We support our customers from concept through manufacturing, and can provide an adaptable approach to customer needs for any medical application.
IN DESIGN & DEVELOPMENT
Got an Idea?
We have the solution! Our team has experience with almost any solution involving absorbable polymers, at any stage, and we support our clients through the entirety of the idea-to-market evolution. We leverage that skill and expertise to provide our clients with a competitive edge in a growing global marketplace. Our Design & Development process consists of five phases, as outlined below. Each of these phases is based in the ISO 13485 and 9001 methodologies, which are ingrained in everything that Poly-Med, Inc. produces.
The pre-design phase of device development is intended to do research, and take a strategic look at, a client’s project, which helps them gain the competitive advantage. Here, we determine the problem the product is trying to solve, and the opportunities the client is trying to capture.Examples include, supply of polymer or extruded fiber or developing analytical testing data
The proof of concept phase is where we analyze the integral parts of the process, including examination of materials and suitability, of the application. Evaluating these prospects for success is vital to the applications effectiveness in the market.Examples include, electrospinning a custom polymer for a hernia mesh application and testing against a predicate device, or melt extrusion of PLA copolymers for use in a knitted product.
The design phase entails product verification and validation through late-stage prototyping. In this stage, we work to finalize the material and process used to produce the end product. Prototypes are prepared using Manufacturing Instructions for traceability, and are often used for pivotal in vitro and in vivo evaluations.Examples include, preparation of a mesh for biocompatibility testing, or operational qualification examination of variability within an extrusion process.
After the material and manufacturing course has been finalized, a series of activities are performed to complete the manufacturing transfer. These processes involve scaling, validation, and implementation of cost savings measures to assure the product is manufactured in the most efficient manner, within with client requirements for cost and quality.Examples include, improving the efficiency of an electrospun product to allow for higher throughput and increasing process scale to meet forecasting.
Throughout the manufacturing phase, we enlist a number of processes to meet client requirements for consistent quality of delivered product. We do this by maintaining equipment and process validations, validating forecasts from our partners, and remaining flexible to meet any changing requirements. Because the design & development is performed in house, we have the ongoing support of engineers that are familiar with the entire design arch of the product. They are able to maintain the agility needed to handle any issue that may arise, quickly and effectively.Examples include, producing a monthly supply of 100,000 meters of monofilament, or a quarterly order of 5,500 round extruded tubes that meet exacting requirements.
Contact us to learn more about how we help clients convert their ideas into approved products.
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