There is a normal for this class and type of device. This is way outside normal for this class and type of device- source, I've designed them for 20 years.
Surely you understand that some systems don't have a in vitro model. Particularly , the biological response and interaction is the unknown. I'm working on such a project now. It'll likely require many dozens of large animals if not hundreds to collect some semblance of data to support human use. I would consider anything less unethical and irresponsible development