None of these are particularly compelling reasons IMO. > 1> Loss of competitive advantage Patient safety trumps business considerations. Skipping clinical tri

None of these are particularly compelling reasons IMO. > 1> Loss of competitive advantage Patient safety trumps business considerations. Skipping clinical trials would be a major competitive advantage (lower costs, quicker to market etc.), but we don't allow that for the same reason > 2> Open source is not necessarily any safer (heartbleed bug ... ) I'll agree, in so far as saying making it open source doesn't necessarily make it safer. However, it should, at worst, be no less safe - the requirements on the manufacturer (testing etc.) should be the same regardless > 3> If software for the pacemaker is allowed to be updated like that on a computer, someone will update it with buggy software that can cause adverse side effects. You can open the code but, for example, required a signed binary before a device can be updated. The openness of the code and the openness of the device itself are linked but separate issues.