The Scientist looks at present initiatives in mass production of engineering autologous organs for transplant. Note the elephant in the room when people wonder why medical development is so challenging: if phase II trials go well, "the company will schedule a larger, Phase III trial. What happens then is still somewhat unclear. The FDA has never been asked to approve an autologous human organ. What safety criteria will it consider? What kind of quality control procedures and infrastructure will the company need to employ? 'It's not like we're stamping out a million pills a day. We have to custom-grow a new organ for every patient.' ... 'I think the task of trying to commercialize this type of custom-made organ for patients is pretty daunting.' From the beginning, the company interacted with the agency to educate it about how the technology works, scheduling 'at least five' pre-IND meetings. 'The FDA had to create new sets of standards for us,' Sender says. A handful of bladders is one thing; mass producing them is quite another. ... You can probably understand maybe doing one at a time, two at a time, three at a time.Now imagine having to grow thousands of organs a year. Or maybe thousands at one time." In a sane world, those laboring to bring benefits to humanity would just get on and do the job, absent the ball and chain of regulation for the sake of regulation.