Medtech’s year of living dangerously

Bleeding Edge documentary
Image courtesy Netflix

The medical device industry went through a rough patch in 2018, at least in the public eye. Historically, it has been relatively sheltered from the sort of opprobrium directed toward sectors such as Big Pharma and the plastics industry. That shifted this year, as the Netflix documentary The Bleeding Edge and the Implant Files report were released.

The Bleeding Edge catalogued complications with the Essure birth control device from Bayer, metal-on-metal hip implants and vaginal mesh implants. These are not new controversies and have been the target of countless lawsuits, but the 90-minute documentary, which gave voice to people who have been harmed by these devices, renewed public interest.

The filmmakers argue for more rigorous regulatory oversight to prevent incidents of this kind in the future. Sister brand MD+DI, a business-to-business publication for the medical technology industry, produced an online poll asking its audience for feedback on the documentary. I found it interesting that the readers generally did not lambaste the film. Even some who found it “one-sided,” noted that they “agreed with many things in the film” and that it “brought out some issues we need to address.”

The Bleeding Edge started streaming on Netflix in the summer. Then in November came the Implant Files report. More than 250 journalists from dozens of media outlets across the world conducted a yearlong investigation of adverse events involving medical implants. The report noted that FDA has collected 5.4 million adverse event reports over the past decade, which included 1.7 million reports of injuries and almost 83,000 deaths. I was critical of the way in which some medical device associations, speaking on behalf of industry, punched back. We’re painfully familiar with the when-they-punch you, counterpunch-harder technique, but I don’t think it’s a winning strategy in the long run.

Both The Bleeding Edge and the Implant Files report called out FDA’s 510(k) program as being an antiquated tool for regulating medical devices. FDA’s 510(k) process lets low- to medium-risk devices on the market as long as the manufacturer can show “substantial equivalence” with an existing device, which may be decades old. The agency itself has tacitly acknowledged that it can do a better job regulating medical devices and has proposed a modernization of the approval process. In a statement issued the day after media outlets began reporting on the Implant Files, FDA recognized that allowing medical device manufacturers to rely on comparative testing against “predicate” devices that may be more than 10 years old is not advancing medical technology. “That doesn’t mean the products are unsafe,” FDA stressed in the statement. “But it does mean that some devices may not be continually improving, which is the hallmark of health technologies.”

Enough sturm und drang, though—in 2018, as in every year that I’ve been alive, there were countless examples of the medtech industry applying advanced technologies to saving lives and improving quality of life. For the purposes of this article and because, well, we are PlasticsToday, I will limit the scope to advances in the world of medical polymers.

A peak year for PEEK

It was a very good year for polyether ether ketone (PEEK) in medical applications. As Len Czuba noted in an interview with PlasticsToday, “this unique material can be sterilized by any of the most commonly used methods of sterilization and is virtually inert when exposed to solvents and any natural fluids found in the human body. These properties make it an ideal material for long-term implant devices, whether they are orthopedic hardware, such as bone pins, plates and screws, or components of a joint-replacement device. For this reason, the variety of specialty products made with the ketone polymers have grown dramatically while the range of polymers offered for these applications has also grown.”

For example, a micro-porous hydrophilic PEEK technology developed by medical polymers company DiFusion Inc. (Austin, TX) was named one of the top 10 spine technologies of 2018 by Orthopedics This Week. ZFUZE PEEK Composite received the recognition because it supports bony in-growth in orthopedic implants while retaining the mechanical properties and imaging capabilities of traditional PEEK. Described as a new biomaterial capable of being injection molded, 3D printed or machined, ZFUZE is currently being scaled up for commercial launch in early 2019.

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