Len Czuba, President of Czuba Enterprises Inc. (Chicago), will moderate a panel discussion on the future of medical materials at the forthcoming co-located PLASTEC and Medical Design & Manufacturing (MD&M) Minneapolis event. His company works with medical device OEMs, among others, to bring products from concept to production, with a special emphasis on material selection and processing. PlasticsToday asked him about the impact that materials, and specifically plastics, have on advances in medical technology. He shares his thoughts below.
The panel discussion is scheduled for Oct. 31 at 2 PM at MedTech Central (booth 1347). Participants include Donna Bibber, Vice President, Isometric Micro Molding; Jeremy Harris, PhD, Director, Research, Secant Group; and Jacqueline Anim, Principal Materials Engineer, SME Polymers and Plastics, Ethicon & OneMD, (J&J). PLASTEC/MD&M Minneapolis comes to the Minneapolis Convention Center on Oct. 31 and Nov. 1.
PlasticsToday: One of the themes of your panel discussion involves advances in materials and technologies that are driving medical innovation. Can you give a couple of recent examples that illustrate this?
Len Czuba: I would guess that every person working on new medical devices or therapies is hoping to find the best material that can do the job at the lowest cost. It is no surprise that some of the highest cost materials offer performance advantages that lower cost materials can’t achieve. Take, for example, polyether ether ketone, or PEEK. 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.
Another material that offers new properties are the resorbable polymers used for non-permanent implant devices as well as drug-delivery products, sensors and even dissolvable electronics. As the availability of materials grows in variety and properties, more new products are designed only because of the unique properties these materials bring to the product.
I have also worked with companies that are designing products around the interesting family of materials referred to as polyether, block-amides, or PEBA, to take advantage of their high moisture permeability. Other medical devices or products use high-barrier materials, such as fluoropolymers, to provide just the opposite performance—high-moisture barrier for some liquid-containing products that require storage without permeation weight loss.
As the industry continues to grow in parallel with the explosion in sensors, telecommunication devices, patient health monitoring and health maintenance devices, the need for good, reliable materials grows with this evolving market.
PlasticsToday: What are some common mistakes that medical device OEMs make in terms of material selection? In one of your articles, you noted that product function dictates material selection. Can you expand on that?
Czuba: I believe that one of the biggest mistakes made in material selection is to settle for “legacy” materials that are already in the company’s products or that product engineers are accustomed to using. Rather than find the best material for the application, it is easier to make do with what is available and that everyone is already familiar. I know this is a generalization, but device engineers and designers don’t always invest the time and energy to find the latest, best and most well-suited material for their new products.
It takes investment of time and resources to attend conferences and walk trade shows and meet with companies offering the latest extrudable PVC replacement or injection moldable transparent contact lens polymer. Too often, I hear that medical device engineers can find most everything they need online and by searching the internet. Although that method of research may provide much of the information available, there is much to be learned by talking face-to-face with companies engaged in new materials development. Finding what is on the drawing board or in the labs and what is coming down the new materials pipeline and then combining this with what the design engineers need or would like from their wish list can help both the suppliers and the materials users achieve better and more interesting functional products.
PlasticsToday: Are there any unmet needs in the medtech space that, in your opinion, should be on the radar of medical device engineers and OEMs?
Czuba: I think that the long-time goal of replacing phthalate-plasticized PVC with other clear, flexible, biologically safe, steam sterilizable (and optionally RF heat sealable) materials that are in the same low-cost neighborhood as PVC is still one of the largest unmet needs of our industry. We have so many polymers that can offer the properties—or at least most of the properties—of flexible PVC but can’t come close to the cost. Replacing PVC, the major workhorse material of our industry, remains one of the biggest unmet needs in my opinion.
Another emerging need is for materials of all sorts across the entire spectrum of polymers that can be processed by some of the new additive manufacturing (AM) techniques. I should mention that I don’t have full expertise on this topic, but the speed at which parts can be produced and the breadth of equipment for AM that is available and continually being developed makes possible the production of low-volume production parts or customized medical devices that can be tailor-made for individual patients. Whether it is a support cast for the muscular dystrophy child that needs support devices and braces or a muscle-enhancing limb fixture that could give a person who does not have his or her own musculature a chance to walk or to lift their arms—all this is made possible with customized products that fit their arms, legs and physique. Materials for these applications would need to be compatible with the equipment used in this newest manufacturing technology.
PlasticsToday: What do you hope attendees will take away from the panel discussion?
Czuba: Well, as I mentioned above, many in our industry neglect the opportunities to learn from other colleagues in the field. This panel discussion will give attendees a chance to hear from subject matter experts from major healthcare corporations who are on the cutting edge of the latest new products being offered to the global healthcare market. Attendees will hear what is on the minds of these providers, notably:
- What do these subject matter experts see on the horizon in the next five to 10 years?
- In materials,
- In processing technologies,
- And in medical devices?
- Who do they follow to stay ahead of the pack?
- What trends do they see coming?
- How important is cost when it comes to new medical products?
- How do these leaders stay on top of the relevant news?
There will be plenty of food for thought at this panel discussion and, indeed, throughout the conference sessions and on the show floor. To learn more about the event, go to the PLASTEC or MD&M Minneapolis website.