Medical Device Design Industry Blog

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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.

Hand,Of,Woman,Using,Mobile,Phone.she,Is,Deciding,To,Make

Author: Carrie Britton | 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....

Author: Dan Sterling | 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...

person typing on a keyboard with security graphics overlay

Author: Keith Handler | July 23, 2019

Why Cybersecurity is Becoming More Important in the Medical Device Industry

Cybersecurity in the medical device world has evolved from a footnote to a front-page headline. Articles with titles like “Medical Devices are the Next Security Nightmare” (Wired) and “Medical...

Author: Keith Handler | July 16, 2019

A New Era of Cybersecurity

Cybersecurity has become a major concern over the years as technology has advanced. Device manufacturers are searching for ways to keep security up to date with the demand for stricter scrutiny for...

Author: Keith Handler | February 7, 2019

US FDA Recognizes New Cybersecurity Standard UL 2900-2-1

What Does it Mean for the Medical Device Industry? The current ever-changing landscape of cybersecurity threats and hazards, amongst ransomware campaigns and remote vulnerability cracks, call for...

Author: Dan Sterling | October 24, 2018

Software FMEA

The Effective Software FMEA Risk Management Approach Software FMEA, (Software Failure Modes and Effects Analysis) is a method of risk management that identifies single-fault failure modes in...

Author: Dan Sterling | October 7, 2018

ISO 14971

Considered the internationally accepted standard for the medical device industry, ISO 14971 is a guide for risk management of medical device manufacturing....

Author: Dan Sterling | April 2, 2018

FDA 483

Understanding Form FDA 483 Observations The FDA conducts inspections on Class II and Class III medical device companies either for pre-approval before products are cleared for release, impromptu...

Author: Dan Sterling | February 24, 2018

Gap Analysis

Bridging the Gap between Good to Even Greater All medical devices and software are required to undergo a series of mandatory safety testing in order to satisfy standards such as the FDA Quality...

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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Medical Device Design Industry Blog

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

Device Manufacturers Face Challenges to Balance Opportunity and Risk

Why Cybersecurity is Becoming More Important in the Medical Device Industry

A New Era of Cybersecurity

US FDA Recognizes New Cybersecurity Standard UL 2900-2-1

Software FMEA

ISO 14971

FDA 483

Gap Analysis

Resources

Medical Device Concept Development: Important Factors to Understand

5 Mistakes Medical Device Startups Make

Implanted Drug Delivery System

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