Episode Thumbnail
Episode 104  |  35:35 min

Greenlight Guru In the Classroom: A University's Real-world Approach

Episode 104  |  35:35 min  |  11.07.2019

Greenlight Guru In the Classroom: A University's Real-world Approach

00:00
00:00
This is a podcast episode titled, Greenlight Guru In the Classroom: A University's Real-world Approach. The summary for this episode is: Greenlight Guru continues to bridge the gap in biomedical engineering education by helping students learn and understand the importance of quality systems, design controls, and risk management. By collaborating with the Joint Department of Biomedical Engineering (BME) at the University of North Carolina and North Carolina State, Greenlight Guru’s efforts benefit both students and staff. Today’s guest is Devin Hubbard, UNC/NCSU teaching assistant professor, who describes how Greenlight Guru has made him a better educator for BME students. Some of the highlights of the show include: ● Students were told what to do, not taught why to control quality, design, or risk. Greenlight Guru solidifies their understanding of the concept to make that connection. ● The Risk Matrix is used to teach BME students which design controls need to be added to manage different levels of risk. ● Devin appreciates the Design Control Matrix because it captures user needs through validation. ● It’s difficult to teach the subtleties of the design and document control process, along with what some people consider unrelated links, such as risk. ● Using a spreadsheet for traceability caused problems for Greenlight Guru’s 510(k)s. It was the driving force behind the creation of Greenlight Guru’s Traceability Matrix. ● University students create a perfect test environment. If a concept isn’t clearly explained, then implementing it in the classroom will be a complete disaster. ● Students, and those who hire them, are impressed by their ability to articulate an understanding of quality systems, regulatory affairs, and risk assessment.
Greenlight Guru continues to bridge the gap in biomedical engineering education by helping students learn and understand the importance of quality systems, design controls, and risk management. By collaborating with the Joint Department of Biomedical Engineering (BME) at the University of North Carolina and North Carolina State, Greenlight Guru’s efforts benefit both students and staff. Today’s guest is Devin Hubbard, UNC/NCSU teaching assistant professor, who describes how Greenlight Guru has made him a better educator for BME students. Some of the highlights of the show include: ● Students were told what to do, not taught why to control quality, design, or risk. Greenlight Guru solidifies their understanding of the concept to make that connection. ● The Risk Matrix is used to teach BME students which design controls need to be added to manage different levels of risk. ● Devin appreciates the Design Control Matrix because it captures user needs through validation. ● It’s difficult to teach the subtleties of the design and document control process, along with what some people consider unrelated links, such as risk. ● Using a spreadsheet for traceability caused problems for Greenlight Guru’s 510(k)s. It was the driving force behind the creation of Greenlight Guru’s Traceability Matrix. ● University students create a perfect test environment. If a concept isn’t clearly explained, then implementing it in the classroom will be a complete disaster. ● Students, and those who hire them, are impressed by their ability to articulate an understanding of quality systems, regulatory affairs, and risk assessment.

More Episodes

Past, Present, Future State (and World) of Quality in the Medical Device Industry

Focusing on the Intent of the UDI Requirements from FDA's Final Guidance Doc

Addressing the 'Who, What, When' of Quality in the Medical Device Industry

Meet a Guru: Maryann Mitchell

Why Storytelling Matters for Medical Device Companies

A Breakthrough Device that Aims to Prevent Osteoporosis