Design & Development

Design & Development

Vertically integrated design and development supports our customers from concept through manufacturing.

Biomaterials & Processing Catalog

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.

FEASIBILITY

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.

Markets

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.

Soft Tissue Reinforcement & Scaffold Implants

Our absorbable & synthetic biomaterials may be processed into hernia meshes, plastic surgery meshes, macroporous tissue scaffolds, & barrier applications.

Orthopedics & Craniomaxillofacial Implants

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.

Advanced Wound & Burn 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.

Absorbable & Synthetic Biomaterials

Our raw absorbable & synthetic polymer may be purchased to be converted via injection molding into solid implantable medical devices.

Solutions

We support client medical device ideas with advanced absorbable materials and processing.

Bioresorbable Polymers

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.

Bioresorbable Extrusions

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.

Biomedical Textiles

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.

Electrospinning

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.

3D Printing

Create lattice-based architectures with 3D-printed absorbable implants via filament-based and resin-based approaches that are inaccessible via injection molding.

LET’S CONNECT

Looking for a trustworthy & competent partner to co-create and manufacture your next-generation absorbable implant? Contact our team to speak to an expert.