While straightforward in principle, the question of whether or not a new 510(k) is required, and what documentation is required otherwise, is one that both industry and FDA struggle with.

William A. Hyman

Perhaps from shortly after the dawn of the 510(k) there has been the question of what changes to an existing 510(k) cleared Class II device require a new 510(k) submission. There is a companion question of how to document that a new 510(k) is not required when that decision is made. Generally, this has been handled with a letter-to-file, and in some circle this...

September 7th, 2016
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In an uncertain reimbursement climate, some device manufacturers are considering new ways of billing to ensure revenue and profitability.

Rina Wolf

The medical device industry is facing a number of revenue-related pressures impacting growth and profitability due largely to healthcare reform initiatives, changes in purchasing and supply chain management, and billing and reimbursement issues. To succeed against this backdrop and ensure the greatest opportunity for product adoption, manufacturers must not only demonstrate a device’s value proposition in clinical and economic terms, but pursue strategies that optimize their ability to obtain timely reimbursement. 

Value-Based Reimbursement Has Redefined Device Purchasing

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September 7th, 2016
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For your product to successfully pass the value analysis gantlet, you’ll need to avoid these blunders.

Jamie Hartford

The value analysis committee is the gatekeeper that determines which medical devices make it onto a hospital’s approved products list. Comprising stakeholders such as administrators, physicians, supply chain professionals, and other stakeholders, the value analysis...

September 2nd, 2016
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You might be able to make more money working in another field, but a career in medtech still offers some pretty nice perks. 

Jamie Hartford

Each year, we conduct MD+DI’s Medtech Salary Survey as a service to our readers. We ask highly personal questions about your job and compensation in order to glean larger insights that can help you and your medtech peers go into your next performance review armed with information to...

September 1st, 2016
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Want to learn more about transcatheter mitral valve replacement technology before it become mainstream? Two experts offer an introduction to the TMVR market opportunity.

Marie Thibault

The CardiAQ-Edwards TMVR system, which is entering a CE Mark trial, is one of several transcatheter mitral valve replacement technologies in development.

Over the past few years, whispers about the promised of transcatheter mitral valve replacement (TMVR) technology have grown louder. Excitement about TMVR is reaching an all-time high, as several large medtech companies have invested in the area. In 2015 alone, Edwards Lifesciences purchased CardiAQ Valve Technologies, Medtronic bought Twelve Inc., and Abbott acquired Tendyne...

September 1st, 2016
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In the fast-changing world of medical wearables, the right product development and design partnerships can save time and resources, and accelerate ideas to market.

Deepak Prakash

To ensure a smooth transition from prototyping into full-fledged production, OEMs and suppliers should first ensure that every component in the wearable design can be procured in mass quantities at acceptable price points.

From primary care to clinical trials, healthcare providers, researchers, device developers, insurers and others are exploring how...

August 29th, 2016
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Although imports currently represent 90% of the market, the Saudi government is encouraging development of a domestic manufacturing base for medical devices and instruments.

Curt Cultice and and Linda Abbruzzese

Saudi government initiatives and lifestyle trends continue to drive Saudi Arabia’s healthcare market to be the largest in the Middle East. While the government accounts for nearly 80% of healthcare expenditures, privatization is creating new opportunities for U.S. businesses in specialties such as medical facility construction, hospital management and operation, information technology, education and training, medical devices, pharmaceuticals, and more. In the following Q&A, senior commercial...

August 29th, 2016
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Medtronic's management offers a peek into the company's future as an LVAD maker just days after closing its acquisition of HeartWare.

Marie Thibault

Medtronic recently closed its acquisition of HeartWare, the maker of the HVAD left ventricular assist device.

The HVAD is now a Medtronic product. How will HeartWare's left ventricular assist device (LVAD) business change now that it is part of Medtronic's massive product portfolio?

Executives at the medtech giant recently gave a glimpse of how HVAD will fit into its broad cardiovascular offerings and what Medtronic's R&D capabilities can bring to LVAD technology.

Speaking on Medtronics' latest earnings call, chairman and CEO Omar Ishrak...

August 29th, 2016
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Unitron is focused on improving the design of hearing aids to make them comfortable, aesthetically pleasing, and easy to use.

Marie Thibault

Unitron's Moxi Kiss hearing instrument is the recipient of product design awards.

Unitron, a hearing instrument company based in Kitchener, Ontario, is focused on turning the hearing aid—that ubiquitous harbinger of aging—into a comfortable companion worn without embarrassment. The company's developers are using design thinking and a patient-centric design philosophy to achieve this goal.

It's unique to hear about the latest design principles applied to what some may view as the old technology of hearing instruments...

August 26th, 2016
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Several of the surgical robotics company’s patents are set to expire at the end of the year, which could open the door to even more competition.

Josué Villalta

Intuitive Surgical's da Vinci Xi surgical robotics system

In the 2012 movie “Prometheus,” a female character enters a computerized and automated surgical operation machine that performs an emergency caesarean section to remove an alien fetus.  While only science fiction, such movies have often provided us with a window into what might be possible in the future of medicine.  Though fully automated surgical operation...

August 25th, 2016
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