Open source in Medical Devices: Part of the Cure or Part of the Disease?
The Economist recently published a very interesting article on the merits of open source in medical device development, which raises some questions and sparks an important discussion.
In general, it is more common to see open source adoption in non-regulated industries. However, we are seeing it more and more in regulated industries primarily because it encourages rapid innovation at far lower costs. That said, it is important to caution those in the regulated industries (aerospace & defense, medical, industrial automation, energy, automotive) towards embracing open source concepts without investing in lifecycle management tools to support the building of safe and effective devices. [Proprietary software on the other hand, is a better fit for companies that design devices in environments where changes are few and far in between. Proprietary software also enables better control of the ecosystem, the lower the stack you go.]
As the Economist puts it, “exposing a design results in safe products.” Maybe…Designing a device or ecosystem with safety in mind, results in safer products, hence the need for “design for safety.” The FDA mandates a safe and effective design for any devices that gets approved in the US market — this requires companies to have better control of their ecosystem. Done proactively, this is an efficient method for product development; however, done reactively, companies incur a lot of costs and overheads trying to make open source fit.