Medtech legal specialist and blogger Erik Vollebregt has a bone to pick with the Economist. On his medicaldeviceslegal blog, Vollebregt takes issue with an article on the use of open source software in medical devices that was published in the Economist Technology Quarterly (Q2, 2012).
The article initially summarises the benefits of open-source development models. Indeed, the deck that appears under the headline—”Medical technology: Applying the “open source” model to the design of medical devices promises to increase safety and spur innovation”—strikes a very positive note.
All well and good, comments Vollebregt. Things get a little messy towards the end of the article, however, when the author concludes “that open source has no place in the current regulatory environment and points only to FDA regulation,” writes Vollebregt. The piece quotes a pessimistic open-source proponent who affirms that it is impossible to get open source through the regulatory process. “It may happen . . . in parts of the world where strict regulation does not exist,” writes the Economist. “I would rephrase that,” retorts Vollebregt, “to where inflexible regulation does not exist.”
Reminding readers of his credentials as a stalwart proponent of Europe’s regulatory system for medical devices, Vollebregt writes that the EU system “is actually ideal for delivering open-source software to the device market without compromising safety or regulatory rigour in the least.”
How? I suggest you go to the source at medicaldeviceslegal blog and find out for yourself.Norbert Sparrow