Healthcare is amid a high-tech transformation. Medical devices, for example, are becoming increasingly smaller and more complex as sophisticated technologies and materials are introduced, each bearing the promise of improved patient care and delivery. However, miniaturization is only one of many innovations that challenges medical device engineers to design products that cost-effectively deliver reliable performance, meets end-users’ expectations, and keeps up with the rigorous and ever-changing regulatory standards. And in such a highly competitive market, material decisions are critical to the functionality and differentiation of the device. These decisions can impact long-term usability if engineered with the incorrect materials, ringing true specifically in venous access and catheter insertion.
While device engineers and manufacturers have greater access to various materials today, industry leaders such as Access Vascular emphasize the importance of turning to biomaterials to provide long-term infection protection and minimize vessel trauma during catheter insertion. Speaking on this timely topic at Medical Design & Manufacturing (MD&M) West, Jim Biggins, CEO of Access Vascular, will explore “Designing with Biomaterials for Better Medical Outcomes” on Tuesday, April 12 at 11:00 a.m. – a marquee session that is a part of the event’s Design. Engineer. Build. conference, exclusively available to registered attendees.
MD&M West is slated for April 12-14 at the Anaheim Convention Center, running adjacent to four other engineering trade shows: WestPack, ATX West, D&M West, and Plastec West.
In anticipation of the upcoming event, I had the chance to speak with medtech expert and renowned MD&M West speaker Jim Biggins, CEO of Access Vascular. We touched upon industry trends and what attendees can look forward to learning about in his upcoming session.
As medical research progresses, we see more advanced biomaterial technologies transform healthcare delivery. What are the recent advancements in the biomaterials space?
Biggins: The reality is that many of these new advances are being made with materials that were developed decades ago but that are just now making their way into medical applications and demonstrating clinical improvement. This delayed implementation is primarily because it takes a long time to perform the testing and research required to give regulators and product developers the confidence necessary to incorporate them into new medical products. Accepted medical device infrastructure is also built around thermoplastics and high-grade metals, so introducing a new material that doesn’t immediately fit within that traditional system requires additional time, resources, and capital. Other factors for this lag include new understandings of how the body works, new supporting technologies that change the performance or application of these older materials, and sometimes just a renewed interest in tackling specific problems.
For example, in the case of Access Vascular, we are applying hydrophilic materials in a novel way for vascular access and catheter technology. Polyurethane has long been considered the best option for this application because it is very flexible and durable, yet it is also known to cause complications and trigger the body’s natural defense mechanisms. While it has been used regularly since its introduction, we are seeing a new willingness to consider innovations to the standard of care for even this most common of medical procedures. So, we were able to modify and apply this biomaterial in a novel way to improve a critical element of hospital care significantly.
Beyond our work, the two most prominent and exciting biomaterial innovations are resorbable technology and hydrogels' continued proliferation. These two biomaterial categories are exciting because they can do much more than simply serve as structural materials. Both can play essential roles in drug-delivery applications and more therapeutic-use cases. This gives them much greater functionality than the thermal plastics most commonly utilized in these areas.
What opportunities remain untapped, and what do we need to do as a medical device industry to execute on these opportunities?
Biggins: We’re still on the front end of new advances and applications for resorbable and degrading or encapsulation technologies. It’s exciting to see them in action, but we’ve probably only tapped the surface of what’s possible. The potential is the stuff of science fiction. Think of movies like Inner Space or Osmosis Jones that treat the human body as an unknown, new frontier for exploration. That’s really where we are with some of these biomaterials. As we begin to understand what’s possible more fully, the potential treatments and procedures multiply. And biomaterials bring with them the promise of safer, more effective, and longer-lasting treatments.
Our hydrophilic material is an excellent example of this possible path. Right now, we are hyper-focused on catheters and eliminating the complications that occur in the 30% of patients with polyurethane catheters. But what happens once we’ve established this technology as the new standard for vascular access? Once it becomes an industry-accepted proof that our materials avoid triggering the body’s natural defenses? We see an endless number of other applications in various areas of medicine, starting with expansion into more cardiovascular use cases.
I understand you’re speaking at MD&M West in April. What can attendees look forward to learning about in your session?
Biggins: Well, I’m still working on my thoughts for this session. One of the exciting things about this space is it’s moving fast. So, I want to give attendees the latest and greatest insights as part of my presentation. But I think one crucial topic will be the changing regulatory environment around biomaterials and how to improve or approach approval for using these new materials.
What excites you most about reuniting with your peers in person at MD&M West?
Biggins: I’m thrilled at the prospect of being part of an in-person event again. It’ll be great to catch up with friends and colleagues whom I haven’t seen in person for a very long time.