Stanford Webinar: Regulation & Health-Eco Value Assess. - Two Critical Gauges for MedTech Innovation

Stanford Webinar presented by The Product Creation & Innovative Manufacturing and the Management Science & Engineering certificate programs
Regulation & Health-Economic Value Assessment - Two Critical Gauges for MedTech Innvation
Speaker: Jan Pietzsch, Stanford University

To successfully bring a new medical technology to market, innovators must obtain regulatory approval and reimbursement for their device.

Join Stanford’s Dr. Jan Pietzsch as he discusses the current regulatory and payer environment, as well as the growing need to assess and demonstrate the value proposition of new medical technologies early in the innovation process.

You will learn:

-The changing medtech eco-system in the U.S. and abroad
-The relevance and requirements of regulation and health technology assessment in bringing a new technology from bench to bedside
-Methods used to evaluate new technologies, and the challenges and opportunities they create for medical technology innovators

About the Speaker:
Jan Pietzsch's professional and academic work focus on early-stage technology assessment and strategic decision-support for investors, manufacturers, and research institutions. A primary emphasis is on the early evaluation of the value proposition of new technologies to provide quantitative input into the selection of the most promising technology concepts and their targeted development. This includes model-based assessment of the clinical and health-economic benefit of new diagnostics and therapies.

Dr. Pietzsch is co-founder, President and CEO of Wing Tech Inc., a technology consulting firm focused on health-economic and value assessment. He holds an appointment as Adjunct Professor of Management Science and Engineering at Stanford, where he serves as Director, Health Economics and Value, at the Stanford Byers Center for Biodesign, a leading program in medical technology innovation. Dr. Pietzsch received his academic training at Stanford University (Ph.D., M.S.) and at the University of Karlsruhe, Germany (Dipl.-Wi.Ing.). He has been a research fellow with the U.S. FDA’s Office of Device Evaluation.

0:00 Introduction
2:36 Medical Devices: A wide range of Technologies
8:34 Relevance of Regulation and Health-Economics
10:25 Importance of Regulatory Requirements in the Development and Commercialization of Devices
11:33 Background on Regulation
11:48 Safety and Effectiveness defined
19:13 Challenging Economic Outlook
20:59 Two Major Objectives of any Healthcare System
23:05 Implications for Innovators (1)
27:20 Questions for Discussion
31:16 Cost-Effectiveness Findings for TAVR, U.S.
32:36 Summary (2)
40:17 Stanford Center for Professional Development