Some of the medical device industry’s most heralded disruptors wound up being its biggest failures. Here’s what we can learn from their mistakes.
Fink Densford, Associate Editor
No one in medtech sets out to fail. No one invests in building a device believing that, despite years of research and development, it won’t make the cut.
There are few other fields in which disruptive, innovative technologies can make waves as big as they do in medtech – where outcomes can be life or death.
The discovery and exploration of antibiotics revolutionized infection treatment and saved billions of lives. X-rays gave us an actual window into ourselves and changed how we view and treat the human body.
Advances in robotics are making surgeries faster and more repeatable and are returning mobility to paralyzed patients. Next-generation 3D-printed biologics and advances in DNA modification, such as CRISPR, aim to change how we develop and design regenerative therapeutic products.
But not all technologies – even seemingly well-vetted, cutting-edge innovations – manage to make an impact on the field. Many companies fall short when it comes to products that initially promised disruptive innovation. Sometimes their quest for revolutionary change can veer to catastrophe.
Notable megaflops include Theranos, which promised to revolutionize blood testing with its needleless, micro-sized nanotainer and lab-in-a-box Edison tester. Then there are washouts like Johnson & Johnson’s Sedasys, which the company hoped would eventually automate the delicate anesthesia process. And who could forget the fiasco of metal-on-metal hips, on which major medtech players placed bets that they would significantly improve mobility and health?
Exploring the failure of these devices offers valuable insights into what it takes to make a truly innovative device.
“This industry has gotten very good at talking about things that we’re proud of and things that we do well. That’s terrific, but one of the things that we’re not very good at is talking about things that we don’t do well, in order to try to figure out how to be able to do them better,” said regulatory consultant Michael Drues, president of Vascular Sciences (Grafton, Mass.).
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There are very few ideas so good that they can survive being poorly executed. In addition there are a whole lot of folks who can speak very convincingly while being quite devoid of correct information.
Given that combination it is quite possible to launch a terrible disaster.
The basic concept behind Theranos looks like a great idea, and possibly it could still be a great product if no mistakes or shortcuts led the development astray. OR the reputation may be so very damaged that it will not ever happen. I don’t have enough data to say.
Given the reliability of computer controls and common operating systems who, being aware of that track record, would possibly trust a computerized anesthesiologist. Certainly not this experienced engineer.
It is certainly useful to be able to learn from the errors of others without having to suffer the same pain as they did. It is not a “finger pointing” thing to choose to study what went wrong, it is, much rather, an attempt at “learning from history”, since those who don’t learn from past mistakes are doomed to repeat them again.
Thanks, William! Those are really good points. Hope you found the article useful.