eQMS in Academia: Practical Learning for Biomedical Engineering Students

Global Medical Device Podcast powered by Greenlight Guru

Have you ever thought about the versatility of an eQMS? As it turns out, the use of one medical device eQMS solution in particular is extending across multiple sectors.

In this episode of the Global Medical Device Podcast, Jon Speer talks to Renee Rogge and Devin Hubbard, two academic professors/faculty members of biomedical engineering programs which are involved with the Greenlight Guru Academic Partner Program.

Jon, Renee, and Devin discuss their work together in the program and Renee and Devin share their experiences using the eQMS from Greenlight Guru in the classroom and how it's helping students engage and better understand medical device risk and quality management concepts and practices.

Some of the highlights of this episode include:

• Introducing Greenlight Guru to students has helped them to understand eQMS and how they can take the things they learn in theory and apply them in practice.
• Biomedical engineers need to be taught design principles, technical writing, and how to conduct tests and case studies with a risk matrix.
• Students should have a working knowledge and understanding of quality and regulatory affairs to prepare them for real-world application.
• The traditional approach to teaching risk in an engineer setting is to focus on failure modes and effects analysis (FMEA) and design failure modes and effects analysis (DFMEA). However, this singular approach is not efficient and can leave some medical device risks undetected, resulting in harm.
• Case studies should include ways to be reasonable, realistic, and helpful in product design and quality systems to think about how other options could fail.
• It is challenging in capstone design to deal with risk. Capstone courses are overwhelming for students and difficult to teach. Tackle risk in manageable way.
• Students don’t like doing busy work associated with quality management and risk assessments, but there’s a reason for it: ensuring the safety of people using a device you designed.

Memorable quotes from this episode:

“Using Greenlight in particular, introducing that to our students has really opened a lot of eyes and doors for our students at understanding what quality management systems look like and how they can take the things they are learning in theory and then apply them in practice.” Renee Rogge

“There’s things that our students are getting out of an eQMS platform like Greenlight that they wouldn’t get if we were trying to do a paper-based system. There’s just subtleties and nuances that are built in that we don’t really have to teach. They can learn by experience.” Devin Hubbard

“It’s not just a bunch of checkbox things they have to do. It’s critical for the development of the product that they communicate their ideas because someone’s going to pick it up and run with it later.” Renee Rogge

“Risk is bigger than just a thing that you do as part of your design. It is a thing that drives your design.” Devin Hubbard

“I think it’s easy to make risk boring. I think it’s hard to make risk engaging in a way that is educational for the students.” Devin Hubbard

Links:

Renee Rogge

Rose-Hulman Institute of Technology

Devin Hubbard

University of North Carolina/NC State - Joint Biomedical Engineering Program

GuideWire Podcast

FDA - Medical Devices

FDA - Design Controls

FDA - 510(k) Premarket Notification

ISO 14971: Medical Devices - Application of Risk Management

GuideWire Podcast

Greenlight Guru Academy

The Greenlight Guru True Quality Virtual Summit

MedTech True Quality Stories Podcast

Greenlight Guru YouTube Channel

Greenlight Guru