In this presentation, which was recorded at the 2013 Medical Devices Summit West in San Francisco, David Vogel of Intertech Engineering and Aimee Raymond of Cordis discuss some current problems and solutions in medical device development, including how to: - Manage the real hierarchy of harms, hazards, and causes - Prioritize and manage risk - Implement traceability to ensure risk controls have been implemented correctly - Deal with overall risk assessment and residual risk

1. www.inea.com info@inea.com
Boston: 100 Lowder Brook Drive, Suite 2500, Westwood, MA 02090 T: (781)801-1100
Chicago: 475 Half Day Road, Suite 110, Lincolnshire, IL 60069 T: (773)915-2290
Pragmatic Medical Device Risk Management
Current Problems and Solutions
David A. Vogel, Ph.D. – President – Intertech Engineering Associates, Inc.
Aimee Raymond – Principal Quality Engineer – Cordis®
- a Johnson & Johnson company
© 2013 – Intertech Engineering Associates, Inc.
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2. • David Vogel, Ph.D.
President and Founder
Intertech Engineering Associates, Inc.
Dave has been helping medical device companies bring quality products to market for over 30 years, with a 100%
safety record with his company. He has participated in joint AAMI/FDA workgroups to develop standards for validation
and risk management, like IEC 62304, TIR32:2004, and TIR36:2007. As an AAMI instructor and respected industry
expert, he was named by MD&DI magazine as one of the “100 Notable People in the Medical Device Industry” in
2008.
Dave published “Medical Device Software: Verification, Validation, and Compliance” in late 2010, which is
considered a must-read by most in the medical device industry, especially since it’s much easier to read and
understand than our government regulations and recommendations.
• Aimee Raymond
Principal Quality Engineer
Cordis®
- a Johnson & Johnson company
As a Bay-area professional with over 20 years of experience in product development and systems engineering,
Aimee has helped bring many medical products to market with an emphasis on good processes and strong quality
control. Armed with a Six Sigma Black Belt, she has been successful with deriving requirements and driving them to
measurable data points for better decision making in the development of her projects. As part of her current role at
Cordis, she has implemented an integrated and traceable solution for design and risk control.
Aimee recently received a Masters of Science in Systems Engineering.
About Speakers
© 2013 – Intertech Engineering Associates, Inc.

3. More detail …
3
© 2013 – Intertech Engineering Associates, Inc.
Much of the content of this talk is covered in more detail
in Chapters 8 and 18 of this textbook.
For more information, see www.validationtext.com

4. Zoom Out on Risk Management
• Do we as an industry really know what we
are doing with Risk Management?
• With all the regulatory “help”, standards,
technical information reports, guidances,
webinars, workshops … has the industry
really improved?
© 2013 – Intertech Engineering Associates, Inc.

5. Why Formal Risk Management
is Needed
1. As a design and development tool
2. As a focus for continued post-market attention to RM
3. As a communication tool
a. Internally
b. With regulators
Which of these makes the devices safer?
Which are necessary for compliance?
Which do many companies worry about more?
© 2013 – Intertech Engineering Associates, Inc.

6. Many Types of Risk
• Safety Risk
• Business Risk
– Project Risk
– Sales and Marketing Risk
– Image and Reputation Risk
• Regulatory Risk
© 2013 – Intertech Engineering Associates, Inc.

7. Risk Hierarchy
14971 Standard defines or mentions:
– Risk
– Hazard
– Hazardous Situation
– Cause
Real projects easily identify complex
hierarchies that don’t fit these definitions
© 2013 – Intertech Engineering Associates, Inc.

8. Requirements & Risk
Work Together
 Requirement management drives
product development
 User Needs/Intended Use [UR]
-> Product Requirements [DI]
-> Detail Design Specification [DO]
-> PRC, DWG, BOM, DOC (code)
 Risk management asks what happens if
the requirement is not satisfied

9. Typical Requirement Cascade
Requirement
Document
Sample Requirement
Intended Use to improve long-term vascular patency following
angioplasty by releasing drug locally into the vessel
wall to inhibit neointimal hyperplasia.
User Requirement
[UR]
Stent reservoirs must contain similar drug API dosage
as current marketed product.
Product
Requirement [DI]
Provide API drug dose of X.X µg/mm2
Detail Design [DO] Every reservoir contains Y.YYY µg of drug.
API concentration in drug solution shall be ZZ%
Process Spec
[PRC]
Deposit X layers of drug solution.
Place Y to Z drops of drug solution per reservoir per
layer.

