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.
Doctors take an oath to “First, do no harm.” Medical technology companies make the same pledge. In fact, I'd say the industry’s commitment to helping patients live longer, healthier, more productive lives is matched only by its dedication to quality and safety.
Recently, researchers at Brigham and Women’s Hospital published an article in JAMA Oncology that sought to compare the performance of FDA-approved companion diagnostics (FDA-CDs) and laboratory-developed tests (LDTs). In recent years, public debate and scrutiny has intensified regarding the oversight paradigm for diagnostics as well as the highly disparate treatment of tests that are the same from the perspective of patient risk and safety.