Nina Kohnen, Covidien - Speaker at the marcus evans Medical Device Manufacturing Summit Fall 2012, held in Colorado Springs, delivered her presentation entitled Product Design and Innovation

1. Product Design & Innovation
Medical Devices Summit – Colorado Springs 2012
Nina Kohnen
Director Operational Excellence,
Design Excellence

2. Agenda
Importance of Achieving Success in Innovation
& Product Leadership
A Roadmap for Success
2 | 12/3/2012

3. About Covidien
• Global manufacturer of medical devices and
pharmaceuticals
• 43,000 employees with 51 manufacturing
facilities located i 18 countries
f iliti l t d in ti
• 2012 Sales – $11.9 Billion
Medical Supplies
Nursing Care, SharpSafety,
Medical Surgical, OEM
Surgical
15%
17%
68% Medical Devices
Endomechanical, Energy,
Pharmaceuticals Soft Tissue Repair,
Specialty Pharmaceuticals, Airway & Ventilation,
Contrast Products, Oximetry & Monitoring,
Radiopharmaceuticals,
p Vascular
Active Pharmaceutical
Ingredients
3 | 12/3/2012

4. Achieving Market Leadership
“Best Product”
Innovation / Product Leadership
Apple, Google, Intel, Nike, 3M
Wal-Mart, FedEx, Southwest, Dell Airborne Express, Home Depot, IBM
Operational Excellence Customer Intimacy
Best Total Cost, Ease of Use “Best Total Solution”
Convenience,
Convenience etc
Source: The Discipline of Market Leaders- Michael Treacy
4 | 12/3/2012

5. There is no Shortage of Advice on How to do it Right
Bring clarity and certainty
through analysis
Reduce complexity by
focusing on process
design
Take larger strides to
a e a ge st des
speed up the pace of
improvement
Fix execution to
accelerate improvement
5 | 12/3/2012

6. What is Innovation?
6 | 12/3/2012

8. This is one of very few 7 stars hotel in the world
It was built in only 18 months...
And opened its doors in 2003.....
8 | 12/3/2012

9. 9 | 12/3/2012

10. 10 | 12/3/2012

11. What About These Innovations?
• Apple vs. Rest
• DVD vs. Streaming Video
• Mobile Phones vs. Landlines
• E-mail vs. Snail Mail
• Paper Maps vs. GPS
11 | 12/3/2012

12. My Take on Innovation
• Innovation is the Ability to Invent, Commercialize and Expand a
Product or Service Along a Customer’s Dimension of Value.
Customer s
– Invention Requires a System to Generate, Prioritize & Process Ideas
– Commercialization Requires a Robust Product Development
Process to Launch Ideas
– Expansion Requires a System to Fully Manage & Exploit Post
Launch Utilization of the New Products or Services
12 | 12/3/2012

13. Why is Innovation Important?
• Innovation is the Only Competitive Advantage a Company Really
Has. Quality Improvements & Price Reductions Can be
Q y p
Replicated.
• A Company Should Proactively Make its Own Products Obsolete
Before Competitors Do.
– Creative Destruction
– Planned Obsolescence
13 | 12/3/2012

14. •OHLCCursor
•Chart Scale
•CHART SETTINGS
Values
NFLX
•RESET
Netflix
Blockbuster
14 | 12/3/2012

15. Impact on Investment Value
• Innovation is Important to Financial Markets in Determining the
Value of a Company over the Long Term
• About 91% of Executives Surveyed Consider Increasing the
Company's Capacity for Innovation was Critical to Creating Future
Competitive Advantage and Earning Profits1
• Fortune Magazine: “Secrets of America’s Most Admired
Corporations”- New Ideas and New Products are the Key2
p y
1 A study by Bain & Co. published in Harvard Business Review (Oct 2002)
Co (Oct.
2 B. O’Reilly, “Secrets of America’s Most Admired Corporations: New Ideas, New Products.” Fortune
15 | 12/3/2012

