In our new episode, we talk about Medtech, software development for medical devices, and regulations. Wessel Kooyman is a consulting expert who has lots to share with our audience.
We started our interview by discussing what kind of skill set a developer needs to have to develop quality software for medical devices. Then Wessel defined SaMD and what is it for.
Another important part of our conversation was dedicated to the process of managing a company that operates in medtech.
Wessel also told us the secret on who is the main startup investor in Europe. Do you want to find that out? Check out our new episode of Digital Health Interviews.
00:00 Greetings
00:59 Wessel's introduction
02:17 How did you get into medtech and digital health?
04:08 What are the differences between software development for medtech and regular web development?
05:02 How much time would it take to learn the needed skills to be a coder in digital health?
05:56 Tell us about the startup Moodbird where you've worked for a little bit?
07:45 What Helpilepsy (Neuroventis) is about?
08:33 SaMD - Software as a Medical Device. How would you define this term and what are the examples?
09:37 How should the process of documentation of a product be organized?
10:49 Whose responsibility is to come up with documentation?
13:46 Does a new member of a team need to go through all of the documentation of a project during his onboarding?
15:35 Does the agile approach actually work for medtech industry?
17:35 Should a startup be developed considering all the regulations from day one?
20:10 What types of certifications are the most difficult to get?
22:22 Where is it harder to get approval for a medical device - the US or Europe?
23:36 What's the minimum time possible in order to get approval?
26:20 What are the differences in developing software in the US and Europe?
29:21 Wessel's recommendations for startup founders in medtech and digital health.
If you have any questions you'd like to ask, please add them in the comments to this video or shoot us an email.
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Our previous episode with Nick Guldemond. The Biggest Problem of Digital Solutions in Healthcare.
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