Sean Fenske

West Orange

Editor-in-Chief at Medical Product Outsourcing

Editor-in-Chief at (ODT) Orthopedic Design & Technology Magazine

Following the medtech industry and new innovations in it. My thoughts and opinions are my own.

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Articles

What Do FDA Changes Mean for Medtech?

1 week ago | odtmag.com | Sean Fenske |Orthopedic Innovators

By Sean Fenske, Editor-in-ChiefFollowing the results of the 2024 presidential election, a new administration took its place in the White House in January 2025. With it came promises of significant changes to many government agencies, including HHS and FDA. Now with many of those changes being implemented, expectations and speculation of how it will impact healthcare is taking place. For medical device manufacturers, the cuts could lead to a variety of outcomes.
How to Identify the Right Manufacturing Partner

2 weeks ago | mpo-mag.com | Sean Fenske

By Sean Fenske, Editor-in-ChiefAs medical device manufacturers reevaluate their supply chains and service partners, they are also seeking methods with which to measure the compatibility of new organizations with which to do business. This can be challenging, however, when the two groups have never worked together. As such, it’s important to learn best practices for identifying and selecting the right partner. There are a number of ways to effectively evaluate such a potential partner.
Ultra Polyimide Tubing Material Made Available

2 weeks ago | mpo-mag.com | Sean Fenske

To provide increased strength for medical tubing, Confluent Medical Technologies provides Ultra Polyimide, which the company states is the strongest version of polyimide in the industry. It offers strength that is nearly double traditional polyimide. “This advancement enables device designers to reduce material usage while maintaining essential column and tensile strength,” stated Jill Ellison, vice president of operations for Confluent’s High Precision Polymer Tubing Center of Excellence.
Don't Take Medical Device Coatings at Face Value

3 weeks ago | mpo-mag.com | Sean Fenske

The medical coatings market is predicted to be strong and steady in 2025. According to Technavio—a data analysis firm—from 2024 to 2028, the global medical coatings market will grow by about $5 billion with a compound annual growth rate of nearly 6% during the forecast period.1 An aging population is the driving force for market growth, with R&D trending toward developing advanced, multifunctional coatings for implants.
Intravascular Lithotripsy: The State of the Technology

3 weeks ago | mpo-mag.com | Sean Fenske

Intravascular lithotripsy (IVL), a novel therapy designed to treat calcified artery disease, is quickly proving itself to be a new star player in the cardiovascular device space. Heads turned across the medical device industry last year when the first commercially approved intravascular lithotripsy device, made by Shockwave Medical, was acquired by Johnson & Johnson for $13 billion.
Human Factors: An Investment that Pays for Itself

3 weeks ago | mpo-mag.com | Sean Fenske

In the competitive ecosystem of the medical device industry, medtech companies consistently seek ways to enhance their products’ safety, effectiveness, and marketability. A potent strategy to achieve these goals is through the integration of human factors engineering (HFE) into the design, development, and usability testing process.
The Power of a Common Vision in Developing Complex Medical Devices

3 weeks ago | mpo-mag.com | Sean Fenske

In the previous column, we described how to set up the right organization for new product development of complex medical devices. In this column, we discuss how to empower the team for success. CONCEPT 5: The Team Truly UnderstandsProduct development is a team sport. The ability to collaborate and function within a team setting is as important as an individual’s skill set or technical expertise.
Better RED Than Dead in Medical Device Cybersecurity

3 weeks ago | mpo-mag.com | Sean Fenske

So, the title of this article needs some explanation. It’s a play-on-words with an anti-communist phrase used during the Cold War—”Better dead than red.” The thinking at the time was that it was better to be dead than a communist. As an interesting side note, the phrase has been attributed to the Nazi propagandist Joseph Goebbels, expressed in 1945—a fact few who repeated this slogan in the 1960s were likely aware of. In this case, however, RED does not refer to communism.
Think Tasks and Skills: Successfully Accelerating the Integration of AI

3 weeks ago | mpo-mag.com | Sean Fenske

One of the biggest questions facing the medtech industry today is how generative artificial intelligence (AI) will redefine the future of work. From clinical studies to product design to software engineering, just about every aspect of device development, manufacturing, and marketing will be transformed by the proliferation of the technology. No doubt its impact will help OEMs put advanced life-saving products into the hands of clinicians and patients more quickly and cost effectively.
Is the 23andMe Bankruptcy a Call for Improving Patient Data Privacy Laws?

3 weeks ago | mpo-mag.com | Sean Fenske

If you haven’t already heard, 23andMe has filed for bankruptcy. The human genome identity organization provides a saliva collection kit for customers to submit to gain insights into their genetic makeup and historical matches. That’s the consumer-facing identity for the public, anyway. On the backend, the company houses a genetic archive for as many as 15 million customers, according to some reports.