16. America’s Most Admired Companies
Rank Company
1 Apple
2 Google
3 Amazon.com
4 Coca Cola
Coca-Cola
5 IBM
6 FedEx
7 Berkshire Hathaway
8 Starbucks
9 Procter & Gamble
10 Southwest Airlines
Most Admired Linked to Most Innovative!
Source: Fortune, March 2012
16 | 12/3/2012

17. Top 10 Most Innovative Companies
Rank 2012 Rank 2011 Company
1 1 Apple
2 2 Google
3 3 3M
4 7 Samsung
5 4 General Electric
6 5 Microsoft
7 9 Toyota
8 8 Procter & Gamble
9 6 IBM
10 n/a Amazon
Most Admired Linked to Most Innovative!
Source: Booz & Company Inc
17 | 12/3/2012

18. How Difficult is Product Innovation?
• Expected Failure Rate is 35% - 45% and Depends on the Industry1
• An Estimated 46% of all Resources Allocated to Product
Development are Spent on Cancelled or Failed Products1
• 56% of Products Meet Their Market Objective and About 50%
Launch on Time2
• The Consumer Electronics Show (CES) is the Biggest Stage of the
Technology Industry
– Most of the Products Showcased This Year Will Not See
Commercialization!!
Boosting a Steady Stream of Successful New Products is Not an Easy Task.
1 Robert G. Cooper: Product Leadership 2nd edition.
2 Behnam Tabrizi and Rick Walleigh “Defining Next-Generation Products” Harvard Business Review.
18 | 12/3/2012

19. How Difficult is Product Innovation?
10,000
“If we knew what we were doing,
3000 Raw Ideas (Unwritten)
it wouldn’t be called research
wouldn t research,
1000 would it?” — Albert Einstein
Number of Ideas
300 Ideas Submitted
I
100 125 Small Projects
9 Early Stage Development
10
0
4 Major Development
1.5 Launches
1 1 Success
1 2 3 4 5 6 7
Stage of New Product Development Process
Source: G. Stevens and J. Burley, “3000 Raw Ideas = 1 Commercial Success!”
Research•Technology Management, 40(3): 16-27, May-June, 1997.
19 | 12/3/2012

20. Agenda
Importance of Achieving Success in Innovation
& Product Leadership
A Roadmap for Success
20 | 12/3/2012

21. Key Components of Innovation / Product Leadership
Metrics
Balanced
Scorecard
Customers, Market Environment & Senior Mgt Team
ology Strategy
Performance
Goals
ENABLERS
orporate Strategy
DFSS &
Lean PD TOOLS
ment
Portfolio
Innovation & Techno
Outputs
Managem
Stage 5
Stage 4
Stage 2
Stage 1
ORGANIZATION
Stage 3
& PEOPLE
∑
Co
TECHNOLOGY
Gaps Between Actual
& Desired Goals
Lean/Sigma Design Product Development Process
Desired Goals
Best Practice Sharing
21 | 12/3/2012

22. Success Through Innovation is Key
• About 50% of Executives Consider Innovation Very Critical1
• More than 54% Indicated Increased Investment in the Last Two
Years1
• Ab t 90% of Executives Consider O
About fE ti C id Organic G
i Growth Th
th Through
h
Innovation Essential to Success2
• About 70% of Senior Executives Say That Innovation in One of the
Top Three Drivers of Growth for Their Company in the Next 3-5
Years3
Innovate or Die!
1 Cheskin and Fitch: Worldwide, 2003
2 The Boston Consulting Group, innovation 2005
3 The McKinsey Quarterly September 2007
22 | 12/3/2012

