i could save 10,000 lives but it’s too hard

I have an idea.  It’s a brilliant idea (in my not-so-humble opinion).  It’s for a new medical device.  Based on death data in the United States, if this device was used on 1/3 of the population currently affected by this affliction, it would save 10,000 lives ANNUALLY.  That breaks down to just over a life an hour.

Unfortunately, this idea probably won’t happen.   That’s due to three nasty letters: F.D.A.

If you remember, in a blog not long ago, I praised the FDA on their resistance to approving the drug Tredaptive.  Unfortunately, their processes can also be harmful, and I’ll show why.

The first line of the FDA’s mission statement reads, “FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.”  Most of that sounds good to me, but I’m a little hung up on one part.  Protecting the public health by ensuring… efficacy.  Now I understand the need to measure and promote efficacy.  Otherwise we’d have people peddling all kinds of stuff that wasn’t efficacious, like vitamins, or herbal supplements (which Jim Gaffigan calls, “the horoscope of vitamins”), even prescription drugs, described as supplements (I’m looking at you GNC.).    Well, let’s ignore that for a second, because maybe those are bad examples.

Instead let’s look at how the FDA stepped in on medical apps for smart devices.  The full link is here (APP guidelines.).  It’s an interesting read for sure, but it says basically three things.

1. Most apps aren’t devices and the FDA doesn’t care about them.

2. Other apps are devices, but they can’t really do any harm, so the FDA doesn’t care about them either.

3. Some apps are legitimate, FDA-devices, because they talk to another FDA-device, and the FDA sure wants to run those through the ringer.

It’s an interesting approach on how to define things.  I like the idea of products being free-to-market if they can’t cause harm.  The idea I have is in line with that definition.  It’s not benign, in that it does provide a medical intervention.  The device itself, though, can do no harm.   If it fails, the worse possible outcome is no different than no intervention at all.  So why does it require FDA approval?  It requires approval because it’s not an app.  It’s a physical device that touches a person.  Seems like a little bit of a double standard you’re pulling here, FDA.  I should be clear, I want the device to be 100% effective.   What’s really upsetting is what it takes to prove that to the FDA.

According to the Medical Device Manufacturer’s Association, in 2010, it cost approximately 24 million dollars to get a device through FDA approval.  You’re thinking, “Cf course! It costs millions to build a new smartphone as well.”  If that’s your thought then you didn’t read the statement correctly. I didn’t say costs to get from concept to market.  I said costs to get through the FDA.  One company reported spending upwards of 75 million dollars to get a product through the FDA.   The same report said the total concept-to-market cost for a new device is an average of 31 million dollars.  So to recap: 7M to build and market; 24M to get approval.  That seems a little off.

I don’t have 31 million dollars.  I wouldn’t know how to get 31 million dollars.  I would have to get 7 million dollars, to build a product to convince someone to give me 24 million dollars, to get the product approved.  Seems like this might make it hard for me to get the original 7 million dollars.

At the end of the day, I’m stuck where Sergey Brin (Google Founder) said I would be. “… generally, health is just so heavily regulated, it’s just a painful business to be in. It’s not necessarily how I want to spend my time. Even though we have some health projects, we’ll be doing it to a certain extent. But I think the regulatory burden in the U.S. is so high, I think it would dissuade a lot of entrepreneurs.”

So I have a great idea, but it’s too hard, and that makes me sad.


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