Brian Pedlar, CEO of Covalon Technologies writes, A simple dressing application holds the power to both heal and harm. However, beneath their seemingly straightforward design exists a realm of concerns. When the wrong dressing is used it can cause significant harm affecting everyone from the tiniest of babies in the NICU to vulnerable adults, clinicians, caregivers, and even hospital administration.” Read more what he has to say.

Harvey writes, “When we looked at cybersecurity and medical devices last fall, the Food and Drug Administration (FDA) did not have express federal statutory requirements for medical device manufacturers regarding cybersecurity. However, it is clear that there are real dangers. In September 2022, the Federal Bureau of Investigation (FBI) reported that as of January 2022, 53% of connected medical devices and other Internet of things (IoT) devices in hospitals had known critical vulnerabilities.” Read on.

Christopher Cauble writes, “There are many risks and a few rewards to an intellectual property strategy that foregoes patent protection in non-U.S. jurisdictions. Startups or midsize medical device companies should include intellectual property specialists in strategy sessions for market development.” Read to learn more.