Ten Questions With ... Ed Margerrison.

Abstract

I helped out in my father's pharmacy when I was young, and some sort of healthcare was inevitable. I literally don't want to do anything else. What can be a better career than this?I was CEO of a small biotech company in Montreal before I joined the FDA. The excitement of being literally at the center of the whole product development process is something that nobody in their right mind would turn down.We are the equivalent of the R&D arm of CDRH. Our main function is to stay one step ahead of the technology that has been built into new devices, so when a manufacturer comes to CDRH for approval or clearance, we know what questions to ask. The thing that keeps me awake at night would be if somebody came to get clearance or approval for a new life-saving device, and we said, “Well, that's very clever, come back when we understand it better.” We can't let that happen.The second big priority is research to develop new methods and tools that we release publicly. Then if a device is evaluated by a manufacturer using one of our tools, we understand what the tool is. We don't have to ask questions about how it was tested. We can ask questions about safety and effectiveness. That makes the whole regulatory process more efficient.Being surprised every single day about the breadth of modern medical technology, and being massively impressed with the dedication, expertise, and ability of my colleagues.Balancing resources and priorities: both the short-term regulatory reviews and the enormously important regulatory science that we do, which will lead to more efficient regulatory processes. It's the equivalent of an R&D department in industry.Wondering what I'm going to do with all my suits and ties.The increase in focus on tools to help de-risk early technology and product development is the most profound for a long-term impact. Also, the increased focus on early biomarkers.It had a bad short-term impact as we basically stopped all lab-based regulatory research. We are now picking up again, but you can't just turn a large scientific organization off and on like a light switch.Being involved in products to regenerate articular cartilage in industry and meeting some of the patients who could walk again.Galileo—objective evidence and proof is everything in science, and opinion without evidence is irrelevant.