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Effective Risk ManagementAlvin Tai
Founder, CEO
Why do we need Risk Management?
May 27, 2015
Don’t just execute the standards,learn and understand why they exist
● ISO 14971○ Application of risk management to medical devices
● ISO 13485○ Quality management systems
● FDA.gov
ISO 14971 is the industry standard
Risk Management Strategy
1) Risk Management Planning
2) Risk Analysis
3) Risk Evaluation
4) Risk Control
5) Residual Risk Evaluation
6) Risk Management Report/File
Hazard/FMEA Tables
Choose the right risk techniqueD
evel
opm
ent
Method Purpose
Hazard Analysis Identify hazards and drive design decisions
Application FMEA Identify user failures and prevention
Fault Tree Analysis Top-down approach starting with unintended consequences
Design FMEA Identify potential design failures from sub-component level
Process FMEA Identify potential process failures (i.e. manufacturing)
An example in Hazard Analysis
ID Hazard Foreseeable Sequence of Events
Hazardous Situation
Harm S P RI Risk Mitigation Verif. Residual (S)
Residual (P)
Residual (RI)
1 Electro- magnetic Energy
ESD causes pump and pump alarms to fail
Failure to deliver insulin unknown to patient with elevated blood glucose level
Minor organ damage
4 2 UN Information for Safety: warning in user manual
Protective Measures: notification when unit is not grounded
Inherent to Design: IEC 60601
PR152431.5.25
PR152431.6.21
PR152433.6.5
4 1 ACC
2 Decreased consciousness
3 3 ACC 3 2 ACC
3 Coma, death 5 2 UN 5 1 ACC
S = Severity LevelP = ProbabilityRI/RL = Risk Index/Risk LevelVerif = Verification
Evaluating risk in Montana
Risk Controls
● Bear Spray
● Bear Bag
● Make Noise
Trace risk control to test case
Hazard AnalysisFMEA
Reference to Product Requirement or
Test ReportProduct
Requirements
Reference to Test Step/Test Protocol/Test Report
Test Reports
Reference to Test Protocol Step
Test Protocols
Reference to Product Requirement
FDA guidance on risk management
● FDA QSR 820.30 - Design Controls● Submissions● Investigational Devices● Guidance Documents for specific devices● Software - SOUP/OTS - IEC 62304
Risk management doesn’t stop after R&D
Hazard Analysis
New Hazards
Adjust Risk Levels
New Product Development
Complaints
CAPAs
Non-Conformance
Reports
Change Orders
Service Records
It’s not just about compliance
1. fda.gov
Compliance
Business Risk
Patient Safety
658FDA Warning Letters
in
2014
It’s not just about compliance
1. “The Business Case for Medical Device Quality” - McKinsey and Company
Compliance
Business Risk
Patient Safety
It’s not just about compliance
1. 2014 FDA.gov2. Open.FDA.gov
Compliance
Business Risk
Patient Safety
It’s not just about compliance
1. 2014 FDA.gov2. Open.FDA.gov
Compliance
Business Risk
Patient Safety
Be proactive, not reactive
“Risk is like fire: If controlled it will help you; if
uncontrolled it will rise up and destroy you.”
Theodore Roosevelt
Future of the Medical Device Industry
● Mobile Health○ AliveCor, Glooko, Smart Monitor
● Personalized Medicine○ Theranos, 23andMe, Guardant Health
● Quality System and Regulation Maturity○ Electronic submissions, Single Audit Program
How Core Input is working with a changing regulatory landscape
● Cloud-based Complaint Handling
● Lower cost of maintenance
● Integrated compliance
Prioritize patient safety and reduce healthcare costs
Thank you
