Date(s) - 02/28/2019
1:00 pm - 6:30 pm CST
MetroPoint Business Center
NAMSA’s complimentary Start-Up Summit event provides a unique opportunity for early-stage medical device organizations to learn directly from the industry’s foremost thought leaders. This small, intimate gathering will offer attendees with limited medical device knowledge to draw upon NAMSA’s 50+ years’ experience with efficient, cost-effective product development. Presenters will share information based upon real-world global development efforts, including recommendations, best practices and resources that are critical to successful market introduction and commercialization. (Registration will take place from 1:00 – 2:00 PM, with a brief welcome at 2:00 PM; Networking Reception will be held from 4:45 – 6:30 PM.)
2:15 – 2:45 PM | Product Development Process
Presented by: William Garcia de Quevedo; Project Manager, Naglreiter MDDO
Description: Times have changed for the medical device industry. Any new or innovative medical device concept now days is rarely enough to gain investor interest or commitment, even when supported with unique or novel IP. Development professionals within the field not only need to understand why this ‘truth’ has evolved so dramatically, but also how it will drive change for future development efforts. Only then will device organizations truly recognize how to operate effectively within the new paradigm to become, and remain, competitive. This presentation will:
- Explain how and why investment in novel medical device technology has quickly evolved
- Formulate expectations related to paradigm shifts and understand their impact to the New Product Development operating environment
- Identify necessary activities in order for start-ups to remain competitive in medical device innovation and development efforts
- Identify the various development options that exist, and their key differences
- Understand the benefits of the Medical Research Organization (MRO®) development approach, a process that accelerates development, reduces costs and drives value
2:45 – 3:15 PM | Reimbursement for your Novel Device
Presented by: Edward Black, Director of Global Reimbursement Strategies, NAMSA
Description: Prior to the Patient Protection and Affordable Care Act of 2010, most technologies found their way into the marketplace based upon FDA clearance. Now for many, reimbursement has become a greater barrier to success than dealing with the FDA or designing comprehensive clinical trials as successful reimbursement pathways are less clear and more variable than in the past. This presentation will:
- Identify the fundamental components of a successful reimbursement strategy
- Discuss the challenges for obtaining broad coverage of new technologies among government and commercial insurers
- Demystify the process by which a successful strategy can be developed
- Present the case for early reimbursement planning that is fully integrated into your strategy development for regulatory, clinical, and product development processes
3:15 – 3:45 PM | FDA Trends & Guidance for Industry
Presented by: Jason Krzeszak; Director, Product Development Strategy, NAMSA
Description: The old adage that “the only constant in life is change” directly applies to the medical device landscape, and even more so to the U.S. Food & Drug Administration (FDA). With a new Medical Device User Fee Act in its fourth iteration, a series of changes from the FDA are expected over the next five years. Likely shifts include shorter approval decision times, more patient involvement and increased utilization of real-world evidence. Broader trends in government, technology and society will also directly drive new requirements within the medical device industry. Staying abreast of these trends, and understanding practical aspects of FDA roll-out, is key to accelerating development of innovative technologies and creating successful product introductions. This presentation will:
- Provide an understanding of current FDA regulatory trends
- Allow an understanding of how to navigate the ever-evolving U.S. regulatory landscape
- Examine proven, time-tested strategies and frameworks that lead to accelerated regulatory approvals for any device type
4:00 – 4:45 PM | PANEL: How to Begin and Run a Start-Up Efficiently
Presented by: Robert Wilson, MD; Founder & CEO – Egg Medical, Inc. & Doug Killion; President & CEO – Pursuit Vascular, Inc.
Description: This panel will provide an opportunity for attendees to interact with event speakers, including start-up entrepreneurs, Dr. Wilson and Doug Killion. Discussion will include the challenges of managing an early-stage device organization and insights and lessons learned along the way.
