Thought Leadership

Doctor researching medical device information.

Author: Carrie Britton | January 13, 2023

Uncovering Medical Device Industry Challenges

In 2022, the global medical device market was valued at approximately $536 billion and is expected to grow to approximately $773 billion by 2027 (1). With an aging population, an expanding...

Healthcare professional developing a medical device concept

Author: Steven Hartman | December 5, 2022

Medical Device Concept Development: Important Factors to Understand

Medical Device Concept Development: Important Factors to Understand Designing, developing, and bringing to market a new medical device is a complex enterprise. Each step is a learning process...

Person In Scrubs Holding CE Puzzle Pieces

Author: Carrie Britton | November 14, 2022

CE Marking for Medical Devices

Medical device companies are usually anxious to get their product to market – they want to start meeting their business goals and they want their innovation to start helping people. Before...

Engineer examining results of 3D printed hand model

Author: Jeff Triolo | October 5, 2022

3D Printing in Medical Device Design

Innovation is the keystone of the medical device industry – companies constantly strive to use more advanced technologies to more efficiently create higher-quality devices. The use of 3D...

Telemedicine appointment between physician and patient shown on laptop screen

Author: Jamme Tan | October 4, 2022

Telemedicine Software Development: Challenges in Opportunity

The medical device industry has experienced a shift in the last several years in the types of products being produced. Advancements in software technologies and mobile medical device development...

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...

Alarm clock next to laptop on desk with bar graphs on screen

Author: Carrie Britton | 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...

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....

Healthcare worker holding marker on MDR graph

Author: Carrie Britton | August 8, 2022

New Proposed FDA Medical Device Quality System Regulations

New Proposed FDA Medical Device Quality System Regulations and What It Means for You Earlier this year, the U.S. Food and Drug Administration (FDA), the regulatory body that oversees medical...

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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Thought Leadership

Uncovering Medical Device Industry Challenges

Medical Device Concept Development: Important Factors to Understand

CE Marking for Medical Devices

3D Printing in Medical Device Design

Telemedicine Software Development: Challenges in Opportunity

Wearable Technology in Healthcare

Using Regulatory Strategy to Reduce Medical Device Time to Market

Medical Device Supply Chain

New Proposed FDA Medical Device Quality System Regulations

Resources

Insight on Updated FDA Device Software Guidance

5 Mistakes Medical Device Startups Make

Scalp Cooling System

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