Lessons learned from the Metal-on-Metal Hip fiasco |

Lessons learned from the Metal-on-Metal Hip fiasco

Failure to thrive: Lessons learned from medtech innovations that missed the mark (MassDevice)

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.

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.).

Next-gen metal-on-metal hip implants: Test from every angle or face the consequences

Metal-on-metal hip implant problems are not a recent issue. In the 1970s, studies of early versions of the devices showed serious adverse reactions from cobalt and chromium ions released over time as part of standard wear-and-tear.

Studies indicated that cobalt-chromium implants would release metal ions that could infiltrate local tissue with long-term adverse effects, including, in some cases, permanent disabilities.

But their potential promise – a lifetime of reliability, resistance to wear-and-tear, a lower risk of dislocation and a more active lifestyle – were hard to resist.

So, despite early indications of metal-on-metal’s health risks, hip resurfacing with metal components saw a resurgence in the late ‘90s and 2000s. The hope was that innovation would reduce the risks seen in earlier versions.

Over time, however, similar problems emerged for all makers of MoM hips. Johnson & Johnson’s woes are but one example: In 2010, its DePuy subsidiary recalled the ASR hip prosthesis; in 2012, J&J pulled the Pinnacle implant; and last year the company agreed to settle a raft of product liability claims for $1 billion. (MoM hip makers still face thousands of similar lawsuits.)

Metal-on-metal implants are a good case study of a major hurdle device makers face: How to appropriately test implanted medical devices meant to last a lifetime.

“It’s a tough one, because it’s an implant. It’s hard to say, ‘Let’s do a bunch of studies and watch a bunch of users with this implant.’ I mean, you do say that, but you can’t,” KraMer said.

“You’d have to backpedal and say, ‘Where along the way could they have done something different that could have alleviated this decision to go metal-on-metal?’ That’s a hypothetical guessing game at this point, but they certainly couldn’t have found out that repetitive, usage-bearing weight is going to do this unless they set up some sort of long-term tests,” he explained.

With external devices, user testing can provide input on material use. But with an implant, patient feedback doesn’t cover the material; as KraMer observed, only long-term studies would have detected the long-term effects of micro-sized particles.

But he theorized that attempting to think outside the paradigm of medical device development could have caught the problem.

“It’s a tough scenario. Maybe you could look at the automotive industry and say, ‘Well, you know, pistons and cylinders in a car’s engine undergo a lot of revolutions. What do they do to not have particulate?’” KraMer said. “Maybe you could learn some lessons there. You could talk to mechanics and automotive engineers and find out when does this go bad, and what causes it to go bad. What causes it to go wrong? And then try to use those ideas to create your own tests for your specific implant.”

For now, metal-on-metal hip implants are mostly disused again due to the array of problems that cropped up with them, and testing may never get done to explore how to improve the devices to avoid shedding dangerous metal particulate.

Read the other failure case studies here