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.


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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Safety Icons on Blocks

Author: Indre Larson & Jeni Leberknight | March 16, 2022

Medical Device Safety Standards

Approaching Medical Device Safety Standards Compliance In the United States, medical device companies that manufacture, repackage, relabel, and/or import medical devices sold in the U.S. are...
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Physician working on tablet in hospital room

Author: Keith Handler | March 15, 2022

Recent Advances in Medical Technology

The impact of the COVID-19 global pandemic will be evaluated, studied, and felt for years to come, especially in the medical device industry. To protect public health, health care providers...
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Physician’s hand holding FDA approval sign

Author: Indre Larson | March 14, 2022

What is FDA Premarket Approval?

At Sterling, we have helped bring hundreds of medical devices to market. While the products vary, the questions posed by the companies developing them are often the same. They want to know what it...
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Physician organizing single use surgical masks.

Author: Bruce Swope | March 14, 2022

What are Disposable Medical Devices and Why Are They Important?

There is an increased demand in reusable materials in order to reduce waste, but when device companies can create disposable medical devices, it increases patient safety and reduces risk....
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Doctor showing x-ray to patient on tablet

Author: Bruce Swope | February 14, 2022

What are Implantable Medical Devices?

According to a November 2021 report by MarketWatch, the implantable medical devices market is expected to exceed $138.5 billion by 2025. This boom is attributed to several factors. As with most...
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Letters GLP, representing Good Laboratory Practice

Author: Carrie Hetrick | February 14, 2022

Preparing for GLP Guideline Regulations in Medical Device Development

Preparing for GLP Guideline Regulations in Medical Device Development As you begin the process of designing, developing, and manufacturing your medical device, there are many things you must...
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Resources

design-medical-device-sharp

September 11, 2020

Keys to Success in the Digital Health/Mobile Medical Device Market: Experienced Partners

Digital health, including mobile medical devices and applications, is offering patients, providers, health systems, and insurance carriers’ real-world opportunities to improve medical outcomes and enhance the efficiency of healthcare around the world....
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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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