David Van Sickle:
“While working on this project, I’ve been keeping track of some ways in which we might better stimulate successful open source hardware projects in global health. Many of my thoughts and suggestions focus on the academic setting, but could readily be applied to the community at large.
1. Aggregate information on open hardware projects in global health to maximize participation and activity.
There are many open source software projects in (global) healthcare, but far fewer hardware undertakings. For example, one list of 50 open source projects that are changing medicine doesn’t include a single piece of hardware.
To change this, we need an active inventory of open hardware projects in global health. As it is today, there’s more effort marshaled toward developing clever kitchen robots and fun backyard kits than global health hardware. That said, we can learn from the hobby-tech industry, by applying a similar approach to open hardware projects in global health technology that Make Magazine has done for DIY projects. Highlighting successful projects could spark a similar spirit and energy, and even draw the attention and input of the creative, resourceful, and talented members of the Make community.
2. Involve students eager to learn and apply their skills to real-world health problems.
In my experience, recruiting a team of bright and motivated students to work on the spirometer was the single best step for the project. Many universities with engineering programs require their students to participate in at least one semester of an applied design course, which often solicit project ideas from the public and from across campus. Typically, the students are eager to apply their growing skill sets to the design and development of innovative, workable solutions to challenges in global health technology. Often times, the result is a compelling proof of concept that can be very influential in securing support and funding for further development. This is the path I was able to follow with Asthmapolis – which uses a device I developed to track the time and location where asthma inhalers are used.
3. Develop innovative funding strategies that anticipate sizable requirements and unique opportunities.
Open hardware projects can have significant funding requirements, particularly when the project has an educational component. As others have noted: software can be made with time, but hardware needs time and money. Our spirometry team has to purchase and test components; buy old spirometers and take them apart; print and assemble electronics; and eventually pay for tooling and prototyping. And while this can get expensive, project teams can often generate working funds from design and prototype competitions, as well as university and community business plan contests.
In addition, the Open Source Hardware Bank aims to help open source teams move to production by achieving the scale necessary to lower their unit costs. A similar effort, especially if integrated in an incubator (see below), could provide seed funding and guidance for open hardware projects targeting global health.
4. Broaden participation to create non-obvious but essential project scaffolding.
Our open spirometry project has a growing international network of supporters and active local participants, including software and electrical engineers, clinicians and health care providers. Their help and insight is invaluable and they donate extraordinary amounts of time and equipment to the project, while actively mentoring the students. Unfortunately, with so much technical expertise, it’s easy to develop a lopsided emphasis on the mechanical and electrical requirements and overlook the need to develop marketing, manufacturing, and distribution tactics.
Here’s how to remedy the deficit: Recruit business students to outline marketing and distribution strategies, develop financial projections and draw up viable for profit or non-profit business models; rally anthropology students to conduct formative research, outline use cases, or field test and evaluate ideas and prototypes; mine other departments on campus for students and faculty who want to contribute to global health technology projects. Such efforts would likely be more successful, and would even more closely resemble the real-world interdisciplinary teams common in healthcare design and engineering.
5. This includes regulatory affairs.
Building a medical device is an engineering challenge but also a formidable regulatory one, and the process for complying with the required documentation, testing, and certifications is often neither obvious nor straightforward. Some type of not-for-profit regulatory affairs consultancy or clearinghouse could guide and advise teams designing and developing open hardware tools for global health. Such an agency could help by collecting and organizing best practice documents, providing regulatory documentation templates, developing training materials or curriculums for students, or organizing and summarizing foreign regulations on importing devices. In the absence of such a group, we have searched for and sought the assistance of law students with an interest in medical devices, so far unsuccessfully.
6. Create global health technology incubators to advise and fund open hardware projects.
Another possible strategy, that could productively encompass many of these suggestions, would be to establish global health technology incubators on campus, along the lines of startup shops such as Y Combinator or TechStars. These global health greenhouses could help to organize, fund, test, market and mentor open hardware technologies emerging on campus or off. Ideally, they would offer small-scale funding, provide access to a diverse set of committed advisors, and help avoid wasteful duplication of efforts. In addition, collaboration and cross-pollination among teams would also generate many new innovations and unforeseeable efficiencies. It should be noted that there is growing recognition that low cost innovation can have valuable applications to our own economy (See recent articles in The Economist and the Wall Street Journal). As such, these global health incubators might begin to develop solutions to rising healthcare costs in the US as well.
7. Help teams build and appropriately license solutions that are defensible against infringement claims.
As an open source project we tolerate a bit of uncertainty that we may be targeted by patent trolls or may unknowingly infringe on prior art. Yet university intellectual property (IP) offices are not organized to help open source projects navigate the IP landscape, or develop and protect alternative IP models, but rather to establish and license profitable IP. Any open hardware project, especially those working to develop low cost solutions to commercially-available technologies, has seemingly endless legal research to do in order to identify a workable solution that is defensible and to ensure that the optimal licensing is chosen for the end product. Again, it seems that an organization (on campus or off) dedicated to helping open hardware teams working on global health technologies develop an appropriate IP approach, and respond to any threatened litigation, could accelerate many of these projects.”