The document outlines strategies for successful design transfer from research and development to manufacturing in the medical device sector, emphasizing the importance of alignment between R&D and manufacturing processes. It discusses critical elements, case studies, and the role of innovation throughout the process, highlighting that successful design transfer is vital for delivering high-quality products. Key takeaway factors include thorough planning, stakeholder engagement, and validation at each stage of development and manufacturing.

1. Strategies to Accomplish Successful Design
Transfer to Manufacturing
Siddharth Desai, Vice President, R&D
Date: 06/27/2012

2. ‘A classic picture of Innovation!’

3. ‘A classic picture of Innovation!’

4. Objectives
• What is the anatomy of innovation?
• H
How i i
is innovation tied with Manufacturing and R&D
ti ti d ith M f t i d
in the innovation process?
• What are critical elements of a successful design
transfer to manufacturing?
• Are there examples of great design transfer to
manufacturing?
• How do we accomplish successful design
transfers?

5. Objectives
• What is the anatomy of innovation?
• H
How i i
is innovation tied with Manufacturing and R&D
ti ti d ith M f t i d
in the innovation process?
• What are critical elements of a successful design
transfer to manufacturing?
• Are there examples of great design transfer to
manufacturing?
• How do we accomplish successful design
transfers?

6. I-Flow: Leader in infusion therapy
I-Flow commences sales of medical devices in 1991
• Loyal customer base
• Trusted products in the field, pioneer
• Pain Management leadership – ON-Q brand
Key Product Lines
• Homepump
• ON-Q
• Easypump
Product used in different therapies
• Pain Management
• Antibiotics
• Chemotherapy
I-Flow has a long history of delivering innovative therapeutic solutions over last 21 years!

7. R&D/Engineering Mission
“Science Passion and Pursuit of Excellence ”
Science, Excellence.
7

8. ON-Q® Painbuster®
• A simple, disposable pain relief
system that automatically delivers
a local anesthetic to or near a
surgery site over multiple days.
• Portable and easy to wear.
• Smallest device on the market.
• Unique, patented catheter

9. Innovation:
“Technically, "innovation" is defined merely as
"introducing something new;" th
"i t d i thi " there are no qualifiers of
lifi f
how ground-breaking or world-shattering that something
needs to be—only that it needs to be better than what was
there before. And that's where the trouble starts when an
organization requests "innovation services" from a
innovation services
consulting firm. Exactly what are they really requesting?
The fact is, innovation means different things to different
people.”
-B i
Businessweek, J
k January 31 2006
31,
Innovation has nothing to do with how many R&D dollars
you h
have... It' not about money. It' about th people you
It's t b t It's b t the l
have, how you're led, and how much you get it. -Steve Jobs
9

10. What is innovation?
“Innovation is dreams realized!’
• Innovation is Invention + Execution + Renewal!
• Innovation is Creating something new!
• Innovation is the journey that commences from Idea
to Execution and to Renovation.
10

11. Examples of Manufacturing and R&D
alignment leading to success:
g g
• Medical Devices
– Conversion of glass bottles to flexible containers
• R&D I
R&D: Innovation i container d i
ti in t i design
• Manufacturing: Innovation due to film manufacturing
processes
• (Source: ‘Innovating for Change, The story of Baxter
International,
International Thomas G Cody’)
G. Cody )
– Angioplasty catheters to address arthrosclerosis blockages
• R&D: Innovative idea to enable a balloon to increase hoop
stress on the artery.
• M
Manufacturing:
f t i Multi-lumen extrusion i
M lti l t i innovation and
ti d
balloon molding capabilities
– Flexible Silicone Intra Ocular Lenses
• R&D: Foldable lens enables smaller incision for IOL
insertion
i ti
• Manufacturing: Liquid Injection Molding with Platinum
Cured Silicone process enables high volume manufacturing
11

12. Examples of Manufacturing and R&D
alignment leading to success:
g g
• Medical Devices
– Elastomeric Pumps
• Unique IP related to elastomeric
pump based on Hagen-Poiseuille
equation
• R&D: Material properties enable
power source and container in one
device coupled with flow restrictor
technology.
t h l
• Manufacturing: Flow restrictor and
Bladder manufacturing processes
enable evolution of the product.
12

13. Objectives
• What is the anatomy of innovation?
• H
How i i
is innovation tied with Manufacturing and R&D
ti ti d ith M f t i d
in the innovation process?
• What are critical elements of a successful design
transfer to manufacturing?
• Are there examples of great design transfer to
manufacturing?
• How do we accomplish successful design
transfers?

