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Professors of Practice

Professor of Practice Mike Gara

Professor of Practice Mike Gara is now a principal with Equinox Medtech Partners, a consultancy for medtech companies. Prior to this he was Director of Healthcare innovation for the Department of Bioengineering at Clemson University. He held numerous posts for Wallace Coulter Foundation, including foundation director. Describing demands today’s students may face, Professor Gara said, “As a scientist turned business person, I have had the challenge of dealing with innovation and product development from many different perspectives. I am encouraged by the nascent field of bioengineering, which brings together skill sets in engineering, science and biology to tackle today’s challenges in the industry. Before the emergence of bioengineering, companies and disciplines were more often in silos, and communication and problem solving was more difficult. Today’s bright faculty and students are better equipped and determined to meet those challenges.”

Professor of Practice Steve Johnson

Professor of Practice Steve Johnson’s interests lie in technology commercialization, medical device development, managing start-up companies, intellectual property management and financial analysis. He regards his specialties as technology transfer, new company start-ups and strategic planning and execution. Currently, Professor Johnson heads Compass Bioscience Advisors, a consultancy which focuses on strategic planning, market assessment and financial analysis in the life science field. Of his professorship in bioengineering at Clemson, Professor Johnson said, “I believe this has been a two-way street. For me, it motivates and excites me to see very bright and committed students who are innovating in the life science field. For them, I hope it is a way to reach out beyond what they read in a textbook and get a real-world perspective on a range of subjects from FDA approval to how start-ups get funded.” Professor Johnson started the first technology transfer company in South Carolina over 20 years ago and has held executive management positions in both Fortune 500 companies and startups.

Professor of Practice Scott Robirds

I was originally trained as a clinician and worked exclusively in the clinical setting for several years. During a reorganization at my company, I was given the opportunity to lead a Regulatory Affairs team and loved it!

For many people Regulatory Affairs is black and white—simply check a few boxes in submission, gain your approval and then you're ready to market your product. The truth is actually quite different. Product registration requirements for the US and the rest of the world are constantly changing and it’s up to the regulatory professional to understand the changes and help guide the development team on what design requirements will be needed and how performance attributes, including clinical studies, should be tested. This is a very strategic role in new product development and, if done correctly, can result in a competitive advantage for a company due to quicker submission review times and shorter time to market.

Helping bioengineers understand the gray that exists in Regulatory Affairs and how it can be exploited to benefit a product’s sponsor is very rewarding to me. By discussing the framework of the relevant regulations, real world examples of regulatory successes and failures, and trends for new regulatory requirements, a member of a development team will have a better understanding of the latitude available within the boundaries of the regulations. This will have a significant favorable impact on the team’s overall effectiveness, and in the end, bring safe and effective products to the global market sooner.