Device Regulation ? May Worsen Before It Improves

Device Regulation – May Worsen Before It Improves

The attached piece from David Lewis at Morgan Stanley on Device Regulation was brought to my attention this morning.
I've thought It could be interesting to share with the cove!

Re: Device Regulation – May Worsen Before It Improves

It's an interesting and well written piece, but it's fundamentally wrong-headed in regard to the effect of more rigorous US regulation.

US companies are so strong in world markets, not because we're inherently smarter than the Europeans or the Japanese or the upcoming ROW competitors, but because historically we have had the most rigorous regulation. Our medical products have been the most-reliably-proven safe and effective.

Efforts to wring out of the system the slack and loopholes that shortsighted decisions have allowed to creep in, are excellent strategy for US medical manufacturers, in my opinion.

Our strongest selling point in other countries, outside the EC, is that we operate under FDA jurisdiction. I want the FDA to continue to maintain a fearsome level of review. The more global news stories there are about the FDA whacking an insufficiently rigorous medical device company, the better able we are to compete in global markets.

Re: Device Regulation – May Worsen Before It Improves

I've just spoken with a Business Development Manager of 3M about same eletronic component solution in medical device. He told me that they are able to compete with no American company manufactory because in the medical field the FDA want a very high quality from the material to the process (in other fields are not the same, the cost reduction is more important than the quality of the product).
So I agree with you, the high standard of the field of the medical devices due by FDA directives is a constant stimulus to improve the competitive for the USA companies.

Re: Device Regulation – May Worsen Before It Improves

I can't argue with tighter controls to ensure better, safer products.

This longer approval cycle time is driving companies to look to market outside the US first. If you can get to market faster outside the US, why wouldn't you? And with longer and longer approval times on the horizon, I would expect that trend to continue to increase. So the potential is there, at least, for the US product reputation to tarnish. Not to mention the delay in getting innovative devices to patients in the US!

I think that along with the tighter regulations, we need to also figure out somehow to speed up the process. I'm only on the periphery of RA activities but here's what I often see: you make your submittal and the timer starts. When the timer is about to expire, you get a request for more information. This resets the timer and the loop begins again. I expect device companies try to use this 'technique' to their benefit often by submitting incomplete packages just to get in the queue. So I'm not pointing fingers at either side, just pointing out that there's some inherent issues with the current process that could be exacerbated by additional controls / longer cycle times.

I think the strategy needs to both excising those loopholes miregmgr cites and also to eliminate the non-productive wait times.

Ok, now on to Middle-East peace, solving world hunger, ...