The medical device industry needs your help.
Real Problem# 1
FDA Recall 'Epidemic'
The chart at right started the 'problem'. An FDA report (Medical Device Recall Report FY2003 to FY2012 had this chart and later the comment "The annual number of medical device recalls increased by 97 percent from FY 2003 to FY 2012". And, at the end "FDA will continue to use recall information to better inform our decision-making across the total product lifecycle, provide guidance to industry, and help identify firms and device areas for inspection and appropriate, targeted interventions."
Fast forward to 2016 and a Medical Device and Diagnostic Industry magazine cover article, titled "Medtech’s Recall Epidemic" reports a record high number of FDA medical device recalls in 2014. The authors, Joshua R. Dix, Suraj Ramachandran, and Darin S. Oppenheimer, blame manufacturers and their poor risk management.
The authors may have had good intentions. But, they didn't give any specific guidance. Doing more of the same will not help. The industry needs to learn how to do risk management differently.
'Epidemic' vs. Economics
The chart at right shows what's really going on. There has been a rise in FDA recalls since 2012, but this correlates with the number of new medical device introductions. More devices means more recalls. It's more economic than epidemic.
The real problem is that new device company risk management is not any better than what older companies do. And, everybody struggles. So the industry needs to find and learn a new and better way to do risk management that is more aggressive and probes deeper.
FDA Compliance Crisis
FDA Recall Prescription
• Aggressive risk management using Detection that systematically mitigates more faults and drives down failure probabilities.
• Iterative approach that increasingly mitigates known faults and finds more unknown failure modes to incrementally exceed global and proprietary standards of quality and safety.
• Embedded learning program that leverages knowledge of past risks and contributes new risks and info as corporate proprietary assets.
• Integrated project teams and risk teams.
• Internal tracking of fault/failure modes and risks for meetings, for reporting and for interfaces required by analysis.
• Interfaces to software via API for Failure Mode and Effects Analysis (FMEA) and Fault Tree Analysis (FTA).
FDA Compliance Prescription
A project management platform that holds and enforces an organization's Quality Management System, supports medical device manufacture using aggressive risk management, and generates project communications and compliance documentation for history files and records.
• Effective and efficient meetings
• Comprehensive and efficient reporting
• Task tracking to completion
• Internal "For the Record" chat channels that form a permanent record for each issue, task, meeting, report, and project, etc., and help document compliance.
• Stakeholder alerts for reviews
• Automatic reminders & update alerts
• Relay of chat messages to team member or stakeholder email and texts via API
• Integrated document management for each issue, task, meeting, report, project, and community / QMS
Better risk management
Fewer device defects
Fewer FDA recalls
Better industry reputation
Fewer design errors
Fewer 483 observations
Fewer warning letters
Better task performance
Fewer missed deadlines