Supply Chain Interruptions

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Supply Chain Management

Supply chain interruptions can wreak havoc on your ability to deliver a product on time and budget. Your medical device is a carefully crafted piece of equipment, with each piece serving a specially designed purpose. If even one part is missing or altered, the whole device could cease to function or be ineligible for sale on the market.

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Project Redesign

If your supply chain challenges are too great to overcome, sometimes the best and only option is to redesign your product. For the past 25 years, Sterling Medical Devices has offered industry knowledge and expertise in medical device system development to help you overcome and avoid supply chain issues. From hardware to mobile apps, Sterling has helped companies – ranging from small startups to leading medical device organizations – overcome design challenges and develop innovative medical devices with successful regulatory submissions.

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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 17, 2023

New FDA Guidelines for Artificial Intelligence and Machine Learning in Medicine and Medical Devices

Are you developing cutting-edge technology using artificial intelligence (AI) or machine learning (ML) in medicine? Are the vague regulatory requirements for AI and machine learning in medicine...

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.

Implanted Drug Delivery System

Sterling Medical Devices designed and developed a Class III pain medication delivery system for patients with spinal injuries. The system is comprised of three devices: an implantable pump, a handheld Clinician Programmer, and a handheld Patient Therapy Controller. The pump is surgically implanted into the patient, and the two handheld devices each communicate with the pump when held within close proximity of it....

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