I can answer questions about the medical device industry. I'm happy to explain how devices work, how they're tested, the state of the industry, how they're regulated, how a new device makes it to market, what it takes to earn FDA approval, testing standards, how to test devices that don't have established test standards, how to write/file reports with the FDA, where medical device technology is headed, validation/sterilization and more. I can talk about navigating complex bureaucratic systems, forging strong partnerships with clients, mentoring employees and large-scale problem solving. I approach challenges from a perspective of building on what's working rather than simply fixing what's broken. I'm convinced solutions-minded approach is the foundation of any successful venture, whether it's earning FDA approval or advancing a belt level in tae kwon do. I can also discuss my experience in starting a new business, being a female business leader in a male-dominated industry, maintaining work/life/family balance (I have a husband and two young sons) and the failures I've experienced on my journey that have been critical to my overall success.
By education, I'm a biomedical engineer. By practice I'm also an entrepreneur and CEO. In 1988 I started a mechanical testing company because I'd been working for a medical device manufacturer and saw how few options there were for the rigorous medical device testing that the FDA requires. Empirical has since grown into a family of companies and 30 employees who work the entire process for FDA approval once a medical device design is complete. I was recently selected for the FDA’s Entrepreneurs-in-Residence (EIR) Tactical Team, a select group of medical industry experts who work with FDA staff to develop ways to improve the FDA approval process. Since 2001, I've participated in ASTM committees focusing on orthopedic devices, which keeps me abreast of pertinent regulations and industry changes. As a consultant, I work with clients throughout the approval process to support their success. As an educator, I speak at industry events around the world on a variety of topics, including trends, improving efficiency, marketplace challenges and more. I hold an inventor patent for the Stackable Cage System for Corpectomy and Vertebrectomy.
Biomedical Engineering Society Society of Women Engineers American Society of Biomechanics
Medical Design Technology OrthoTec ASTM International
MS in Biomedical Engineering from the University of Akron, Ohio
National Association of Professional Women 2011-2012 Professional Woman of the Year Nationwide Register’s WHO’S WHO In Executives and Business, 2001-2002
My business is my passion. I know I'm a direct link between medical device innovators and the patients who need life-saving or life-enhancing technology. I love what I do.
The medical device industry is growing rapidly as more active adults reach a point where they need procedures to preserve their quality of life. I appreciate being a part of making their lives better.
It can take more than 10 years for a new medical device to gain the regulatory approval required to reach consumers.
The Affordable Care Act is having a wide range of effects on the medical device industry and the companies that develop them.
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