Dawn A. Lissy

In 1998, Lissy worked for a medical device manufacturer in Cleveland. She'd recently earned her master's in biomedical engineering and had started a career in developing new devices. For the past three years, she’d been designing spinal implants. But she realized there were few options for mechanical testing, a crucial step in gaining regulatory approval from entities like the FDA. So she launched her own company, Empirical Testing Corp., with herself as the sole employee. The following year she brought on her husband Chris to help develop the rapidly growing business. In 2004 they relocated the company to Colorado Springs, Colorado, to meet the growing needs of the company and their family. At the time, 10,000 square feet and four employees handled the workload. Ten years later, that space has doubled, and 30 people now work for the family of three companies that compose Empirical. It's a reflection of the growth of the medical device industry and Lissy's commitment to developing long-term partnerships with clients.

As her business has grown, Lissy has worked to stay abreast of progress in the medical device industry, educate her peers and help her clients gain and maintain regulatory clearance for life-saving medical devices. She was recently hired by the FDA as part of their Entrepreneurs-in-Residence program, a select group of medical industry professionals helping the FDA streamline the approval process. She's invited to speak at industry events around the world on topics related to medical devices and regulatory issues. She also volunteers for the Perry Initiative, a nonprofit dedicated to bringing more women into engineering and orthopedic surgery.

She holds an inventor patent for the Stackable Cage System for Corpectomy and Vertebrectomy. She’s a member of the Biomedical Engineering Society, Society of Women Engineers and the American Society of Biomechanics. She earned her MS in Biomedical Engineering from The University of Akron, Ohio.

She’s also the mom of two high-energy young boys and wife to an equally high-energy husband. Each day is a new opportunity to adjust and enjoy the precarious balance of business, personal and family growth.

Expertise includes: Biomedical Engineering, Medical Devices, Mechanical Testing, Orthopedics, Building your own business, How the FDA works, Regulatory approval of medical devices (FDA and International), Bringing medical technology to market.