Yes, which is another way of saying "skewed heavily toward the interests of the behemoths," IMO.
For me the missing piece here is how the behemoths now see the VC-driven startups. I think Medtronic probably never saw them as much of anything other than an opportunity to increase its market valuation throughout most of the feeding frenzy of the 90s and 2000s. By the late 2000s, I think it started to lose interest in little fish and decided it was "ready for some real food," eg, Covidien.
As far as what happened with the 510(k), De novo, FDASIA...at the time, I think Medtronic may have been too busy "thinking strategic" to consider how their change in strategy (from little fish to real food) might affect their perspective on startups. I don't think startups should have much interest to Medtronic now, not as food for market valuation. This leaves the odd idea that startups might actually be of value for their innovative devices. The problem here, as I see it, is that the market valuation feeding frenzy was a disaster for innovative devices, with many VC-driven startups destroying more than they developed ("9 out of 10...")
Now I think (hope?) that we are at a point where there will be no room for clueless VC-driven startups. I think there may be a place for the not-clueless, but that depends on their exit strategy. If it involves acquisition, will the behemoths still want to acquire?
Which brings me to my other missing piece. In some quarters, it's very popular to say that the behemoths are "terrible at innovation." I don't know that this is true, or at least that they are appreciably more terrible than many of the VC startups that parted fools from their money during the feeding frenzy. I may have come up with a way to find out...will let you know. In the meantime, I have been told that Medtronic is "very good" at me-too'ing. Since this has been commonly accepted as "innovation" for decades, I don't see how that fits with "terrible." Maybe not the kind of innovation I want to see, but still.
I think the model Richard describes, "let one company do all the work" and perhaps more to the point, take all the risk, could work well for the behemoths...if they don't want to take on the risk and are ready to start acquiring innovative devices instead of market valuations.
But what do I know. All I've got to go on are a few little clues I find here in my little tidepool, and a few more I manage to scavenge now and then, on my expeditions inside the bubble.
This still leaves me wondering who started this, as opposed to who got on board later on. Anything that results in legislation tends to have a long, if not always very visible, history.
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Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com------------------------------
Original Message:
Sent: 14-Feb-2019 09:40
From: Ginger Glaser
Subject: Proposed Rule: Medical Device De Novo Classification Process
"In this fractionated environment, what is good for the one is not necessarily good for the other, and not infrequently, quite the opposite. I have my own perspective, but of equal or more interest to me is who wanted all of this in the first place? Has it played out the way they thought it would? Or is it another example of getting something imprudently wished for? Or perhaps in the end, just much ado about nothing, after all this."
If memory serves, some of this is related to the fact that De Novo is now part of the MDUFA commitments and has related FDA timing commitments around it....
g-
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Ginger Glaser RAC
Chief Technology Officer
MN
Original Message:
Sent: 13-Feb-2019 08:35
From: Julie Omohundro
Subject: Proposed Rule: Medical Device De Novo Classification Process
Ginger and Richard, it depends on which of many perspectives you are looking at this from.
There is the perspective of the behemoths, which bring to the table the perspective of potential legitimate acquirer, potential rip-off artist, and internal developer. There is that of the legitimate small to mid-size device company and of the startup masquerading as a small to mid-size device company. There are the perspectives of inventors, VCs, owners of the privately held companies, corporate shareholders, speculative investors, insurers, providers, CROs, consultants, American employees, and, invariably last instead of first, of the hapless patient, not to be confused with patient advocacy groups, which have their own perspectives on everything. Up in the bleachers, there is also the politicians. And then, for me by far the most intriguing of the lot, there is CDRH's own perspective on all of this. I would kill to know.
In this fractionated environment, what is good for the one is not necessarily good for the other, and not infrequently, quite the opposite. I have my own perspective, but of equal or more interest to me is who wanted all of this in the first place? Has it played out the way they thought it would? Or is it another example of getting something imprudently wished for? Or perhaps in the end, just much ado about nothing, after all this.
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Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
Original Message:
Sent: 12-Feb-2019 21:26
From: Julie Omohundro
Subject: Proposed Rule: Medical Device De Novo Classification Process
I would be very surprised if additional comments are not posted. I'm guessing they are taking what time is available to them to review the Proposed Rule thoroughly.
I haven't looked at it yet, but I'm planning to review it and most likely comment. I'm hoping for a "mini-PMA," with the basic requirements the same as a PMA, but the amount of data needed to meet the requirements scaled back. I've been working forever on an analysis of the De novos that have been granted. My information is no longer up to date, but the clinical data seemed to be scaled back from what you would expect to see in a PMA.
I think I'd rather see classification addressed early on, separately from safety and effectiveness. I think it would be helpful if companies could resolve classification concurrently with collecting the data needed to support safety and effectiveness.
I am unhappy that a newly classified De novo device would be immediately available to serve as a predicate.
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Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
Original Message:
Sent: 12-Feb-2019 15:58
From: Sean Bundy
Subject: Proposed Rule: Medical Device De Novo Classification Process
Is anyone aware of an industry group collecting comments on the proposed regulations for De Novo? The comment period closes on March 7th, and at this point there is only one substantial comment, and that only focused on FDA's right to conduct pre-approval inspections. I realize the comment period is frequently extended, but was just wondering if AdvaMed or any other group is aggregating comments.
For those who have not reviewed the proposal, it's worth a look. Essentially the new regulations carry about 90% of the PMA submission requirements from 814.20 into the new De Novo requirements. With the exception of manufacturing information, De Novo requests will have the same content, same evidentiary standards, and same requirement to demonstrate clinical benefit as a PMA. Given the push underway to redefine the 510k program in such a way that an increasing number of submissions will be NSE, I find this a bit concerning. I agree we need more codification of the content and expectations for De Novo, but if the requirements are essentially identical to those for a PMA, one wonders at it's value. It seems less a de novo classification than a PMA approval with concurrent downclassification.
I'd be interested in contributing to any ongoing effort to comment on this docket.
Thanks,
Sean
https://www.regulations.gov/docket?D=FDA-2018-N-0236
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Sean Bundy RAC
Director Regulatory and Quality
Greenwood Village, CO
United States
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