23. The Building Blocks For Innovative Organizations1
• Formally Integrate Innovation Into the Strategic Management
Agenda of Senior Leaders
• Create the Conditions That Allow Dynamic Innovation Networks to
Emerge and Flourish
• T k Explicit St
Take E li it Steps to Foster an Innovation Culture Based on Trust
t F t I ti C lt B d T t
Among Employees
– People Understand That Their Ideas are Valued
p
– Trust That its Safe to Express Those Ideas
– Create High Risk – High Reward Environment
– Publicize Important Failures
Innovation is an Important Driver for Growth
1 Leadership & Innovation, The McKinsey Quarterly Jan. 2009
23 | 12/3/2012

24. Fail-
Publicize Important Failures (Internally) Forward
Culture
Don’t Punish
D ’t P i h
Discuss Failure Publish Failures
Appropriate Failure
To promote appropriate risk taking, 3M reinforces its culture of risk Approximately 90 grants of $50K
Former Lockheed Martin CEO, taking by sharing stories of are given to 3M employees each
Dan Haughton, gathered the past failures and second year to pioneer new product
company’s manufacturing chances. ventures. The product champion
p p
executives to discuss his own recruits his / her own team to develop
failures, including the admission One example is Francis Okie’s and launch the product.
that the failure to purchase the 1922 attempt to replace razor
Douglas Aircraft company was a blades with a new sandpaper If the venture does not succeed team
product. The product failed as a
costly mistake.
shaving tool but was ultimately the
tool,
members are guaranteed their
g
basis for a successful line of fine- previous jobs. There is no
grained, waterproof sandpaper punishment for a product failing in the
products. market.
Post-It
Post It notes were
developed by
accident. Intolerance
for failure likely
would have killed the
concept.p
Source: Corporate Executive Board, Tuck Business School Center for Global Leadership, 3M Company Website
24 | 12/3/2012

25. Covidien’s Strategic Initiatives
• Innovation
• Portfolio Management
• Operational Excellence
• Globalization
• Talent management
Innovation is a Key Component of Covidien’s Strategy
25 | 12/3/2012

26. Key Components of Innovation / Product Leadership
Metrics
Balanced
Scorecard
Customers, Market Environment & Senior Mgt Team
ology Strategy
Performance
Goals
ENABLERS
orporate Strategy
DFSS &
Lean PD TOOLS
ment
Portfolio
Innovation & Techno
Outputs
Managem
Stage 5
Stage 4
Stage 2
Stage 1
ORGANIZATION
Stage 3
& PEOPLE
∑
Co
TECHNOLOGY
Gaps Between Actual
& Desired Goals
Lean/Sigma Design Product Development Process
Desired Goals
Best Practice Sharing
26 | 12/3/2012

27. New Product Innovation Strategy
• Without a Sound Strategy, a New Product is Most Likely to Fail
– Successful Companies Implement a Company-Specific Approach Driven by
p p p y p pp y
Business Objectives and Strategies with a Well-Defined Product Innovation
Strategy at its Core1
• Innovation Strategy is a Component of the Overall Business
Strategy2
– Includes Defined Goals that Tie to the Overall Company Strategy
– Includes Deployment Decisions
– Includes Attack and Entry Points to Markets
– Forms the Basis for Project Selection and Portfolio Management
j g
– Well Communicated
1 Booz-Allen& Hamilton, New product management
2 Product Leadership, Robert Cooper 2nd ed. 2002
27 | 12/3/2012

28. Key Questions to Ask for a Robust Innovation
Strategic Plan1
• What Markets Do We/Can We Serve?
• In What Segments Do We & Our Competitors Actively Participate?
• How Large is the Business Opportunity?
• What are the Key Value Propositions?
• What Will We Establish as the Major Differentiators?
• What are the Platforms to Address the Targeted Customer and
Markets?
• What are the Resources Required to Deliver Against the Product
and Technology Strategic Plans?
• What is the Expected Business Outcome?
• How Will this Strategy Integrate with the Corporate Strategy?
1 Maurice F. Holmes and R.B. Campbell Jr.
28 | 12/3/2012

