broad view of the medical device market
– Outsourcing companies are extremely sensitive to trends in the market
that may not be evident to a Startup
12. 12
Advanced Medical
Operations
Mental Acuity Product
• Initially targeted to demonstrating ongoing brain acuity
• Best-Path EMT process identified other opportunities such as
potential in Alzheimer’s and also in monitoring the results of
medication on brain function as a POC (point of care) product
• Helped Startup present a larger potential market during the funding
process
Brain Activity
Historical
Analysis
13. 13
Advanced Medical
Operations
Hardware/Software/Internet Product
• Medical device captures patient data
• Data sent unencrypted over the Internet to a computer
• Results compared against expected norms stored in a database on
the Internet
• Best-Path EMT process identified likely HIPAA (Health Insurance
Portability and Accountability Act) concerns
• Changing the architecture at the concept stage was simple
• Would have been extremely difficult after design start
14. 14
Advanced Medical
Operations
Automated Cell Counting
• Technology is not new and is well
understood
• However, Startup’s concept
required detecting very small
variations in very small cells
• Locating an optical system that
could meet the need at a
reasonable cost was key to the
business plan
• Best-Path EMT process identified
this critical need
• A technology provider was
identified giving confidence to
move forward to attract funding
15. 15
Advanced Medical
Operations
Making the Product Right
• Complete Best-Path program is a
structured methodology for developing
the strategies and associated
documentation for a product launch
that meets user and FDA
requirements, at the target cost, and
within a predictable schedule.
• Minimizes risk for medical
instrumentation companies giving
confidence to proceed to formal
product design and market deployment
strategy
• Going from Best-Path EMT to a
complete Best-Path program provides
a seamless means of ensuring the
most rapid time to market.
16. 16
Advanced Medical
Operations
Conclusion
• Startups benefit with Best-Path EMT by bringing forward key
analyses of the business plan, technical feasibility of the concept,
differentiation, and competition. Issues and concerns are raised and
solved much earlier in the process saving both time and money for
the startup
• Best-Path EMT gives the startup the opportunity to have a larger
view of the technology. This can lead to recognizing that the
technology has broader applicability than originally anticipated
which can provide a stronger case for funding
• Best-Path EMT can be combined with an entire Best-Path program.
Best-Path leads the client through the process inside of the FDA
QSR guidelines to productization
• Best-Path EMT and Best-Path work together to confidently know
that it’s the right product for the market and that you’re developing
the product right
