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.

Author: Erik Hilliard | March 16, 2023

Unlock Your Device’s Potential with an Expert Medical Device Engineering Company

As a medical device developer, you know that success depends on having the right team in place. But what does it take to find the right medical equipment engineers for your project? In this...

Medical device engineers discussing project

Author: Erik Hilliard | February 25, 2023

Medical Device Engineering: It Takes All Types

Medical devices are highly regulated products that must be designed and developed according to stringent regulatory requirements and quality standards. A variety of expertise is needed in...

Author: Indre Larson | February 16, 2023

Is the FDA De Novo Pathway the Right Medical Device Regulatory Pathway for You?

If you're developing a medical device, you've probably heard of the FDA's De Novo classification process. You may be wondering if it's the right regulatory pathway for your device. In this blog...

Author: Jeni Leberknight | February 9, 2023

Unlocking the Mystery of Premarket Approvals (PMAs) and 510(k)s

Are you a medical device developer with questions about when and how to file for regulatory approval? Navigating the complexities of the FDA premarket approval process can be daunting. But it...

Man conducting third party compliance audit.

Author: Jeni Leberknight | February 2, 2023

Uncovering the Benefits of Third-Party Compliance Auditing

The importance of maintaining a high level of quality and compliance can’t be overstated for medical device companies. Failing to do so can put patients at risk, land you in hot water with...

Stethoscope holding down money with calculator and charts

Author: Steven Hartman, Larry Bischoff, Jamme Tan, & Jeff Triolo | January 26, 2023

Unraveling the High Costs Behind Medical Device Development

Developing medical devices is an expensive endeavor, but understanding the key components involved can help medical device companies better anticipate costs and estimate pricing. The overall...

Doctor showing medical supply chain process to avoid medical supply chain vulnerabilities.

Author: Larry Bischoff | January 24, 2023

Avoid Medical Device’s Supply Chain Vulnerabilities with These Five Tips

Supply chain breakdowns in medical device companies are becoming increasingly common. With the ever-evolving complexity of design and development processes, medical device developers are...

Doctor researching medical device information.

Author: Jeni Leberknight | 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...

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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...

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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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Medical Device Design Industry Blog

Unlock Your Device’s Potential with an Expert Medical Device Engineering Company

Medical Device Engineering: It Takes All Types

Is the FDA De Novo Pathway the Right Medical Device Regulatory Pathway for You?

Unlocking the Mystery of Premarket Approvals (PMAs) and 510(k)s

Uncovering the Benefits of Third-Party Compliance Auditing

Unraveling the High Costs Behind Medical Device Development

Avoid Medical Device’s Supply Chain Vulnerabilities with These Five Tips

Uncovering Medical Device Industry Challenges

Medical Device Concept Development: Important Factors to Understand

Resources

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

5 Mistakes Medical Device Startups Make

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

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