29. Key Components of Innovation / Product Leadership
Metrics
Balanced
Scorecard
Customers, Market Environment & Senior Mgt Team
ology Strategy
Performance
Goals
ENABLERS
orporate Strategy
DFSS &
Lean PD TOOLS
ment
Portfolio
Innovation & Techno
Outputs
Managem
Stage 5
Stage 4
Stage 2
Stage 1
ORGANIZATION
Stage 3
& PEOPLE
∑
Co
TECHNOLOGY
Gaps Between Actual
& Desired Goals
Lean/Sigma Design Product Development Process
Desired Goals
Best Practice Sharing
29 | 12/3/2012

30. Portfolio Management
• Portfolio Management– Focuses on:
− New Opportunities, New Products, New Ventures
− All Products a Company has in Development or Available for
Customer at any Time
• The Goals are:
− Maximize Value
* Net Present Value (NPV)
* Expected Commercial Value (ECV)
* Internal Rate of Return (IRR)
− Balanced Portfolio (Short vs. Long Term, Breakthrough vs. Line
Extension, etc.)
− Strategic Alignment
30 | 12/3/2012

31. Portfolio Management Practices
Worst Performers
4
Formal Portf. Mgnt. Process in Place 31 Best Performers
46
Alignment with Bus. Strategy 66
4
Good Balance Projects/Resources 38
12
Good Project Prioritization 41
8
Resource Breakdown Reflects Strategy 66
19 31
Excellent Balance of Projects
1
38
Portfolio Contains High Value Projects
P tf li C t i Hi h V l P j t
0 10 20 30 40 50 60 70
Source: Product Development Institute 2010. %
31 | 12/3/2012

32. Is This a Balanced Portfolio?
High
Potential Stars
cess
(Pearls)
hnical Succ
Bread & Butter
Probabili of Tech
$14 M 12 10 8 6 4 2 0
Reward (NPV)
ity
White Elephants
Long Shots Low
(Oysters)
Risk Reward Bubble Diagram
Source: Robert G. Cooper: Winning at
Circle Size = Resources (annual)
New Products, 3rd edition.
32 | 12/3/2012

33. Balance of Products in the Portfolio – Product
Life Cycle
(3) Cash from
(2)Cash from ‘C’‘B’
used to support ‘D’
supports growth of D
Sales (1) through used to
‘C’ ‘A’ is at maturity
The possibly growth
and product
stage – extension
finance cash cow.
stage and to
portfolio – four
( )
(1) ( )
(2) ( )
(3) Generates .
launch ‘D’. the for
strategy Din funds
products
the development of
portfolio
‘A’ now possiblyaa
‘D’
“B” Now possibly
dog?
Dog?
D
B
A C
Time
33 | 12/3/2012

34. Key Components of Innovation / Product Leadership
Metrics
Balanced
Scorecard
Customers, Market Environment & Senior Mgt Team
ology Strategy
Performance
Goals
ENABLERS
orporate Strategy
DFSS &
Lean PD TOOLS
ment
Portfolio
Innovation & Techno
Outputs
Managem
Stage 5
Stage 4
Stage 2
Stage 1
ORGANIZATION
Stage 3
& PEOPLE
∑
Co
TECHNOLOGY
Gaps Between Actual
& Desired Goals
Lean/Sigma Design Product Development Process
Desired Goals
Best Practice Sharing
34 | 12/3/2012

35. Product Development Stage Process
• An Operational Map For Moving New Product Projects From Idea
to Launch
• It is Like a Playbook in a Football Game
− It Maps Out What Needs to be Done, Play by Play Huddle by
Done Play,
Huddle and How to Do it in Order to Win The Game
• Each Stage Has Clearly Defined Deliverables
g y
• Each Stage is Cross Functional
− No Department Owns Any One Stage
35 | 12/3/2012

36. Typical Stage Gate Process
The Five Stages of Product Development
Ve
Feasibility of Concept
F
erification & Valida
Commer
Idea Ge
Devel
n
y
rcializatio
lopment
eneration
n
on
Stage
g Stage Stage Stage ation Stage
g Post Launch
1 2 3 4 5 Surveillance
Successful New Product Launches Go Through the Process
36 | 12/3/2012

