Medical Devices

Both Ethylene Oxide (EtO) and gamma radiation are highly effective sterilizers for medical devices, but they face significant supply chain vulnerabilities that have already led to shortages within the United States. To mitigate these risks and bolster the sterilization supply chain, the FDA recently approved a new “Established Category A” sterilization method and implemented three key programs designed to encourage medical device manufacturers to adopt alternative methods, all within the last five years (FDA, 2024).

The development of lithium-ion batteries, also known as “Li-ion” batteries, has brought game-changing portable, rechargeable power to a vast array of products, including modern-day smartphones and electric cars. The life science industry has taken notice: many medical devices, ranging from electric wheelchairs to defibrillators to oxygen concentrators, have been designed to work with lithium-ion batteries. While the efficiency and longevity of such batteries can be extremely beneficial and, in some cases, lifesaving, their use comes with safety trade-offs over traditional batteries. Medical device manufacturers must consider these trade-offs carefully when electing lithium-ion batteries as the power source for their products.

Wearable devices have come a long way from the 13th century’s invention of eyeglasses. The first wearable computer was created in 1960, launched by the notable brand Casio which marketed the first calculator wristwatch. Fast forward to today, where wearable devices can now gather extensive data, specifically about our bodily systems, including exercise, food consumption, weight, sleep, noise exposure, heart rate, skin temperature, and respirations. It is more than just our location using GPS. What’s more, this data is compiled and exchanged with little to no user involvement—in many instances, users are not even aware this information is being tracked. Do you now have a potential new witness to “interview” in your litigated claims? Yes, you do.