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zomg

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Tech folks pivoting to medical always throws off some alarm bells to me

Same for me. I've been in the medical device industry for 15+ years now and came from "tech". What a lot of techies under/don't appreciate is that the medical device industry is heavily regulated and moves at a muuuch slower pace than other technologies.

There are lots of regulatory and quality/testing hurdles that you must clear (namely verification and validation testing, in addition to your 510(k) clearance or approval, if PMA) before you can market and sell your device.

I tell customers, on average, a Class II medical device project can take 18-24 months and cost $3M to 4M, minimum.

i find it hard to be sympathetic here. they sold their business to unilever, a multinational consumer goods company, for $326m in 2000 ($613m in today's money).

25 years later, jerry thinks the company has lost its independence? the independence was lost before the ink dried on the sales agreement. unilever never cared about their social mission, period. they've been "dealing" with it since the acquisition.

why not take the sale proceeds and pursue other social missions? btw, phish food is my favorite flavor! <3

i've had quite a few experiences with AWFUL uber drivers as well. i think it would be beneficial for uber to require some sort of ODB monitoring like some insurance companies do. one time on a trip to the airport, i almost had the driver pull over on the side of the road to let me know. i was GENUINELY scared by her driving.

more relevant for this audience is the digital health platform and wearable apnimed has developed to support their clinical trials. i saw their presentation "Sensor-Based Digital Health Technology Enables Digital Medicine for Sleep-Related Breathing Diseases" recently at ATS 2025 in san francisco.

* https://www.healio.com/news/pulmonology/20250518/platform-li...

* https://x.com/atscommunity/status/1923417506460455360

* https://www.eurekalert.org/news-releases/1083591

All of these comments are wrong and you sound very uneducated.

- Certain states have serialization requirements and registration once a firearm is assembled (the slide is connected to the frame).

- Many states require a permit to conceal carry but may only require a driver’s license to purchase (meaning you can own but not conceal without a permit).

- If a store posts signage saying firearms are prohibited, you legally can enter, however you can be trespassed if they discover you possess a firearm. This is generally not a criminal charge, unless your firearm is possessed illegally or another violation has taken place.

- A “suppressor” (the more correct and accurate term) is purchased from an FFL and transferred to the buyer via an ATF Form 4 (not a Form 1). Additionally, certain states do not allow the possession of a suppressor, regardless of the legality at the Federal level. FFLs don’t generally manufacture suppressors, they sell them.

i was thinking the same but with respect to this entire article -- feels like we're missing the second half and/or much more detail. feels like the article was due in to the editor by 11pm and the author forgot and started writing it at 10pm. :x

either way, very fascinating experiment. i look forward to hearing about the results!

i miss the early aol days. i remember all the havoc you could wreak using punters and mass mailers. ah, to be a script kiddie again! xD

can someone explain how the "mini-moon" breaks out of earth's gravitational pull? it would seem logical that once an object is affected by the gravitational pull of another object, it would require some outside force to "break" free. what am i missing?

FDA clearance only means a company can legally market the device.

additionally, product testing != human trials. they are two very different things.

final product testing is called "design verification and validation" (aka dV+V) where a statistically significant number of devices are tested against several different categories.

human trials can run the gauntlet from a small IDE studies to phase I through IV.

the drug approval process is MUCH different than the medical device process.

another confounding problem is how the FDA classifies and approves devices for clearance. most regulatory strategies have the company strive to find a predicate and prove they are substantially equivalent (SESE), which generally means a class II device, which does NOT require clinical data for clearance.

it's frustrating that the article uses the term "approve" which is specific to PMA devices (class III), whereas class II devices are "cleared" by the FDA.

- a medical device executive

i don't agree with any of the above. in fact, it's cringy, tbh.

once you appreciate the dance that all functional teams perform in an organization, you'll experience true success.

i find that the automotive/gearhead youtube channels i enjoy most tend to be ones run by individuals who do it on the side and enjoy documenting and sharing their work. the content on these channels is also very technical in nature.

a few to check out are Dieselcreek, I Do Cars, and Watch Wes Work.

just like people like to talk about themselves, i think people want the satisfaction of knowing that someone acted on their advice.

one time i gave a friend some advice and he did the exact opposite. oh, the satisfaction! xD