Thought Leadership

Author: Anthony Caivano | September 20, 2021

Ways to Improve Medical Device UX Through Better Design

When it comes to the design and development of medical devices, ensuring a positive user experience (UX) is not a nice-to-have; it’s essential. As users’ needs expand and more connected...

Author: Larry Bischoff | September 10, 2021

Types of Medical Device Patents: What You Need to Know

In recent years, we’ve seen more innovation in medical devices, particularly with the proliferation of mobile medical devices—a trend that exploded further due to the COVID pandemic. With...

Author: Carrie Hetrick | September 1, 2021

How Long Does it Take the FDA to Approve a Medical Device?

According to research, time-to-market is a primary competitive driver in the medical device industry, second only to innovation.* You can’t start making money until you get FDA approval for your...

Author: Carrie Hetrick | August 26, 2021

FDA’s Software Precertification Program

In today’s digital era, Software as a Medical Device (SaMD) is revolutionizing the healthcare field. From informing and driving medical decisions to diagnosing and treating patients, SaMDs offer a...

A woman works on a plan for medical device startup companies

Author: Erik Hilliard | August 11, 2021

5 Mistakes Medical Device Startup Companies Make

Medical device startup companies play an integral role in the medical device industry. They have the ability to be nimble and take more risks on a unique product that larger, more established...

Author: Erik Hilliard | August 10, 2021

The Proliferation of Mobile Medical Devices—Revolutionizing Healthcare

Mobile devices are ubiquitous in today’s day and age; they’re everywhere—and for good reason: your smartphone is a hand-held computer allowing you to stay connected at all times. As a result,...

fda real world evidence on mobile device

Author: Carrie Hetrick | July 28, 2021

FDA’s Real-World Evidence Program – Summary of Patient Data Assessment Report

The FDA is responsible for ensuring the safety and effectiveness of regulated medical devices and assuring that patients have timely access to the devices while advancing innovation. It is a...

technician manufacturing medical devices

Author: John Campbell | July 21, 2021

Good Manufacturing Practices for Medical Devices: Risk Management

The clients we work with at Sterling Medical Devices often know they want to produce a high-quality medical device, but unfortunately too often do not fully understand an element essential to good...

Man performs verification and validation testing

Author: John Campbell | July 7, 2021

Do you know the difference between verification and validation?

Medical device verification and validation (V&V) are crucial steps in the medical device development process. But what’s the difference between the two, and why do we need them? Verification...

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September 1, 2021

How Long Does it Take the FDA to Approve a Medical Device?

According to research, time-to-market is a primary competitive driver in the medical device industry, second only to innovation.* You can’t start making money until you get FDA approval for your...

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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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November 23, 2020

Sterling Helps Print Parts Win Contract with City of New York for Production of Medical-Grade Nasal Swabs

Sterling Medical Devices performed design services for a Class III breathing pacemaker with Major Level of Concern software, intended for use by patients who have lost neurological control of respiration. This life-sustaining device is comprised of two main components: an internal passive receiver and an external controller....

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