Therac is one of the reasons I get nervous about "health hacking." Yes, people can verifiably benefit from some of the advancements made in this movement, like the DIY diabetic insulin pump, and yes, I prefer to see such advancements be open source than locked up in proprietary designs and trade secrets. And there probably is room in health regulation for trimming the red tape anyway even for innovations originating from the commercial sector.
On the other hand, when corners are cut (no hardware interlocks, for example) and edge cases aren't considered, even innocently, then you get things like this. It makes products more expensive to design and more costly to buy and maintain to do the extra engineering. It is certainly a barrier to entry, too. But do we want another case like this because people said "this is good enough"?