“The Bleeding Edge” is a phrase often used to describe the place where the boundaries of possibility are stretched and game-changing innovations meet the world.
In a world where technology is revolutionizing so many aspects of our lives, striving to push the boundaries is critical, but in certain industries a little more caution is wise. For example, the pharmaceutical industry is rightfully limited by a regulatory straightjacket – no one wants the latest wonder drug to be unleashed on the world without suitable testing. Innovations here are checked and balanced by vital clinical trials.
However, there is a related industry where regulations are less stringent. A recent Netflix documentary titled “The Bleeding Edge” has uncovered some of the flaws in the Medical Devices approval process – an appropriate title considering what it reports.
To my mind, there is a delicate balance to be kept. There are countless medical devices on the market which are improving the quality of life for millions of people around the world. Many would argue that lighter-touch regulations are essential in fostering innovation and development, but when you are putting something inside your body, you need to know that it almost definitely won’t harm you.
Medical device manufacturers aren’t as strongly regulated as their pharma cousins, but they still have a duty of care to ensure that they are improving their patients lives.
The biggest problem reported by the documentary (and a genuine issue in the industry) is that of equivalence. The 510(K) premarket submission process allows device manufacturers to demonstrate a product’s safety and effectiveness based on it being ‘substantially equivalent’ to another product that is on the market. While that allows companies to (crucially) innovate on the basis of something that already exists, it also provides a loophole for those firms who want to cut a few corners.
Bayer’s Essure birth control and the recent Johnson & Johnson surgical mesh scandals are two prominent examples of the balance between innovation and safety.
I am not sure where the line should be in the ground, as who knows how many amazing devices might not exist without this lighter regulation, but I sense that as the pace of technological change increases, this could be worth revisiting.