Design & Development
Vertically integrated design and development supports our customers from concept through manufacturing.
Biomaterials & Processing CatalogVertically integrated design and development supports our customers from concept through manufacturing.
Biomaterials & Processing CatalogLearn more about our five-phase pathway to commercialization. Our Biomaterials & Processing Catalog details how we work with our clients to realize their ideas.
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.
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.
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.
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.
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.
Our absorbable & synthetic biomaterials can be converted into a variety of implantable medical devices for markets that include soft tissue reinforcement & scaffolds, orthopedics & craniomaxillofacial, and advanced wound & burn tissue scaffolds.
Our absorbable & synthetic biomaterials may be processed into hernia meshes, plastic surgery meshes, macroporous tissue scaffolds, & barrier applications.
Our absorbable & synthetic biomaterials can be converted into load-bearing sutures, tendon meshes & bands, and bone scaffolds, as well as non-load bearing nanofibrous tissue scaffolds.
Our absorbable & synthetic biomaterials may be converted into nanofibrous tissue scaffolds to facilitate the healing process, as well as converted into barrier applications to augment fluid exchange.
Our raw absorbable & synthetic polymer may be purchased to be converted via injection molding into solid implantable medical devices.
We support client medical device ideas with advanced absorbable materials and processing.
Absorbable polymers can transform the healing process by temporarily restoring functionality in targeted areas. After use, they resorb within the body without a trace, minimizing the need for follow up surgical procedures.
Our polymers can be extruded into monofilament fibers, multifilament yarns, or films as inputs into biomedical textile applications. Don’t design for a filament, select the filament for your design.
Our polymers can be constructed into a variety of fibrous articles and medical textiles. More polymers equal more responsive designs, with better outcomes. Don’t design for a polymer, select the polymer for your design.
Regenerative scaffolds aim to mimic the physical, chemical, mechanical, and biological cues observed in a normal tissue environment. This technology can be tailored to partially, or fully, absorb during the healing process.
Create lattice-based architectures with 3D-printed absorbable implants via filament-based and resin-based approaches that are inaccessible via injection molding.
Our polymeric materials can be used as excipients to allow for facile processing with active pharmaceutical ingredients (APIs) and customizable continued-release profiles for combination medical devices.
Looking for a trustworthy & competent partner to co-create and manufacture your next-generation absorbable implant? Contact our team to speak to an expert.
We provide an adaptable approach to customer needs for any medical application. How can we help you?
Interested in learning about Poly-Med's bioresorbable polymer portfolio and processing capabilities? Complete this form to receive the catalog.
We provide an adaptable approach to customer needs for any medical application. How can we help you?
Please provide your name and email to view our ISO Certificate.
Please provide your name and email to view our Max-Prene® Polymer Data Sheet.
We provide an adaptable approach to customer needs for any medical application. How can we help you?
We provide an adaptable approach to customer needs for any medical application. How can we help you?
Please provide your name and email to view our Photoset® 311 Resin Data Sheet.
Please provide your name and email to view our Dioxaprene® Polymer Data Sheet.
Please provide your name and email to view our Glycoprene® Polymer Series Data Sheets.
Please provide your name and email to view our Lactoprene® Polymer Series Data Sheets.
Please provide your name and email to view our Aquaprene® Polymer Data Sheet.
Please provide your name and email to view our Lactoflex® 7415 3DP Filament Data Sheet.
Please provide your name and email to view our Dioxaprene® 100M 3DP Filament Data Sheet.
Please provide your name and email to view our Lactoprene® 100M 3DP Filament Data Sheet.
Please provide your name and email to view our Strataprene® 5525 3DP Filament Data Sheet.
Please provide your name and email to view our Caproprene® 100M 3DP Filament Data Sheet.
Please provide your name and email to view our Strataprene® Polymer Series Data Sheets.
Please provide your name and email to view our ISO Certificate.