Medical Product Development & Optimization

Prototype development and product concept optimization is a core expertise for Polyzen. We have nearly three decades of experience developing and optimizing a wide variety of polymer-based medical components and assemblies.

Our in-house engineering team includes more than 15 engineers, with six having advanced degrees. These include biomedical, mechanical, industrial, chemical, and material science experts. We take pride in helping customers bring new medical device concepts to market in the shortest possible time and within budget.

Polyzen has become a trusted resource for entrepreneurs and medical device companies seeking to convert medical device concepts into innovative products. During the concept stage we seek to understand all technical and functional requirements of the prospective medical device. Regulatory requirements and design for manufacturing are also essential considerations early in the product development life cycle.

Early in the prototyping stage, our material scientists identify regulatory compliant materials with properties suitable for each device component. As needed, our team develops custom polymer formulations to provide optimal results. In-house tool design and an array of polymer processes allow us to create components and assemble prototype devices rapidly for evaluation.

Project Management

At Polyzen, we use a robust stage-gating process to ensure that every product we develop meets the customer’s design and functional requirements. Our process also ensures all of our products are high-quality, safe, effective, and easily transferrable to sustainable manufacturing processes.

We assign a multidisciplinary team to each project, with expert personnel from our business development, engineering, quality, regulatory, and production teams. All of our development and optimization projects are led by a project engineer and reviewed by our technology leadership team.

Design for Manufacturing

Robust manufacturing processes are required to ensure each device complies with regulatory verification and validation protocols. This must be achieved while ensuring manufacturing processes requirements support functional and economic requirements for the marketed device. Throughout the process, our team of engineers ensures all components are designed for manufacturability, and the process can be quickly scaled up and transferred to production.

We also work closely with customers to transfer existing manufacturing processes from their in-house or third party facilities to our world-class production facility in Apex, North Carolina, USA. Whether we’re acting as a customer’s primary or secondary supplier, our goal is to ensure the highest quality products and the greatest value.