A recent Supreme Court ruling in a case involving toner cartridges for printers is important for manufacturers of single-use medical devices. Here's why.

Joseph Re and Paul Stewart

On May 30, 2017, the Supreme Court of the United States decided the case of Impression Products, Inc. v. Lexmark International, Inc. in a way that may cause many medical device manufacturers to reconsider how they distribute their patented products. The case held that a patent owner could not sue someone for patent infringement for refurbishing and reselling products that the patent owner had previously sold under a sales agreement that explicitly restricted refurbishing and reselling. This new rule could be particularly important for manufacturers of devices intended to be...

June 13th, 2017

Taking these three steps for a sound clinical trial design strategy will allow device makers to successfully demonstrate the effectiveness of an embolic protection device.

Richelle Massey

Although embolic protection devices (EPDs) have shown mixed success in clinical trials, the EPD market is expected to grow into a billion-dollar industry. The devices have already entered the European market and have just achieved the first US FDA clearance.

To join the emerging EPD market, device manufacturers will need to design their EPD trials to clearly demonstrate the effectiveness of their...

June 9th, 2017

Here are five key tips for medical device manufacturers planning to offer value-based discounting arrangements to health insurers.

Meena Datta, JD

Health insurers are increasingly focused on optimizing health outcomes for the patient populations they manage as a means to lowering costs. As a result, there is a growing demand in the marketplace for medical device manufacturers to offer value-based discounting arrangements to health insurers. This article provides five key considerations for the medtech industry with respect to such arrangements.

What Is Value-Based Discounting?

Value-based discounting is the industry term of art that describes rebate arrangements between manufacturers and insurers or other customers...

June 9th, 2017

Medical device makers should take these factors into consideration when evaluating the best enterprise resource planning (ERP) deployment for their needs.  

Ed Potoczak

Cloud-based enterprise resource planning (ERP), with its promise of greater agility and the ability to reduce infrastructure costs, is becoming a viable choice in the manufacturing sector. In fact, research firm Gartner has observed that manufacturers turning to cloud ERP systems range from large corporations aiming to get divisions up and running quickly to small to mid-size enterprises seeking to increase value and improve the flexibility of their ERP deployments.

However, no one ERP deployment scenario fits all. This is particularly true for medical and diagnostic device...

June 7th, 2017

Audio and voice-controlled platforms are already a major trend among consumers. When will hearables become part of the medical device and healthcare realm? Sooner than you think.

Marie Thibault

Many of us already have hearable, voice-controlled devices at home, reminding us to pick up milk and answering our trivia-like questions. But when will similar applications become commonplace in the medical field?

In fact, hearables are already becoming part of the medical environment. As MD+DI has reported, Boston Children’s Hospital has incorporated Alexa-enabled Amazon devices to give clinicians basic reference information and guide users through...

June 6th, 2017

Recent developments in patent law have made it more difficult to secure patent protection for certain technologies for healthy aging,  such as personalized medicine, new diagnostics, biologics, interconnectivity, and big data. Learn what factors can make these technologies patent-eligible inventions. 

Rose Thiessen and Nathan Lee

As the number and proportion of older adults grow in the world, technologies for healthy aging are in greater need than ever. Today’s healthy aging products and services are not limited to just traditional means for healthy aging, such as cardiac stents, joint replacements, pharmaceuticals, and the like.  Rather, products and services for healthy aging are benefiting from the development of newer technological...

June 5th, 2017

When companies jump too quickly to declare a corrective and preventive action is needed, "death by CAPA" occurs.

Alex Butler

For companies, bad things can come in all shapes and sizes. When something goes wrong, it could possibly lead to the company's demise. Because of the serious consequences that can occur, taking quick action to correct problems is a necessity, but is also important not to overreact.

For companies operating under the auspices FDA, when something goes wrong, such as a nonconformance, customer complaint or deviation, it’s called a quality event. If one of these occurs, a...

June 2nd, 2017

We want to raise the profile of the young people doing groundbreaking work in the medical device and diagnostic industry. Do you know any industry innovators under the age of 30? Tell us who should make the 2017 list! 

Check out last year's list here.


June 1st, 2017

The Personal KinetiGraph System from Global Kinetics Corporation offers objective measurement and analysis of patient movement, allowing clinicians to better assess and treat the disease.

Marie Thibault

The PKG-Watch is worn on the wrist and monitors patient movement.

Global Kinetics Corporation may be a digital health company, but it doesn’t offer the typical wearable device.

The Melbourne, Australia-based company has developed the Parkinson’s KinetiGraph (PKG) System—known as the Personal KinetiGraph in the United States—for patients with Parkinson’s disease. The technology includes the PKG-Watch, a wrist-worn data logger...

June 1st, 2017

A regulatory expert discusses the most significant changes in the new European Medical Device Regulation that manufacturers will need to look out for and gives guidance on how to adapt your business to meet the new requirements.

Paul Brooks

Medical device manufacturers are currently faced with a three-year transition period before full application of the new European Medical Device Regulation (MDR) in 2020. The MDR will replace the existing Medical Device Directive (MDD) and the Active Implantable Medical Device Directive (AIMDD) in providing requirements and EU market access. There is a lot to do in this relatively short time-frame, including assessing all currently marketed medical device products against the new guidelines. This is a particularly onerous task with changes to the...

May 31st, 2017