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Usability, What We Learn From Post Market Use

Wednesday, April 11, 10:30-12:00
Meridian Ballroom 2/3, Graduate Minneapolis

Organizer: Richard Stein, Active Implantable Medical Device Expert, British Standards Institution

Panel Discussion:
Dean Hooper, Owner and Principal, HE Consulting
Robert North, Human Centered Strategies, LLC
Elisabeth Roche, Director of Research & Strategy, Ximedica


Session Abstract:

This panel will explore what usability lessons we can lean from the medical device users who are involved in formative testing, clinical trials, post market clinical follow-up and post market release. The FDA has published guidance and procedures on post approval studies. The EU has published the MDR that contains requirements for post market surveillance and post market clinical follow-up. The lessons learned may come from patients, caregivers, clinicians, technicians, journals, published studies, medical device registries, manufacturer’s complaint files, VA/FDA complaint databases or blogs. This panel will explore what was done, what can be done better and what we can convey to others in implementing usability in the medical devices and the process to develop the devices.


Session Organizer Bio:

Richard Stein is product expert in implantable medical devices reviewing submissions to Europe for British Standards Institute and has over 25 years developing medical devices for St. Jude Medical, Boston Scientific, Guidant and Starkey Hearing Technologies, incorporating Human Factors into devices. He has been on AAMI and IEC committees developing standards for human factors, safety/EMC tests and hearing aids. Richard advises the U of MN’s Biomedical Engineering Senior Design course on developing medical devices. Inventor and patent holder of various medical devices. Winner of the Design Excellence Award.


Speaker Bios:

Dean Hooper, Owner and Principal, HE Consulting
Dean is a regulatory human factors professional focusing on the detection  and analysis of human failure to make the (medical device) world a safer place.

Robert North, Human Centered Strategies, LLC
Bob North is a human factors consultant and expert on current regulatory trends in pre-market and post-market medical device compliance with FDA regulations. He has worked with over 100 manufacturers of medical products on analysis and testing of use related risk, and for the past 9 years, has been the faculty lead for the Human Factors short course offered by AAMI, and is a member of the AAMI human factors standards committee.

Elisabeth Roche, Director of Research & Strategy, Ximedica
Elizabeth has over 20 years of experience in the space of Human Factors and Design Research involving both consumer and medical products in the US, EU and emerging markets. Elizabeth is currently the Director of Research and Strategy at Ximedica, where her team is involved in Human Factors support across the end-to-end product development process.


Related Sessions:

Designing Medical Devices for People: Contextual Inquiry and Needs Analysis

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