What medical device companies must consider when selecting an EMS provider

June 09, 2020 //By Charlotta Linnell
EMS provider
Over the last 20 years, medical device companies have shifted their focus from the challenges and complexities associated with building products to that of product IP, handing over most manufacturing responsibilities to electronic manufacturing service (EMS) providers.

There are a number of factors that have contributed to the growing relationship between medical device companies and EMS providers; not least the ever-increasing pressure to quickly deliver new products at lower costs.

Other contributing factors include the rise of personalized medicine, rigorous regulatory requirements, and increasing product complexity due to technology innovation. These are all areas that EMS providers have become experts in on behalf of medical device companies, freeing them to focus on medical device innovation.

Today, some EMS providers are taking this collaboration a step further, providing support to medical device companies who are faced with complex challenges as they design new products. The design phase is a critical period when many important decisions need to be made in a short period of time, adding further pressure to an already involved process.

Unfortunately, a medical device company may opt to work with the first available supplier or implement the first component offered to them, simply because they are time poor and don’t have the bandwidth or internal resources to thoroughly research alternative options.

Some single source suppliers will try and capitalize on this situation. All too often, this results in a scenario whereby a medical device company gets ‘locked in’ with a supplier that fails to meet its commitments or gets stuck with a high cost component during the lifecycle of a regulated medical product. This leaves them no alternative but to spend time and expense implementing a change that requires them to go through all of the regulatory reviews and approvals for a second time.


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