Event

Basics of Market Access for Start-ups in Medical Technology

October
05-06
Online

The Event will take place online and in English. We recommend to attend both seminar days as the content was created based on a holistic approach. #fromideatomarket

Join us for Part II of the Seminar Series “Market Access and Basics of Regulatory Affairs for Start-ups in Medical Technology”. All participants will receive a certificate of attendance.

 

Moderation: Dr. Stephan Binder, Kalms Consulting GmbH

Presentation: Kalms Consulting

 

Registration:

Register via Eventbrite.

 

Content Summary: 

Join us for Part II of the Seminar Series “Market Access and Basics of Regulatory Affairs for Start-ups in Medical Technology” and get an overview of the regulatory landscape and regulatory stakeholders in Medtech, understand the major principles, concepts and processes and learn how to sequence the necessary steps and build awareness of possible pitfalls when bringing a Medtech product to the market. All participants will receive a certificate of attendance.

 

Agenda:

 

Day 1: Tuesday, 5 October 2021, 9:00 – 12:00

– Health Care Market Germany – An Overview

– Overview of the German Reimbursement Framework (In-Patient / hospital)

– Market Research & Data acquisition

– Economically supported argumentation, medical-economy

  • Value Pricing & Cost per Case Argumentation

– Experience from the practice

  • Role of Key Opinion Leaders
  • Strategic and Operational Market Development, Success Stories
  • Business Case per Product / Indication

Day 2: Wednesday, 6 October 2021, 9:00 – 12:30

– Think out of the box – Market Access across the four biggest east Asian economies – China, Japan, Korea and Taiwan (in cooperation with Intralink)

– Overview of the German Reimbursement Framework (Out-Patient / ambulatory)

  • Reimbursement of Medical Devices in Doctor’s office
  • EBM, GOÄ
  • Nutzenbewertungsverfahren (§135, §137e) (Benefit Assessment)
  • Medical Aids (Hilfsmittel), Wound dressings

– Stakeholders-identification and -management (Health Funds, Medical Societies, Patient Organizations, etc.)

– AOP-Catalogue (ambulatory surgeries) as an example of the transition In-patient to out-patient

– Germany after the Elections – (how) will the health policy framework change?

– Latest Developments: Special Case DiGA (Digital Health Apps)

 

Throwback:

Part I: Medical Device Regulation (MDR) and the necessary steps until market entry.  

The Seminar is part of a two-part-series. Part I, “Basics of Regulatory Affairs for MedTech Start-ups”, is scheduled for May 18-19.