AAMI News January 2018

One on One: Rob Menson

Rob Menson
Rob Menson
is the owner and manager of Menson & Associates, a Sarasota, FL–based medical device and pharmaceutical consulting firm specializing in design controls, risk management, and quality systems. Menson also is a faculty expert for AAMI University’s Quality System Requirements and Industry Practice course.

How did you first get interested in risk management?

I first got interested in risk management as an adjunct to my interest in design controls. The consulting firm I was working for asked me to teach a failure modes and effects analysis (FMEA) class for a client. At that time, FMEA was considered to be synonymous with risk management, which it really isn’t. The class I taught was based on the automotive FMEA process. The consulting firm then asked me to adapt the automotive FMEA to use in the medical device industry.

At the same time, the E.U. recognized the need for a risk management process to fulfill the requirements for the Medical Device Directive of 1993. I switched from developing the FMEA course to one aligning with the nascent risk management standard, which eventually became ANSI/AAMI/ISO 14971, Medical devices—Application of risk management to medical devices.

What is the biggest mistake medical device manufacturers make when it comes to risk management?

The biggest mistake is not starting the process early enough to help drive design decisions.

How can this be addressed?

We have to show companies that risk management is a great business process and not just a bureaucracy established by regulatory authorities.

What is the biggest opportunity for medical device manufacturers in 2018?

I see the biggest opportunity being the move toward a single quality system standard worldwide, ANSI/AAMI/ISO 13485, Medical devices—Quality management systems—Requirements for regulatory purposes. Although there will be work required to adapt to the global regulatory environment for some companies, in the future, the benefit will be a less complex quality system.

Why is it important for quality system professionals to learn about ISO 13485 in addition to the FDA’s Quality System Regulation?

As long as a company does not plan on entering foreign markets, knowledge of the FDA regulation may be sufficient. Once a company plans on being a more global player, then understanding 13485 is mandatory. It is widely accepted as a quality system in a large part of the world, including the E.U., Canada, Australia, and New Zealand. Also, as I understand it, the FDA under an executive order has established a task force to evaluate the feasibility of adopting the standard in lieu of the Quality System Regulation.

What is the best part of being an AAMI University faculty member?

The best part of my AAMI faculty assignment is the association with other faculty members and the ability to share my knowledge with the students in class, especially those few “aha moments” when something really clicks for a student.

What do you like to do outside of work?

My passion for many years has been boating. Originally, I sailed my own boat, and now I help run sailboat races.

What is something people might not know about you?

My wife, Margo, and I took two months off in 1998 and traveled around the world with a focus on wine and food.