In 2010, Dave Shalaby took on the role of president of Poly-Med, Inc., after having served on the board of directors for eight years. Under Dave’s leadership, the company has grown into a vertically integrated design, development, and custom manufacturer of bioresorbable medical device and pharmaceutical products. Before stepping into his role at Poly-Med, Inc., Dave was founder and president of InSource Consulting in 1997, providing strategic consulting services to financial service companies to improve process and business efficiencies through the use of process analysis methodologies.
During his tenure, Dave personally led major merger and acquisition operational integrations for several Fortune 100 insurance companies and has overseen countless key strategic efforts in support of the InSource clients.
He grew InSource Consulting into a multimillion-dollar specialty management consulting firm aimed at providing strategic support services to large companies within the healthcare, financial service, and federal government sectors. InSource Consulting was acquired by Virtusa, Inc. (NASDAQ: VRTU) in 2009. At that time, he joined their leadership team as Senior Vice President responsible for their Insurance practice.
This unique mix of strategic and business acumen has led to significant growth at Poly-Med, Inc. Several key initiatives encouraging the team to achieve elegant solutions are advancing the company to the next level while staying true to the legacy of Dave’s father, Dr. Shalaby W. Shalaby.
Education: Dave holds a B.S. in Aeronautical Technology from Purdue University (1992) and an MBA from Loyola University of Chicago (1994).
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.
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 that 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 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 the 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 were more difficult. Today’s bright faculty and students are better equipped and determined to meet those challenges.”
Dr. Lawrence Boyd has more than two decades of experience leading product development, engineering and business development efforts for medical devices in orthopedic and spine surgery. Dr. Boyd is president and founder of Palmetto Biomedical, a medical device design and consulting firm based in Columbia. In addition to having founded two medical device-focused ventures (OrthoClip LLC and View Medical), Dr. Boyd is a prolific inventor, with over 60 issued U.S. patents for medical devices and related procedures. Previously, he was Executive Vice President of R&D for Spinal Elements, a medical device firm based in Marietta, Georgia, and Carlsbad, California. Prior to that position, Dr. Boyd was a Director for Medtown Ventures, an Atlanta-based venture investing and consulting firm.
After receiving his BS in Mechanical Engineering and MS in Bioengineering from Clemson University in 1989, Dr. Boyd became product development group leader and engineer at Dow Corning Wright in Arlington, TN, developing implants for use in hands, feet, and knees. Holding positions of manager, director and group director in numerous businesses, Dr. Boyd focused his efforts on research, development, and commercialization of novel medical technologies.
Recognizing the growing importance of recombinant proteins, human tissues, and other biologically inspired materials and potential for applications to the spine, Dr. Boyd began his Ph.D. in biomedical engineering at Duke University in 2000. Upon receiving his Ph.D. in 2007, he accepted a position as Associate Director of the Center for Entrepreneurship and Research Commercialization at Duke. Additionally, he was an adjunct professor for the Biomedical Engineering Department and the Masters of Engineering Management Program at Duke. While at Duke, he developed and taught classes in technology commercialization, risk management, engineering design, and leadership. He established and led the DU Hatch student business incubator, which served graduate, professional and undergraduate students.