There appears to be a deep lack of regulatory experience, along with a deep lack of QC, and it's presented as a jailbreaking, i.e., what is done to your phone.
Some kinds of regulations are written in blood, or, in this case, bloody sputum.
A lament, I wish it were possible to convince tech people that they are not the only clever people in the world: regulatory bodies and medtech and pharma companies are packed with equally clever people, who are quite capable of moving fast but without breaking things, that have an unmatched advantage in having domain experience (part of which is a healthy respect/fear of the unknown in medicine, like you say, regulations are written in blood). It would be a lot more productive to support those people than to do these hackathon projects.