Medical Devices Help Us Live Longer and Healthier

There have been several stories recently highlighting problems with medical devices. 

Without question, some patients’ lives have been severely impacted, and one patient harmed is too many. But as a physician, former FDA regulator, and industry executive, I have seen the process from every side. And I am concerned that alarmist reporting will needlessly frighten patients into forgoing necessary treatments. 

Make no mistake: All of the hundreds of millions of Americans who enter a doctor’s office, ER or other health care facility has benefited from medical technology (medtech) – from heart valves to syringes, to blood tests and imaging systems.  

Millions of medical devices have allowed patients to live longer, healthier lives. FDA evaluates 5,000+ new devices annually before they are go on the U.S. market, and everyone goes through a well-defined, rigorous, science-based FDA decision-making process. 

That context is vital when discussing the medtech industry’s impact and whether or how the process that gets innovative treatments to patients should change. Americans should have confidence in their medical devices and in FDA’s oversight – considered the world’s gold standard.  

As a physician, I want the best for my patients, and I know I can trust the products that undergo FDA scrutiny.  

And as former head of FDA’s Office of Device Evaluation, I know the hundreds of scientists, engineers, and clinicians there are dedicated to their work: helping patients get safe and effective devices and diagnostics. 

Some of the confusion over medical device safety comes from a misunderstanding of FDA’s mission, which is two-fold: to protect and promote public health. 

If, as critics say, the agency’s sole mission was to protect public health, that would be easy: just require exhaustive trials for every new product for every possible contingency. Or better yet, don’t approve any products – after all, a product that never gets to patients can’t hurt them. The problem is no one will be helped either.

That’s where the agency’s second mandate – to promote public health – comes in. To promote public health, FDA determines whether the benefit of a new product outweighs its risk. And when you are trying to alleviate human suffering, there will always be risk. 

But not all risk is the same, and that is especially true with the diversity of medical devices. The genius of the regulatory system Congress created for medtech is that it allows FDA to tailor evidence requirements to a device’s risk. A new type of neural stimulator might require extensive clinical trials to determine safety and effectiveness, while a new contact lens or imaging system might only require bench testing. 

Despite what some critics claim, there are no “loopholes” or “rubber stamps” at FDA. There are distinct pathways based on device risk, but each pathway leads to the same standard of safety and effectiveness.  

If a product is higher risk because of a new use or new patient population or mode of action, FDA can –and will – ask for whatever evidence it deems necessary before allowing it on the market. If that evidence is not forthcoming, that product will not be approved. Period. 

And contrary to recent headlines, the medtech industry has an exceptional safety record, with the vast majority of devices never experiencing a serious recall. 

Finally, as a former medtech executive, I know this incredible safety record is a testament to the 500,000+ men and women of the U.S. industry dedicated to helping patients. In this industry we are always asking ourselves: Is this something I would want used on my child, my parent, myself? What’s more, companies face severe penalties for not following their governing laws and regulations. Also, as competitive as the medtech industry is, a company that does not place a premium on patient safety will not last long. 

That is not to say FDA and industry are right all the time.  

Even with all the science behind FDA decisions, there is no such thing as a perfect regulatory system. That’s why over the last 40+ years medical device laws and regulations have been frequently amended and the system has evolved to better protect patients and still promote innovation. All stakeholders in the medtech ecosystem are committed to finding ways to further enhance a proven system for getting safe and effective products efficiently to patients and physicians.         

We need to do everything we can to ensure patient safety. That’s a given. But we also must make sure that any regulation is both necessary and reasonable so that it does not choke off the innovation that provides patients with newer, more effective diagnosis and treatments. Striking that balance is something FDA and the medical technology industry have done extraordinarily well for over four decades. American patients should feel secure in that.

Susan Alpert, Ph.D., M.D. was most recently the Senior Vice President, Chief Regulatory Officer of Medtronic and was responsible for all Medtronic global regulatory efforts.