Worthwhileness for a small startups to apply for EUA (Emergency Use Authorization) for COVID-19

shimonv

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#1
Hi Folks,
I have been approached by a small IVD startup inquiring about about the worthwhileness of making some changes to the current product being developed so they could apply for EUA for COVID-19.

1. In principle, what would be the benefit for a startup company, in the end of research phase, to pursue EUA from RA or business prospective? After all, it's only a temporary approval and when the EUA is terminated, all unapproved devices will need to be recalled.
2. Have any of your worked with startups on EUA? what is your experience in terms of timeline from start to EUA approval.

Thanks,
Shimon
 
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Watchcat

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#2
My first reaction is, probably not. But, as always, it depends.

What kind of device?

What kind of startup? Academic spin-off? Are the principals experienced with medical devices/FDA? Is it US-based?

Worthwhile in what sense? To attract investors?
 

shimonv

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#3
My question is more on a principal level. This company is a "typical" IVD startup of less than five people; probably academic spin-off, and no prior experience with FDA. Sounds terrible, ha?

I would not recommend it, but I am trying to understand for which startups that would be applicable and why.
 

Watchcat

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#4
EUAs are a politically charged issue. At this point, I think anything could happen, depending on how things go, both with the pandemic and the election. Politically speaking, I don't think FDA is in any position to terminate the EUA process any time soon. Right now it is terminating them for individual products, I think often more as sacrifices to make it look like it is doing something when it isn't, than over legitimate concerns.

The glaring example is antibody tests. At last count FDA had given over 200 antibody tests essentially a free pass. I would guess a follow-up would show that almost all of them got a free pass to nowhere. That is to say, like many devices that startups get through FDA via the 510(k) process, that was the end of their story Of those that someone actually purchased and used, FDA has recalled some.

With that context, I'd answer your question this way, on the assumption that the goal is simply to attract investors:

1) A startup that has run out of steam and sees an EUA as its last hope for raising any more money. Even so, you cited a need to make changes to the product. If it is considering spending its last dime to make the changes, then perhaps only if it thinks it would be pointless to spend it on further pursuit of its original product, i.e., all hope is really lost.

2) A startup that has investors committed to providing further funding if it secures an EUA. Where many of the "road to nowhere" startups fail is lack of funds to address postmarket needs, like marketing, manufacturing, distribution.

The situation with EUAs has been too short and unstable for any timeframes to have emerged. Tim Stenzel, head of the IVD division at FDA went on the record a month or so ago, that "we" expected the "emergency" to last for several years "at least." I don't eliminate this as a possibility, but I'm pretty sure that the statement itself was politically induced and intended to encourage investors to open their wallets, after the innovative crowd complained that they couldn't get anyone to invest in the development of a COVID-19 test, because of the uncertainty associated with EUAs.
 

Ed Panek

QA RA Small Med Dev Company
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#5
I sent an email to [email protected] and was told that because our current device already has a 510(k), an updated special COVID variety would not work for EUA expedition but to "Try it anyway" as the rules are sorta being written as they go. They didnt literally say that but their language was quite vague and wishy-washy. "Might not, may, could or could not were the words they used if I recall.
 

shimonv

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#6
I did't realised how politically charged the whole thing is.

To me EUA sounds more like a gold rush... It doesn't seem to be worth it unless you have a real nugget in your hands. :)
 

Watchcat

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#7
I did't realised how politically charged the whole thing is.

To me EUA sounds more like a gold rush... It doesn't seem to be worth it unless you have a real nugget in your hands. :)
My cynical side thinks most medical device startups are temporary job programs, people talking other people to pay them to pan for gold with a low chance of success. Jobs for jobs sake, producing nothing else of value to anyone. I'm not in a position to know how many investors are really fine with the "9 in 10 fail , but just 1 hits it big" model, and how many have been suckered into/deluded themselves into thinking they have found that 1 in 10, so really no risk, the proverbial "sure thing," or at least a "very high probability thing," rather than a 1 in 10 roll of the device.

As for a gold rush, yes, but...what is gold, what is fool's gold, and who ends up with which?

What it looks like to me is a wholesale raiding of the public coffers. Hard to keep up, but it looks like by April Congress had already spent, or at least committed to spend, the equivalent of an entire year's federal budget to "fight COVID-19!" and is planning to double or triple down. When it is time to pay the bills next year, our government apparently plans to...hazy on this part, either raid the Federal Reserve, too, or just print more money.

As for the "real nugget," IMO, that would be a product developed by a company that has an established track record of developing those types of products. Although, even then, often the track record isn't confidence-inspiring. :( But at least they have the resources and expertise to support marketing, manufacturing, and distribution.
 

Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#8
Well it could be a "We have an idea for COVID but we dont have 12 months to develop it into an FDA approved device." Could be that idea "Never let a crisis go to waste" and how can I line my pockets whilst everyone is distracted.
 

shimonv

Trusted Information Resource
#9
yea, I hear you. I heard from a colleague of mine that FDA is asking for the normal amount of information plus manufacturing information. And that you need to demonstrate manufacturing capabilities large enough so that it can be distributed to the entire domestic USA.
I get the impression that very few startups can actually benefit from EUA. The bigger businesses are in a better position to enjoy this. I am sure few startups will come along for the "ride".

Shimon
 

Watchcat

Trusted Information Resource
#10
how can I line my pockets whilst everyone is distracted.
That's the business question, IMO. A startup that is far short of being a candidate for acquisition can line its pockets by getting investors to fund it, or by selling its device. In the former case, the question is "But will investors give them money based on an EUA?" In the latter, it is "But do you have enough funds (and often know-how) to market, manufacture, and distribute it once you get the EUA?" (Setting aside the pesky matter of demand, because virtually no startup is open to the notion that no one might actually want to buy their device.)
 
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