37. Common Errors & Pitfalls in a Gated Process
• Too Many Bad and in Trouble Projects are Sliding Through
• The Stages Have No Teeth: Once Approved, Projects Never Get
Approved
Killed
• Resource are Either Not Committed as Projects Move From Stage to
Stage or Committed t T M
St C itt d to Too Many P j t at a Ti
Projects t Time
• Executive Pet Projects Get Special Treatment and Bypass the Stages
• Deliverables Overkill
• Process is Too Rigid and Not Scalable
Gated Process is Not a Magic Bullet: It is Only One Piece of the Puzzle
g y
37 | 12/3/2012

38. Key Components of Innovation / Product Leadership
Metrics
Balanced
Scorecard
Customers, Market Environment & Senior Mgt Team
ology Strategy
Performance
Goals
ENABLERS
orporate Strategy
DFSS &
Lean PD TOOLS
ment
Portfolio
Innovation & Techno
Outputs
Managem
Stage 5
Stage 4
Stage 2
Stage 1
ORGANIZATION
Stage 3
& PEOPLE
∑
Co
TECHNOLOGY
Gaps Between Actual
& Desired Goals
Lean/Sigma Design Product Development Process
Desired Goals
Best Practice Sharing
38 | 12/3/2012

39. Enablers - DFSS Tools
• Help Define Customer Requirements (CTQ’s)
• Result in Significant Improvement to Product Quality &
Reliability Levels
• C t ib t to Revenue Growth, Customer Delight, M k t
Contributes t R G th C t D li ht Market
Share, Volume, Price
• Warranty Cost Reductions
y
• Customer Satisfaction / Targets Met
• Focus the product development teams on what is important
Design for Six Sigma as an Enabler
39 | 12/3/2012

40. DFSS Tools Used Early in The Process
Why Important?
Cost to Correct Quality and Reliability Traditional Six Sigma & Lean Efforts are Focused Here
$
DFSS Efforts
are Focused Here
t
Post Launch
Research Design Development Launch Performance
Defects are: Difficult to See/Predict
Easy to Fix
Easy to See
Costly to Fix
Best $ Opportunities Realized Through Product Design
40 | 12/3/2012

41. Application of Lean to Product Development
Approach Description Focus
Lean Product Largely based on the adaptation Time to market,
market
Development of process, organization, and development costs,
System tools used in Toyota Product capacity, quality,
Development System (TPDS) to continuous
develop products better, faster, improvement
and cheaper
Lean Business Application of Lean Principles to Time to market,
Process minimize waste in Business development costs,
Processes capacity
Lean Design Elimination of waste from the Product cost, quality,
product design to reduce customer value
manufacturing costs
41 | 12/3/2012

42. Key Components of Innovation / Product Leadership
Metrics
Balanced
Scorecard
Customers, Market Environment & Senior Mgt Team
ology Strategy
Performance
Goals
ENABLERS
orporate Strategy
DFSS &
Lean PD TOOLS
ment
Portfolio
Innovation & Techno
Outputs
Managem
Stage 5
Stage 4
Stage 2
Stage 1
ORGANIZATION
Stage 3
& PEOPLE
∑
Co
TECHNOLOGY
Gaps Between Actual
& Desired Goals
Lean/Sigma Design Product Development Process
Desired Goals
Best Practice Sharing
42 | 12/3/2012

43. …but there is clearly no standard for which
Most organizations are satisfied innovation metrics are most effective.
with their innovation metrics…
% of respondents who use more than 3
innovation metrics, n=633
% of respondents who use more than 3 innovation
metrics, n=633
Approximately 75% of Companies Studied Use Innovation Metrics in
Some Form, with an Average of Eight Metrics Used
Form Used.
Source: McKinsey Quarterly
43 | 12/3/2012

