Knowledge base
Archived articles from Synergus RWE, kept for reference.
7 articles
The German NUB process, the most risky process for a start-up?
For many medical device companies, the German NUB process to fund innovative medical devices used in the hospitals, has been known as the most attractive option for a European launch. This is a brief overview of how the…
5 key-steps to unlock the potential for the new attractive reimbursement opportunity in Germany
5 key-steps to unlock the potential for the new attractive reimbursement opportunity in Germany The recent change that was announced in Germany regarding the process for innovation funding will become effective 2020. In…
German reimbursement opportunity for medical devices re-opens 2020 !
A change to the German legislation regarding the introduction of new innovative medical devices have just been implemented as of May 1 st . The new law will be applicable as of 2020. It is not clear how all aspects of…
Managed entry agreements / Coverage with Evidence Development – The new home-run for device, diagnostic and digital health start-ups!?
With the evolving evidence requirements for the introduction of new technologies, I would suggest that we should evaluate how we see a successful journey for a start-up company. Historically, most of the start-ups we…
GKV-Spitzenverband says more high-risk medical devices should be assessed by G-BA in § 137h
Background With the introduction of § 137h SGB V in 2016, the German legislator introduced a systematic early assessment of new medical devices based on high-risk methods in the hospital sector. If a hospital applies…
The first submissions for NUB-related benefit assessments for high-risk medical devices
Background With the introduction of § 137h to the SGB V, hospitals have to hand in an extensive value dossier comprising information on the current scientific knowledge of the technology to the Federal Joint Committee…
Introduction of benefit assessment requires complete rethink about how to handle nub-applications for new interventions
There are many aspects that are changing with the introduction of the new 137h process to assess the benefit of the new innovations coming to market. We will provide more information about all of these changes in a…