Orthopedics: 3 R's - Research, Regulatory, and Reimbursement
Thursday, April 12, 10:00-11:30, Ski-U-Mah, McNamara Alumni Center

Organizer: Joan Bechtold, Excelen Center for Bone and Joint Research and Education and Minneapolis Medical Research Foundation
Moderator: Jennifer Marrone, Executive Vice President & Sr. Principal Advisor, Regulatory & Clinical Research Institute, Inc., RCRI®

"Regulatory: Planning for Project Success" 
Mary Beth Henderson, MBA, PhD, Sr. Principal Advisor Regulatory Affairs, Regulatory & Clinical Research Institute, Inc., RCRI®

"Research in relation to regulatory and reimbursement issues" 
Matt Kyle, President / CEO, Circle Biologics, Inc.

"Reimbursement: Proving the Clinical and Economic Value of New Technology" 
Mary A. Fautsch, RN, MBA, Vice President of Reimbursement and Health Economics, Sr. Principal Advisor, Regulatory & Clinical Research Institute, Inc., RCRI®

Session Abstract:

Combination products, such as an eluting coating, are becoming more sophisticated and more common. This session will address the development process from concept and research to regulatory concerns and reimbursement issues. Coordinating the 3R's early in the process will increase likelihood of successful implementation.

Session Chair Bio:

Joan Bechtold, Excelen Center for Bone and Joint Research and Education and Minneapolis Medical Research Foundation
Joan E. Bechtold, PhD, is the Director of Orthopedic Biomechanics Laboratory at Excelen Center for Bone and Joint Research and Education in Minneapolis. She is Professor at the University of Minnesota in Orthopaedic Surgery and Mechanical and Biomedical Engineering, and at the Minneapolis Medical Research Foundation. Dr. Bechtold is also Professor, Experimental Implant Surgery, at the University of Aarhus in Aarhus, Denmark. Dr. Bechtold received her BS in Mechanical Engineering from Michigan State University and her MS and PhD in Mechanical Engineering from the University of Minnesota. She worked at the Mayo Clinic Orthopedic Biomechanics Laboratory and completed a fellowship at the Mueller Institute for Biomechanics in Bern Switzerland, before joining the Orthopedic Biomechanics Laboratory at Hennepin County Medical Center, now the Excelen Center for Bone and Joint Research and Education. Currently, Dr. Bechtold’s main research focus is on improving the bone-implant interface, for which she has received support from NIH, OREF and the Arthritis Foundation. She also works in the areas of musculoskeletal infection and trauma, (DoD support) to heal fractures and bony defects in the presence of acute or chronic implant related infection. She has served as Secretary-Treasurer and President of the American Society of Biomechanics. With the Orthopedic Research Society ORS she has served on several committees (Program, Education and Special Projects, Membership, Nominations) and is currently 2nd Vice President. Her AAOS membership includes Women’s Health Issues Advisory Board, and Bioengineering Committee, and she participated in ORS/AAOS Research Capitol Hill Days, and has been ASTM Committee member.  

Jennifer Marrone, Executive Vice President & Sr. Principal Advisor, Regulatory & Clinical Research Institute, Inc., RCRI®
Jennifer Marrone is a Co-Founder of RCRI, Inc. and a Senior Principal Advisor in regulatory affairs. She has 30 years experience in the medical product industry, preclinical research and overseeing and preparing regulatory strategies and submissions for medical devices (PMAAs, IDEs, HUDs/HDEs, 510(k)s, design dossiers, technical files, etc.). She has worked with all levels of management and has been part of the executive team for several companies throughout the years as well as the present. Her responsibilities have included negotiating with governmental authorities, interacting with clinicians, as well as successfully developing and managing professional staff in regulatory affairs, clinical and quality system/compliance departments for numerous medical device companies. Her experience in executive management, and directing professionals, along with her hands-on expertise in regulatory, quality and clinical affairs, enable her to provide innovative service to the medical device industry. Jennifer holds a Master’s Degree in Business Administration. She is actively networked throughout the medical product industry and has held adjunct faculty positions at St. Cloud State University for the Master of Science in Regulatory Affairs and also at St. Thomas University for degree and certificate-level programs in Regulatory Affairs. Jennifer is a member of the Board of Directors for Excelen, the Center for Bone and Joint Research and Education, and also of the Advisory Board for the University of Minnesota, College of Education and Human Development.

Speaker Bios:

Mary Beth Henderson, MBA, PhD, Sr. Principal Advisor Regulatory Affairs, Regulatory & Clinical Research Institute, Inc., RCRI®
Mary is a Senior Principal Advisor in Regulatory Affairs at RCRI, Inc. and has worked for over 25 years in medical device and biotechnology industries. As a Senior Principal Advisor for RCRI, Mary has worked with clients to develop domestic and international regulatory strategies, draft submissions, and negotiate their approval by FDA and/or other regulatory agencies. Her chemistry and biotechnology expertise help to efficiently support project involving combination products or medical devices incorporating biological materials.

Matt Kyle, President / CEO Circle Biologics, Inc.
Matthew R Kyle is CEO of Circle Biologics, Inc., an emerging medical device company focused on cellular therapies and biomaterial management systems. Mr. Kyle’s expertise includes combining technical, legal and business knowledge to build and guide emerging and small cap medical companies in milestone critical environments, focusing on value creation and ethical medical device development. 

Mary A. Fautsch, RN, MBA, Vice President of Reimbursement and Health Economics, Sr. Principal Advisor RCRI®, Regulatory & Clinical Research Institute, Inc.
Mary Fautsch is the Vice President of Reimbursement and Health Economics and a Sr. Principal Advisor at RCRI, Inc. She has extensive experience in developing and implementing reimbursement strategies for new and established products and therapies. Mary has worked with start-up companies and established market leaders and has experience in all healthcare settings including hospitals, ambulatory surgery centers, and physician offices. She has worked with CMS and numerous private payors at the local and national level, forged relationships with professional societies to obtain CPT codes, trained sales and marketing teams, developed numerous innovative tools and services, and has created, developed and managed high-performing reimbursement teams. Mary has worked with all levels of management and has been part of the executive team for several companies. She has over 18 years of experience in the medical device industry and 13 years in nursing and hospital/clinic business operations. Her clinical background, executive management experience, and hands-on reimbursement expertise enables her to effectively navigate the dynamic healthcare environment. Mary holds a Bachelor of Science Degree in Nursing and a Master’s Degree in Business Administration.  

Presentation Abstracts:

"Regulatory:  Planning for Project Success" 
Developing a regulatory strategy at the earliest stages of product development is critical to project success. This is especially important when developing a combination product. The talk will describe the elements that need to be considered in preparing and maintaining a regulatory plan for a new medical device, including a discussion of combination product questions that need to be considered during strategic planning. 

"Research in relation to regulatory and reimbursement issues" 
Research in relation to regulatory and reimbursement issues.

"Reimbursement: Proving the Clinical and Economic Value of New Technology" 
Reimbursement strategic planning is critical to the market success of innovative technology. Decisions made during the early phases of product development can profoundly affect payer coverage decisions.  Learn how integrating research and development, regulatory and clinical requirements early throughout the product development process can optimize the success of your product upon commercialization.