7 min reading time

*This is not professional advice.*

In fact, it’s borderline irresponsible, but here goes.

So I was talking to this guy who found me from the group. To protect his anonymity, I’ll be vague about his selling proposition.

He told me he’s building an app to predict when a patient’s condition might relapse.

He said he was looking for investors. Optimistically, he’d launch in more than 18 months, after he got FDA clearance.

And I said, “Now, this isn’t professional advice and I’m not an expert in these matters. But have you thought about blowing off the FDA?”

“What do you mean?” he asked.

I said, “Well, if you developed this app in, say, Eastern Europe, and made it available online, FDA would have no jurisdiction over you, right?

And if it’s online, how could they prevent an American from downloading it?

So could you launch without clearance, get some usage and test results, and later – if you still want FDA clearance and believe it will increase your sales – do it then?”

What do you think?

Is that a real strategy or am I totally off base and this is a terrible idea?

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AN EXECUTIVE EDUCATION for MARKETING & SALES

For your calendar: Feb 1-3, 2016 in Tampa, Florida at the University of South Florida

I’ll write more about it in a future announcement.

In the meanwhile, check out the agenda and email me at JHage@MedicalDeviceEvents.com if you want to attend or sponsor. Early bird pricing through Halloween.

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Discussions You May Have Missed (and thanks to LinkedIn’s brilliance, lost forever)

Design vs process improvements

Problem with Implanted Artery Clot Filters

Advice on student design project

Are you aware of new device(s) for POC diagnosis of tuberculosis?
http://bit.ly/TB-diagnosis

Nobody Wants Your Walker

Change of DMR and DHR from “Design” to “Device”

Selling of Product Prior to Shelf Life Test Results

Validation of Low Risk Medical Device

Substantial Equivalence: FDA, CMS, and Patents

Risks for Device Investors

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Make it a great week.

Joe Hage
Medical Devices Group Leader

P.S. Forward http://medgroup.biz/MDMS to a marketer or sales leader you love.

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Jerry Robinson
Consulting Designer: mHealth, IoT, Embedded Products, Wireless Commun, Consumer, and Disruptive Innovation Tech.
If I tell someone “have a nice day” – that is not Medical Advice – and yet you could argue that the FDA has oversight of that…

At what point do they NOT have oversight?

The honest policy would be to quickly work a reasonable process together – sourced FROM the FDA to handle Apps and non-invasive devices… Anything else… . well… people DIE when not getting the help they need…. So what will the body count be BEFORE the FDA issues rational and logical guidelines … and will the FDA help figure out how to streamline the process…

It is a body count to depend on the FDA to take there sweet time in dealing with these issues… and there is COMING a true tidal wave of apps and devices… it’s already here in many respects…

I favor working with within the FDA guidelines on a rational basis… but the US is 4.6% of the world population – and there is a crushing need out there for customer friendly tech in the ROW.

Just simple education on key problems – can save millions of lives… You can parse that into what you have to do to sell and test product – and then meet FDA requirements as well….

Tom Mariner
COO at SynchroPET
Since it is an “app” it may not need FDA clearance — but you’d have to be nuts not to get it.

Here’s my reasoning — the FDA really just asks you to prepare a file with the document your development based on a process you set that makes sure Risks are considered and proper methods are used to build and support.

The time for even 510(k)’s has been dropping — but again, only if you have done what ANY Medical Device company should do. If you have to scramble to get a bunch of paper’s together — try another business area.

The time and costs are going to come in with the International approvals — CE review of technical file times are going through the roof. And third party NRTL’s charge the price of a Space Shuttle to review YOUR files.

Joe Wojniak
ASQ Certified Manager of Quality / Organizational Excellence, Quality Engineer
@Joe Hage- Hi Joe, thanks for providing this spirited discussion topic! I think we have a pretty strong consensus. 🙂

Joe Wojniak
ASQ Certified Manager of Quality / Organizational Excellence, Quality Engineer
Hi Griffin, thanks for linking such an interesting article! I had no idea that the FDA had such a long history. I think that in some ways, the internet is making it possible for the days of the patent medicines to return- and the FDA is working to ensure products promoted online have followed the evaluation process. What do you think?

