Medical Device Approval Process Under Fire

All parents have heard their kids complain that but for 1 or 2 percentage points, they would have achieved a higher grade.

All parents have heard their kids complain that but for 1 or 2 percentage points, they would have achieved a higher grade.

Every kid should receive an A, of course, since psychologists are now professing that every kid is a prodigy in some new measure of intelligence. Academic intelligence, the conventional and obsolescent notion, has been sidelined to make room for other types of smarts, such as musical intelligence, existential intelligence, interpersonal intelligence, spatial intelligence and many others.

I agree that there’s a lot more to being smart than conquering number theory and linear algebra, but I wonder whether this effort to broaden the definition of intelligence is simply so more parents can have smart kids. Personally, I think that the conventional definition of intelligence is too rigid and we should be open to where rigorous research leads.

Fortunately for me, I did not discover that there is a category of navigational intelligence, which would have cost me at least 40 revised IQ points.

In my day, a grade of 94% was a solid A, and we strived to reach this threshold. Were our teachers too lenient? Should a grade of A required that at least 99% of our answers were correct? Where do we draw the lines to separate excellence from acceptable? Who makes the decision?

Last year, a public fight erupted over an Institute of Medicine (IOM) report that had not even been issued that argued for tougher rules for medical device companies. The report had been commissioned by the FDA and was in response to several recalls of medical devices that had malfunctioned and harmed patients. Advocates of medical device companies cried foul claiming that the 12-member panel was biased. Look for a lot more of this strategy when comparative effectiveness research (CER) goes forward. If a CER panel’s conclusion is against your interest, then attack the panel. Lawyers have mastered this technique generations ago. If the facts are on your side, attack the law. If the law is on your side…

Is the IOM on target or is the aggressive pushback from the industry legitimate?  I do know that is an easy task to make medical device companies and pharmaceutical companies appear callous, avaricious and indifferent to human suffering, when this may be entirely false. Can you say ‘demonization’?

Of course, we want medical devices and pharmaceuticals to be safe and effective. We expect that artificial hips, pacemakers, defibrillators and stents will perform superbly. Safety and testing policies should be made by experts independent from industry, but I believe that industry is an important voice at the table. Indeed, several constituencies should be represented, including the public. If we strive to eliminate every real and potential conflict of interest, then we will lose many voices of medical experience from the real world.

I’m not suggesting that reform in the device approval process is unnecessary. But, there are truths that must be acknowledged.

• No medical device or drug is 100% safe or effective.
• A percentage of medical devices will fail which may result in injury, reoperation or death.
• A failed medical device is not tantamount to corporate misconduct

What percentage of medical devices should perform as intended? 90%? 95% 98%?

How much testing and clinical trials should medical devices be required to undergo before they can enter the market? If the device is similar to an existing device, or is an existing device that is applying for a new use, should the testing process be the same as for a new product?

A grade of 98% sounds like an A+ to most of us, but this may not be sufficient in the medical device universe. Would we be content on an airplane knowing that we have a 98% chance of landing safely?

If we all agree that the medical device industry needs tougher standards so that their safety and effectiveness levels approach 100%, then we will need to accept higher medical costs and a reduction in innovation. Will this trade off serve the greater good?

I’m sure if the federal highway speed limit were lowered to 50 miles per hour that lives would be saved. No one is hollering for this reform. What should the medical device speed limit be?