Learn about common misconceptions on medical device risk and design controls. This presentation originally aired during the 2022 Future of QMS Requirements Virtual Summit.

1. FINALLY, A NEXT-GEN CRO
Common Misconceptions
on Medical Device Risk &
Design Controls
www.ProximaCRO.com

2. Rob MacCuspie, Ph.D.
Quality & Regulatory Manager
rob.maccuspie@ProximaCRO.com
• Led 30+ medical device regulatory projects, including:
• 510(k)
• De Novo
• Pre-Submission meetings
• Breakthrough Device Designations
• Regulatory Strategies and Assessments
• EUA and Pre-EUA
• 513(g)
• Wellness devices
• Built Quality Management Systems from scratch
• 7+ years in medical device industry
• 7 years National Lab experience
• Florida Polytechnic University – First Faculty
• 45 peer reviewed publications – 3,800+ citations
Your Presenter Today

3. Common Misconceptions on Medical
Device Risk & Design Controls
Risk
• “Risks can be mitigated without having
completed that part of our QMS”
• “It’s so unlikely we don’t need to write that one
down”
• Reporting Risk Incorrectly - Jumping ahead on
Frequency
• Reporting Risk Incorrectly - Jumping ahead on
Severity
• One person can think of every risk
Design Controls
• “We can design now and wait to start our QMS”
• Design Controls must be perfect the first time
• Design Controls can never change
• Design Controls can always change
• Design Controls must be developed in a specific
order
• Not setting acceptance criteria or ranges

4. Poll #1
C
I’ve contributed to one or am working
on one now
A Never
Have you made a medical device risk matrix?
D I’ve contributed to many
B
I’ve reviewed them but not created
them

5. RISK

6. “Risks can be mitigated without having
completed that part of our QMS”
§ “Both and” thinking…
§ While true, risks can be identified and
mitigated even in the “back of the napkin”
ideation stage (and should!)…
§ If it isn’t documented in the QMS, it didn’t
happen
Every auditor
I’ve ever met:

7. “It’s so unlikely, we don’t need to write that one down”
• If it isn’t documented,
it didn’t happen
• Take credit for the
work you are doing
• Make the risk matrix
work for your device
• Can be 3x3, 4x4, or
5x5

8. Say what you do, do what you say
• Your team knows your device
better than anyone else
• What works for one device
may not work for another
device – make it work for your
device and company
• Risk tolerance, and Benefit-
Risk Analysis

9. Poll #2
C 5 x 5
A 3 x 3
What size risk matrix does your company use?
D We don’t have one, yet
B 4 x 4

10. Reporting Risks Incorrectly – Jumping Ahead on Frequency
Example #1: Push-Button Cover
Mitigation: Push-button cover
Result: Reduced frequency of
accidental button push
Where visionaries live How it started
§ Being a visionary, and connecting
dots others haven’t seen yet, is a
strength of founders and inventors
§ Risk analysis requires going back
to the current SOC, or the design
before the feature was added, and
walking readers through

11. Reporting Risks Incorrectly – Jumping Ahead on Severity
Example #2:
Sharp table corners
Reduced hazard severity from sharp corners

12. ONE PERSON CAN THINK OF EVERY RISK

13. DESIGN CONTROLS
aka – Taking credit for all the hard work invested in designing this device

14. Poll #3
C
I’ve contributed to one or am working
on one now
A Never
Have you written medical device design controls?
D I’ve contributed to many
B
I’ve reviewed them but not created
them
Can include User Needs, Design Inputs, Design Outputs, Design Verification, Design Validation

15. “We can design now and wait to start
our QMS”
Every auditor I
haven’t met:
§ While true, design starts in the “back of the napkin”
ideation stage (and should!)…
§ If it isn’t documented in the QMS, it didn’t happen
§ Quality System compliance is required by law, under
21 CFR 820.
§ Delaying a QMS is a snowballing debt - if you don’t
do today’s work today, you have twice the work
tomorrow.
§ No Design Controls = No Device!

16. Design Controls have to be perfect the first time
§ Perfection is not required
§ Perfection is extremely rarely achieved the
first time…
§ To auditors, not documenting what you did to
get where you ended up likely means you
weren’t following your own documentation
controls – red flag to start digging deeply to
find what other controls were not being
followed

17. Design Controls have to be perfect the first time
§ Revisions show dedication to trying things
until they work
§ Design controls can be revised even after
design reviews, if data from verification or
validation reveals a need for design changes
§ Many examples of this happening

18. Design Controls can always change
§ At some point, you have to launch v1 and tell the
R&D team to keep those improvements for v2
§ Are you fixing v1 so it can launch, or making
a better v2?
§ Yes, it’s frustrating to have v2 ready and not
have it get to market for some time
§ Wouldn’t it be more frustrating to have v1
never launch and help patients, because
later v3 is delaying v2 and v1?

19. Design Controls must be developed in a fixed sequence
§ Yes, User Needs drive Design Inputs which
drive Design Outputs which drive Design
Verification
§ Teams may identify a single user need
then work through to the verification tests
§ Teams may identify all the user needs,
then all the design inputs, then all the
design outputs
§ Yes, Design REVIEWS generally follow a fixed
sequence
§ Assuming you SOPs allow…
§ A design review can be partial (e.g., some
user needs but not all)
§ A design review can be for all of one stage
(e.g., all user needs)
§ A design review can be for multiple stages
(e.g., all user needs and all design inputs)

20. Not setting acceptance criteria or ranges
§ How do you define success?
§ Why is that target acceptable?
§ Why is that range acceptable?
§ What data do you have, or need to
collect, to support this?
§ Not providing scientific justification
for the selections

21. Setting Acceptance Criteria Example
§ User need: fit through patient anatomy (say 5 mm)
§ What is the tolerance that is acceptable?
§ ±1µm? Clearly not from cost of manufacturing
§ ±1cm? Clearly not from anatomy requirements

22. THANK
YOU
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