Medical Device Innovation & Issues

The Fogarty Institute for Innovation, www.fogartyinstitute.org, a nonprofit providing intellectual, physical, and financial resources to medtech startups, just signed an agreement with FDA www.fda.gov to begin a first-of-its-kind educational program.

The goal is to help accelerate medical device innovation by improving communication, collaboration, and understanding between FDA and early-stage medical device innovators.Since the Fogarty Institute began in 2007, support has been given to more than 20 innovative entrepreneurs working in various stages of development.

Several of the startup companies are making progress with technology to greatly benefit patients such as:

  • CyberHeart www.cyberheartinc.com is developing the first non-invasive software to allow cardiologists to treat cardiac arrhythmias and cardiovascular applications
  • Echopixel www.echopixeltech.com provides visualization solutions to enable doctors to work with patient specific body parts instead of images
  • G-TECH Medical www.gtechmedical.com is developing a non-invasive wireless, wearable disposable electrode patch to measure the electrical activity from the stomach, small intestine, and colon

 

To help patients talk to FDA about their concerns on various devices, FDA has just announced that their new “Patient Engagement Advisory Committee” (PEAC) will advise the FDA Commissioner on a range of complex issues related to medical devices, regulation of devices, and their use by patients.

FDA will have the opportunity to obtain expertise on various patient-related topics to improve communication on benefits and risks and will foster patient partnerships with FDA so that the patient is part of the medical device regulatory process.

It was announced in the Federal Register on September 21, 2015, that comments are currently being accepted on potential topics for the Advisory Committee to discuss. For more information, contact Letise Williams, CDRH at 301-796-8398.

FDA recently took steps to further expand their knowledge on medical device failure. For example, recently fourteen employees went to the Thayer School of Engineering at Dartmouth to learn how biomedical engineers are able to analyze artificial knees and hips to see why implants fail.

The program is part of FDA’s Experimental Learning Program conducted with hospitals, universities, and with medical manufacturers. In general, FDA staffers want to have a better understanding of technology so they can improve their review of manufacturers’ applications for new devices.

 

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