System and Product Design for Rapid Product Realization. Accelerating the process from inception to production.

1. Accelerating the process from inception to production
Michael Haessly - SSBB, CMQ/OE, CRE, CQE, CQA, CSQE
http://www.linkedin.com/in/michaelhaessly
Medical Device Manufacturing Summit – 2010

2. Today’s Presentation
Typical Product Realization Problems
Design Process Issues - System
Product Design Issues - Product
Common to all industries not just Medical Devices
Actions to achieve Rapid Product Realization
Current State Future State

3. Typical Product Realization
Greater Than Expected Less than Expected
Product Development Times Product Quality
Product Development Costs Production Efficiency
Implementation Hurdles (DFM) Supplier Quality/Delivery
Initial Production Scrap Rates ROI
Resource Needs Sales/Market Penetration
Customer Complaints Customer Satisfaction
Product Realization Times New Product Introduction Turns

4. Rapid Product Realization
Less than Expected Greater Than Expected
Product Development Times Product Quality
Product Development Costs Production Efficiency
Implementation Hurdles (DFM) Supplier Quality/Delivery
Initial Production Scrap Rates ROI
Resource Needs Sales/Market Penetration
Customer Complaints Customer Satisfaction
Product Realization Times New Product Introduction Turns

5. Current to Future State
Traffic Jam Autobahn

6. Product Realization Contributors
Marketing, Design Engineering, Manufacturing
Engineering, Supply Chain, Operations, Quality,
Regulatory and Sales all contribute to the speed by
which a company can bring new products onto the
market.
This contribution can be either positive or negative.
Teams can be rowing in sync or out of sync

7. Product Realization
Product
Design
Friction
• Lack of
Design
• Prioritization and Focus
Process
• Defined Processes
• Communication/Information Flow
• Resources

8. Product Realization
Product
Design
Synergy
Friction
• Lack of
Appropriate Level of
Design
• Prioritization and Focus
Process
• Defined Processes
• Communication/Information Flow
• Resources

9. Prioritization and Focus
Conflicting Priorities
#1 #1
#2 #2
#3 #3
#4 #4

10. Prioritization and Focus
Multiple #1 Priority Projects
#1
#1
#1
#1

11. Prioritization and Focus
Results in
Juggling
Multiple Directions
Lack of Focus
Solution
Provide Direction and
Focus

12. Prioritization and Focus
Results in
Juggling
Multiple Directions
Lack of Focus
Solution
Provide Direction and
Focus

13. Prioritization and Focus
Example:
Phase V Project
Importance:
Marketing Claim of Superior Performance
Action:
ALL employees informed - Top priority of the company.
Nothing was more important.
Task:
Tooling modification

14. Prioritization and Focus
Prior to Phase V During Phase V
Prod. Dev. Engineer Prod. Dev.
• 1 Day
Engineer
Mechanical Engineer • Immediately
• 3 Days
Machine Shop Supervisor Machinist
• 3 Days • Immediately
Machinist
• 2 Days
Prod. Dev.
Prod. Dev. Engineer
Engineer
• Job Done • Job Done

15. Prioritization and Focus
Result:
Beat competitor to market by 3 months
Gained 3 points in market share.
Reasons:
One #1 priority project (not multiple #1 priorities)
Departmental priorities were aligned
Everyone was informed (no question on priority)
Resources were made available when needed in the
amount needed
There were no wait times.

16. Rapid Product Realization
1. • Establish Common Organizational
Priority
Prioritization • Elimination of Multiple #1 Priorities

17. Defined Processes
Poor or Convoluted Simple Direct

18. Defined Processes
Poorly Defined Processes Well Defined Processes
Poor/changing DIR’s Well defined DIR’s
Incorrect/incomplete Correct and complete
deliverables deliverables
Foggy /missed time lines Time lines are met
Excessive resource usage Resource usage on target

19. Defined Processes
Customer Requirements (Inception)
Engineering Specifications
Product Development
Verification and Validation
Production (Realization)

20. Defined Processes
PHASE I
Customer Requirements (Inception)
• Feasibility
PHASE II
Engineering Specifications
• Development and Verification
PHASE III
Product Development
• Clinical Study and Validation
PHASE IV
Verification and Validation
• Commercialization
PHASE V
Production (Realization)
• Post Commercialization