10. Risks Cascade via Cause & Effect
Requirement
Document
Risk
Document
Links To
Effect
Links From
Cause
Example
Effect
Example
Cause
IFU Harms list Patient
harmed
Not (UR) Increase in
neo
hyperplasia
Not X.X
µg/mm2
User Need
(UR)
aFMEA Not (UR) Not (DI) Not X.X
µg/mm2
drug
Not Y.YY
µg/reservoir
Prod Req (DI) dFMEA Not (DI) Not (DO) Not Y.YY
µg/reservoir
Bad seal
Detail Design
(DO)
pFMEA Not (DO) Not (PRC) Bad seal Open crimps
Process Spec
(PRC)
Control Plan Not (PRC) Not (RCM) Open crimps Crimp force <
Z.z
Controls
(RCM)
Not(RCMl) Crimp force <
Z.z
Wrong pin
gage

11. Advanced RM Tools
Make it Happen in Real-Time
Configure the Requirement Types,
Custom Data Fields and the Link Types

12. Lack of Requirements Corrupts
 Without requirements, then nothing to
trace
 Between requirement types
 To testing
 To risks & issues
 To changes
 Risks are another type of requirement
 Traces are the glue holding the system
together

13. Questions for You
Has anyone ever heard of someone “fudging” the
risk priority numbers?
Why do “they” do that?
Maybe something is wrong with the way we
prioritize risks
© 2013 – Intertech Engineering Associates, Inc.

14. The FMEA Model is Overused
• Risk = “combination of Severity (S) and
Probability (P)”
• Often Detectability (D) also included
• Quantitative FMEA calculates Risk Priority
Number (RPN) as
RPN = S x P x f(D)
• Risk controls are prioritized based on RPN
© 2013 – Intertech Engineering Associates, Inc.

15. What’s Wrong with Severity?
Common Severity Scale
1. Discomfort
2. Reversible Injury
3. Permanent Injury
4. Death
Scaling is linear
If you would pay me $1 not to pinch you (discomfort),
would you only pay me $4 not to kill you?
© 2013 – Intertech Engineering Associates, Inc.

16. What’s Wrong with Probability?
• Historically used for probability of process
failure, mechanical failure, electrical
failure, where probability has real meaning
based on measurements or experience.
• Design failure (esp. software) is the
probability that the engineer made a
mistake … what kind of number do we put
on that?
© 2013 – Intertech Engineering Associates, Inc.

17. Detectability
• Holdover from Process FMEA, with built in
assumption that trained process operators
know remedial action upon detection.
• Very often misapplied to devices
– Detectability is worthless unless a corrective
risk control is triggered in response.
– A car rolling over a cliff is
highly detectable, but …
© 2013 – Intertech Engineering Associates, Inc.

18. Risk Quantification Templates
 Templates for Probability of Occurrence (Po)
and Consequence of Occurrence (Co)
Consequence of
Occurrence
Low Minor Moderate Significant High
Product
Performance
Impact
No illness or injury to
patient or user
(inconvenience; delay to
start; procedure was
successful, but slow to
perform).
May cause transient self-
limiting illness or injury to
patient or user (fever,
bruise, or other condition
not requiring medical
intervention).
May cause significant but
recoverable injury to
patient or user (allergic
reaction, or other
condition requiring
medical intervention).
May cause permanent
impairment to patient or
user (loss of limb or
bodily function).
Potential for death.
Failure in the device or
the procedure can lead to
patient or user death.
Regulatory Impact
Potential for issue
resolvable with normal
quality system
procedures.
Potential for minor
deficiency or violation of
quality system.
Potential for regulatory
warning, product deemed
misbranded or
adulterated.
Potential for significant
regulatory observation,
including warning letter
Potential recall regardless
of clinical severity.
Potential adverse impact
to regulatory status of
product
Schedule Impact
Impact to project critical
path < 1 month
Impact to project critical
path >= 1 month
Impact to project critical
path >= 3 months
Impact to project critical
path >= 6 months
Impact to project critical
path >= 12 months
Cost Impact
Cost variance < 10% or <
0.1M USD of total budget
Cost variance >= 10% or
>= 0.1M USD of total
budget
Cost variance >= 20% or
>= 1M USD of total
budget
Cost variance >= 50% or
>= 5M USD of total
budget
Cost variance >= 100% or
>= 10M USD of total
budget
Probability of
Occurrence
A B C
Probability of Root
Cause Occurring
Likely Maybe Remote

19. Risk Scoring Matrix
 Customize Risk Quantification templates
 Risk Score Matrix based on Probability of
Occurrence (Po) and Consequence of
Occurrence (Co)
Consequence
Probability
A B C
Low 1 1 2
Minor 1 2 3
Moderate 2 3 4
Significant 3 4 4
High 3 4 5
High
Moderate
Low

20. How Do You Know You Have
Addressed All Risks in Your Device
Risk Management Process is effective in
planning risk controls
 How can you know that the controls have
been implemented … correctly
Traceability can be the answer. How is
that implemented?

21. Integrated RM Tools Give Visibility
 Apply Risk Score to each hazard
 Consider number of “AND” conditions
 Apply Bayes’ Theorem of conditional probabilities

22. Dealing with Overall
Risk Assessment
• 14971 – “There is no preferred method for
evaluating overall residual risk and the
manufacturer is responsible for
determining an appropriate method”
That is … you’re on your own.
• For some reason, devices don’t deal with
residual risk as objectively as pharma …
there seems to be a presumption of
achievable perfection
© 2013 – Intertech Engineering Associates, Inc.

23. www.inea.com info@inea.com
Boston: 100 Lowder Brook Drive, Suite 2500, Westwood, MA 02090 T: (781)801-1100
Chicago: 475 Half Day Road, Suite 110, Lincolnshire, IL 60069 T: (773)915-2290
Questions & Answers
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© 2013 – Intertech Engineering Associates, Inc.
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