Workshop: Successful market access to the German healthcare system

Have you developed an innovative medical device and would like to successfully establish it on the German market? The path to reimbursement can be complex. In our workshop, we will show you how you can overcome the hurdles and have your products included in the medical device directory or the directory for digital health applications (DiGAs).
This workshop is aimed at start-ups, product managers and industry partners who want to gain a deep insight into the processes and requirements of the German healthcare system.

What you can expect:

In our interactive workshop, we will shed light on the key steps and requirements for a successful market entry:

• Medical aids vs. DiGAs: Gain knowledge about the German healthcare system, the differences between medical aids and DiGAs as well as the authorities involved and the requirements for inclusion in the reimbursement list.
• Your way into the healthcare system: We explain the application process, all the necessary evidence and quality standards and how you can successfully have your products included in the medical aids register. Find out which criteria your product must fulfil in order to be included in the directory. We cover the requirements for safety, functionality, quality and medical benefits.Statistics and experience: Learn how to maximise your chances. We share our experiences with you and give you practical tips on how to avoid common mistakes.Question and answer session: Ask your specific questions and take the opportunity to expand your network with our consultants

Who is this workshop for?

• All health tech companies that offer class I to IIb medical devices or provide CE labelling.
• Developers and product managers of medical devices and software
• Sales and marketing managers who want to learn more about market access channels
• Anyone interested in the reimbursement process for medical devices and DiGAs

Secure your place now and prepare your product optimally for the German market!

Frequently asked questions

• Does my product have to be CE-marked to take part in the workshop?
  • No, we are happy to support you from the initial idea to the European conformity assessment and CE labelling through to approval for the German reimbursement system.
• Does the reimbursement guarantee the sale?
  • Reimbursement is an important prerequisite for success, but does not automatically guarantee sales. It enables doctors to prescribe your product and health insurance companies to cover the costs. However, successful market access also requires effective marketing and sales strategies.
• Do I have to be a German company to apply?
  • No, your company does not have to be based in Germany. However, your product must comply with all German and European regulations. A local partner can be very helpful in this process.

Short biography of the speaker:

Patricia Alexandra Mattis is Business Development Manager at Fraunhofer ITEM in Hanover and supports companies with the inclusion of their medical devices and digital health applications in the German reimbursement system (medical device directory, DiGA, DiPA). She holds a degree in Biochemistry from the Technical University of Darmstadt and has more than 25 years of experience in entrepreneurship and consulting.
Before joining Fraunhofer, Patricia led marketing and advocacy programmes at Cochlear GmbH, where she built a pan-European volunteer network that significantly increased patient conversion rates. She has also worked as a key account manager and retail consultant in the medical device and consumer health sectors. Her work focuses on bridging science, regulation and business strategy with the aim of helping start-ups and corporates successfully bring innovative healthcare solutions to market.
Patricia is known for her strong network, creativity and collaborative approach that helps build sustainable partnerships between industry, research and healthcare providers.

Costs: €350 (net) per person

Register now and send an e-mail to katja.krempler@leap-up.com!