pragmatic device risk management
DESCRIPTION
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 riskTRANSCRIPT
www.inea.com [email protected]
Boston: 100 Lowder Brook Drive, Suite 2500, Westwood, MA 02090 T: (781)801-1100Chicago: 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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• David Vogel, Ph.D.President and FounderIntertech 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 RaymondPrincipal Quality EngineerCordis® - a Johnson & Johnson companyAs 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.
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
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.
Why Formal Risk Managementis 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.
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.
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.
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
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.
Risks Cascade via Cause & Effect
RequirementDocument
Risk Document
Links To Effect
Links From Cause
ExampleEffect
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
Advanced RM ToolsMake it Happen in Real-Time
Configure the Requirement Types, Custom Data Fields and the Link Types
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
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.
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.
What’s Wrong with Severity?
Common Severity Scale1. Discomfort
2. Reversible Injury
3. Permanent Injury
4. Death
Scaling is linearIf 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.
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.
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.
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
Risk Scoring Matrix
Customize Risk Quantification templates Risk Score Matrix based on Probability of
Occurrence (Po) and Consequence of Occurrence (Co)
ConsequenceProbability
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
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?
Integrated RM Tools Give Visibility
Apply Risk Score to each hazard Consider number of “AND” conditions Apply Bayes’ Theorem of conditional probabilities
Shaft Breaks
Higher tensile force required to retract
shaft
High friction btwn shaft and SR
Lack of lubrication
Tight tolerances
btwn shaft & SR
High coef of friction, SR
High coef of friction, shaft
Additional forces applied to shaft by
user
Pinch shaft in SR
Shaft has low tolerance to tensile
force
High percent elongation of shaft
High percent elongation of raw material
Localized defect in shaft
Small kink occurs under SR
Defect built into shaft
or
or
and
and
or
Timing / Duration
and
or
high primary force, as built
Intra-Procedural Delay
Intra-Procedural Delay
HARM
HAZ-A
HAZ-D
HAZ-AHAZ-D
HAZ-DHAZ-D
HAZ-P
HAZ-P
HAZ-P
HAZ-A
Dealing with OverallRisk 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.
www.inea.com [email protected]
Boston: 100 Lowder Brook Drive, Suite 2500, Westwood, MA 02090 T: (781)801-1100Chicago: 475 Half Day Road, Suite 110, Lincolnshire, IL 60069 T: (773)915-2290
Questions & Answers
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