Regulatory Nirvana Is Going To Cost Medtech A Fortune: Parliamentary Select Committee On Device Regulation Hears About New Levels Of Bureaucracy

In short

As announced on our pages yesterday, UK’s Parliamentary Select Committee on Device Regulation has been in session again, this time with representation from industry and regulators. The themes of Notified Body quality and quantity, Transparency and Post-Marketing Surveillance were all centre stage.

Background

This select committee meeting follows last month’s light grilling of the patient end of the stick, namely the clinicians, patient representatives and evidence-based medicine (nothing wrong with that) campaigners. This time the event saw MPs questioning witnesses from industry, regulators and EU consumer commissioners responsible for driving the new medtech regulatory framework.

In most regards the witnesses spoke as one in what was an interesting, if ever so slightly predictable watch. Everyone used the word “transparency” repeatedly. Everyone pointed the finger at non UK notified bodies and what to do about them. Everyone agreed that post marketing surveillance was preferable to raising the pre-market barrier to PMA levels. And everyone agreed that registries and unique device identifiers were the face of the future.

You can watch the proceedings here, but if you want the contentious bits they probably revolve around the words of Jacqueline Minor, Director of Consumer Affairs at the EU commission, with an exemplary grasp of medtech regulatory affairs and a pretty clear picture of what the future holds… when it eventually comes to pass in 2014/15.

She contended that the original twin objectives of the original regulations, which go back over twenty years now, were protection of health and the creation of free market movement. It seems the latter might have impacted the former if you believe the words of the “British” Notified body representative, the “British” MHRA chief and the “British” ABHI representative. All contended that “British” notified bodies were top notch, and that it was inherently possible that companies, faced with their tough stance, had chuffed off to Greece to find a less rigorous “foreign” notified body… although no examples were given (despite being sought), no countries were actually named and all agreed that the advantage of so doing was limited as companies prefer to be seen to adopting a stiff upper lip and passing muster in “Britain”.

So the concept that companies skip along to the softest body was accepted, but not supported by a single thread of evidence. But going with the argument for a minute, if this was the case, then patient safety was being compromised by heading for a lower regulatory requirement.

The future then seeks to rebalance the equation, not least by improving (ie reducing the number of) notified bodies. This may well be achieved by member states being effectively asked to judge each others’ Notified Bodies with what sounded like a significant amount of bureaucratic shenanigans before the member state is then allowed to designate them as such. It was even suggested that Notified Bodies may end up with restricted areas of competence, which is a good idea in theory (we’ve always advocated greater specialism), but has a few pitfalls, such as for the company who has a broad product range needing to employ a number of bodies to cover it.

It all sounds horrendously expensive… and we haven’t even got to the expensive bit yet.

Here goes. For higher risk devices, a new set-up is on the cards in which a scientific panel exists, available to developers, to guide their regulatory path… ie tell them what they’ll have to do to get to market. For a new class 3 device (the highest risk), companies will be required to notify “in advance” a central body so that all member state competent authorities can see what’s coming. Nice and competitively sensitive that one!

The work-in-progress of the approval will be periodically examined by more of these “scientific experts” and the company could be called in for scrutiny. A committee will finally sign off the product (FDA panel anyone?) before passing its judgement to a notified body for their presumably rubber stamp.

That’s not in any way like a PMA you understand.

Now, the one that nearly slipped under the carpet was Jacqueline Minor’s disclosure that every single device would have information on it, including clinical studies used for approval, available online for clinicians and yes patients to see. When asked, it was confirmed that this extended to class 1 devices, making this website hundreds of thousands of products big.

Ignoring cost for a second, if you’re a clinician faced with a patient who’d reviewed all the surgical gloves for themselves online and decided that Brand X was the one for them, how would you feel about telling them to “sod off, I prefer Brand Y because they’re a nicer shade of blue”?

Flippancy aside, we can see clinicians loving the idea of having to explain their choices and not sweating at all about the potential for litigation if a patient can establish from official sources that product A outperforms product B in a particular clinical study.

So has that really all been thought through? And the cost thing? Has that had a second’s consideration? Transparency’s great, but the cost and implications mean there has to be a line in the sand somewhere… we’d suggest somewhere just below Class IIb because anything less is going to be a list with no clinical evidence (none is required) and no notified body included (for class I, where again none is required to approve).

On briefly to Health Minister Lord Howe, who said he considered the two priorities were firstly ensuring Notified Bodies were fit for purpose, which means consistent across territories and possessing of adequate expertise. And secondly that Post-marketing surveillance was improved, or, as he put it, coordinated. Can’t argue, but for more meat on the bones we turn to the wise words of Sir Kent Woods, boss dog at MHRA and therefore rather close to the action. In explaining why devices were different to pharmaceuticals, he put it rather elegantly:

  • Device development tends to be iterative, so usually based on an earlier design
  • There are lots more of them
  • Failure modes are completely different, varying from sporadic manufacturing problems, through time -related issues of durability and wear, to the operator factor.

He pointed out that the perfect medical device regulatory system had to accommodate  all these factors and the only realistic way to do this is not to raise the pre-market bar, but to improve the post-marketing surveillance of devices, whether through registries or better coordination of adverse incident reporting.

Summary?

So, better Notified Bodies (with “better” defined as more competent and more specialised and more transparent and more consistent across member states)

More transparency of the entire shebang

Better Post-marketing surveillance (with “better” defined as improved use of registries, unique device identifiers and improved coordination across the continent)

The single biggest problem we see is the dramatic increase in bureaucracy and associated cost, which it is pretty clear will end up at the door of industry. Not sure Mr Ellingworth from ABHI banged the table quite enough on that point.

Congratulations to the committee though for a really insightful bringing down to earth of the issues, something not easy to do without being close to the business end of medical devices and their use. Entertaining stuff indeed.