Check Out Matthew R. Jorgensen, PhD, DABT's LinkedIn Stats (Last 30 Days)

Fantastic time with Lindsey Borton, Adam Kozak, and Sarah Belperain presenting at SOT on animal alternatives for biocompatibility across the medical device lifecycle (including shelf life), and when there are sustaining changes. I am happy to see FDA accepting sound scientific rationale and physical/chemical evaluation on these points. Look what we can do when we come together and collaborate! Celebrate the win/win/wins!

The FDA Released their Draft Guidance on E&L for Med Device! What do you like and not-like? I'll go first: I love that they acknoweldge that NVR and chromatographic techniques will never 100% agree. I really don't like the strong push for triplicate extractions and analysis... the burden associated with 3x the number of devices and 3x the analytical cost simply is not justified considering that other data supporting equivalence device to device is so readily available from manufacturers.

Medical device technology is cool, and our medical device expert community is even cooler. I have been trying out a continuous glucos monitor (CGM) for the first time now that Dexcom Stelo is available OTC, and the physical chemist, toxicologist, and gadget lover in me can't stop nerding out about it. First, there is the sensor itself. An enzyme (glucose oxidase) is bound to a tiny flexible wire that acts as a substrate and electrode, generating a small but measurable electric signal in the presence of glucose. The chemistry to get this to actually work is already amazing. Then, there is durability. The chemistry system needs to work more than just an hour or so... it lasts 2 weeks. Importantly, everything that touches the user also needs to not poison them in some way. There is everything that must happen to the signal which must include amplification, transformation by an algorythim, storage, and transmission by bluetooth. Finally, there is all the stuff outside the sensor that needs to be safe and usable: stuff like how does the thing stay in place without causing sensitization or irritation? Is it comfortable? And there is soft stuff, like human factors, can a regular user follow the directions to put the thing on? How do you present medical information like a blood glucose reading to a non-expert user? Countless hours of work by a jillion SMEs in Medical Device to make wearable CGMs happen. Proud to be in the medical device community :) (note: I am not affiliated w Dexcom in any way, just a chemist and toxicologist who uses his Apple Watch to collect an ECG twice a day and fan of wearable technology)

Update regarding 10993-17:2023! 3 months ago I posted a poll: would the FDA accept the new -17? Well, now we know! The standard is accepted with only 4 very minor exceptions (two of which are simple typos)... I am going to go ahead and call this acceptance in full (for all practical purposes)! Happy Holidays everyone, we have taken a big step towards rational risk-based and least burdensome approach to TRA of medical devices. 😍 https://lnkd.in/greU2ce3

Reading through the new 10993-17:2023, what do people think about whether or not the FDA will recognize this standard in full?

What is the best strategy to evaluate the biocompatibility of a gas pathway device and achieve regulatory success? The ISO 18562 series, particularly -4 can be a challenge. I'm excited to be speaking about biocompatibility of gas pathway devices at MedTech Summit US this November in Minneapolis. I would be delighted to have many of you join me at the event! If you're interested in attending, register today and enjoy an exclusive 10% discount by using my referral code: MTUSSPK23. Click the following link to learn more: https://lnkd.in/gMWWqatG . Informa Connect