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.