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Medical Device Design Industry Blog



The medical device industry changes constantly as new innovations and advancements are made in development, medical IT, and healthcare. Our medical device blog features expertise from the Sterling Medical Devices team and the latest information and regulation changes in the medical device industry that you should be aware of.


Author: Jeff Triolo | August 8, 2022

Medical Device Supply Chain

Medical Device Supply Chain Challenges and FDA Action Supply chain delays and disruptions can wreak havoc on any business, especially in the highly regulated medical device industry....
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Healthcare worker holding marker on MDR graph

Author: Jeni Leberknight | August 8, 2022

New Proposed FDA Medical Device Quality Control Regulations

New Proposed FDA Medical Device Quality System Regulations and What It Means for You Earlier this year, the U.S. Food and Drug Administration (FDA), the regulatory body that oversees medical...
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3D prototype of prosthetic hip bone

Author: Tara Miller, Nick Oshman, Steve Hartman | July 29, 2022

How Quickly Can You Rapid Prototype a Medical Device?

Designing, developing, and getting a medical device on the market involves risk. It requires a large investment of your company time, resources, and reputation. It also includes risk for the...
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Robotic hand holding stethoscope

Author: Kuldeep Gandhi | July 27, 2022

The Future of Robotics in Medical Devices

The Future of Robotics in Medical Devices Since they first began appearing in the 1980s, medical robotics devices have revolutionized the healthcare industry. The robotic surgical...
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physician pointing to search button

Author: Indre Larson | July 4, 2022

What does it mean for the FDA to classify a medical device?

One of the most frequent questions we get at Sterling is, “what does it mean for the U.S. Food and Drug Administration (FDA) to classify a medical device?” especially when it comes to...
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3D printing of organ next to computer screen

Author: Indre Larson & Jeni Leberknight | June 29, 2022

3D Printing of Medical Devices at the Point of Care

FDA Action on 3D Printing of Medical Devices at the Point of Care In the medical device field, manufacturers and regulators are constantly trying to balance the advantages of new and emerging...
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FDA medical device regulations graphs.

Author: Indre Larson & Jeni Leberknight | April 4, 2022

FDA Medical Device Regulation Guidance for 2022

In the United States, the U.S. FDA (Food and Drug Administration) provides medical device regulation through the CDRH (Center for Devices and Radiological Health). The agency recently released...
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United States of America and Medicine button on keyboard

Author: Erik Hilliard | March 17, 2022

What Country Leads the World in Medical Innovation

We’ll get right to the point. The answer to the question, “what country leads the world in medical innovation?” is the United States. Medical industry professionals all over the world...
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Doctor examining patient monitoring system

Author: Larry Bischoff | March 16, 2022

The Components of Patient Monitoring Systems

The medical device industry continues to pioneer and improve patient outcomes all over the world. One area of growth centers on patient monitoring systems. Remote patient monitoring systems...
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Resources

October 8, 2015

Developing Medical Device Software

"Developing Medical Device Software," New Med Device Online Article Series by Sterling Medical Devices While nowadays Safety Assurance Cases are mostly limited to infusion pumps, medical device...
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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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active drug delivery system

September 8, 2020

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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