Sunday, June 3, 2012

Pros and Cons of Open Source Medical Design

Medical device design is heavily regulated for obvious safety reasons. But a number of researchers–including those with support from the Food and Drug Administration–are developing “open-source” healthcare equipment. The idea is to offer completely transparent, shared software code and mix-and-match interface and hardware designs. While this might seem risky, the goal is to spark faster and more effective innovation in the medical device field, while making it easier to spot potential programming bugs and other device failures.

A study from the University of Patras in Greece found that one in three such devices sold in the U.S. were recalled between 1999-2005. The FDA found that drug-infusion pumps were linked to 20,000 serious injuries and more than 700 fatalities between 2005-2009. It can be hard to expose specific problems with these products, given that medical software (and hardware) is proprietary and patent-protected, thus veiled in secrecy. The open-source approach could, in theory, make it easier to fix, or even avoid, dangerous flaws before they hurt or kill hundreds or thousands of patients.

Some of the open-source devices currently being designed are so far intended only for use in medical research. They are usually sized for animals or specified for use on cadavers. In other words, the doctors, engineers, and designers working on such equipment aren’t yet addressing U.S. regulation in the medical device arena, but their research could lead to more effective products down the line.

The overview offers a helpful round-up that clearly illustrates a trend–and a thought-provoking one at that.

The Generic Infusion Pump project, which is a collaboration between the University of Pennsylvania and the FDA, is designing a drug-delivery system backwards: researchers started by figuring out potential failures, then will work to avoid or mitigate them in the design.

The Open Source Medical Device initiative at the University of Wisconsin-Madison is working toward a high-resolution medical body scanner combined with radiotherapy machine. The initiative will offer all of the instructions and source code for building one, for free–along with recommendations on how much parts should cost. Researchers say the device should be one-fourth the cost of a commercial body scanner, and might be a good option for resource-constrained communities that otherwise may not be able to have access to such equipment.

The Raven surgical robot is an open source system (pictured at top) that was designed at the University of Washington in Seattle. Researchers use it to try out new processes in robotic surgery. (See Janet Fang’s SmartPlanet summary of what Raven can do.)

The Medical Device Plug-and-Play Interoperability Program is a $10 million initiative (funded by the National Institutes of Health with FDA support) hopes to enforce open standards for devices from various companies to work together.

The Medical Device Coordination Framework that’s being developed at Kansas State University aims to create an open-source hardware platform that would include interchangeable buttons, displays, as well as software that would connect them with sensors and other devices. Inventors could design health equipment from these mix-and-match items.

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