Contact Us
Close Form

Interested in learning more about how we can work together in your current or next medical device design project?

Just fill out this form and we’ll be in touch!

  • This field is for validation purposes and should be left unchanged.

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.


selection agile development

Author: Jamme Tan | November 12, 2021

Agile Development in a Medical Device Company Can Save Time and Money

“The Sterling Approach” to medical device design focuses on our customers’ experience -  a critical component is our Agile project management. Agile development in a medical device company is...
Read More >
medical device regulation compliance

Author: Carrie Hetrick | October 22, 2021

Common Medical Device Regulatory Compliance Roadblocks

The medical device industry is heavily regulated by the FDA, specifically, the Center for Devices and Radiological Health. Unfortunately, while device manufacturers are required to establish and...
Read More >
Computer screen of a medical device

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...
Read More >
person holding a circuitboard

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...
Read More >

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...
Read More >

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...
Read More >
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...
Read More >
Person using mobile medical device app

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,...
Read More >
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...
Read More >

Resources

September 23, 2015

When Medical Device Software Fails Due to Improper Verification and Validation

Software can be an essential component of your medical device, whether you’re designing a new product or improving the functionality of an existing one. Medical device software continues to change...
Read More >
View More Blogs

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.
Read More >
View More Videos

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...
Read More >
View More Case Studies

Need help with your medical device?

Let Sterling Medical Devices show how to bring your idea from concept to prototype to
FDA/CE approval with a free custom project analysis.
Request Free Analysis