Surely Tougher Regs Must Be Trumped By Better Post Marketing Surveillance

The Medical Device industry’s human too

In recent weeks we’ve adopted a somewhat defensive tone on behalf of the medtech industry, not least because in the face of media frenzy we’re feeling the need to ensure that people understand there are usually two sides to every story. Of course it’s the role of organisations such as Consumer Reports and a host of self-interest groups, lobbyists and, yes, victims of some of these medtech disasters, to adopt the stance they do. And rightly so. But when we see the medtech industry being pilloried in the course of doing what it exists to do, we feel the need for a bit of balance.

If a company has charged headlong at a product and used the existence of what the protesters believe are lax regulatory rules to gain a competitive advantage, then of course both the regulator and the company are simply wrong. For companies to adopt an “It’ll be alright on the night” approach to their products is of course flawed thinking, but do big medtech companies really behave like that? In my experience, having been on the end of some hefty deals with mega medtech, they are among the most cautious organisations one could imagine. Their regulatory due diligence practices are, in my experience, always far beyond the auditing practices employed by the regulators, whether FDA or EU notified body, and they typically adopt this defensive, cautious stance for the reason that whatever commercial gain they may get from having a particular technology in their bag, its never worth the pain of one bad call.

There is, of course, a difference between device problems that come up because of deliberate wool-pulling (PIP scandal) and those that come about because of factors which most folk might admit are beyond anyone’s “reasonable” control. But a point often made is that the reasonable controls employed, whether by regulators or within company processes, are really too weak. Of course the industry will scream that regulatory control, especially in USA is anything but too weak, and as Europeans looking in we’d probably agree that point on balance.

The point is that regulations are only good if they catch the problems they exist to catch. And unless FDA exhibits a superhuman ability to spot problems before products get to market, no amount of regulatory oversight of a product’s journey to market will be foolproof. And demanding clinical studies prior to launch of any new product is not much more likely to pick up late problems unless these studies are always looking in the right places, which by definition they can’t be or the developers would have ironed out those creases much earlier. And we did say the problems are really the ones we hadn’t anticipated.

Balanced arguments

So anyway, back to the point of this article, which is to point you at what is actually a rather good piece from CBS News. Well, it’s rather more balanced than last week’s piece reporting on lack of device testing. This article draws quite heavily on the thoughts and opinions of cardiologist Dr Robert Hauser, who’s either a thorn in the flesh of medtech and the FDA or a protector of patients, or both. He makes some very good arguments whatever your stance.

The article also raises the relationship between FDA and its (effective) boss, the Government Accountability Office(GAO), highlighting obvious tensions and rather damning finger-pointing relating to FDA’s laxity in picking up on potential problems early enough.

So our position?

Well, we’re not quite as “anti 510(k)” as most of the nay sayers might like. We happen to believe that predicacy is not a bad principle if implemented adequately. We’ve been in medtech a long time and can’t remember hearing the sort of conversations one would expect to hear if the system was really that lax. You know the kind of thing; “can’t believe we got this one through”. It just doesn’t happen.

What does happen are mistakes. Whether shrinking pacing leads with consequent raised failure rates should have been identified in the risk analysis or not, will always be a question. It will happen again.

No, the only rock solid tenet of our stance is the need for improved and impartial post-marketing surveillance. We can’t have companies going through the motions and marking their own homework if this is going to work.

On this subject, we’ll be back.

Source: CBS, medlatest staff