Working under the assumption that a medical device is in its premarket development stage, the course presents a framework for developing reimbursement and health economic strategies which utilize a product’s preclinical, clinical and launch phases. Beginning reimbursement and economic planning, and execution, early in the product’s development cycle is done with the objective of advancing a product’s commercial reimbursement objectives.
As a result, this class is ideal for those companies that are planning to begin an FDA-approved trial. Even if a company is currently selling products, this course will be relevant should the company’s products in its pipeline require FDA approval. This course covers reimbursement and health economic planning development for conventional, and not combination, medical devices. A conventional device is one for which FDA market clearance is granted through a PMA or a 510K study. As a result of the influence of Medicare policies on public and private healthcare insurance, Medicare will be the payer that is highlighted throughout the course. References and discussions will be made to private payers.
At the conclusion of this course, students should be able to:
The course has two main purposes. First, show that reimbursement and economic planning is complex but does not have to be a “black box” planning and execution process. The course provides a logical framework to design, plan, and implement Medicare reimbursement and health economic strategies. The other course purpose is to demonstrate that reimbursement/ economic planning can begin early in the product’s development cycle, requires support throughout the product’s life, and is a company-wide effort.
The course is appropriate for managers who are responsible for the company’s reimbursement and health economic efforts. In addition, managers who will support these efforts will also benefit from attending. The course will also be helpful for Private Investors and C-level executives who want to understand the investment and planning required to carry out a U.S.-based reimbursement plan.
Basic knowledge of reimbursement and product development would be helpful but is not required.
This course includes two full days for a total of 15 hours of combined classroom instruction, learning checks and a case study exercise. The learning checks and the case study exercise are graded. They have been designed to reinforce the concepts that are taught throughout the course. Lunch is provided both days.
A. Reimbursement Fundamentals
B. Leaning Check to cover Reimbursement Fundamental section
C. Strategic Planning Development (Pre-Clinical Phase)
D. Tactical Planning Development and Implementation (Clinical and Launch Phases)
E. Select a medical device case study and with your team begin to design the reimbursement and economic strategic plans.
A. Fundamentals of Health Economics
B. Learning Check for Health Economic Fundamentals
C. Strategic Planning Development (Pre-Clinical Phase)
D. Tactical Planning Development and Implementation (Clinical and Launch Phases)
Complete and present, as a team, the reimbursement and economic plans that have been designed for your selected case study
The instructional methods used to convey the course’s objectives include lectures, case studies, learning checks, group exercises, and discussion forums. The required text will be the course reader. The reader is given to each participant and it contains all of the instructors’ lecture slides, relevant articles, and a glossary. It is designed to be study aid during the course. The course reader is also intended to serve as a reference book after the course has concluded.
Attendance on both days. Completion of the two learning checks and the Reimbursement and Economic design exercise.
Two learning checks - 40%
Reimbursement and Economic design exercise- 60%
For additional information please contact Susan Rowinski, course director, at susan@suerowinskigroup.com or (650) 522-8520.
Susan Rowinski, M.S.E. principal, Sue Rowinski Group LLC, a reimbursement and marketing consulting firm located in the San Francisco Bay Area. The firm is retained by private and public medical device companies and venture capitalists for customized reimbursement and marketing projects. Projects include due diligence and risk analysis, the design and implementation of reimbursement plans and interim onsite management services for marketing and reimbursement.
In addition to her consulting work, Ms. Rowinski has 15 years of operating experience in the medical device and imaging industries, including management responsibility for reimbursement, marketing and sales. Her experience spans the entire company development cycle and includes advancing companies through the fundraising, product development, and product launch phases. She has raised private equity and managed strategic corporate partners. Ms. Rowinski has secured Medicare reimbursement approvals and has been responsible for three product introductions that included the United States, Eurozone, and Japan markets.
She was vice president, marketing (PharmaSonics, Sunnyvale, Calif.) where she was also responsible for global reimbursement. Previously, she has held several management positions with increasing responsibility; director of marketing (Cardiometrics, Mountain View, Calif.), global marketing manager (Medtronic, San Diego), product manager (Quinton Instrument Company, Seattle). Ms. Rowinski began her life sciences career as a cardiology ultrasound sales representative for Advanced Technology Labs (ATL, Seattle).
