At the upcoming co-located PLASTEC East and Medical Design & Manufacturing (MD&M) East event, a panel composed of materials experts from the medical device industry and the research community will discuss trends in medical polymers. In advance of the session, they shared some insights with PlasticsToday.

PLASTEC East and MD&M East, part of the East Coast’s largest advanced design and manufacturing trade show and conference, will be at the Jacob K. Javits Convention Center in New York, NY, on June 12 to 14, 2018. The panel discussion on medical materials is scheduled for June 13 at 1 PM. For more information and to register to attend, go to the PLASTEC East website.

How materials are driving medical innovation

“Biomaterials are being designed to do more sophisticated work, from controlled degradation to sensors responding to glucose levels and triggering the release of insulin,” said Daniel Heller, PhD, head of the Cancer Nanomedicine Laboratory at Memorial Sloan Kettering Cancer Center (New York, NY). When trying to get a drug to a tumor site, for example, one challenge is to “get the whole particle intact to the disease site before it falls apart,” says Heller. “You need to make sure it is stable enough to take a drug cargo to its destination, where it will degrade.”

Multiple areas of polymer research will advance medical devices and human health over the next decade, adds James Semler, Senior R&D Manager Materials COE, Medication Delivery Solutions, at medical technology company BD (Franklin Lakes, NJ). “In particular, I am excited about the prospects that biomimetic polymers, material-based sensors and advanced 3D printable materials can bring to reduce high incident rate issues within hospital systems as well as reduce development cycle times so that new devices can make it to market faster.”

It's almost certain that 3D printing will be a significant part of the panel discussion, says Ryan Siskey, Principal, Office Director, at Exponent (Philadelphia), a multidisciplinary consulting firm where he is specialized in biomedical engineering. “The group of materials we have to work with as biomedical engineers is actually fairly limited, since they need to be biocompatible,” says Siskey. Once the biocompatibility question has been settled, then it’s a matter of which manufacturing technique needs to be used to obtain a final form product. Historically, that has been injection molding or machining, but additive manufacturing has added a whole new wrinkle, he adds, both in terms of cost and potential for innovation.

“Aerospace and automotive have helped pave the way for the use of more high-end polymers, such as PEEK, in 3D printing,” says Siskey. “Biocompatible materials are now showing up in additive manufacturing. They are opening up the space a little to start to consider tissue interfaces and integrating those interfaces into the build volume and build structure.” In the course of the panel discussion, attendees will get a sense of how additive manufacturing is being applied in commercially relevant spaces, adds Siskey.

Innovation roadblocks

Although materials are the building blocks of medtech innovation, they don’t lend themselves to an elevator pitch when you are trying to attract funding. “New materials are not the first thing a venture capitalist is looking for in an early-stage company,” says Heller. “Great things are happening on the research side,” he adds, but it’s a slog when it comes to finding capital. “Aversion to risk in that regard is slowing innovation.”

For Semler, cost is always a “headwind” when it comes to producing devices that are both profitable and economical to the end user. “This is highly dependent upon the material technologies used and the manufacturability/scalability of said materials,” says Semler. “In addition, the constantly evolving regulatory landscape provides a unique challenge to get new devices to market, especially those incorporating materials that are new to the medical space.”

The U.S. and EU regulatory space has changed considerably over the last few years, adds Siskey, and there is some confusion about where 3D-printed products fit within the regulatory classification system. “We are still talking about material selection but have to consider [the product’s trajectory] through the regulatory system and distribution in the real world,” says Siskey.

The way forward

Materials scientists and polymer chemists should interface more with medical researchers and biologists, recommends Heller. “They need to learn more about the biology to start addressing concerns coming from the medical side and eventually from venture capital folks and show the benefits these materials will have in a in a way that clinicians and biologists will understand,” says Heller.

For Semler, it’s vital that all stakeholders keep their fingers on the pulse of the materials innovation landscape, which is rapidly expanding, he notes. “Understand the maturity of the material technology before embarking on device development,” stresses Semler, “and always keep the device function, manufacturability and end user needs at the forefront when screening new material technologies.”

Another member of the panel, Jackie Anim, contributed an article to PlasticsToday on a related theme earlier this month. Anim is Principal Material Engineer and Subject Matter Expert at Ethicon (Cincinnati, OH), part of the Johnson & Johnson family of companies. You can read her piece by clicking here: "What’s new and exciting in medical materials."