Engineering a Difference

Engineering a Difference
“The goal was to develop a product with advanced capabilities while retaining the initial performance of the first-generation device requirements…”
Implantable Grade Polymers Catalogue

Market differentiation is a difficult but critical part of medical device development, particularly for lesser-known companies. Without an existing sales footprint or long history of innovation, small companies need to have a strong value proposition, one that’s more engaging than their larger counterparts.

Additionally, small companies have limited resources and often need to outsource services to more established groups to help support their product development goals.

Challenge:
Over the last decade, there have been quite a few developments with surgical mesh but there are some design paradigms that, for better or worse, have remained constant. Most surgical mesh is made of polypropylene and is relatively non-compliant. The outcome is a permanent implant with poor long-term results.

“Surgical Mesh Company” recently developed an improved mesh specifically for inguinal hernias backed by animal data supporting improved long-term results. Even with multi-arm, long-range human clinical trials still in progress, the company recognized the need to develop a next generation device, one with a hydrophilic absorbable component and targeted strength retention of 6 weeks. The goal was to develop a product with advanced capabilities while retaining the initial performance of the first-generation device requirements for tensile modulus, elongation and fiber diameter.

To meet their product goals, “Surgical Mesh Company” sought out Poly-Med’s expertise to select the right material and processing steps to create this next-generation device.

Discovery:
The two companies worked together to identify input requirements, engineer various versions of the device, supply the material for additional processing, and test for mechanical performance and strength retention. Poly-Med’s experience with polymerization, extrusion, and fiber processing equipped “Surgical Mesh Company” with the materials and processes necessary to develop their next-generation surgical mesh. “The combination of long strength retention and flexibility, along with requirements for increased hydrophilicity, led the project team to recommend an 80µm microfilament extruded from Aquaprene® 9306. Engineering samples were prototyped quickly and tested in-house, for fast turnaround and a successful outcome.” – Scott Taylor, Ph.D., CTO, Poly-Med, Inc.

Solution:
The finished product, utilizing Poly-Med’s Aquaprene® 9306 polymer and extrusion services, matched the specific input requirements. The final product not only retained the same successful performance properties as the first-generation device, the surgical technique was unchanged, meaning no additional field training was necessary. “Surgical Mesh Company” utilized our catalogue of unique absorbable polymers to develop a product that would continue to provide distinctive advantages in an increasingly crowded marketplace. Poly-Med continues to support “Surgical Mesh Company” with extruded microfilament fibers for conversion into the finished product.“Our first product was unique, leading to good sales growth and the ability to design a second generation device. We knew we wanted this product to be absorbable, and Poly-Med provided the materials and processes necessary to translate key aspects of the device into an absorbable version, further differentiating our product line.” – Andy S., CEO of a small medical device company