4:45 – 6:30 PM | Networking Reception
MEET OUR SPEAKERS
William Garcia de Quevedo: With more than 16 years’ experience within medical device development, Garcia de Quevedo has been involved in over two dozen innovative medical products from concept to commercialization. These device types range from blood processing equipment, catheters for treating ischemic stroke and orthopedic implants to robotic surgical instruments and other leading-edge technologies. At NAGLREITER, Mr. de Quevedo serves as a Project Manager and is part of a team of industry device development veterans—each of them driven by an entrepreneurial spirit and a commitment minimizing risk and optimizing the opportunity for return on investment for medical device companies and entrepreneurs. Mr. Garcia de Quevedo holds a Bachelor of Science in Mechanical Engineering from the Massachusetts Institute of Technology.
Edward Black: Ed Black has over 25 years’ experience in health and provider network management positions with Blue Cross Blue Shield working with hospitals and physicians in the upper Midwest. In 2008, he founded Reimbursement Strategies, LLC, a Minneapolis-based consultancy focused on reimbursement, health economics and market access for the international life science industry. Mr. Black has served on two national advisory boards responsible for leading consistency in medical, benefit, and payment policy, and from 1994 to 2002, he served as the executive director of three managed care business partnerships with large multispecialty clinics for which he was awarded the 1995 Outstanding Contribution to the Healthcare Industry Citation by Medical Alley Association.
Jason Krzeszak: Jason Krzeszak joined NAMSA in 2018 as a Principal Product Development Specialist. With over 15 years of experience in product development of medical devices, he has led activities focused on preclinical and clinical research of devices through the feasibility, pre-market and post-market phases. Notably, Jason has held leadership positions within clinical affairs for both large and start-up companies, which also included cross-functional leadership responsibilities. Mr. Krzeszak also possesses clinical experience in vascular (cardiac, aortic and peripheral vascular), cervical spine and urinary stones, in addition to numerous applications of medical technology in preclinical environments.
Dr. Robert F. Wilson: Robert F. Wilson, MD is an interventional cardiologist, entrepreneur and Professor of Medicine. His work is focused on developing new methods and devices for diagnosing and treating heart disease. Mr. Wilson developed the first coronary Doppler catheter to measure heart blood flow during cardiac catheterization and also founded Acist Medical Systems, were he developed the first semi-automated angiographic injection device, the CVi System. This technology is now a standard for coronary angiography worldwide and is used in over two million patients each year. Dr. Wilson went on to establish HLT, a company focused on development of a nitinol self-inverting transcatheter aortic valve, In 2014, he co-founded Egg Medical, Inc. which is focused on a platform that reduces hospital x-ray lab staff scatter radiation exposure by 91 percent%. Dr. Wilson continues to practice at the University of Minnesota where he interacts with a diverse group of University fellows, doctoral candidates and faculty in the Medical School and College of Engineering.
Doug Killian: Mr. Killion is President and CEO of Pursuit Vascular, a growth stage medical device company that has developed the ClearGuard® HD Antimicrobial Barrier Cap, a breakthrough technology for preventing costly and deadly catheter-related bloodstream infections. He has led the company from just two employees in 2011, through clinicals, FDA, commercialization, to over 4 million devices sold in 2018. Prior to Pursuit Vascular, Doug was President of Sealing Solutions, Inc., where he led the company from inception in 2008 to its successful acquisition by St. Jude Medical in 2010. Preceding its acquisition, Sealing Solutions had developed an innovative vascular closure device capable of enabling a wide range of minimally invasive procedures. Prior to joining Sealing Solutions, he held a variety of cross-functional senior management positions at Boston Scientific including global marketing, business development, and program management. In addition to his role as President and CEO of Pursuit Vascular, Doug serves as a business advisor to the Venture Center at the University of Minnesota. Doug earned his MBA in Strategy and Marketing from the University of Minnesota Carlson School of Management, and holds a BS in Mechanical/Biomedical Engineering from the University of Minnesota.