In this episode, I’m joined by Brian Wayman, a seasoned engineer with a mechanical and biomedical engineering background. Brian shares his journey from studying mechanical engineering at UMBC to pursuing graduate studies at Georgia Tech. He discusses his transition from academia to industry, highlighting his work at various companies. The conversation explores the intricacies of engineering for the medical field, emphasizing risk management, human factors, and meticulous quality control due to the paramount importance of safety in medical device development. 

We also discuss the intricate process of medical device product development, highlighting the importance of understanding user needs, design controls, milestones, and regulatory considerations. Brian shares insights into his lead role, involving cross-functional collaboration, communication with government sponsors, and overcoming challenges. 

Tune in now and learn!

Key highlights from the call

[02:07] Brian’s background 

[04:16] What motivated Brian to engineering

[09:07] The unique approach and considerations in biomedical engineering 

[13:15] The stringency of quality control and checks in biomedical engineering

[17:36] FDA’s role in regulating health-tracking wearable devices made by tech giants

[19:44] The difference between fast-product development with safety-focused industries 

[22:46] The impact of global events like the COVID-19 pandemic and geopolitical conflicts on various industries
 

[24:37] How Brian’s typical day looks like

[26:49] The key milestones in the product development process for medical devices

[32:51] The intricate process of identifying user needs for medical device design

[35:16] The significant impact of engineering in the medical field

[37:59] What Brian does during his free time

[42:10] Guidance for mechanical engineering students aspiring to enter the medical field

[44:24] How to connect with Brian

Notable Quotes

●       What comes to mind when you bring that up is risk management, which is a huge part of what we do in the design and development of medical devices and combination products. As we think about developing any product, in addition to that risk management piece, we think about what we call human factors. 

●       Regulated industries have defined development processes. Within the f d a in terms of medical devices, the regulated process is called design controls, and that's at a high level how you control the development of that design throughout the development journey. The first step in that process is understanding the user's needs.

●       I give back by serving his cub master for the youngest. And so I give back in that regard because the Cub Scouts teach them life lessons and leadership skills in a different way than what they get through sports and school. So being outdoors, enjoying nature, safety learning, just outdoor stuff, is fun and balances them out.

●       Suppose you ever had the opportunity to present at conferences and things of this nature. In that case, it broadens your horizons and perspectives in terms of what opportunities are out there. For those on the fence, I'd say take a look at it. It is fascinating engineering, challenges, and very rewarding, you know, opportunities out there. 

Resou

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