Single-use plastics may be beating a retreat at your local coffeehouse, supermarket and now, it seems, the entire country of China, but there is no shortage of demand in the medical device space. Au contraire: The medical plastics market is forecast to see sustained growth well into this new decade. According to a study from Grand View Research (San Francisco), the size of the global market is projected to expand at a compound annual rate of 6.1% through 2025, reaching a value of $33.5 billion. Medical devices represent the largest market for plastics in terms of value, an insight that will receive ample validation at the Medical Design & Manufacturing (MD&M) West trade show and conference in Anaheim, CA, from Feb. 11 to 13. Described as the world’s largest medical design and manufacturing event, MD&M West, co-located with PLASTEC West, sits at the intersection of what used to be called the miracle material (until graphene came along) and medtech. Especially noteworthy at this year’s event is a daylong conference track devoted to advances in medical plastics presented in partnership with SPE.
On Feb. 11, opening day of the three-day event, 10 industry experts and researchers will explore topics ranging from the proper formulation of materials that come in contact with pharmaceuticals and best practices in plastics processing to the effect of moisture on polycarbonate and similar polymers. Also on the program, a panel will discuss the thorny issue of sustainability from a medical industry perspective.
Following opening remarks by session chair Len Czuba, President of Czuba Enterprises and a familiar presence at MD&M conferences, Eli Lilly engineer Sarah Clark will discuss the unique challenges involved in selecting appropriate polymers for applications where they come into contact with pharmaceutical products. Design engineers increasingly are seeking to eliminate glass as primary pharmaceuticals containers to take advantage of the design freedom that plastics make possible. During the session, Clark will share technical information related to polymer materials and systems that must be considered during this process.
Vipul Davé, Senior Materials Engineering Fellow at Johnson & Johnson, takes the baton from Clark to further discuss material innovations in the medtech/pharma realm. Noting that there is always a need to modify existing materials or develop new ones to meet demands for new applications, Davé will provide an overview of the selection criteria of materials for implantable and non-implantable applications. Davé holds a PhD in materials engineering science from Virginia Tech and an MS in polymer science from the University of Massachusetts, Lowell. He holds more than 28 granted U.S. patents and has 50 patent applications.
It may not take a village, but it will take a panel of industry experts to analyze the environmental responsibilities of the medical device community. This session, which follows the lunch break, will be moderated by Czuba and includes insights from Davé; Frank Pokrop, Director of Regulatory Affairs at Quidel Corp.; Nick Packet, a packaging engineer at Dupont; and Rob Chase, founder and President of NewGen Surgical.
In an earlier interview with PlasticsToday, Chase said that “the medical device industry needs to continue to innovate and create products that save lives and shorten recovery times with less pain, but it also needs to focus on embedding sustainability throughout the healthcare continuum.” His company does its part by focusing on “smart, sustainable design,” and it has developed a skin stapler made partly from plant-based materials and a needle-counter box, both of which eliminate a significant amount of plastic waste. He and the other panelists will weigh in on what the medical device industry can do to keep single-use devices out of landfills and the waste stream, and how it can reduce the use of plastics in the first place.
Polycarbonate (PC) is widely used in medical applications because of its desirable physical and cosmetic properties, but these can be adversely affected by moisture. A recent study showing how these properties can suffer without the proper indication of moisture content in the material will be a central element in the penultimate session of the day. George Yule, President, Plastics Network Resources, and Bill Baskind, President, WSB Engineering, will team up to explain the effect that occluded moisture can have on proper validation of the mold and the molded parts themselves.
“The effect of moisture in the degradation process of PC is well known,” Yule and Baskind told PlasticsToday. “However many processors do not have the knowledge, expertise or proper equipment to recognize these effects. Without this, many processors are satisfied that the absence of bubbles in a molded part equates with the absence of occluded moisture.” They note that PC, as received, can have up to 0.17% moisture, depending on temperature and relative humidity, while the manufacturer’s specification for maximum moisture for processing is 0.02%. “The most efficient, quantifiable method to ensure and certify that the occluded moisture has been removed from the PC is by testing prior to processing with a moisture analyzer,” said Yule and Baskind.
Other condensation polymers can be affected by occluded moisture, as well, noted Yule and Baskind. “Co-polyesters such as PET, PBT and alloys of PC/ABS, PC/PET and PC/PBT are vulnerable to degradation,” they said. “Nylons and all high-temperature resins must be dried. And cyclic olefin polymers (COPs) must be dried, not because of degradation, but [to prevent] cosmetic and demolding problems.”
The conference track will conclude with two presentations wrapped into one session: Identifying materials that withstand the harsh chemicals used in hospital settings and the benefits of E-beam sterilization.
Cheryl Weckle, Development Scientist at Trinseo, will speak to the challenges of developing medical-grade materials that can withstand the the disinfectants and cleaners used in clinics to prevent the spread of hospital-acquired infections. She will examine the key variables that contribute to device and equipment failures associated with environmental stress cracking and best practices for measuring the chemical resistance of plastics.
Recent shutdowns of ethylene oxide processing plants and the global shortage of cobalt-60 is having an impact on medical device sterilization practices. Gustavo Varca of E-Beam Services will present the use of medium-voltage electron beam technology as an alternative method of sterilization. The FDA-compliant technology does not rely on radioisotopes and does not generate radioactive compounds.
That’s the end of this conference track, but it’s far from the last word on medical plastics at MD&M. Dozens of materials suppliers, plastics processing equipment providers and contract injection molding and extruding firms are exhibiting on the show floor. Check out this preview of some of the exhibitors who will be introducing innovations in medical plastics at MD&M West. And come Feb. 11, head to the Anaheim Convention Center and see firsthand how plastics are helping to make medical history today and for the foreseeable future.