John Kapitan is the CEO of Kapstone Medical, a company he founded in 2007 after 15 years in the medical device industry as a design engineer and regulatory affairs executive. John is an entrepreneur and expert in medical device design and commercialization.

Prior to creating Kapstone, John was a founding member of Altiva Corporation, a spinal implant company that was sold to Exactech, Inc. in 2008. His experience also includes AcroMed Corporation, DePuy AcroMed, and the Cleveland Clinic Foundation.

John received his BSME from Cornell University and MBA from the Weatherhead School of Management. He has designed and managed development for dozens of commercialized products, is an inventor on over 20 patents and patents pending, and has authored multiple industry articles. John enjoys spending time on his farm in Asheville, NC with his large family.

Mike Burgan is a business operations specialist and currently the Chief Operations Officer for Kapstone Manufacturing and Kapstone Medical.

He has a background in mechanical engineering and also holds an MBA. Over a 35-year career, Mike has worked in large corporations and small start-ups with responsibilities for profit & loss, new product launch, growth, restructuring, and continuous improvement. Assignments in these roles included personal relocation internationally, leadership of multiple-facility businesses covering the automotive, aerospace, and medical device global markets. The formula for success over Mike’s career has been identifying the customer value proposition, creating value streams minimizing waste, and establishing trusting relationships. 

He enjoys coaching and training runners and competing in running events of all distances.

As Director of Business Development at Kapstone Medical and Kapstone Manufacturing, Hayden Kapitan supports surgeons, startups, and large OEMs in translating early ideas into medical devices that successfully reach global markets. Since 2017, his work has focused on the front end of medical device innovation, collaborating with founders, physicians, and engineering teams to turn clinical concepts into clear, executable development plans. 

Hayden’s career has been deeply immersed in R&D and manufacturing, not as a hands-on engineer or regulatory professional, but on the business side as a medical device guru with a strong understanding of the full end-to-end development and commercialization process. He understands how quality, regulatory, engineering, testing, manufacturing, and commercialization efforts must be aligned and properly sequenced to avoid delays, rework, unrealistic budgets, and costly missteps. He complements the technical experts who execute the work by ensuring scope, timing, and expectations are clearly defined from the start. 

This perspective allows Hayden to accurately assess where a product sits in the lifecycle, identify gaps, and define a clear and defensible path forward. He specializes in scoping and structuring medical device programs, helping teams avoid fragmented development and false starts by providing a practical, integrated approach from day one. 

Based in Germany, Hayden serves as a direct link between U.S. and EU operations. He holds an undergraduate degree in business and is currently pursuing his Executive MBA at the Technical University of Munich (TUM), with a focus on global markets and regulated industries. 

His approach is shaped by growing up on a ranch, where accountability, follow-through, and integrity were non-negotiable. Outside of work, he spends as much time outdoors as possible, often bow hunting in the mountains. 

David Considine is the Director of Engineering at Kapstone Medical, where he leads the design and development of innovative surgical implants and instrumentation. David brings deep experience in designing and launching medical devices, particularly in orthopedics. He brings technical expertise, leadership experience, and a commitment to consistently going above and beyond for our customers.

David holds a Bachelor of Science in Biomedical Engineering from The University of Connecticut and brings over a decade of industry experience focused on the spine market. Prior to joining Kapstone Medical, David held engineering roles at Spine Wave, Alphatec Spine, and ICU Medical, contributing to the development of both implants and enabling technologies across the medical device landscape. David is the inventor on multiple patents for novel surgical instrumentation.

Outside of work, David enjoys hiking, camping, and exploring the national parks with his wife. He also enjoys spending time on the golf course, optimistically working on his score.

Kara Johnson is an accomplished leader serving as Kapstone’s Vice President of Regulatory Affairs. Kara is a seasoned RAQA professional with extensive experience in regulatory affairs and quality assurance within the healthcare sector. Her expertise encompasses regulatory strategy, compliance, and assisting companies in achieving and maintaining market access for innovative medical products. 

Prior to joining Kapstone, Kara has built and led cross-functional teams, developed regulatory strategies for product development and commercialization, and managed successful submissions to both domestic and international authorities. Her strategic vision and attention to detail have been instrumental in accelerating time-to-market for new medical devices. Kara is committed to fostering a culture of pragmatic compliance and quality, staying ahead of evolving industry trends and regulatory requirements.

Kara received dual BA degrees in Physics and English from Mount Holyoke College, and a MS degree in Drugs, Biologics, and Medical Device Regulatory Affairs from Northeastern University.

In addition to her professional achievements, Kara is dedicated to mentoring emerging RAQA professionals and actively supports industry initiatives to advance patient safety and access to cutting-edge medical technologies. In her free time, Kara enjoys various athletic recreational outdoor pursuits.

Nikhil Mangale is Vice President of Quality for Kapstone Medical and Kapstone Manufacturing, providing senior leadership across quality systems and regulatory compliance for both consulting and manufacturing operations. At Kapstone, he partners with clients to deliver practical, scalable quality and regulatory solutions across the medical device lifecycle.

 

Nikhil brings over 18 years of experience in the medical device industry, supporting companies across the full product lifecycle—from early development through commercialization and post-market support. He is known for his pragmatic leadership style and his ability to align regulatory requirements with business objectives while maintaining a strong focus on patient safety.

 

Prior to joining Kapstone in 2022, Nikhil worked with global medical device manufacturers including Boston Scientific, Stryker, and LinkBio. He holds a Master's degree in Electrical Engineering and is based in central New Jersey, where he enjoys spending time with his family, traveling, and staying current with emerging technologies.

Avery leads the Administration and Accounting departments at Kapstone Medical and Kapstone Manufacturing, a role she has helped shape over the past decade, and informally since Kapstone’s founding. Since officially stepping into her position, she has become part of the core team, managing HR, accounting, operations, and other essential administrative functions.

 

In parallel with her work at Kapstone, Avery has a strong background in the equestrian world, training horses and individuals of varying levels. The discipline and attention to detail required in the field has translated seamlessly into the role she plays with the company.

 

Outside of the office, she is an artisan jewelry designer and creator, and is passionate about living sustainably on her family’s farm in WNC.