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.
Opioid addiction claims the life of one American every 19 minutes. A rapidly escalating epidemic, the rise in drug addiction is fueling one of the most pressing health crises of the 21st century, and certainly one of the most complex health problems I’ve seen in my lifetime.
But how do we address the problem? There is much public dialogue and debate surrounding this very question. Solutions are being discussed, changes in policy are being proposed and all the while millions of American lives are hanging in the balance.