Design & Development
Vertically integrated design and development supports our customers from concept through manufacturing.
Development of Absorbable Medical Solutions
Our team has experience with almost any solution involving absorbable polymers and medical device design 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.
Design the Future
Learn more about our five-phase design and development process. Our welcome package details how we work with our clients to realize their ideas.
Our Vertically Integrated Process
Our design and development process consists of five phases, as outlined below. Each of these phases is based in the ISO 13485 methodologies, which are ingrained in everything that Poly-Med, Inc. produces.
Exploration
The pre-design phase of device development is intended to conduct 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.
Feasibility
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 application’s 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.
Design
The design and development phase entails product verification and validation through late-stage prototyping. In this phase, 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.
Development
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 insure the product is manufactured in the most efficient manner, and within client parameters 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.
Manufacturing
Throughout the manufacturing phase, we employ specific processes to meet client requirements for the consistent quality of the delivered product. These include maintaining equipment and process validations, validating forecasts from our partners, and remaining flexible to meet any changing requirements. Because design and 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 to meet exacting requirements.
Work with us
We can help you develop a device or drug delivery system from polymer to finished good. Let's get started.
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Latest News
Building the Future: Poly-Med, Inc. expands medical device manufacturing facilities in the UpstateJuly 1, 2020 - 6:37 pmPoly-Med, Inc. (PMI), the leader in bioresorbable materials and medical device development, has recently opened a state of the art 23,000+ sq. ft. development and manufacturing facility located at 116 Leader Drive in Piedmont, South Carolina. This new facility greatly expands PMI’s capabilities to offer medical device development for medical-grade electrospinning, extrusion, additive manufacturing, and […]