HYALEX ORTHOPAEDICS - Key Persons
Job Titles:
- Executive, Investor, Advisor, Ex - CMO Smith & Nephew
Job Titles:
- Chief Executive Officer
- President
- Chief Executive Officer, President, and Member of the Board of Directors at Hyalex Orthopedics
Carl Vause is the Chief Executive Officer, President, and member of the Board of Directors at Hyalex Orthopedics. Carl brings extensive experience in the orthopaedic industry and new technology development and commercialization, in both large publicly traded and early-stage companies.
Prior to Hyalex, Carl has worked extensively in orthopaedics at both CONMED Orthopedics and Smith & Nephew, leading the development and global launch of groundbreaking new products. He served as the founding CEO of Soft Robotics Inc, an early-stage venture established to translate groundbreaking polymer science out of the academic lab and address critical unmet needs in the global robotics and material handling industries. While CEO of Soft Robotics, Carl led multiple venture funding rounds, established a number of strategic and commercial collaborators, and built an industry-transforming line of products. Carl also serves as a Global Platform Fellow for the World Economic Forum's Advanced Manufacturing Platform. Carl earned a BS in Electrical Engineering from the Virginia Military Institute, an MS in Management Information Systems from the University of Maryland, and an MBA from the London Business School. Carl enjoys spending time with his family and is an avid aviation enthusiast.
Job Titles:
- Vice President of Clinical and Regulatory Affairs
Chris Cain serves as Vice President of Clinical and Regulatory Affairs at Hyalex Orthopaedics. He brings more than 25 years of medical device industry experience to Hyalex.
In his role at Hyalex, Chris has global responsibility for all aspects of clinical research and regulatory affairs for the HYALEX Cartilage System. Prior to joining Hyalex, Chris was VP of Clinical and Regulatory Affairs for Devoro, Inc. (acquired by Boston Scientific), Conformal Medical, Inc., and Corindus Vascular Robotics (acquired by Siemens) In his previous roles, he was responsible for global clinical activities supporting regulatory marketing clearances and approvals and clinical evidence generation contributing to the companies' publication portfolios. He also led global regulatory strategy resulting in marketing clearances/approvals worldwide. He earned a B.S. in Nursing from the University of Central Missouri and an MBA from University of Missouri Kansas City. In his free time, he enjoys traveling, hiking, and skiing.
Job Titles:
- Director of Product Development
Craig Fryman is the Director of Product Development at Hyalex Orthopaedics, bringing more than 15 years of medical device testing, development, and manufacturing experience to the team.
At Hyalex he is working to develop novel solutions utilizing our HYALEX bearing material for use in orthopaedic applications. Prior to Hyalex, Craig worked at Zimmer Biomet working in roles of increasing responsibility included hands on testing (mechanical, wear and user evaluations), material development, technology scouting and evaluation, and product development. Craig supported projects in knees, hips, extremities, trauma, and sports medicine during his time at Zimmer. He received his BS in biomedical engineering degree from Marquette University, MS in mechanical engineering from the University of Notre Dame, and completed a certificate in Human Factors from Penn State University. Craig enjoys hiking, skiing, and being outside with his wife and four kids during his free time.
Job Titles:
- Vice President of Research and Development
Mary Beth Schmidt is the Vice President of Research and Development at Hyalex Orthopaedics. She brings more than 25 years of experience in the medical device industry developing orthopaedic biomaterials to Hyalex.
Mary Beth is utilizing her expertise in the fields of cartilage biomechanics and tribology to lead the development of the Hyalex platform technology for cartilage repair products. Before joining Hyalex, Mary Beth was the Chief Technology Officer at Advanced Mechanical Technology Inc (AMTI), a global leader in joint simulator testing. She also served in various technical leadership roles at several Johnson and Johnson companies. Mary Beth additionally built a successful R&D consulting practice, working with early-stage medical device companies to develop preclinical testing programs that led to successful regulatory approvals of a variety of medical devices. Mary Beth earned her PhD in Biomedical Engineering from Rensselaer, with a concentration in biomechanics, and her BS in mechanical engineering from Lehigh University. She lives in beautiful northeastern Connecticut where she enjoys hiking, kayaking, and gardening with her husband and daughter.
Job Titles:
- Chief Technical Officer
- Member of the Board of Directors
- Osage University Partner
Mike Hawkins is the Chief Technical Officer and member of the Board of Directors at Hyalex Orthopaedics. He joined the board in December 2017 and brings more than 35 years of extensive experience as an orthopaedic medical device leader having worked in all functions of medical device development with the exception of finance.
Mike is an expert in materials science and processes as related to medical device research and development along with experience leading teams across the United States, Europe, and China, which he uses to help guide the Hyalex Orthopaedics team in their product development efforts. Mike is also a US Patent Agent since 1998, with 21 issued patents across the world, and uses that experience to help build a robust IP portfolio for Hyalex. He served in various leadership roles at Zimmer Holdings, Inc. and subsequently is active in the medical device innovation community in Indiana and across the country via his roles at AcceLINX where he is a co-founder and OrthoWorx. While working full-time, Mike received his PhD from the University of Notre Dame in Mechanical Engineering. In his spare time, Mike enjoys being active outside - he has restored 4 antique automobiles with only 7 to go and even built his own cabin in which he resides in Indiana.
Job Titles:
- Vice President of Quality Affairs
Rich Balano is the Vice President of Quality, bringing more than 30 years of experience in Quality and Regulatory fields in the medical devices industry across various specialties including orthopaedics, cardiology, and nephrology.
At Hyalex, Rich is leveraging his experience to lead the team in the implementation of a modern and efficient electronic quality management system to support the company's rapid development of its product portfolio and successful presentation to regulators for approvals. Prior to joining Hyalex Rich served as Vice President of Quality at MC10 from product approval to acquisition by Medidata, div. of Dassault Systèmes SE. Before MC10, he served in various leadership roles in Quality, Regulatory, and Servicing at Medtronic, CR Bard and at various early-stage companies. Rich has successfully implemented ISO 13485, QSR, and MDSAP compliant Quality Management Systems at multiple companies presenting to international regulators, including the US, EU, Japan, S. Korea, and Canada. Rich holds a Juris Doctor from the Massachusetts School of Law and is licensed in Maine and Massachusetts. He also holds a Bachelor of Science degree in Technology from Purdue University. He lives in Maine and enjoys boating, lobstering and fishing on the coast of Maine; biking throughout York county; and skiing the Northeast with his wife and two teenage boys.
Job Titles:
- Osage University Partner
- Osage University Partners