Develop winning medical devices with early supplier engagement

Early collaboration enables more efficient, effective design and development.

Keith Glaser

To stay competitive in a crowded and ever-evolving industry, medical device manufacturers must consistently deliver value in two ways. The first is through innovative products that improve safety and efficacy for the patient. The second is by maximizing cost-effectiveness throughout the product life cycle from development and launch through scale-up and mass production. Suppliers play a central role in a manufacturer achieving these goals, but many companies don’t use these strategic partnerships to their full advantage, or they bring experts into the process too late to influence the effectiveness and efficiency of product development.

Early supplier engagement

A primary benefit of bringing suppliers into the development process early is the elbow room it provides for creativity. This is especially true if a manufacturer needs help solving a problem. The key strategic shift occurs when supplier partners can collaborate with the manufacturer to develop performance specifications, rather than being invited to bid on existing product specifications. For example, a fastener component supplier might recommend using a different resin to improve product performance or reduce cost – or recommend an entirely different fastener type more suitable for the application or to enhance patient use. In cases where standard materials might be insufficient to meet an industry or customer requirement, the supplier can work with its own supply chain partners to develop an innovative alternative.

Early collaboration with suppliers also enables more efficient and effective design and development in compliance with FDA regulations and ISO 13485. Supplier partners can accelerate design verification and validation of the medical device, for example, ensuring biocompatibility of the materials and subassemblies reduces the risk of biocompatibility failure in the completed device. An additional benefit of early collaboration is supplier design for manufacturing, so the resulting design transfer to device manufacturing is much faster and trouble-free.

Maximize results

Medical device manufacturers can gain more value by aligning themselves with total solutions providers, who often bring best practices and market knowledge outside the industry customers know best and can tap into a more diverse supply chain. These companies also prioritize solution development over selling a specific product or part; they listen to the customers’ challenges and goals and commit to finding high-impact, lasting solutions.

As medical device manufacturers seek to up their innovation game and drive competitiveness and profitability, enhancing how they work with suppliers can yield critical advantages. One easy change is to bring suppliers into the product development process early so they can fully use their knowledge and expertise to problem solve, enhance production efficiencies, and successfully launch products that can be built for years to come. The big picture benefits awaiting manufacturers that do this right – including cost management, improved manufacturability, reduced risk, and shortened development times – are well worth the investment.

About the author: Keith Glaser, director, Medical & Hygiene, YKK (U.S.A.) Inc., is part of YKK’s team of medical industry experts who work one-on-one with customers to find solutions to their unique challenges.


March 2022
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