Early Supplier Involvement Is Essential During Medical Device Development

Medical device manufacturers benefit by involving their suppliers early on in the development process.

Medical device designers are under increasing pressure to develop medical devices faster and cheaper than their competitors. Project managers are seeking ways to cut timelines, streamline processes and tighten deadlines. The development of new medical devices takes several years, so when a project gets funded it’s all hands on deck to make sure it stays on track.

This pressure often results in shortcuts on product design, according to Machine Design. One example occurs when the team is trying  to expedite the proof of concept (POC) stage. To shorten the build time, the prototype will be made of readily available standard components. The intention is to customize these components during future prototyping, but this isn’t always realized. Product performance, design and cost can suffer as a result. Early supplier involvement can help eliminate this disadvantageous shortcut, while keeping the development schedule on track. 

Choosing a Medical Device Supplier and Contract Manufacturer (CM)

Choosing supply partners is an important part of the medical device development process. Most components are single sourced to reduce development and regulatory approval costs. An approved supplier list (ASL) is often used to select several prospective suppliers. From there, a manufacturer needs to carefully select one supplier for each component. 

The right strategic suppliers, most often, should be able to see the product from conception to launch. Medical device manufacturers should select suppliers and a qualified CM (if applicable) who can be on board for the entire product lifecycle, have medical device manufacturing experience, employ design engineers who can be dedicated to the project, deploy stringent quality assurance and change order processes, and invest in the appropriate manufacturing technology.

When Medical Device Manufacturers Should Engage With Suppliers

As the article illustrates, ideally, medical device designers would engage with their suppliers during the early phases of development. As soon as the project has the green light from management and the internal development team is identified, the medical device manufacturer should start involving strategic suppliers. This allows for an efficient and accurate development schedule with upfront feedback from each supplier.

During the development, suppliers and the manufacturer can easily collaborate and evaluate design changes and how they’ll impact the overall product design, development timeline and cost. They may even be able to streamline the process by starting on the customized parts, while testing prototypes; avoiding the dreaded hurry-up-and-wait cycle that often plagues medical device development.

Developing this trusted partnership with early supplier involvement allows all parties to commit to a schedule, clearly communicate changes and keep the big picture in mind. 

AMS welcomes (and encourages!) early supplier involvement with its medical customers. We have the medical industry experience, reliable systems and regulatory knowledge to aid in the development and production of your medical device. Our team follows a  17-step process, which is proven by our 99.5 percent on-time delivery record and 97 percent customer satisfaction. Let’s review your application today!