Drugs & Devices Become One: Polyzen Ventures into the Combination Product Space

Polyzen joins the movement of progress as the firm expands production capabilities and makes its way into the newly emerging market of combination drug-delivery products.

The medical device industry is poised for growth. The next wave of discovery is projected to be within drug/device combination products. According to market research reports, the drug/device combination products are slated to reach $18B by 2014, out of which the US will account for over 30% of revenue. Polyzen, Inc. joins the movement of progress as the firm expands production capabilities and makes its way into the newly emerging market of combination drug delivery products.

According to the Food and Drug Administration, combination products are defined as “therapeutic and diagnostic products that combine drugs, devices, and/or biological products.” These unique products bring a considerable amount of regulatory challenges and raise questions for manufacturers related to testing, processing, and other regulations. Manufacturers must also be cognizant of the quality systems that need to be in place before tackling production. Scott Culbreth, R&D Manager at Polyzen, describes the company’s place in this new emerging market, “We are responsive, highly versatile, our learning curves are quick, and we are willing to fulfill customer needs to their exact specifications, all while maintaining the highest quality standards.”

However, he also notes that with any new innovation, there are a host of challenges that must be addressed and understood. Scott adds, “…it is critical to understand the effects of such stressors as processing, handling, and storage and what the drug can and cannot handle to prevent drug degradation. The key is to understand the marriage of the drug and the polymer and the interaction between both.”

Polyzen’s entry into the combination products market is complementary with their current practices. A strong heritage of delivering high quality, cost effective, and innovative solutions allows Polyzen to understand polymer processing and the challenges faced when deciding on the right polymer for the right drug and balancing the relationship between both. The intellectual property surrounding the company’s many core processes validates their knowledge on selecting the appropriate platform and polymer for processing the device and the drug successfully. Polyzen understands the dynamic of polymers mixed with drugs. This know-how is critical for meeting customer requirements by understanding their specific requirements and delivering a quality product that satisfies specifications set forth.

Polyzen’s capabilities combining drug delivery with medical device products are fortified through their talented team of R&D engineers and chemists. The team has experience in medical spaces such as oncology, cardiology, wound care, and ophthalmic applications, where they have been successful in combining powdered drugs with unique polymer solutions that yield polymer drug matrixes, films, tablets, and coatings on such devices as stents, bags, chambers, or medical balloons.

About Polyzen

Polyzen, Inc. is a leading contract developer and manufacturer of custom medical-grade polymer components and products for medical device manufacturers worldwide. With fully equipped facilities in Apex, NC, we’re capable of taking any customer’s concept from prototype to full-scale production. We offer a variety of technologies and turnkey services to meet the most demanding application and regulatory challenges.

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