In October 2020, the first programmes were listed as “Digitale Gesundheitsanwendungen” (digital health applications) in the official DiGA directory of the German Federal Institute for Drugs and Medical Devices (BfArM). Since then the list has grown to include twelve applications (as of March 2021). Henrik Emmert, CEO and founder of aidhere, was among the first five applications to be approved with his digital adiposity therapy zanadio. Today he gives five tips on what to consider for a successful application process for DiGA approval:
1. Early alignment as a medical device
Anyone who intends to be admitted as a DiGA must first register or approve their product as a medical device. This is because only medical devices in risk class I or IIa can be approved as DiGA. For this reason, we focused completely on medical device approval and also on the requirements for a DiGA at a very early stage in product development. The earlier you deal with the requirements, the more likely you are to avoid extensive changes to the product later on.
2. Generously plan resources
Submitting an application in the DiGA procedure requires a great deal of time and effort in terms of personnel and content. Therefore those who plan their resources generously for this are well-advised – internally, but also with the help of external support. The DiGA application will be the most important and labour-intensive issue in the company for several months. Queries from the BfArM (Federal Institute for Drugs and Medical Devices) about the submitted documents often arrive at short notice and have to at times be answered within three days – this requires full focus from everyone involved.
3. Focus on evidence
Evidence generation is the most important building block in the DiGA approval. Those who are unable to conclusively prove a positive treatment effect for their product when submitting their application must demonstrate the anticipated effect by means of systematic literature research and data analysis. For zanadio, we also conducted a pilot study with 60 participants that showed the first positive results of digital adiposity therapy. Experience in conducting clinical trials is elementary for the success of a DiGA application. In this respect, the team should be well prepared.
4. Seek exchange with BfArM
The BfArM offers consultations as part of the DiGA approval and was very cooperative and responsive throughout the process. Applying companies should definitely take advantage of this opportunity to exchange information! This will help to clarify any questions and to avoid mistakes or misunderstandings. If in doubt, I would always pick up the phone and contact one of the advisors at the BfArM.
5. Networking with other providers
The exchange of experiences with already listed DiGA producers or those who are still in the process is very valuable. Here you can benefit from each other’s experiences and discuss important issues. The German National Association for Digital Health Care is also a good place for organised networking and acts as a mouthpiece for DiGA manufacturers. Since the events and services of the association offer very practical knowledge on the topics of legal issues, evidence, data security or communication to target groups. For all those who intend to get a DiGA admission, the association is a very good contact point. I wish all future DiGA applicants every success!
The start-up aidhere is one of the regional EIT Health Catapult finalists 2020 and builds digital behavioural health solutions for the cardiovascular space, combining behavioural therapy with artificial intelligence to change automatic health-related behaviour on a large scale. Their first product – zanadio – focuses on obesity/adiposity, one of the main causes and major risk factors behind lifestyle diseases.