Griffin Jones
Sr. Manager: Agile Consultant / Coach – Specializing in regulated industries (FDA and Financial Services)
For me, the (limited) description of the software application feels similar to a patent medicine. FDA has a deep history of educating the public to risks and successfully struggling with and enforcing the law on the patent medicine industry. I would expect a similar result eventually with such software applications. http://www.fda.gov/AboutFDA/WhatWeDo/History/Overviews/ucm056044.htm

Joe Wojniak
ASQ Certified Manager of Quality / Organizational Excellence, Quality Engineer
I may be rehashing what’s already been said, but- I have been reading Warning Letters that CDRH has issued. There are around 9 Warning Letters that have been issued to companies this year alone based upon statements made on their company web pages regarding products that the FDA considers medical devices- just as important, the FDA has jurisdiction if the product is sold in the U.S. (even if it’s an on-line sale). Selling a medical device in the U.S. without a PMA or IDE elicits the strongest FDA response- i.e. an immediate cease & desist order or the company could be facing regulatory actions. I definitely would not suggest to anyone to try selling a product in the U.S. (via web or otherwise) without a PMA or an IDE- here are a few of the warning letters if you’d like to check it out yourself-
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm449737.htm
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm449578.htm
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm449545.htm
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm449703.htm

Bogdan Baudis
Prinicipal Software Engineer at Cambridge Consultants
I agree with Burrell. FDA may not be perfect or even good, but it is still very good that it is there. I also have been around the world a little, actually living in two other countries than US. And that was NOT a “third world” … Why we should to strive to do better we may want to keep in mind that we could have been much worse …
Better FDA: yes.
Less FDA: NO!

Julie Omohundro
Principal Consultant at Class Three, LLC
And the reason Congress passed it was because industry lobbied for it.

Karen Boyd
Owner / Operator at QMS Consulting LLC
I suspect one would want (or expect) the government to “be there” / uphold their responsibilities when needed; the same should apply in reverse.

Burrell (Bo) Clawson
I research patents & design products to get a patented competitive position: Over 30 patents.
If someone thinks the FDA is “bad” or whatever, go to the second & third world and see what sort of medicines and devices you get. Been there & it’s not pretty.

Karen Boyd
Owner / Operator at QMS Consulting LLC
Likewise, whether one “respects” the FDA or not, you must comply with them as a device manufacturer, distributor, or seller, and rely on them as a consumer of foods, drugs, devices, etc.. The FDA is not a “partner”, but a governing body.

Michael Wienholt
Director of Regulatory Affairs at Q² Solutions
Rick, MDUFMA was an act of Congress, not something implemented by FDA unilaterally. Whom do you view as a “reliable partner to monitor public health”?

Adam Morris
Director of Transducer and Probe Development, SonaCare
May not work as a download now anyway – since the FCC now has full jurisdiction over internet content and what will or will not be allowed – good luck

Burrell (Bo) Clawson
I research patents & design products to get a patented competitive position: Over 30 patents.
Michael, there is situation worse than being on just “bad” terms with the FDA.

A nameless respiratory company, a competitor to mine in the late 80s, had an unannounced visit from FDA inspectors and the owner literally pushed them back out the door and locked it. It didn’t take 3 months. One day later, the FDA inspectors were back … with a County Sheriff and a court order and padlocks. The business assets were sold at auction.

Bogdan Baudis
Prinicipal Software Engineer at Cambridge Consultants
This may be somewhat Off-Topic but even when disregarding morals and possibly successfully bypassing FDA or some other regulatory bodies there still will remain liability issues, including civil and possibly criminal exposure.

US has a very well deserved cred for being a litigious society but I can assure you that legal systems in some EU countries could be quite onerous:
Spain claims universal jurisdiction (yep! not only US invention after all!), Italy would not shy away from multiple jeopardy (they will happily keep invalidating/reinstating/appealing forever), Poland will lock you up first, then (eventually) will get to the (not so pressing) matters of investigation if there is a reason for it (no, no, you are not in jail, this is just a temporary arrest …) …
At some point the court in Strasbourg will exonerate you or at least rule that the original treatment was excessive and unjust … if that is enough of consolation …

I also would like to stress (as I think already some have done here..), that privacy laws in EU tend to err on the other side than these in US …
So I would err the side of caution.
As a consolation: at least some of the necessary activities are common sense due diligence anyway?

Michael Zagorski
Medical Device Quality and Regulatory Expert, RAC, CQE, CQA
Yes, but there is a difference between a routine inspection, and for cause or a witch hunt. A routine may be a few days or a week. If you’re on bad terms with the FDA they’ll spend 3 months (or more) at your facility.

Jon Gardner
Technology Consultant
The FDA doesn’t make a decision whether to trust you or not. You are always guilty, every time an inspector walks in your door, unless and until you can prove yourself innocent. The primary function of the FDA is no longer safety & efficacy, but to enforce bureaucratic policies & procedures. It is a regulatory morass that stifles innovation and drives up costs. The only way to defend yourself and your intellectual property is to know those regulations, and leverage that knowledge to deal with the FDA. If you have a safe & useful product, and your situation or location are such that the FDA has no legal jurisdiction–even if only on a technicality–then why not run with it?

Julie Omohundro
Principal Consultant at Class Three, LLC
Mark, well said. In reading your comment, I realized that a lot of people on the device side might not be familiar with the painful details of the generic drug scandal in the 80s. Rumor had it that some companies finally went so far as to relocate and change their names in an effort to get out from under the seemingly permanent cloud of FDA mistrust, and the consequences thereof. And that wasn’t even the painful part.