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Comment by glesica | Hacker News Reader

To launch a Facebook clone you sign up for Heroku or AWS, push some Rails code, and start promoting yourself. To launch a medical device you spend years cutting through regulation and red tape, negotiating with and marketing to an industry that is probably threatened by your existence and will do its best to stop you.

Screw up at Facebook, you get yelled at on Twitter and your share price dips for a few days. Screw up a medical device, you get sued out of existence.

This probably doesn't explain the whole thing, but it is certainly related.

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> Screw up a medical device, you get sued out of existence.

Or, you know, people die.

People also die because of late or never materialized medical technology. We just prefer that people die from inaction (because is "normal") than from mistakes. This may be psychologically attractive because we avoid SEEING all the blood and dead bodies, but probably not the best way to minimize death and suffering.

Of course this is nothing new (Economic version: "That Which is Seen, and That Which is Not Seen"). Just another cognitive bias.

There is some more-or-less optimal middle ground between too little and too much regulation, but I don't think we're on it now. In fact, maybe it would be worthwhile to have a two-tier system, one for ordinary medical devices, another for experimental "this will probably kill you but perhaps you have nothing to lose" situations.

The most scary moment - one of the applications we've written was used to take life-saving medications on time. Scary stuff I'm telling you.

Off-topic, but I'm curious how you handled that situation. Personally, a safe-guard I might build in would be to audit our code by an independent third-party. Was this at all feasible in your situation, and/or how did you handle QA?

Well... External QA for app which costs 2.99$ (or less at times)? No. We just tried to make sure it worked properly - some code reviews, several unit tests to cover some nasty edge cases and that's it. I really hope everybody is alive and well. :)

Also it did help that the users grew confident in it over time. It was not like these overnight success stories (not even success story) which you hear all over the news :)

When I was a kid, volunteering at a hospital for Community Service, I was assigned a task to transfer pills from bottles to those plastic + foil single serving wrappers using a hot glue machine, and deliver said pills to the wards. I had no training, supervision, or QA/QC in this job.

http://c2.com/cgi/wiki?TheracTwentyFive

Because consenting adults aren't allowed to engage in an exchange of medical services without the approval of federal bureaucrats + lurking personal injury lawyers.

All we need is just one state with medical contractual freedom.

No thank you, Christian Scientists are "experimental" enough. We don't need the Tim Ferrises of the world selling snake oil to parents (as medicine).

We also don't need the government telling adults what kinds of contractual agreements they can or can't enter into. "Caveat Emptor" and all that. People are, at the end of the day, responsible for the outcome of their own actions. Interestingly enough, this is still true even if we DO have a nanny state and an FDA and all the accompanying B.S.

Spin the FDA off as a non government agency, with no force of law behind it, let it create a voluntary approval process (something akin to the UL process for approving home electrical devices, for example) and let it be.

Yes I agree with this, I think the current system is worse than snake oil because you have government people telling you exactly what is medicine. And they are the FOOD and Drug administration. They are now telling people what they can label on things like blueberry extracts. That should just not be their business, they should just keep dangerous chemicals out of our lives.

In ayurveda, there are 3 types of medicines, food, herbs and poisons. The current allopathic system is purely the last type. It is heavily regulated because it is big money. There is not big money in the first two. (You may think there is money in food, but not fresh food which you actually have to prepare and eat within an hour, not prepare and let sit and pump full of preservatives).

Besides, creating Facebook clones is sexier. At this moment, your content is rated lower than @benihana's scathing criticism of @raganwald's outrageous assumption that saving lives is somehow nobler than squeezing out yet another social app-turd.

. To launch a medical device you spend years cutting through regulation and red tape, negotiating with and marketing to an industry that is probably threatened by your existence and will do its best to stop you.

I know someone, kind of financially successful, who swears by everything that his team developed a cure for AIDS, but they found out after years of politics that they will never get approval from legal entities to release.

Do they have any available information? Preliminary test? Cured it in vitro, animal models, a few humans? Patents? Any other interesting medical/biological result published?

There are a lot of people that proclaim that have cure for AIDS/cancer/whatever, and many of them blame the establishment for blocking it. The same history appears with perpetual movement machines. Without more proof, probably it just another too optimistic investigator, a scammer or a crackpot.

If true that's so outrageous you can count on me to work really hard for free on their behalf to get the word out.

Can you put me in contact with them?

I am not saying I believe it, but they keep making the claim every time the subject comes up.

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