Rebooting Value: Part 1 Complexity of Medical Devices

This past week I was influenced by 3 events that seemed random until Sunday; 1-colleagues at various US hospitals continue to work through product quality issues and medical device recalls, 2- while listening to a Med Tech Guru podcast the guest was directing comments to medical device manufacturers about the importance of the connection of customers to their products, and 3- the trifecta was complete when I read an article relating device complexity and human factor engineering. A review that I call “down the rabbit hole” led me to take a deep dive into the cause of medical errors; the 3rd highest cause of death behind heart and cancer.

Those on the outside of healthcare looking in may have thought that the Covid19 pandemic brought on the growth of medical device innovation however those of us within healthcare have known that new technology was increasing at a pace to meet the demand to improve care. You knew that innovation was the real thing when software was defined as a medical device and FDA guidance documents were developed.

However, the caution flag has been raised; with rapid growth comes the threat that if manufacturing project requirements are not managed well overall quality can be compromised. Here in lies my passion for safe care; in 2020 there were 5567 new medical device approvals-510K, PMA and DeNovo and 3045 medical device recalls-Class1, 2 and 3. The number one cause of medical device recalls in Q1 2020 and for the 16th quarter running was software related.

By now you realize why this topic will have more than one part. Check out Part 2 when we will discuss human factor engineering.