Confidential
Evaluate the Risk Assessment at
Different Phases of Device
Development Cycle
Asmita Khanolkar, CeQur
March 28-30, 2017 | Minneapolis, MN
Confidential
CeQur Background
• CeQur was established in 2008
• Headquarters in Horw, Switzerland with Operations in Marlborough,
Massachusetts.
• CeQur is dedicated to helping people with Type 2 diabetes
• PaQ is a wearable insulin delivery device that delivers both basal and bolus
insulin for 3 days at a time.
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Asmita Khanolkar
• Manager, CeQur, Manufacturing Engineering & Operations
• Earned her Master’s degree in Material Science & Engineering from
Worcester Polytechnic Institute , Worcester, MA
• Over 20 years of manufacturing and automation scale-up experience,
specializing in the Medical Device industry
• Managed device projects starting from concept to high volume
manufacturing launches
• Product portfolio includes devices in diabetes management, surgical
devices, orthopedics, respiratory, cardio, patient safety, and health
monitoring devices, biomedical and cell regeneration devices, drug
delivery, sports regenerative surgery, blood collection,
pharmaceutical, diagnostics, needle protection, and airway products
• Presents, chairs, and participates in panel discussions at various
medical device conferences
• Volunteering activities include FRC Robotics Team Mentor, STEM for
Girls, Women in Engineering, Future Healthcare Professionals, Global
Outreach STEM initiative for underprivileged kids
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Overview
Evaluate the Risk Assessment at Different Phases of Device
Development Cycle
• Explore Solutions to De-risking the process from design through
manufacturing
• Evaluate the product cycle from start to finish
• Assess risk impact at different stages of product development
• Account for controls to minimizing risks
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Risk management process ISO 14971
Risk Management Planning
Risk Analysis
Risk Evaluation
Risk
Assessment
Risk Control
Risk
Management
Risk Management Report
Production and Post – production info
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Activities in Risk Analysis
Risk Management
Planning
•Cross functional
team
•Criteria for
acceptability
Risk Analysis
•Intended use and
safety
•Identify risks, factors,
hazards
Risk Evaluation
•Risk Acceptability
Decisions
Risk Control
Risk Management
Report
•Residual Risk
evaluation
•Risk/Benefit Analysis
•Review of overall risk
•Evaluation of overall
residual risk
Production & Post
production
information
•Monitor risk
•Review events
Risk Management Tools:
• Failure Mode Effects Analysis (FMEA)
• Failure Mode, Effects and Criticality Analysis (FMECA)
• Fault tree analysis (FTA)
• Hazard Analysis and critical Control points (HACCP)
• Hazard Operability Analysis (HAZOP)
• Preliminary Hazard Analysis (PHA)
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Examples of Risk Categories
Product Design
Product Performance
Test Methods
Technology
Safety
Efficacy
Power Consumption
Manufacturing
Material Processes
Equipment
Tooling
Supply Chain
Cleanliness
Measurement
Other Processes
System/Software
Manufacturing
Market
Data Accuracy
Market Calibration
Security
Customer Adoption
Maintenance
Reimbursement
Connectivity
Cost
Purchasing
Shipping
Incoming Quality
Process Capabilities
Validation
Inventory Management
Loss of Product
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Approach – “De-Risking Product Development”
Marketing
Unmet Need
QA/Regulatory
Requirements
R&D Product
Knowledge
Manufacturing
Process
Knowledge
Design Input
Intended use
Safety related
Characteristics
Hazard Analysis
Research prior
clinical trials
Fault tree Analysis
Device Use FMEA
Design Output
Design Failure
Mode and
Analysis (dFMEA)
Biocompatibility
risk analysis
Usability
Engineering
Analysis
(Formative)
Design
V &V
Process Failure
Mode and
Analysis
(pFMEA)
Usability
Engineering
Analysis
(Summative)
Clinical Report
Risk Analysis
Design
Transfer
Risk Control
Implementation
verification
Re-evaluate
pFMEA post
control
implementation
Clinical Patient
Studies
DESIGN CONTROL PROCESS
Product
Release
Risk Control
verification of
effectiveness
Complaint
and CAPA
processes
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Usability studies
Define uses,
users and use
environments
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•
Identify Hazards
Conduct device use FMEA
Unanticipated hazards (Formative)
Ensure strategies and controls are
effective in reducing risk
(Formative)
• Verify functional and operational
requirements of device
• Validate safe and effective use of
device (Summative)
Usability
testing
Device Use
FMEA
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Validation & Testing Based On Risk
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•
•
•
•
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Evaluate acceptance criteria based on risk
Risk Based Validation
Statistical Sampling Plan based on risk
Attribute and Variable assessment
Hazard Operability Analysis (HAZOP)
Preliminary Hazard Analysis (PHA)
High
Medium
Low
Supplier Controls
Vendor audit
Vendor
documentation
Approved supplier
Functional Testing
Test every lot at
extreme limits
Test under normal
and high loads
No testing
Audits
Regular
For cause
No audits
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FMEA
Input or
Function
Potential
Failure
Mode
Potential
Effect of
Failure
Determine
Severity
Potential
Cause
Current
Control
Determine
Occurrence
Determine
Detection
Calculate the Risk
Priority Number
11
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THANK YOU
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