Reducing Time & Cost to Market for Medical Devices

Developing and launching a product is never a linear process, and the medical device pathway to market can entail numerous complexities. In this webinar, a multi-disciplinary team with various experiences will weigh in to provide tactical advice on avoiding costly missteps when commercializing a new medical device. Practical tips based on prior knowledge and experiences will help those who have not gone through the process many times before.

Register for this webinar to:

• Gain a deeper understanding of each step of the process — including market fit, research and development, prototyping and go-to-market strategy
• Learn from experienced professionals on what should be considered when launching
• Hear the failures and successes of bringing devices to market

Speakers

Carolyn Guthrie, Director of Quality Assurance & Regulatory Affairs, Kapstone Medical

Carolyn Guthrie is the Director of Quality Assurance & Regulatory Affairs at Kapstone Medical, a full-service product realization consulting firm exclusively serving medical device companies and inventors. She has 15 years of experience in QA and RA in the medical device industry. She has worked for, and with, both large corporations and start-up companies. She’s worked with many device types including in vitro diagnostic devices, orthopedic and dental implants, software products and packaging and sterilization solutions. Carolyn has experience globally, with a focus on North America and Europe, in both the pre-market and post-market functions, including pre-market submissions (510(k) and CE Mark), as well as day-to-day operations in quality assurance and quality systems.

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Justin Rowland, Director of Business Development, Kapstone Medical

Justin Rowland serves as the Director of Business Development for Kapstone Medical. He has a background in biomedical engineering and also holds a master’s in business. He has been in the medical device industry for 10 years, working in various product engineering and project manager roles. Justin’s experience has primarily been with surgical-related devices, but having been involved with dozens of projects, the products he’s worked on span much of the medical device industry.

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John Kapitan, CEO and Founder, Kapstone Medical and Kapstone Manufacturing

John Kapitan is an entrepreneur, inventor and currently the CEO and Founder of Kapstone Medical and Kapstone Manufacturing. Kapstone Manufacturing is a contract manufacturing firm serving medtech clients worldwide. John has a background in mechanical engineering and also holds an MBA. John has worked with large corporations and has launched, or been a part of, dozens of start-up companies in the medical device industry over his 25-year career. Through his decades of experience as an executive, John understands all the resources, efforts and activities that are needed to successfully commercialize a new medical device.

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Mike Burgan, Chief Operations Officer, Kapstone Medical and Kapstone Manufacturing

Mike Burgan is a business operations specialist and currently the Chief Operations Officer for Kapstone Manufacturing and Kapstone Medical. Mike has a background in mechanical engineering and also holds an MBA. Over a 30-year career, Mike has worked in large corporations and small start-ups with responsibilities for profit & loss, 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.

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Meg Sinclair, Senior Quality Specialist, Qualio

Meg has 10+ years as a Quality Assurance, Regulatory Affairs and Compliance professional with a range of cross-functional skills and experience spanning non-profits to start-ups. Meg helps companies adapt to and master new and complex subject material with organization and attention to detail.

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