The PocketECG aims to reinvent arrhythmia diagnostics through enhanced physical activity monitoring data.

Kristopher Sturgis

The PocketECG mobile cardiac telemetry system from MEDICALgorithmics includes extensive data on physical activity.

When it comes to diagnosing heart arrhythmia, running a simple electrocardiogram (ECG) often only tells part of the story of a patient’s heart. ECGs are often used to diagnose arrhythmias, but they can also help diagnose other serious conditions like coronary heart disease and cardiomyopathy. While the results are quick and painless, the data can still be limited when it comes to long-term monitoring of the heart.

A new cardiac company based out of Poland, known as ...

June 28th, 2017
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Medtech manufacturers can achieve a host of benefits—from speeding development to forming new partnerships—by looking outside their existing networks for technology solutions.

Bronwyn Monroe

Open innovation has become a mainstream practice for most technology-driven companies looking to accelerate time to market and stay ahead of the competition. The open innovation concept is based on the premise that a technology solution may exist in a more mature form outside of your own network and that connecting to an external solution provider will speed up development of new or existing products.

These external solution providers could be inventors, entrepreneurs, research labs, academics, or even Fortune 500 companies working on their own innovation for a particular application....

June 26th, 2017
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A call to put patient safety at the top of the list of priorities for healthcare reform includes a directive for the medical device industry.  

Jeffrey R. Ellis, PhD, MBA

Very soon, it is likely that both houses of Congress will agree on legislation to revise the Affordable Care Act (ACA) passed during the Obama administration. There is an almost universal bipartisan consensus that the bill passed earlier this year by the House of Representatives is unsatisfactory, as it removes many millions of Americans from affordable health insurance. Another failing is that the House bill does not give any consideration to how patient safety in hospitals can be improved. 

From personal previous research, I've concluded that directives for...

June 23rd, 2017
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The convergence of medical devices and pharmaceuticals presents advantages and growing pains for medical product manufacturers. 

Alex Butler

Combination products, or those that merge two or more different types of regulated drugs, medical devices or biologics, combat patient illnesses and ailments using a multifaceted approach, and they’ve been a hot topic at many of the industry trade shows and conferences I’ve attended in the past year. While traditional industry and regulatory lines have largely kept devices and pharmaceuticals separate, companies on both sides of the equation are beginning to see great potential in joining forces both from a treatment and a business perspective. As they do, the lines between drug and device are becoming blurred,...

June 22nd, 2017
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Learn more about the landmark Supreme Court decision that has important implications for medical device manufacturers.

Baldassare Vinti, Esq.

Last month, the U.S. Supreme Court issued a precedential decision likely to impact medical device manufacturers that have relied on patent rights to impose post-sale restrictions (e.g., single use restrictions, importation/exportation limitations, etc.) on their products. 

In Impression Products, Inc. v. Lexmark International, Inc., the Supreme Court addressed two specific questions concerning the use of patent law to enforce post-sale restraints: (i) whether a patent holder that places specific restrictions on how a buyer may use or resell a patented product may enforce such post-...

June 22nd, 2017
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Device designers must balance several factors in selecting the best battery for their specific device design.

Steve Risser

There has been an incredible surge in the number and types of wearable medical devices being introduced to the market, ranging from simple sensors and monitors to complex insulin pumps and neural stimulation devices.

As the number and type of wearable devices continues to grow, there will be increasing market pressure to make these devices smaller, lighter, longer-lasting, and less obtrusive. In most devices, this means that great care must be taken in selecting the proper battery for the device. However, the diversity of wearable device types means there is also a wide range in device power and energy needs. No single battery technology...

June 21st, 2017
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The second installment in a series on women in medtech focuses on Luann Pendy, senior vice president of Global Quality at Medtronic.

Maria Shepherd

You can’t be in medtech and not know about the accomplishments Medtronic has achieved in bringing advanced medical technology to market. Contributing to Medtronic’s growth is Luann Pendy, senior vice president of Global Quality at Medtronic. Luann’s energy is a positive and powerful force, and rang through our telephone interview loud and clear. 

Luann is an enthusiastic advocate of Medtronic’s programs to increase opportunities for women. While some of these programs are not unique to Medtronic, what is exceptional is the commitment to and passion about diversity within the ranks of the world’s largest...

June 19th, 2017
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Legislation purporting to focus on the safety and effectiveness of medical equipment servicing is underway, but is there a problem with the quality of equipment servicing?

William A. Hyman

Who services medical equipment, and how or if they should be regulated is an occasional hot topic. A key question here is whether there is a systemic problem with respect to inadequate service which leads to harm, noting that a systemic problem does not mean an anecdote or two, or a hypothetical scenario.

Part of this issue is the classic struggle between manufacturers and in-house and third part service organizations. Manufacturer’s desire to curb outside service is typically couched in terms of patient safety and at least uncertainty about the quality of...

June 14th, 2017
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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
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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
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