Supply Chain Interruptions

Obsolescence in Medical Devices

Obsolescence is a challenge many manufacturing companies face, but it is especially problematic in highly regulated fields like the medical device industry. It can happen for any number of reasons including delayed or discontinued production of a part, updated regulation requirements, or increased security measures. No matter the reason, not having what you need to build your product means broken commitments, damaged relationships, frustrated customers, and lost revenue.

Resources

April 8, 2021

What’s the Difference Between a Class I and Class II Medical Device?

One of the most common questions when it comes to medical device regulation is, “What is the difference between a class I and class II medical device?” Today, we will explore the topic in more...
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February 18, 2021

5 Mistakes Medical Device Startups Make

Startups are the lifeblood of medical device innovation. Without universities researching ways to solve pressing healthcare problems or doctors with experience in a particular field who have an idea to develop a prototype medical device that could help patients, the future technologies needed to help save lives wouldn't happen. But the long, arduous road through the FDA submission process to get market approval can take a long time and cost a lot of money without help. Sterling Medical Devices has been helping startups through the FDA approval process since 1998 without ever having a submission rejected.
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people developing a product

November 23, 2020

Sterling Helps Print Parts Win Contract with City of New York for Production of Medical-Grade Nasal Swabs

Sterling Medical Devices performed design services for a Class III breathing pacemaker with Major Level of Concern software, intended for use by patients who have lost neurological control of respiration. This life-sustaining device is comprised of two main components: an internal passive receiver and an external controller....
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