Based on the implementation of regulation in the US, I'd say the purpose of regulation is clear: To make a monopoly / oligopoly on drugs. > It is regulated for

Based on the implementation of regulation in the US, I'd say the purpose of regulation is clear: To make a monopoly / oligopoly on drugs. > It is regulated for reliability. Then why aren't the tests and methods of testing reliability required to be published? > it is regulated because a failure to operate would be dangerous The risk of not having it at all far outweighs the risk of the injector failing. Not to mention that regulated injectors fail too due to manufacturing defects. > sometimes there is also a need for careful engineering and rigorous testing. But should that need preclude private individuals from assembling their own life saving devices on a small scale (1-10 units)? We're not talking about someone else stealing your design, process, research, and building their own production line here. Furthermore, careful engineering and rigorous testing is needed when you're creating a production line of these things. A competent individual can assess and test their own device. Yes, it's more time consuming, but for something as essential as a life saving drug, it's probably worth the extra time.