Medical Devices II: Market Access
This pack of lectures provides knowledge about the main elements to consider and work with when introducing a medtech product into the market, including the development of health technology assessment, the definition of market access strategies and knowledge of the regulatory pathways, from both a European and a US perspective. What should I demonstrate about my product? Who should I contact to introduce my product into the hospital? Should I patent it in the US or in the EU first?
Medical Devices Regulation (double session)
This course consists of two parts and will provide information about the regulation of medical devices, specifically in comparison to the pharmaceutical process, and with regard to the United States market, under Multiple Technology Appraisal (MTA) guidance. Luis Soenksen will increase our knowledge about the regulatory approval required from the Food and Drug Administration (FDA) in the USA. You will also take an in-depth look at the European regulatory process under the CE Marking process, and the key differences between both approvals. International regulation on medical devices for other regions such as South America, Asia, and the Middle East is also presented. Numerous products and case studies will be covered.
The objective of this session is to teach attendees the fundamental principles of European reimbursement and health economics, so that they understand the importance of it in health innovations from the very first day.
Health Technology Assessment
This session is a very useful introduction to the healthcare value chain. and will teach you how to bring an idea into the market. Some of the topics that will be covered are: economic context, healthcare paradigm, healthcare technology life cycle, the basis of market approval and quality analysis, etc. You will learn the basic steps of HTA (Health Technology Assessment) and what is considered value in this specific market.
Market Access, Reimbursement Strategy and Implementation
This lesson covers reimbursement, which is a key process in the medtech sector. The lecturer explains what reimbursement is, the difference between countries in terms of reimbursement strategies, and the implementation strategies available to medtech start-ups.
We offer a 50% discount (for any category, but not accumulative) to students who are in their final academic year at university, or who are studying a Masters degree related to the following fields: business, engineering, life sciences or design. If interested, please send an e-mail to firstname.lastname@example.org, with the subject "Short Programs Discount", providing your details and attaching a copy of your university registration. Promotions are limited and will be assigned on a first-come, first served basis.
Companies participants in Boost4Health Project coordinated by Biocat at the Bioregion of Catalonia will have free of charge registration to training from Moebio Short Programs. The eligible SMEs will need to register to Boost4Health.eu and select their interest in receiving coaching. Then Biocat will provide the procedure to access the training and a registration code that will be valid until 3 business days prior to the starting of the activity. Those registrations made with the code without participating in Boost4Health program will not be able to access the room.
To withdraw from a session you must send an e-mail to email@example.com.
If cancellation is received more than one week (7 working days) before the date of the Short Program session, you will be reimbursed for 100% of the registration fee.
If cancellation is received during the week prior to the date of the lesson, you will be reimbursed for 50% of the registration fee.