An expert offers a primer on popular medical device coatings and their applications.

Kevin Guenther

A catheter with a lubricious coating.

In the world of low friction, lubricious coatings for medical devices are diverse and complex. There are many different types of coatings, each with their own advantages, disadvantages, and applications. This is a basic overview of the most popular medical device coatings and what can be expected from each type.

Lubricious coatings are most commonly distinguished by their degree of lubricity, or the amount of reduction in friction they provide. To understand what these measurements mean, we must first learn how these measurements are obtained. In the medical device industry,...

January 24th, 2017

How do you design a usability test that mimics the panicked, stressful situation that a user may be in when he or she is using your medical device in the real world?

T. Grant Leffingwell

Imagine you are manufacturing a handheld combination product, designed to be used in a very rare “rescue” type of scenario. You need to test this product with users but you don’t know how to do it in a way that provides insight into how it will be used once it’s on the market. How do you design a usability test that mimics the panicked, stressful situation that a user may be in when he or she is using your device in the real world?

Regulations released by FDA in February 2016 ("Applying Human...

January 20th, 2017

It's easy to assume the medical device industry comprises for-profit companies of all sizes, yet non-profits also play a major role in the sector. Here are more than a dozen ways non-profits help the device industry.

Nigel Syrotuck

I recently read a great article about the indirect benefits that non-profit organizations provide to our economy and our society in general. Knowing they also play a recurring and prominent role in many of our clients’ core technology, I spent some time examining the benefits non-profits provide to the medical device industry as a whole.

Here are 14 ways that non-profits contribute to the medical device Industry:

January 19th, 2017

Here's how to take on the challenge of selecting the right materials for an implantable medical device.

Len Czuba

I don’t think that there is any challenge more confusing to product development teams than selecting materials that can be used for long-term implantable medical devices.

Are there databases where implantable materials are featured? Can we go to our local supplier and ask them to recommend a material that can be used for implant applications? Usually the answer to both questions is “No." There are not databases that offer a variety of implantable materials like produce at a supermarket, nor would they be accurate if they did exist. 

As with most materials used in medical devices, the end use application dictates the selection of the...

January 18th, 2017
More on the potential for corporate tax reform and repatriation

Alex Gorsky, Johnson & Johnson chairman and CEO—“Based upon the conversations that we’ve had, the opportunity to go to more of a territorial-based system will result in us being much more competitive, hopefully taking out some of the anomalies that cause us to do inversions, other factors that result in us being less competitive. That could be a very good thing. Secondly, just lowering the rates so that we can be more competitive. Third, a very important issue is, how do we repatriate some of...

January 17th, 2017
The potential for market impact from uncertainty around ACA "repeal and replace"

Omar Ishrak, Medtronic chairman and CEO—“To the degree that we can tell, we haven’t really seen anything dramatic. This thing is pretty steady, the U.S. market is holding. We think that our new product introduction cycles in the U.S. especially have a bigger impact on our growth rates at this stage than the markets themselves. The markets are pretty steady . . .”

Alex Gorsky, Johnson & Johnson chairman and CEO—“We haven’t seen a significant increase in hospital volumes . . . I think...

January 17th, 2017
The potential for new HHS leadership

Omar Ishrak, Medtronic chairman and CEO—"Improve outcomes and lower costs—that’s what value-based healthcare is. I know there is overall support for that notion. The journey toward value-based healthcare is not going to change, no matter who the administration is. There is no other alternative. I think there is general agreement around that. The question is, how do you get there? We think that some of the programs that have been put in place by CMS are ones that will probably stay in some form. I think the CJR will almost certainly stay and...

January 17th, 2017
The potential for corporate tax reform and repatriation

Karen Parkhill, Medtronic CFO—"We would say that the Republican blueprint, as written right now, is a slight benefit for Medtronic if the details remain similar to what is written on the high level. There are puts and takes in the tax reform. The benefit of repatriation would be the largest benefit for us.

On the repatriation side, it is our assumption that there will be an impact on both accumulated foreign earnings and on cash currently overseas. We have...

January 17th, 2017

Medical device executives look ahead to the changes expected to come out of Washington, DC this year. Here's how they see issues like the medical device tax, repatriation, and agency leadership impacting their companies.

2017 is set to be a year of upheaval. The Trump administration and the new Congress are expected to usher in legislative changes while unwinding current policies. This of course is likely to mean big changes for the healthcare industry.

One move anticipated by many industry onlookers is a permanent repeal of the medical device excise tax. According to recently...

January 17th, 2017

If you’re heading to Anaheim, CA, for the world's largest annual medtech expo and conference February 7–9, 2017, be sure to check out these goings-on at the event.

Jamie Hartford

Next month, medical device professionals from across the country will converge in sunny Southern California to attend Medical Design & Manufacturing (MD&M) West, the world’s largest annual medtech event.

For more than three decades, the MD&M West expo and conference has united the industry’s top innovators with cutting-edge suppliers and forward-thinking influencers to help speed their medical device products to market. This year’s event will bring together more than 20,000 engineers and executives for three days of networking and...

January 13th, 2017