These seven medtech products have been nominated for the Prix Galien Foundation "Discovery of the Decade" awards. 

The Prix Galien Foundation has named 33 nominees for its "Discovery of the Decade" awards in three categories—Pharmaceutical, Biotech, and Medical Technology. Commercial success and name recognition won't sway the decision. According to the foundation...

September 28th, 2016

Seven major private payers and health technology assessment groups have raised their hand to give interested medical device companies early feedback on clinical trial plans and potential evidence requirements.

Marie Thibault

In what is akin to an expansion of the Parallel Review program, CDRH has publicized the names of seven private payer and health technology assessment (HTA) organizations who have volunteered to help medical device companies gain more insight into clinical evidence needed for reimbursement coverage.

September 28th, 2016

Universality inspires commitment from customers, but can also bring rocky relationships. Here's why medical device makers should care about universal design.

Nigel Syrotuck

I’ve always wanted to open an article with a headline along the lines of "The Paradigm Shift is Happening Right Now." In reality, two news stories in the last month prove that paradigm shifts are the last thing people want. They show that universality makes consumers comfortable in their product relationships and resistant to change, even if that change come from a place of greed.

The first news story was the now-infamous EpiPen price hike, where Mylan increased the price of a set of two from around $100 (a few years ago) to closer to $600 for no apparent reason. For most people who use EpiPens,...

September 23rd, 2016

A medtech entrepreneur explains why more medical device startups need to be run lean and the lessons he learned building a lean device company. 

Dr. Shantanu Gaur 

Tech startups have built a whole culture—practically a religion—around running lean and producing high-quality products with minimal capital expenditures. Medtech startups, on the other hand, tend to take on large amounts of investment early on, often before they know their market or what products will best serve that market. 

Of course, information technology and medicine are two different realms, with specific requirements and limitations. However, there's a lot that medical device companies in particular can learn from tech startups when it comes to running...

September 23rd, 2016

FDA gave the medtech industry draft guidance on additive manufacturing earlier this year, but how can manufacturers translate the agency's thoughts into their process validation and quality assurance practices? 

Marie Thibault

A few months ago, FDA issued draft guidance on additive manufacturing for medical devices. This document offered industry a better idea of the agency's thinking on the use of 3-D printing and additive manufacturing for devices, but didn't give manufacturers an exact map for navigating these relatively new waters.

As a group of legal experts ...

September 23rd, 2016

Here's an innovative recipe for shaking up the medical device product development process.

Andrew Hyncik

When it comes to new product development, medtech companies are facing ever stronger headwinds. From higher regulatory hurdles to pricing pressure, or from talent shortages to the need for greater clinical validation, the prospect of shortening development cycles looks bleak.

That is one way of looking at things. Another way is to see an industry ripe for change or even disruption. After all, innovation doesn't apply just to how medical products work, it can also be applicable to how they get developed. 

Companies that are successful in changing how their products get developed stand a greater chance of reaping the rewards...

September 22nd, 2016

Most medtech professionals say they are happy with their careers. But a minority of employees say they are disenchanted with medical devices and diagnostics. What's behind their dissatisfaction and what industries are they targeting for their next job?

Marie Thibault

The medtech industry has a lot of devotees. In response to MD+DI's 2016 Medtech Salary Survey, many medtech professionals told us that they love the industry for its job security, innovation, and its meaningful impact on patients.

But, as with any industry, not every person surveyed was head over heels for their job in medical devices and diagnostics. In our survey, we asked whether...

September 21st, 2016

As device manufacturers try to improve cybersecurity, they need to consider how users might perceive and react to security measures.

T. Grant Leffingwell

Digital medical devices continue to grow in complexity and as such, cybersecurity is becoming increasingly important. Medical device manufacturers are developing sophisticated ways to ensure the digital integrity of their devices as well as the confidentiality of the information they contain or transmit.

With this increased focus on cybersecurity, it is imperative for manufacturers to consider how such security measures impact usability. This is especially important because poor usability in a medical device can result in harm.

It can be challenging to determine how to balance...

September 19th, 2016

If financing weren't an issue, regulatory hurdles were absent, and reimbursement were guaranteed, what dream medical device would you design?

MD+DI is launching our fourth Dare-to-Dream Medtech Design Challenge, a contest of bold ideas and limitless possibilities.

The idea is simple: If financing weren't an issue, regulatory hurdles were absent, and reimbursement were guaranteed, what dream medical device would you design?

The grand prize winner gets $500, while the first and second runners-up will receive $250 and $100 respectively.

To enter, fill out the form below. Along with written answers to the questions, please submit a good-quality rendering or image of the device you are dreaming up.


September 19th, 2016

To survive past launch, mobile health products must show strong evidence across clinical outcomes, usability/workflow, security, scalability, and economic value.

Anand K. Iyer, PhD, MBA


Mobile health continues to attract startups and developers. The space is still new and exciting, and the needs it can help address are vast. So, how do you ensure that your company’s mobile health application rises above the fray?

If your organization is developing a wellness ...

September 16th, 2016