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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.


Woman checking glucose monitor on arm

Author: Jamme Tan | September 13, 2022

Wearable Technology in Healthcare

Developing Wearable Technology in Healthcare: Keys to Success In almost any aspect of our lives, we try to make things easier and more convenient – if there’s something we have to do, we...
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Alarm clock next to laptop on desk with bar graphs on screen

Author: Indre Larson & Jeni Leberknight | August 9, 2022

Using Regulatory Strategy to Reduce Medical Device Time to Market

Using Regulatory Strategy to Reduce Medical Device Time to Market According to recent estimates (1), the global medical device market is expected to grow from over $455 billion in 2021 to...
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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 Control 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 | 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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Resources

doctor pointing to screen with icons

April 30, 2020

Device Manufacturers Face Challenges to Balance Opportunity and Risk

With an increased focus on technology advancement and product development, medical device manufacturers are beginning to improve their devices and seize new opportunities. However, this comes with an...
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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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July 12, 2022

Scalp Cooling System

Overview Paxman has been pioneering scalp cooling technology for over a quarter of a century. Paxman’s clinically proven cold cap technology has helped over 100,000 cancer patients in more than 60...
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