Budget cutbacks due to healthcare reform, hospital pricing pressures, and changes to reimbursement are limiting money funneling into the medical device R&D pipeline. Yet manufacturers are still expected to deliver high-performing, cost-saving medical devices. The result for OEMs is that what used to be primarily, or sometimes exclusively, in-house operations are now relying on outside vendors to function as an extension of their R&D efforts. OEMs are shifting from a culture of organic innovation to innovation via acquisition. Additionally, phrases like “supplier-enabled innovation” and “R&D outsourcing” are becoming commonplace when describing relationships between suppliers and medical device manufacturers. The takeaway is that the new climate within the industry is making it inherently incumbent upon those who’ve traditionally been behind-the-scene players to step up and ask for the ball.

Changing Landscapes

Fig. 1 – OEMs are benefitting from research, development, and testing undertaken by forward-thinking polymer tubing suppliers.

The change is subtle, but significant. While polymer tubing companies have always partnered at one level or another with device manufacturers, the work was usually limited to material recommendations for more traditional applications and related incremental device design for second- and third-generation products. Today, more OEMs are signaling that they’re wide open for feedback on just about everything including, but not limited to: product development, customized secondary services or value add operations, and—perhaps most importantly—breakthrough ideas to lead the charge in fostering real innovation with a focus on addressing clinical challenges and ultimately improving patient care.

Polymer tubing companies are taking a two-pronged approach to address and meet these needs and challenges. The most forward-thinking among them have always conducted organic research based on trends they see in the marketplace, and this approach remains in place. The second prong, however, has shifted slightly. Most polymer companies will meet with clients in the field to discuss projects and troubleshoot issues. However, now more than ever, these companies are relying on interactive dialogues with OEMs to help identify and overcome their challenges. They’re asking OEMs questions about their current and future goals, and what’s potentially limiting or altogether preventing them from getting there. The polymer companies then take back the information they’ve gleaned from these meetings and work internally—often with no contract or guaranteed payment in place—to find solutions. After all, component suppliers into the device industry are only as successful as their customers. A truly concerted effort to find new ways to advance device development has never been more prevalent and necessary than it is today.

To the extent that a conversation between a device company and a supplier doesn’t action an effort or point to a specific area of focus, some suppliers have taken it upon themselves to understand what the clinical community is saying and how they can perhaps address unmet needs. A real world example comes from one extruded polymer tubing company that entered the field of bioaborbables after listening to what doctors were telling them they hoped would be possible in the future to treat coronary artery disease. The company spent years evaluating materials and developing processes that positioned them at the forefront of meeting demand when these conceived possibilities became reality. That company was in a position to offer a product by listening to and anticipating the needs of those directly involved from a clinical standpoint.

Indeed, industry dynamics have changed dramatically from the past when having a stake in the game was as simple as responding to requests from OEMs in a timely fashion. But a reactionary approach is no longer sufficient. To remain relevant in today’s market, polymer companies must get out ahead of the curve and anticipate what design, product, and material requests will be coming down the pipeline. They must then position themselves and stand ready to meet those needs. What often goes unnoticed or unrealized is the amount of effort—strategic alignment, research, development, testing, quality/ regulatory review, and resource (human and capital) allocation—that’s occurring at the supplier level to bring forth solutions and foster industry advancements. (See Figure 1)

Small Steps, Big Leaps

While bigger breakthroughs in any area are always exciting, incremental advancements are an undeniable necessity to next-generation products and applications Breakthrough devices require more testing, are subject to higher levels of scrutiny, and, therefore, carry longer development cycles and subsequent regulatory pathways. The device industry needs an effective ratio of new devices to incremental changes in order to address clinical needs and advance patient care. Below are examples of a number of advancements, breakthrough and incremental, that have come about in the current budget-minded landscape.

Stent encapsulation with electrospun non-woven polymers: Traditional methods of suturing graft material onto a stent body can take upwards of 24 hours. A graft material combined with a novel encapsulation process has shown some very positive early results for performance and efficacy. The new encapsulation process takes a mere seven to eight minutes, providing both cost savings and improved graft performance properties.

Fig. 2 – Recently introduced peelable heat shrink reduces downstream catheter processing, increases yield, and improves safety.
New fluoropolymer heat shrink removal techniques: Catheter construction has always been a delicate and laborious process that leaves no room for error. For years, tubing companies have heard from OEMs about the burden associated with the last step of removing the recovered heat shrink after the outer shaft reflow process. As the most critical and time-consuming step, heat shrink removal is where the greatest amount of production waste and longest cycle times occur. (See Figure 2)

A recent product introduction removed that burden with a peelable heat shrink. With a linear tear, workers were able to easily remove the heat shrink, improving efficiencies and workplace safety. OEMs using the product report reduced downstream processing, increased yield and minimal scrap, all of which resulted in cost savings.

Pad printing on PTFE: In a similar example, pad printing on polymers has also been around for years. However, this process has always been labor intensive and getting proper adhesion was often difficult or compromised, especially with PTFE. Recent advancements have made this process more effective, improving cycle times and ink adhesion.

Fig. 3 – Operations such as flanging, flaring, tipping, and more conducted by tubing suppliers can significantly enhance products while streamlining OEMs’ manufacturing operations.
Engineered surface tubing: Used for everything from custom profile slot liners to fiber optic sheathing and percutaneous delivery systems, engineered surface tubing enhances the lubricity on either the ID or OD (or both) of the polymer’s surface. Recently released findings indicate that a surface engineered PEEK tube was found to be up to 42 percent more lubricious than a standard PEEK extrusion. Engineered surface tubing offers engineers more material options with a wider array of properties without sacrificing as much lubricity as would typically be the case. This technology is most attractive in minimally invasive delivery systems and is being evaluated across a number of market segments and applications. (See Figure 3)

Streamlined process improvements for optimized tubing solutions: Vendor consolidation is a hot topic in the device industry. Streamlining process improvements for value added operations such as flanging, flaring, tipping, and more can represent significant product enhancements and eliminate downstream costs for medical device manufacturers. As cost containment and budgetary considerations continue to surface, the ability of a polymer tubing manufacturer to increase efficiencies and improve cycles times for OEMs is a crucial component to ongoing relationship management. Remaining mindful and showing an understanding of the OEM’s profitability needs is vital to long-term trust and partnership.

A Continuing Evolution

From pricing and sourcing to technical challenges and breakthrough innovations, the scope of the relationship between device manufacturers and component suppliers continues to evolve. OEMs will continue to seek expertise outside their walls for partnering. Anticipating this need, some polymer tubing companies have created multidisciplinary teams of technical experts available to meet in the field with device manufacturers anytime and anywhere in the world.

While it would have been easy to set innovation aside during budget cutbacks, the opposite effect has occurred. Extruded polymer tubing companies are stepping up their games and being proactive in delivering ideas and innovations to the doorsteps of medical device manufacturers, who are, more than ever before, willing to listen.

This article was written by Aubrey-Anna Sanders, Market Specialist, Zeus Inc., Orangeburg, SC. For more information, Click Here .