Top 3 Takeaways:
- "Once you understand your product, who's going to be using it, you can then build a risk assessment around that. But if you do not know what your product is, and you do not know the modes of failure, you really are going to struggle with this process."
"So the UK is relatively easy for software devices. The EU has now become more difficult. Whereas previously the EU was considered to be easier than the US FDA, now companies are now considering the US FDA first, as they find that regulatory pathway easier"
- "build quality and regulatory at the start of your idea"
0:45 "Do you want to introduce yourself?"
2:15 "What do you exactly do day to day?"
4:00 "How does this how does this relate to neural implants?"
7:15 How is software different from physical devices in regulatory approval?
9:00 "Let's say you're you have really cool technology. What would be some next steps that you would see as you're trying to get FDA approval?"
11:15 "How are things different in the UK and EU versus the US?"
13:15 "What were you doing before you started the consulting?"
16:00 "What is a common mistake that you see being made?"
17:45 "Let's talk about the podcast the MedTech podcast."
22:30 "Do you want to talk about the time zone shifts?"