14. Innovation Funnel: Basic Framework
References
• Wheelwright. S C
Wh l i h S. C. and Clark. K. B., 1992, R
d Cl k K B 1992 Revolutionizing P d
l i i i Product
Development, The Free Press, New York.
14

15. Commence Development
• Understanding unmet needs initiates planning process.
• P tf li selection commences th pursuit of i
Portfolio l ti the it f innovation.
ti
• Strategic decision making and prioritization through
ranking or programs
programs.
• Initiation of programs.
• Key stakeholders include Business R&D Marketing
Business, R&D, Marketing,
Manufacturing, Quality, and Finance.
15

16. The Journey: Development Process!
Renovation
Review unmet needs
Improve/Enhance/Rec
reate
Concept • Design Development
• Ideation • Proof of • Launch
g
• Brainstorming • Convert to concept • Manufacture • Customer
• Unmet needs concepts • Validations interface
Commercializa
Invention Design
tion
16

17. Is innovation about revolution?
"Since we moved away from serendipity led R&D nobody
Since serendipity-led
yells 'Eureka!' anymore."
17

18. Innovation Process: Stage Gates
Concept Feasibility Design and V&V Plan Launch
• Develop an • Develop Development • Process • Build and
outline alternative • Select a capability capacity plan
• Define ideas prototypes concept • Process meet
• VOC • Define initial • Develop Validation requirements
• Develop process manufacturing • Design output • Product
specification design processes and • Trace Matrix performance
• Review equipment meeting
• Review • Manufacturing
financials • Customer requirements
options in process
manufacturing g • Selection needs tested finalization • Customer
criteria for • Financial and Capacity satisfaction
ti f ti
• KOL opinion metrics Plan • Financial
• Customer metrics
focused
feedback
18

19. • Where are the requirements?
– FDA requirement: 820.30 CFR for Design Controls and ISO
820 30
• Design Input
• Design Output
• D i V ifi ti and V lid ti
Design Verification d Validation
• Design Reviews
• Design Transfer
– Business requirement
• Speed to market
• Revenue plans
• Quality metrics
• Manufacturing metrics
19

20. Design Control
ISO Requirements: ISO13485:2003
Product Realization Process Flow Diagram
User Review
Needs
Design
g
Input
Design
Process
Verification Design
Output
Medical
M di l
Device
Validation
20

21. Objectives
• What is the anatomy of innovation?
• H
How i i
is innovation tied with Manufacturing and R&D
ti ti d ith M f t i d
in the innovation process?
• Why is successful design transfer to manufacturing
critical?
• Are there examples of great design transfer to
manufacturing?
• How do we accomplish successful design
transfers?

22. Risk Mitigation through Integration
g g g
R&D Risk Review Manufacturing
World class new products Business Risks World class manufacturing
Differentiated product designs Speed to Market Manufacturing core competence
Well designed processes Supply Predictable mfg. metrics,
Design for Mf Assly.
D i f Mfg., A l Launch
L h Supply and capacity on ti
S l d it time
Integrated at all phases Schedule Integrated at all phases
Design dossier and History File Regulatory Approval
egu ato y pp o a Co p a ce o the site, &
Compliance of t e s te, V&V
Product and Program Costs Financial Risks COGS, Capital Costs
Process focus for ease of mfg Process Development Financial Risks
Unique product and processes Differentiated Product Unique products and processes
build knowledge link Design provide core competence
22

23. Critical Elements of A Design Transfer Plan
g
• Develop a plan
• Process Flow Diagram: From material to finished device
• Selection of Suppliers
– Supplier quality
• Complete process, assembly assessment
– BOM Drawings Critical components and processes
BOM, Drawings,
– Tooling, Fixtures, CpK of processes
– Launch plans and capacity plans
• Documentation M
D t ti Management
t
– Error free transfer to manufacturing
• Quality plan
– Process FMEA, Inspection, V&V plans, Test plans
• Financial Elements
– Cost of components, Manufacturing process financials
23

24. Objectives
• What is the anatomy of innovation?
• H
How i i
is innovation tied with Manufacturing and R&D
ti ti d ith M f t i d
in the innovation process?
• Why is successful design transfer to manufacturing
critical?
• Are there examples of great design transfer to
manufacturing?
• How do we accomplish successful design
transfers?

