Economist, Why so Pessimistic about Open Source Medical Devices Software?

I read an interesting article in the Economist’s Technology Quarterly of June 2nd-8th of 2012, p. 17-18, on open source medical devices software. Let me summarise for you: the article starts by showing all the benefits of medical devices software that is developed using open source models, and there are many. For example, security of high risk medical devices that might be hacked at a distance to be used against the patient could be much improved if many creative minds with different points of view work collaboratively on software for devices.

The article concludes however that open source has no place in the current regulatory environment and points only to FDA regulation for that conclusion. It quotes a pessimistic open source protagonist who states it is impossible to get open source through the regulatory process but that “It may even happen (…) in parts of the world where strict regulation does not exist.” I would rephrase: where inflexible regulation does not exist...

As you know, I am an outspoken protagonist of the European CE system because I am a believer in its flexibility and have defended this against attacks to the effect that it would result in unsafe devices entering the market, for example here, here and here. In my view, the EU CE system is actually ideal for delivering open source software to the devices market, without compromising on safety or regulatory rigour in the least...