Knowledge: Streamlined

Knowledge: Streamlined
“The FDA clears hundreds of medical devices every year. In an increasingly crowded marketplace, improved functionality and differentiation are key to a successful product launch”
QUALITY SERVICES

As with all medical devices, correct material selection is critical, but often the right material has unique processing and storage requirements to maximize its effectiveness.

Challenge:
To rework a soft tissue repair product utilizing the same flexibility and strength as an existing device, with improved material performance properties.

Company “Alpha” recognized a market opportunity for an absorbable soft tissue repair product that performed the same way as their existing device made from polyethylene. The polyethylene provided flexibility that allowed the device to move with the patient but with enough strength to maintain wound fixation. What “Alpha’s” existing product did not offer was the transient, fully degradable nature of an absorbable polymer material eliminating the risk for (e.g.) introducing foreign bodies into a delicate repair site. To achieve their desired combination of performance and flexibility, company “Alpha” reviewed the use of absorbable polymers. They soon recognized to fully develop this unique device combination; the need to partner with a company that had extensive experience working with these materials was crucial.

Discovery:
Poly-Med worked with Company “Alpha” to develop input requirements to assess the design needs, prototype several versions of the device using three polymers readily available, and test against the key requirements of (1) flexibility, (2) tensile strength, and (3) three month strength retention.

Poly-Med has been designing absorbable devices for more than 20 years, and was able to help “Alpha” avoid many common design and processing mistakes to accelerate their development cycle.

Our Lactoprene® polymer family provided a long-lasting, flexible polymer base that met the design needs for the finished process. We were able to provide in-house processing and our experience allowed for more accurate design iteration and fewer process-related hurdles.

Solution:
The finished product, based on Poly-Med’s Lactoprene® 7415 polymer, combined flexibility and a three- month strength retention to help “Alpha” meet their performance specifications.

Company “Alpha” relied on Poly-Med’s knowledge for materials selection and prototyping, but also utilized the in-house processing and full cycle development services to help design drying, packaging and storage conditions for the finished device. Poly-Med continues to support “Alpha” with polymer and film extrusion for the finished product.

“Medical devices have inherent risks. With Poly-Med’s history, we were able to de-risk many aspects of our design and complete the project ahead of schedule” – Dan C., Lead Product Engineer for a small medical device company