44. Breakdown of Projects by Project Type (%)
45 40 Best Performers
40
40 Worst Performers
35
28
27
30 25
25
% 19
20
12
15
10 6
5
0
Packg Changes Incremental Major Product New to the
Improvement Revisions Business/World
Source: Robert G. Cooper: Product Leadership 2nd edition.
44 | 12/3/2012

45. Percentage of Revenue and Profits from New Products
42.4
45 Revenue
38 Profits
40
35
27.5 28.4
30
25
%
20
15 9 9.1
91
10
5
0
Ave. Business Top 20% of Bottom 20% of
Businesses Businesses
Source: Robert G. Cooper: Product Leadership 2nd edition.
45 | 12/3/2012

46. Success, Fail & Kill Rate of New Products
79.5
Top 20% of Businesse
80
Bottom 20% of Businesses
70
60
50 37.6
%40
28.4 25.7
30
20
8.1
4.3
10
0
Success Failure Late Kill
Source: Robert G. Cooper: Product Leadership 2nd edition.
46 | 12/3/2012

47. % On Time & On Budget for New Products
79.4 79
80 Top 20% of Businesse
70 Bottom 20% of Businesses
60
44.3
44 3
50
%
40
30 20.5
17.2
15.5
20
10
0
On Time On Budget Slip rate
Source: Robert G. Cooper: Product Leadership 2nd edition.
47 | 12/3/2012

48. % New Product Projects Meeting Objectives
Top 20% of Businesse
100
Bottom 20% of Businesses
90 77.1
74.5
74 5 73.4
73 4
80
70
60
% 50
29.3
40 26.9 29.6
30
20
10
0
Meeting Profit Meeting Sales Meeting Market Share
Objectives
j Objectives
j Objectives
j
Source: Robert G. Cooper: Product Leadership 2nd edition.
48 | 12/3/2012

49. Top 10 R&D Metrics Used Across Industries
% Companied
Metric Using Metric
1. R&D Spending as a % of Sales 77%
2. Total Patents Filed/Pending/Awarded/Rejected 61%
3. Total Current R&D Headcount 59%
• Many Companies Invest Only in R&D Resources. Product Development is
4. Cu e
Current-Year % Sa es Due to New Products Released in Past X Years
ea Sales ue o e oduc s e eased as ea s 56%
not Just R&D
tJ t
5. Number of New Products Released 53%
6. • Number Invest in Other Support Functions (QA, Manufacturing, Procurement,
Must of Products/Projects in Active Development 47%
7.
7
Engineering, etc)
% Resources/investments Dedicated to New Product Development 41%
8. • Number of Products in Defined/Planning/Estimation Stages
A Study by Booz Allen showed no Correlation Between: 35%
9. − R&D to Sales Ratio, Projects Payback
Average Project ROI or AverageR&D to Sales Growth, R&D to Gross, Net Profits
31%
10.
10 Percentage Increase/Decrease in R&D Headcount 31%
• However, most Innovative Companies outperformed their peers with respect
to revenue growth, EBITA as a percentage of revenue, and market cap
growth
Source: industryweek May 2008
49 | 12/3/2012

50. Top 10 Innovators vs. Top 10 Spenders
80
Top Innovators
80 6
67 p p
Top Spenders
70 56
54
60
50 42
%40 35
30
20
10
0
Revenue Growth EBIT as % of Market Cap Growth
Revenue
5-yr CAGR 5-yr Ave 5-yr CAGR
Source: Booz Allen.
50 | 12/3/2012

51. Top 10 R&D Spenders
Rank Rank Company Spend % of
2010 2009 $Billion Sales
1 1 Roche Holdings $9.65 21.1%
2 5 Pfizer $9.41 13.9%
3 6 Novartis $9.07 17.9%
4 2 Microsoft
Mi ft $8.71
$8 71 14.0%
14 0%
5 14 Merck $8.59 18.7%
6 4 y
Toyota $8.55 3.9%
7 10 Samsung $7.87 5.9%
8 3 Nokia $7.78 13.8%
9 11 General M t
G l Motors $6.96
$6 96 5.1%
5 1%
10 7 J&J $6.84 11.1%
It is not How Much you Spend, It is How you Spend it!
Source: Booz Allen 2011
51 | 12/3/2012

