Accelerating device development

To remain competitive and offer affordable therapies to patients, medical device manufacturers constantly seek to reduce the production costs of devices in development and on the market. The best approach is to work together with experienced component manufacturers from the start of a project to save time, reduce costs, and produce premium-quality products, while maintaining the goal of a smooth transition to serial production. A good manufacturing partner will adhere to Design for Manufacturing (DfM) principles to help ensure efficient and cost-effective processes at high volumes and may also offer process validation, including different configurations and high-end and low-end samples.

If the development process begins with a design firm that is inexperienced in manufacturing, challenges can arise in the hand-off from design firm to manufacturer, requiring significant design changes that impact cost and time to market. Additionally, many manufacturers are not equipped to scale up from prototype to production volumes. Therefore, it’s critical to select the right partners at the outset.

A dedicated team of experts at a rapid development center (RDC) can improve the process. Collaborating on innovative, complex product design can deliver significant benefits in cost reduction, speed to market, product quality, and customer satisfaction.

Quality resources, techniques

When medical device makers partner with component manufacturers in the design phase, they can ensure cost control and scalability. Many RDCs offer several core competencies suited for medical device and pharmaceutical parts, including design, toolmaking, high-precision machining, silicone and thermoplastic molding, secondary operations, automation, and assembly.

Another way RDCs bring value to customers is with quality control processes. A good component manufacturer with rapid development capabilities gives customers access to raw material traceability, Class 7 cleanrooms, and established validation processes.

These facilities are typically ISO 13485:2016 and ISO 9001 certified and meet requirements from the U.S. Food and Drug Administration (FDA) and European Medical Device Regulation (MDR).

It’s critical for medical device manufacturers to partner with a component manufacturer that understands the design, material, and production implications and has the dedicated experts to execute at every stage of the process.

A dedicated team

RDCs offer a relational environment as opposed to a transactional one, helping medical device makers discover what they need and how to get there. With a dedicated team of experts and quality tool-making equipment, RDCs can support medical device manufacturers throughout the development process, from device and component design to prototyping, testing, scale-up, and long-term supply of components and annuity production. RDC experts can also design and create certain prototypes as quickly as 24 hours, delivering sample parts right out of the tool while retaining additional samples for potential future analysis.

The increasing demand for medical device components to be manufactured quickly and at a lower cost makes partnering with suppliers who have rapid development capabilities a critical component of the process. And it all starts at the design stage.

Trelleborg Healthcare & Medical
https://www.trelleborg.com/healthcare

About the author: Chris Tellers is the Rapid Development Center Director at Trelleborg Healthcare & Medical. He can be reached at chris.tellers@trelleborg.com.