Today we’re going to be talking to our good friend Mike Drues from Vascular Sciences about the intersection of usability and risk management. There are so many tips and great pointers that you will not want to miss this show! Have a pen and paper or your note-taking device available, because this episode is chock-full of information that you won’t want to forget.


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Some of the highlights of the show include:

  • What usability means and how it applies to the medical device production process.
  • Where the FDA stands on the topic of usability and what types of guidance documents are available.
  • How the topic is handled by international and world agencies in addition to the FDA, as well as how cultural differences can impact usability studies.
  • The difference between a usability study and a clinical trial. A usability study is focused on the user and a clinical trial is focused on the patient, but today, the two are often one and the same.
  • Why usability needs to be more “real-world.” Many times, what the engineer intends is not how the doctor or surgeon will actually use the device.
  • The importance of instructions for use and labeling, and how that relates to risk management.
  • The relationship between usability and product liability.


Mike Drues on LinkedIn

Vascular Sciences

IEC 62366

ISO 14971

MD&M East (Jon & Mike will both be speaking)

Should design controls have prevented the recent reprocessing tragedy: Do we need new regulation?

Greenlight Guru 

Quotes by Mike:

Usability and usability testing is even more important if the device is going to be used by the general public as opposed to a trained medical professional.

People in one part of the world might use a device one way, while in another part of the world, it’s used another way.

Usability needs to be thought of in a real-world sense.

About The Global Medical Device Podcast:

The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

Like this episode? Subscribe today on iTunes or SoundCloud.