21. Defined Processes

22. Defined Processes
PRODUCT DEVELOPMENT CHECKLIST APPROVAL MATRIX
O = Owner(s), S = Support, A = Approval * = Maintenance Project Owner
Maj.
Maint.
Stage 5 Prerequisite
Design Project Supply
Index Deliverable / Action To Move To ME QA Clinical Regulatory Operations
No. Engineering Mgmt. Chain
Next Stage
x x 5.1 Design History File (DHF)/Project Master File Filing X O S* S S S
Evaluate Commercialization Performance and
x x 5.2 X S S* S S S O S S
Trends
x x 5.3 Lessons Learned Meeting/Project Planning Review X S S* S S S O S S
x x 5.4 Stage 5 (Post Commercialization) Review X O S* S S S S S S
X O S* A A A A S A

23. Defined Processes
2 - Development and Verification
• Biocompatibility Testing Protocol/Report (VEP,VER), Design Input Requirements –
Updates (DIR), Design Verification Protocols and Reports (VEP, VER), Device
Master Record (DMR), Equipment Validation Installation Qualification (IQ),
Operational Qualification (OQ), Product/Process Qualification (PQ)
Protocol/Report (as needed), Hardware Software Architecture (HSA), Instructions
for Use (IFU), Packaging Development Testing (Distribution /Stability/Shelf Life)
Protocol (VEP, VER), Pre-validation regulatory submission documents, Product
Drawings and Component Specifications (DD, AD, CS, etc.), Product FMEA (FME),
Product Manufacturing Instructions, Quality Inspection and Test Plans and
Records (MI, II, IR, MQR, TI, TR), Product Requirements Tracing Matrix (RTM),
Product/Usage/Manufacturing Process FMEAs (FME), Regulatory Path
Assessment (RR) , Risk Management Documents (RMP, RAR, RCR, RMR), Software
Architecture Specification (SAS), Software Requirements Specification (SRS),
Software Validation - Product (VAP, VAR), Sterilization Efficacy/Assessment Test
Protocol and Report (VEP, VER), Supplier Qualification Activities including
Surveys and Audits
• Phase II – (Development and Verification) Review and Design Freeze

24. Rapid Product Realization
• Phase Gate Approach
2. • Defined inputs and
Well deliverables
• Decision points and criteria
Defined • Responsibilities for ownership,
support and approval
Processes • Training on the process

25. Communication/Information Flow
Specialized areas of
knowledge Marketing
Required by others to do
their job efficiently Sales
Engineerin
g
Key to Rapid Product
Realization Product
Realization
Collective Intelligence
Information shared by Quality Production
entire team
Correct information Regulatory
available at the right time

26. Communication/Information Flow
Marketing Engineering Production Regulatory Quality Sales

27. Communication/Information Flow
Result – Repetition (i.e. Rework)
Design Verification and Validation Builds and Testing
Regulatory Submissions
Clinical Trials
Missed Deadlines
Incomplete testing
Poor quality

28. Communication/Information Flow
Solution
Collective Intelligence
The Borg
A collective of assimilated
individuals, linked up into a
"hive-mind," which operates
at an emergent level above
the members, combining the
intelligence of each with
synthetic components (i.e.
computers and other
hardware) to create a super-
intelligent, nearly
indestructible entity.

29. Communication/Information Flow
Critical Information – Not Communicated or Shared
Marketing
Complete customer needs and market analysis
31% succeeded with poor homework
75% succeeded with superb homework
Regulatory
510(k) or PMA submission requirements
Reduce resubmissions
Operations
Equipment/Process capabilities, limitations
Capability or Capital Equipment

30. Communication/Information Flow
Critical Information – Not Communicated or Shared
Supply Chain
Supplier capacity & delivery capabilities
Supplier response times to changes in sales
Engineering
Proper dimensioning, tolerancing
Critical inspection requirements
Quality Assurance
Statistical confidence and sample size requirements
Sterilization validation requirements and timing
CADD models are perfect, parts are not

31. Rapid Product Realization
• Information must be
• Complete
3. • Accurate
Communication
• Available at the right time
/ Information
• Available to the entire team
Flow
• Teams must have a Collective
Intelligence to be efficient

32. Resources
Quantity
Lean is GOOD. Too Lean is BAD
Corners are cut & vital activities are omitted.
Market deadlines are missed
Projects are "dumbed down“
Morale suffers
Experience
Function
Empowerment

33. Rapid Product Realization
• Quantity
4. • Experience
• Function
Resources • Empowerment

34. Rapid Product Realization
• Establish common priority
Prioritization • Elimination of multiple #1 priorities
Well Defined • Defined inputs, outputs, decision points
Processes • Ownership, support and approval
Communication / • Collective intelligence
Information Flow • Correct information at right time
• Quantity, experience, function,
Resources empowerment

35. Thank you - Questions
http://www.linkedin.com/in/michaelhaessly