Prevent Delays in Medical Device Manufacturing with an Experienced ECM

The supply chain is the biggest and most obvious factor in manufacturing delays right now. Lengthy lead times for the specialized electronic components used in devices determine how quickly you can get your device to market. However, FDA approval for medical device components doesn’t help speed up the process either. The regulations on medical devices are extensive, FDA approval is necessary, and that takes time. An additional factor is the demand for components. As the industry grows, more demand is put on an already struggling supply chain, and predicting the end of the supply chain shortage is nearly impossible.

There are a few ways to cope with the component shortage:

• Partner with an experienced ECM

Your ECM will have developed relationships with vetted suppliers, will understand the FDA approval process and help you source components effectively, and will have a plan for redesign and reverse engineering when components aren’t available.

• Stock Up On Components When They’re Available

There is a risk to this strategy, as you don’t want to be stuck with a large supply of obsolete components, but in some cases, the reward of quicker manufacturing is worth the risk.

• Anticipate Your Needs

Knowing what you’ll need months, or even years, in advance, can make a big difference in those components being available to you.