Getting approvals, finding the needed key to complex regulations, and proving a medical effect – are just a few issues on the way to becoming part of DiGA. Startup founders are trying to wear many hats and do it all by themselves but sometimes you just need to ask for help.
In our new episode of Digital Health Interviews, we talked to Sebastian Vorberg, a lawyer and consultant in the space of German digital health.
Sebastian was also a bit surprised at how fast a new reimbursement system was approved in Germany but now the pace slowed down a lot and lots of problems appeared that are yet to be fixed.
In this interview, we covered lots of important aspects, such as software security, legislation, differences between FDA and BfArM, and much more.
We highly recommend watching for everyone who is planning to apply for DiGA and create a digital health startup in Germany.
00:49 Sebastian’s introduction
01:41 What kind of services do you provide to your clients?
02:27 Are you also providing security audits to your customers?
03:07 Have you heard of any data leaks in digital health in Germany?
05:11 What do you think about the case of Moderna suing Pfizer and BioNTech for stealing part of vaccine research?
06:16 Is it a common practice to provide stock options to the employees of a startup?
06:54 Do you think it’s an important motivation to choose a company?
07:41 Did you expect DiGA to be approved that fast?
08:47 What is the process of getting approved for DiGA?
10:09 How long would it take to get approval?
10:56 Can companies without DiGA approval still operate on the market?
12:09 So would the startup most likely fall apart if it doesn’t get into DiGA?
12:53 Should startup founders start preparing for the approval process from day one?
13:22 How would you evaluate a market of telehealth in Germany?
15:11 Is there a big competition in telemedicine now?
16:00 Can telehealth be a part of DiGA someday?
17:06 Which approval is harder to get – FDA or BfArM?
18:14 Do you think the legislation is moving with the same speed as innovation?
19:32 Should a startup founder find a consultant in order to handle all the regulations in Germany?
21:14 Do you see more investors are ready to invest in digital health startups now?
23:03 Sebastian’s recommendations for startup founders in digital health.
QuR.digital: https://www.qur.digital/
If you have any questions you’d like to ask, please add them in the comments to this video or shoot us an email.
BeKey: https://bekey.io/
BeKey Startup Hub: https://startuphub.co.il/
https://www.linkedin.com/company/bekeyinc/
Our previous episode with Hannes Klöpper. HelloBetter – Story of Success for Mental Health Startup.
https://youtu.be/YReR1UOhL2w
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