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Keeping the innovation pipeline flowing.

It's that time of year again--MPO's annual compilation and review of the medical device industry's leading companies. As expected, there are the usual mergers, acquisitions, up-sizings and downsizings, legal tussles, management changes and tales of regulatory victories and roadblocks. After all of that, however, perhaps what's more interesting than the corporate intrigue and machinations is the new technology. Not only is it a reminder of how creative and prolific the medtech sector is, but how most of the amazing product developments detailed in this year's list (as it has been in years past) are the result of U.S. innovation. That's our edge.

We, as an industry and certainly as a government (think tax reform), need to foster that. If more U.S. companies such as Medtronic Inc. decide it makes more sense to move overseas to save on their tax bill (see Top of the News on page 12), eventually that steady pipeline of U.S. creativity could begin to slow down. Nurturing innovation and systems to support the growth of the next big medtech idea has become even more important. My editor's note in the last issue highlighted a new medtech incubator getting under way at the University of California, San Francisco, called the Rosenman Institute. Switching coasts, a new medical device-focused development center has opened in New York. Mount Sinai Heart at the Icahn School of Medicine at Mount Sinai Hospital in New York City has created the Center for Medical Devices (CMeD) to advance the field of cardiovascular medicine and accelerate the delivery of promising medical devices to cardiac patients. Julie Swain, M.D., an experienced cardiothoracic surgeon and medical device expert, has been recruited to help lead the initiative.

A practicing cardiothoracic surgeon for more than 25 years, Swain is also a clinical trials expert who has consulted for the division of cardiovascular devices at the U.S. Food and Drug Administration (FDA) for 20 years. In addition to her role as director of CMeD, Swain will serve as professor of cardiovascular surgery and director of clinical research in the Department of Cardiovascular Surgery at Mount Sinai.

"Our mission at CMeD will be to provide the critical expertise and guidance needed by medical device companies, inventors, and researchers to further develop and test innovative cardiac medical devices that show promise to advance the field of cardiovascular medicine and the heart health of patients around the globe," said Swain.

At CMeD, Swain joins forces with Mount Sinai Heart's leadership team including Valenhn Fuster, M.D., Ph.D., director of Mount Sinai Heart and physician in chief at the Mount Sinai Hospital, and David H. Adams, M.D., chairman of the Department of Cardiovascular Surgery, who are both members of CMeD's executive leadership committee.

"Dr. Swain brings to Mount Sinai her vast expertise and knowledge in testing the latest medical device technology in clinical trials and navigating the regulatory approval process. Together, our CMeD team's in-depth knowledge and experience in all aspects of designing and conducting clinical trials will improve the evaluation of promising cardiac medical devices at Mount Sinai Heart," said Fuster.

"Dr. Swain is internationally acclaimed for her leadership as the key advisor on cardiac device trial design and data interpretation for the (U.S.) Food and Drug Administration over the past decade. She has been at the center of every major cardiac device trial in this role, and is thus uniquely positioned to lead our medical device program going forward. I expect this program to be a national-level resource that will bring us access to a number of cutting-edge clinical research opportunities, and ensure our position as a leader in this space," Adams said.

CMeD's team will help further develop technologies and test medical devices in advanced clinical trials toward the strategic goal of regulatory approval, thus accelerating cardiac medical devices delivery to patients who may be in need of beneficial therapies. Services available through CMeD include cardiac medical device assessment and evaluation, regulatory approval strategies, advanced clinical trial design, data interpretation, assistance with FDA submissions, and potential access to clinical testing at Mount Sinai.

In addition, CMeD will be a training center for future medical professionals looking for experience in advanced clinical trial design and evaluation of medical devices.

"If you need help at any stage of your promising cardiac medical device's research and development, ranging from the earliest development of your medical device to the final regulatory FDA approval, our experienced team at CMeD at Mount Sinai Heart can help," Swain said.

Help? Absolutely. To keep our edge, every little bit helps.

Christopher Delporte

Editorial Director
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Title Annotation:Editor's Letter
Author:Delporte, Christopher
Publication:Medical Product Outsourcing
Date:Jul 1, 2014
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