Open Source Medical Devices
Please note: the singular, Open Source Medical Device, refers to one specific project
Discussion
From the Economist's Technology Quarterly:
"Frustrated by the lack of co-operation from manufacturers, some academics now want to reinvent the medical-device industry from the ground up, using open-source techniques. In open-source systems, the source code is freely shared and can be viewed and modified by anyone who wants to see how it works or build an improved version of it. Exposing a design to many hands and eyes, the theory goes, results in safer products. This seems to be the case for desktop software, where bugs and security flaws in open-source applications are typically fixed much more quickly than those in commercial programs.
The Generic Infusion Pump project, a joint effort between the University of Pennsylvania and the FDA, is taking these troublesome devices back to basics. The researchers began not by building a device or writing code but by imagining everything that could possibly go wrong with a drug-infusion pump. Manufacturers were asked to help, and several did so, including vTitan, a start-up based in America and India. “For a new manufacturer, it’s a great head start,” says Peri Kasthuri, vTitan’s co-founder. By working together on an open-source platform, manufacturers can build safer products for everyone, while still retaining the ability to add extra features to differentiate themselves from their rivals.
Mathematical models of existing and new pump designs were tested against the possible risks, and the best-performing models were used to generate code, which was installed on a second-hand infusion pump bought online for $20. “My dream”, says Dave Arney, a researcher on the project, “is that a hospital will eventually be able to print out an infusion pump using a rapid prototyping machine, download open-source software to it and have a device running within hours.” “By working together on an open-source platform, manufacturers can make safer products”
Equally ambitious is the Open Source Medical Device initiative at the University of Wisconsin-Madison. Two medical physicists, Rock Mackie and Surendra Prajapati, are designing a machine to combine radiotherapy with high resolution computed tomography (CT) and positron-emission tomography (PET) scanning. Their aim is to supply, at zero cost, everything necessary to build the device from scratch, including hardware specifications, source code, assembly instructions, suggested parts—and even recommendations on where to buy them and how much to pay. The machine should cost about a quarter as much as a commercial scanner, making it attractive in the developing world, says Dr Prajapati. “Existing devices are expensive both to buy and maintain,” he says, whereas the open-source model is more sustainable. “If you can build it yourself, you can fix it yourself when something breaks.”
Open-source devices are also to be found literally at the cutting edge of medical science. An open-source surgical robot called Raven, designed at the University of Washington in Seattle, provides an affordable platform for researchers around the world to experiment with new techniques and technologies for robotic surgery.
All these open-source systems address very different problems in medical science, but they have one thing in common: all are currently prohibited for use on live human patients. To be used in a clinical setting, open-source devices must first undergo the same expensive and lengthy FDA approval processes as any other medical device. FDA regulations do not yet require software to be analysed for bugs, but they do insist on a rigorous paper trail detailing its development. This is not always a good fit with the collaborative and often informal nature of open-source coding.
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More intriguing still is the Medical Device Co-ordination Framework being developed by John Hatcliff at Kansas State University. Its aim is to build an open-source hardware platform including elements common to many medical devices, such as displays, buttons, processors and network interfaces, and the software to run them. By connecting different sensors or actuators, this generic core could then be made into dozens of different medical devices, with the relevant functions programmed as downloadable “apps”.
Eventually, medical devices might evolve into collections of specialised (and possibly proprietary) accessories, with the primary computing and safety features managed by an open-source hub. The FDA is working with Dr Hatcliff to develop processes for creating and validating safety-critical medical apps. (http://www.economist.com/node/21556098)