Go-To-Market Academy – guiding you into market!

We are happy to announce our newly launched seminar series, the Go-To-Market Academy, focusing on stepstones for MedTech start-ups on their way into the market.

The jointly organised seminar series is composed of several modules, addressing topics ranging from basic regulatory affairs to reimbursement strategies. Are you a healthcare professional, a healthcare entrepreneur with business ideas or do you have an early-stage start-up? Participate in our free of charge seminars to get support for low barrier access!

As healthcare markets are highly regulated, it is inevitable to bear in mind necessary processes and requirements as early as possible in the development phase. The seminars will provide you with key knowledge that is relevant in the field of medical technology and digital health. You will receive a solid overview of the legal requirements of the European/ US market, the generation of clinical evidence and the German reimbursement system. Another seminar will focus on the topic of DiGAs/ medical apps.

What are the dates of the seminars?

• Medical Technology: Regulatory Affairs Workshop – 14/15 June 2022 (register here)
• Medical Technology: Best Practice Insights – 20 June 2022 (register here)
• Medical Technology: Clinical Development – 5 July 2022 (register here)
• Medical Technology: Market Access Workshop – 5/6 October 2022 (register here)
• Digital Health Reimbursement: Digital Health Applications in Germany – 18 October 2022 (register here)

What is the scope of the seminars?

Basics of Regulatory Affairs for Start-ups in Medical Technology – a two days workshop

This seminar is your chance to acquire basic and some advanced regulatory know-how, that will help you to better understand the regulatory requirements of the health care market.

Among others, the seminar will cover the following topics:

• Steps to CE Mark
• V&V and Technical Documentation
• Clinical Evidence
• US Market Access for Medical Devices
• Start-ups and Regulatory Affairs – Avoiding Pitfalls

Best practice insights: “From the idea to the successful medical device – learning from the mistakes of others”

This seminar is an opportunity to learn from the experiences and mistakes of others. Seleon GmbH has accompanied many MedTech companies over the years. They know the needs and difficulties of young enterprises and will thus share their learnings and best practice examples. The focus of this event is on exchange and experience sharing. To freshen up your theoretical knowledge of regulatory affairs, we recommend also visiting our introductory workshop “Regulatory Affairs for Medical Technology”.

Basics of Clinical Development for Medical Technology and Digital Health Technology

Generating and using evidence is one of the most important steps for MedTech companies on their way to the market. And even when on the market, evidence remains an issue in terms of post-market surveillance. This seminar provides you with an overview of the necessities of clinical studies. Our partners from Profil GmbH will cover regulatory and ethical requirements, and share theoretical knowledge and their experience from the development phase of a medical device.

Profil GmbH has been involved in several innovation processes and combines long-term clinical experience with the needs of innovation project consortia.

Market Access for Medical Technology – two days introductory workshop

The German healthcare market is complex. This seminar provides you with a solid overview of reimbursement in the inpatient and outpatient settings. You will learn which sources you can use to analyse your “customers” and thus the size of your market. Our partners from Kalms Consulting will also share their expertise regarding stakeholder management and the interaction with key opinion leaders. Finally, there will be a session on pricing strategies.

Digital health reimbursement in Germany with a focus on digital health applications

This seminar is your chance to get an overview of important aspects of a successful strategy for a digital health product. Our partner fbeta GmbH will cover the DiGA fast-track as well as alternative reimbursement options. Another focus will be on proving the positive healthcare effect of digital applications.

Fbeta is highly experienced in working with digital manufacturers. In this seminar, they will share their Do’s and Don’ts and help you to check if you have considered all relevant issues.

If you have any further questions, please feel free to contact Sebastian.Meuer@innovationinhealth.eu or Ida.Scholz@innovationinhealth.eu.

The seminar series is a joint event from Innovation in Health, EIT Health RIH Germany-Switzerland and several partners. It is supported by the Ministry of Science, Research and the Arts Baden-Württemberg.

See you there!