52. R&D Spending - Medical Device Companies
16%
11.8% 11.6%
12%
10.6%
9.3%
9 3% 9.2%
9 2%
% of Total Sales
7.8%
8% 7.2% 6.8%
6.1%
4.8%
4%
0%
• Data for GE, Siemens and Phillips are for their healthcare business only
• J&J and Abbott numbers include the pharma spend
52 | June 6, 2012

53. Top 10 R&D Metrics Used By Industry
%C
Companied
i d
Metric Using Metric
1. R&D Spending as a % of Sales 77%
2. Total Patents Filed/Pending/Awarded/Rejected 61%
3. Total Current R&D Headcount 59%
4. Current-Year % Sales Due to New Products Released in Past X Years 56%
5. Number of New Products Released 53%
6. Number of Products/Projects in Active Development 47%
7. % Resources/investments Dedicated to New Product Development
p 41%
8. Number of Products in Defined/Planning/Estimation Stages 35%
9. Average Project ROI or Average Projects Payback 31%
10. Percentage Increase/Decrease in R&D Headcount 31%
“If you are Not Keeping Score, you are Just Practicing”
Vince Lombardi
Source: industryweek May 2008
53 | 12/3/2012

54. Key Components of Innovation / Product Leadership
Metrics
Balanced
Scorecard
Customers, Market Environment & Senior Mgt Team
ology Strategy
Performance
Goals
ENABLERS
orporate Strategy
DFSS &
Lean PD TOOLS
ment
Portfolio
Innovation & Techno
Outputs
Managem
Stage 5
Stage 4
Stage 2
Stage 1
ORGANIZATION
Stage 3
& PEOPLE
∑
Co
TECHNOLOGY
Gaps Between Actual
& Desired Goals
Lean/Sigma Design Product Development Process
Desired Goals
Best Practice Sharing
54 | 12/3/2012

55. Best Practice for Best Practice Sharing
• Establish a Process for Identifying Individual Best Practices
Throughout all Appropriate Areas of the Organization
• Create a Forum or Channel for Sharing Best Practices Formally.
Link it to Strategy
• Create a dedicated process/System with Clear Responsibilities
p
• Review Effectiveness of the Process and Improve
55 | 12/3/2012

56. Must Do For Medical Device Product Development
• Get Clinical Data Pre-Launch Rather Than Post Launch
• Consider Global Product registration Requirements Early in the
g q y
Process
• Integrate Package Design, Development and Validation into Product
Development Process
• Consider Sterilization Method Early in the Process
• Reimbursement Considerations - second largest barrier to market
entrance
• Direct Input from Healthcare Professionals
• Pricing Considerations early in the Process
56 | 12/3/2012

57. Summary - Achieving Success in Product
Design & Innovation - High Level
• Process Must be Led by Senior Management - Walk the Talk
• New P d t I
N Product Innovation and T h l
ti d Technology St t i Linked t
Strategies Li k d to
Corporate Strategy
• Portfolio Management – Alignment of Resources, Projects, Right
Markets etc.
• Multi Stage Product Development Process to Ensure:
– DFSS & Lean PD Tool Usage
– Regular Project Progress Reviews
– Robust & Reliable Product Designs
• Use a Balanced Score Card to Track Metrics and Provide a Closed
Loop System with Periodic System Assessments
• Share Best Practices
57 | 12/3/2012

58. “The world we have created today
as a result of our thinking thus far
has
h problems which cannot b
bl hi h t be
solved by thinking the way we
thought when we created them.”
Albert Einstein
Thank you
y
58 | 12/3/2012