The Washington Post recently published an opinion piece by critic Jeanne Lenzer and a colleague which contained misleading and inaccurate claims regarding the safety of medical devices and FDA’s oversight of these products. I want to set the record straight so that patients can have confidence in the safety and effectiveness of the medical devices they depend on to live longer, healthier, more productive lives.
Last week, an article by Barbara Bridgman Perkins, PhD, was published in the Washington Post admonishing the relationships between industry and health care providers to advance radiotherapy treatment. Here is what I submitted in response.
When we talk about “life-changing medical innovation,” we’re really talking about patients like Susan and millions of Americans like her. And when we talk about the “medical device industry,” we’re talking about the thousands of people working at 600+ device manufacturers in Medical Alley alone whose work led to breakthroughs like the procedure that changed Susan’s life. These people are working today on the breakthroughs that will help patients tomorrow.
For the past several years, policymakers and industry have been exploring ways to improve the quality of health care furnished to individuals while promoting efficiency and value. As I have discussed in the past, I believe that medical technology companies can be a key player in these coordinated care efforts in light of their specialized clinical knowledge, economic expertise, data analytics proficiency, and supply chain management capability. Unfortunately, various regulatory roadblocks stand in the way of the medtech industry’s full participation in the shift to more coordinated care.
Ensuring medical devices are shielded from cybersecurity threats is, in the words of the U.S. Food and Drug Administration, a "shared responsibility" among all stakeholders. Medical technology companies, hospitals, physicians, IT professionals, providers, regulators and patients all need to work together so that the safety and integrity of interconnected medical devices – everything from pacemakers and ICDs to monitors and infusion pumps – is not compromised due to cyber threats.