Susan Rowinski holds a master's degree in engineering from the University of Washington and a bachelor of science degree in health physics from Purdue University.
Ms. Rowinski is a member of the instructor advisory board for the University of California- Berkeley (UCB) Extension. She is also the director and an instructor for the UCB-Extension course “Developing U.S. Reimbursement Strategies for Medical Devices”. Other lecture engagements include the University of California Haas School of Business; Purdue University BIOMEDSHIP program; Rensselaer Polytechnic Institute (RPI) and the Medical Marketing Association.
Thomas Bramley, RPh, Ph.D., senior director, Xcenda, a health outcomes research and consulting firm based in Tampa, Fla. Dr. Bramley joined Xcenda in 2001 and leads the Health Outcomes Solution team there.
Dr. Bramley has over 10 years of experience in health economics and health outcomes research, managed market strategies, and product commercialization support where he provides strategic and research consulting for major pharmaceutical and biotechnology firms. He has participated in the design and development of approximately 50 economic models. Furthermore, Dr. Bramley has published numerous manuscripts, presented several posters, and been invited to speak at many national conferences. He has managed and/or provided input on well over 150 outcomes research and strategy engagements. In addition, Dr. Bramley is currently of the editorial board of Health Policy Wire.
Dr. Bramley received his bachelor of science in Pharmacy from Drake University in 1997 and his Doctor of Philosophy in Pharmaceutical and Health Outcome Sciences from the University of South Carolina in 2001.
Amy L. Grogg, Pharma.D., vice president, Xcenda. After receiving her doctor of pharmacy degree from Mercer University, Southern School of Pharmacy, Dr. Grogg completed a clinical practice residency at Hamot Medical Center in Erie, Pa. Dr. Grogg completed a two-year fellowship in pharmacoeconomics at Sandoz Pharmaceuticals Corporation and the University of South Carolina. She then joined Janssen Pharmaceutica and held various internal and regional positions within the outcomes research group. She most recently lead the outcomes research and medical informatics groups who are responsible for all health economic, quality of life, patient-reported outcomes research studies as well as statistical analysis support for medical affairs activities for all marketed products from Janssen Pharmaceutica in the United States. She was a member of medical affairs management team, chairman of the J&J Global Health Economics and Outcomes Research Council, and chairman of the Janssen Women’s Leadership Initiative.
Dr. Grogg has partnered with strategic account management teams to appropriately and effectively disseminate results of outcomes studies to external customers to aid in formulary and reimbursement decisions. She has been involved in more than 150 unique research studies and strategic marketing engagements. Dr. Grogg’s work in the pharmaceutical industry has included pharmacoeconomics, quality of life and outcomes management research, presentations and publications for developmental and marketed products in hypercholesterolemia, oncology, analgesia, neurology, osteoporosis, pain management, psychiatry, neurology, gastroenterology as well as many other therapeutic areas. She is now vice president with Xcenda leading the reimbursement and value team and serves as the chair-elect of the Institutional Council for the International Society of Pharmacoeconomics and Outcomes Research.
Judith Hickey, M.B.A., founder and president of Princeton Reimbursement Group (PRG), a reimbursement consulting firm focused on medical products, located in Minneapolis.
Ms. Hickey is an experienced medical marketing executive and expert in medical product reimbursement. She has been responsible for the development and execution of reimbursement strategic plans, marketing positioning strategies, and policy analysis for medical products manufacturers throughout the United States and Europe.
Prior to the formation of PRG in 1991, Ms. Hickey’s background included positions in marketing management and reimbursement for medical product companies, including Medtronic and Datascope.
In addition to consulting, Ms. Hickey is a faculty member of the Heart Rhythm Society (HRS), a medical specialty group representing more than 3700 specialists in cardiac pacing and electrophysiology in 64 countries, and has served as co-chairman of the reimbursement special interest group for Minnesota Medical Alley. She has written numerous published articles on reimbursement issues and is a sought-after speaker on various reimbursement related topics. Ms. Hickey is also a lecturer at Stanford University, the University of Minnesota’s Carlson School of Management, and the University of St. Thomas.
Ms. Hickey holds a B.S.B.A. in marketing from the University of Missouri and an M.B.A. from the University of St. Thomas in St. Paul.
Please return to the catalog description to enroll in this course.