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.
Having spent the majority of my career in the life sciences industry, I often hear the personal stories of those impacted by medical innovation. So many families, including mine, are living it. My daughter has Type I diabetes and relies on technology to avert life-threatening low blood sugar levels and related complications. Each story I hear is so uniquely powerful, and serves as a reminder of the importance of continued innovation to society and patients everywhere.