Design the Future
Learn more about our five-phase pathway to commercialization. Our Biomaterials & Processing Catalog details how we work with our clients to realize their ideas.
Pathway to Production
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.
The Feasibility Phase is often described as “Proof of Concept”. Laboratory work and R&D activities typically begin in this phase and generally show the potential of a given process to produce a functional prototype. Material prepared within this phase may not meet targets provided by a client based on a limited run. Feasibility establishes early boundaries to begin discussions around specifications. This iterative process will define the true material/component needs prior to the full design and development cycle leading into production.
DESIGN & DEVELOPMENT
In the Design & Development Phase, a functional prototype from Feasibility Phase is fully characterized, and the manufacturing process is identified. Prototypes are prepared using initial manufacturing instructions (MI), or work instructions, for traceability. A key activity of this phase is conducting ranging studies to examine the variability of the process and material inputs, process settings, and standardization of the manufacturing process.
TRANSFER TO PRODUCTION – PROCESS VALIDATION
The Transfer to Production phase is a continuation of work conducted in the previous Design & Development Phase while including the activities for manufacturing transfer. Activities involve process validation and repeatability to stay in line with client requirements for product costs and Poly-Med requirements for process capability.
PRODUCTION – SMALL SCALE
Throughout the Production Phase, we engage in a number of processes to meet client requirements for consistent quality. We perform equipment maintenance checks and work to meet your established forecasts.
PRODUCTION – COMMERCIAL SCALE
As your product continues to drive market adoption and demands, at your request Poly-Med can re-evaluate your production process and current scale to increase our outputs while maintaining the consistent quality of your validated product. Our engineering and production teams will reassess current production lines and determine what would be required to increase our level of performance, output, and efficiencies.