Matt DeNardo
speaker
183 appearances
1 recordings
1 series
first heard Jul 2026
last heard 11 Jul
Matt DeNardo’s voice in public audio — every appearance, attributed to the second.
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recordings per month · last 12 monthsRecordings per month over the last 12 months — 1 in all, peaking in Jul 2026 with 1.
Appearances
Thanks, Azusa.
I appreciate you having me on.
Sure, I'd be happy to.
So, as you said, my background technically is in biomedical engineering.
And that's a really diverse field where it spans everything from biotechnology, biochemistry to medical devices and kind of all things in between.
I've focused in my undergraduate and graduate work much more on the medical devices aspect, specifically in biomechanics and moving later as my career began to develop into bioelectronics.
And early on...
My first postgraduate work in the industry was at a company that was adding design services to their already well-developed medical device manufacturing capabilities.
And so there I learned a lot about what it took to bring a product to market, including the clinical studies aspect of it.
And that's actually also where I got my first exposure to conducting clinical trials outside of the U.S.
The company I was with had done work in Paraguay for both cardiovascular devices as well as gastroenterological devices.
And they had built up a relationship with clinicians in Paraguay that sounded to be mutually beneficial, where they were able to bring some new technology to Bayer at the clinics there.
And in return, they were able to collect data that was used to further develop the device and later support further clinical study submissions.
But that was a really eye opening experience for me that kind of coming out of school, you get very like drilled into the very U.S.
centric view of the world where, you know, this is how it's done at the FDA.
And these are the things you need to do to have an FDA cleared regulatory submission.
And here are the things you need to do for an IDE trial and so forth.
And understanding that there are other pathways at that early in my career, I think, unlocked the idea that there's more than one way to do things and that there are benefits to other approaches.
And those should be balanced with what the needs of the company are, the risk profile of the device and the needs of the clinicians that you're working with in those other jurisdictions.
I can go on to more about how my career developed and kind of led to Axof, but certainly can take any questions on that early stage, especially that particular clinical trials experience.
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