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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?
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.
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?
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
Make it a great week.
P.S. Forward http://medgroup.biz/MDMS to a marketer or sales leader you love.
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….
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.
Burrell (Bo) Clawson
Burrell (Bo) Clawson
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.
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:
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 …
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