25. Two Case Studies; Case 1
Case 1: Multilayer Bladder Construction to a Single Layer
Bladder Construction with Material Change
Fundamental Business Objective
Develop a Latex free and DEHP free product
Manufacturing and R&D Objectives
Improved consistency
Improved flow rate accuracy
p y
25

26. Case 1: Latex to Silicone conversion
Concept Phase
Evaluated several material options.
Operations described manufacturing and supplier
p g pp
requirements.
Designers developed alternative suppliers.
Marketing described customer requirements
g
throughout the world.
Feasibility Phase
R&D developed prototypes from different material options.
3 Layers vs. 1 A single layer bladder vs. a three layer bladder was chosen.
Operations assessed alternative materials and related financial
impact.
impact
Precise Extrusion process defined.
Regulatory affairs prepared global registration plans.
26

27. Case 1: Latex to Silicone conversion
Design and Development Phase
R&D optimized design. Bladder design was optimized for
stable modulus of elasticity.
Operations led validation efforts in the plant.
Complete assessment was carried out with regards to
process capability, cost of goods and ROI.
Marketing p p
g prepared launch p plans.
Complete trace matrix was developed.
Launch
Full launch occurred with marketing launch plans.
Sales dashboard metrics measured.
Follow up on post launch monitoring for fixes.
27

28. Two Case Studies; Case 2
Case 1: A new Phacoemulsification equipment that is compact in
size and more reliable in performance.
Fundamental Business Objective
Develop a compact electromechanical system that is more reliable
reliable.
Manufacturing and R&D Objectives
Prevent too many DOAs.
Prevent several failures of modules during use.
Ensure consistency in p
y performance.
Develop critical success metrics.
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29. Two Case Studies; Case 2
Suppliers
• Power Supply
• Footswitch
Components
# of Boards: 22 vs 5
vs.
Testing
• Reliability studies
• BBurn-in t t
i tests
• ICT, AOI
Design Transfer Plan
Limited Launch
29

30. Case 2: Compact Phaco Equipment
Concept Phase
Evaluated fundamental requirements regarding
existing product for reliability and functionality.
Developed a core list of non-negotiable items for
design, manufacturing and service.
Developed initial concepts.
Feasibility Phase
R&D developed non-functioning industrial design prototypes to
reflect size and number of components.
Operations developed critical development requirements
Size of the machine (Refrigerator vs. Desktop)
vs
# of PCB
Reliability metrics
Operations p p
p prepared manufacturing p
g plans.
Regulatory affairs prepared global registration plans.
30

31. Case 2: Compact Phaco Equipment
Design and Development Phase
R&D optimized design. Design with 6 total PCB vs. 21 current.
Power Supply chosen was from a q
pp y qualified supplier.
pp
Component tests added to ensure reliability
Finished device tests such as burn-in tests were added.
Operations led validation efforts in the plant.
Service strategy was included in the assessment metrics.
Pilot launch with few units was carried out.
Marketing prepared launch plans.
Launch
Full launch occurred with marketing launch plans.
Sales dashboard metrics measured..
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32. Two Case Studies; Case 2
Overall Summary
• Innovation through R&D and Manufacturing integration.
• Design transfer to manufacturing ingrained with overall
project plan.
• Q alit is designed in the prod ct and processes
Quality product processes.
• Thorough validations.
• Limited launch plans.
32

33. Objectives
• What is the anatomy of innovation?
• H
How i i
is innovation tied with Manufacturing and R&D
ti ti d ith M f t i d
in the innovation process?
• Why is successful design transfer to manufacturing
critical?
• Are there examples of great design transfer to
manufacturing?
• How do we accomplish successful design
transfers?

34. 10 Commandments of Successful Design Transfer
1. Thou shalt not start a project without a project leader and a core team.
2. Thou shalt not publish schedule without 80% confidence.
3.
3 Thou h lt t t t Design Transfer d t il without a detailed plan.
Th shalt not start D i T f details ith t d t il d l
4. Thou shalt not miss Design For Manufacturing assessment.
5. Thou shalt not work without a supply and capacity plan.
6. Thou shalt not work with unproven suppliers.
7. Thou shalt not proceed without complete validations.
8.
8 Thou shalt not launch a product without a launch plan including limited
launch, capacity plans and robust forecasts.
9. Remember, on a signoff day, R&D and Operations, shall be fully integrated
for phase gate closures.
10. Thou shalt not ignore learning from prior launches and post launch
monitoring.
34

35. Five Blind Men and an Elephant - - -
• What did each one say?
A Tree
A Rope
A Wall
A Snake
A Spear

36. Conclusion
A true Design Transfer to Manufacturing success comes from
execution excellence in all phases of Innovation Processes including:
Project Management
Customer Intimacy
Design
Manufacturing Processes
Supply Chain
Launch Planning
Risk Assessment
36