Medical Product Safety presented at FDA/OCRA conference 2009

1. Jack Dhuwalia
MS, MBA, DTM
President, JD Consulting

2. Topic
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3. © JD Consulting, 2009 3

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5. Presentation of Ideas
• My background
• Flow-chart
• From my experience
– Note areas creating conflicts
– Set-ups
– How to prevent
• Take-aways
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6. Background
• Technical education
• Consumer foods
• Medical devices since „79
• Problem solving - RA/QA, systems, design and
manufacturing
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7. TYPICAL NEW PRODUCT INTRODUCTION
PROJECT DESIGN & PROTOTYPE
START DESIGN
DEVELOP- BUILD &
FREEZE
MENT TEST
S
VERIFICATION PILOT CLINICAL
SCALE UP
& VALIDATION PRODUCTION TEST
TRANSFER INITIAL LOTS
FULL INVENTORY
TO PROCESS V
PRODUCTION BUILD
PRODUCTION & DESIGN V
A
MARKETING
FULL PROJECT
SALES & MARKETING
MARKET COMPLETION
LOGISTICS TESTS
RELEASE
READY
© JD Consulting, 2009 7

8. Areas Creating Conflict
• Usually starts before it really starts
– Company culture
– Reward/bonus system (often significant)
– PMOs for the directors/VPs
– Market/time pressures
– Resources inadequate – more with less
• Leader is now assigned – let‟s move on
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9. Team Leader
• Usually a good engineer/performer
• Often lacks experience in leading multi-functional
teams
• Often doesn‟t have clinical experience to really
understand how the product is used
• Often doesn‟t have access to top management
when problems develop
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10. Project Plan
• Often missing
• Doesn‟t look at the whole picture
• Tends to get bogged down in details too early
• Interfaces often missed
• Plan not really reviewed, updated
• Plan considered merely an “activity” to satisfy
Design Control Requirements
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11. Design Input
• Probably the second most problem area
• Not enough understanding of the market needs or
user needs
• Typically projects are R&D driven – works fine
until it meets market
• Too much detail - thinks in terms of “inside the
walls” and misses the “market-needs”
• Not really used as a live document
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12. Prototype Build & Test
• The best opportunity for real R&D (my opinion)
• Often rushed into design freeze
• This is where “maturity” and “integrity” meets
“reality”
• Prefer to see QE involvement at this stage even if
no test protocols are required – relationships
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13. Design Freeze
• Good place to be, often premature
• It will come back to haunt you – corollary of
Murphy‟s Law
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14. Design Verification
• Goes through routine verification tests
• Problems usually ignored – hoping they‟ll go away
– they seldom do!
• Tendency is to pass “questionable” test results
FACT:
It costs less to fix it now than later.
—Jack Dhuwalia
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15. Design Validation
• Not really “official” since the product doesn‟t
simulate real production
• I suggest performing some degree of validation
testing as a “sanity check” of the design (I
suppose I‟m getting into prevention, huh?)
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16. Pilot Build
• First “taste” of manufacturing
• Usually built by R&D technicians (prefer trained
manufacturing technicians)
• Usually for developing test batches for data
collection resulting in submissions and or clinical
trials
• Relationships – between R&D and manufacturing
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17. Scale-up
• Third most significant area of concern
• Depends upon who is in-charge at this stage and
the experience level
• Often manufacturing is not really interested until
they perceive that the product is “real” (most
products don‟t make it to manufacturing) –
companies often don‟t wait for clinical trials to be
complete
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18. Production Transfer
• Documentation is usually lacking – rush may
cause incompleteness or inaccuracies
• Labeling and artwork fall behind
• Project leadership must transfer smoothly or
problems arise
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19. Process and Design Validation
• Pressure mounts – confusion starts
• Process validations might be performed by people
unfamiliar with processes and equipment – big
problem, mistakes
• Opportunity for a thorough design validation often
missed. DV must look at user needs and
intended use and often it gets lost in translation.
Fourth significant concern.
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20. Take-away
• Design Input is a live document – use it!
• Really understand market, user and regulatory
requirements
• Prototype build & testing is the best R&D
• Fix problems before scale-up
• Perform an in-depth design validation
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21. Market Release
• Of all design reviews, I believe that this is the
most significant since the company has one more
chance to take a look.
• Having said that, it is usually too late to stop the
train.
• Keep your fingers crossed.
• Hope that you won‟t have to say “I‟m sorry!”
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22. Other information
• Contact Jack Dhuwalia
– Email: jdhuwalia@jdconsultingsite.com
– Phone: 949-854-4534
– www.jdconsultingsite.com
• FDA
– www.fda.gov/cber biologics
– www.fda.gov/cder drugs
– www.fda.gov/cdrh devices
• OCRA website - www.ocra-dg.org
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23. © JD Consulting, 2009 23