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Is Poor Risk Management Holding Your Medtech Company Back?

Is Poor Risk Management Holding Your Medtech Company Back?
Medical device companies can increase efficiency by tightening up their risk management practices.  

Medical device companies can increase efficiency by tightening up their risk management practices.

Jamie Hartford

Efficiency is the name of the game for medical device companies today, and one way for manufacturers to get their products to market faster and at lower cost is to take a close look a their risk management practices.

“Addressing risk management deficiencies is a low-hanging fruit that yields positive results across the board,” says David Amor, managing partner at Medgineering, a Minneapolis-based firm providing remote quality systems, regulatory, remediation, and compliance consulting.

That’s because risk management pervades nearly every step of medical device manufacturing.

“Risk management drives 99% of decisions for medtech companies—from receiving and inspecting product to handling and addressing postmarket deficiencies,” Amor says. “Not having a robust system that impacts so many daily decisions leads to compliance issues, product issues, and quality issues.”

For those that want to tighten up their risk management practices, Amor will be leading a free course, “Practical Risk Management: How to Integrate ISO 14971 into Your Product Development Cycle” from 2–3 p.m. Eastern April 28–30, 2015.

The course, which is sponsored by EtQ, a provider of integrated quality and FDA compliance management software, will focus on the basics of the ISO 14971 standard for application of risk management to medical devices.

The first class will provide an overview of the standard and explain how to integrate it into your company’s product development process and design controls at various stages. Day 2 will spotlight risk analysis techniques such as failure mode and effects analysis and fault tree analysis. The final day of the class will highlight postmarket risk—an especially timely topic because complaint files and poor postmarket surveillance integration with a product’s risk management file have been among the top three findings in FDA warning letters since 2007.

Amor, who has consulted on risk management remediation at several Fortune 500 medtech companies, says integrating risk management remains a struggle for firms of all sizes.

“I see a lot of issues with companies that aren't familiar with how to integrate risk management with non-product development tasks,” he says. “Like we cover in the course, the risk management file should have inputs like complaints, process capability, and new clinical data for products while impacting other quality management system processes like CAPA and supplier controls.”

Amor says those who attend the free class will come away with knowledge they can use to help their companies improve their risk management processes.

“The course is geared towards anybody who wants real, practical information that isn’t ‘Google-able’,” he says. “I reference information from previous risk management remediation projects and break things down in a nutshell so that attendees get actionable insight, not just a listing of ISO 14971 text.” 

Jamie Hartford is MD+DI's editor-in-chief. Reach her at [email protected] or on Twitter @MedTechJamie



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