The open source model has been a successful way of improving software, whether it be the 3D modeling software Blender, or whole operating systems such as Ubuntu and the Linux kernal it is built on. Not only is the software free of charge, but the lack of restrictive intellectual property enables end users to modify the software to fit their individual needs.
The open source model has also created a rapid and decentralized method of correcting flaws in software by allowing the public to scrutinize its source code. The security and ease-of-use implications of this are obvious, but even more important might be the consumer's peace of mind when they don't have to trust a single, centralized organization.
Some scientists, engineers, and biohackers, recognizing these benefits, have applied the open source model to healthcare products. These products range from vaccines and other therapeutics to homemade bioreactors, giving individuals more power than ever over their own healthcare, should they have the skill or need to use it.
Vaccines
Motivated by the SARS-CoV-2 pandemic in early 2020, one such organization of scientists and engineers, Rapid Deployment Vaccine Collaborative (RaDVaC), set out to develop an open source vaccine platform which can be easily made and rapidly altered in response to the latest scientific information.
A key feature of our rapid deployment strategy is the flexibility of the vaccine platform, allowing very fast and efficient updating of vaccine designs in response to recent research. On multiple occasions we have updated vaccine designs with important information published in the biomedical literature only weeks or days earlier.
The development of the vaccine, which is intranasally delivered, relies on self-experimentation rather than clinical trials. This may seem like a daunting restriction, but it has not stopped over 100 people from self-administering various versions of the vaccine, which is now on its 11th generation.
While long-term safety cannot be determined at this time, RaDVaC's frequently asked questions page reports that the most severe side effect of their vaccine has been headaches and the most common has been nasal congestion.
The RaDVaC team stresses that their vaccine is primarily an R&D project and not a replacement for commercial vaccines, but it is easy to imagine what open source vaccine development will mean for the future. The zero-trust nature and rapid adaptability of open source products makes the model a perfect candidate for future health crises.
Medical Supplies
Meanwhile, as RaDVaC was working on the pharmaceutical side of the pandemic, Open Source Medical Supplies (OSMS) - now a network of over 74,000 people - was designing and uploading the files for essential medical equipment.
Like RaDVaC, OSMS was motivated by the SARS-CoV-2 pandemic. The project was started in March 2020 by Resolve, a non-governmental organization dedicated to sustainable development.
According to their impact report, which covers the period of March through September 2020, over 200 open source designs - ranging from face shields to the OpenPCR - were submitted to their website. The report also estimates that over $271 Million in supplies were manufactured and donated as a result of their project library.
EpiPens
While some open source projects are made to assist pharmaceutical companies and regulatory boards, others are made to combat them. In 2016, anarchist, biohacker, and physics PhD Mixæl Laufer responded to outrageous EpiPen prices by unveiling The Four Thieves Vinegar Collective. The collective's first release was the plans for the EpiPencil, an epinephrine autoinjector made from three commercially available parts at a cost of just over $30.
WHEREAS The pharmaceutical industry continues to put profits above human life, and
WHEREAS Autoinjectors and epinephrine are technology which belongs to the world, and
WHEREAS EpiPens save lives every day, but only for those who can afford them, and
SINCE The Four Thieves Vinegar Collective is dedicated to providing access to everyone
WE HAVE developed the EpiPencil, an epinephrine autoinjector which can
be built entirely using off-the-shelf parts, for just over $30 US.
Sources for the three items you require are linked below, followed by a video which details how to assemble them.
Stay healthy,
Bioreactors and Insulin
The Four Thieves Vinegar Collective later released an even more ambitious project: the Apothecary MicroLab. The MicroLab is a homemade bioreactor, that synthesizes chemical compounds with the help of a small computer. Typically, bioreactors are expensive devices operated by lab technicians in professional laboratories, but the MicroLab is an accessible alternative made from simple components such as mason jars.
On the Four Thieves Vinegar website, the outline for manufacturing Pyrimethamine - a patented anti-parasitic used to treat toxoplasmosis - is featured. Unfortunately, at the time of writing, neither the MicroLab plans nor the outline can be downloaded from their site until the MicroLab 4.0 is released. Though, the EpiPensil instructions are still available.
The Four Thieves Vinegar Collective are not alone in their disgust with patent-enabled monopolies, nor in their desire to bring bioreactors nearer to the consumer. The Open Insulin Foundation's (OIF) most recent blog post rightly laments about patent monopolies. The OIF aim to design an open-source bioreactor to make microorganisms, which then go through a system called Fast Protein Liquid Chromatography (FPLC) to purify proteins. Once the FPLC purification - which also requires an open-source alternative - has been completed, the proteins are used to make insulin.
The OIF, originally the Open Insulin Project, was started in 2015 at Counter Culture Labs, a community microbiology lab in Oakland, California. Through a crowdfunding campaign, the project was able to acquire $16,000 and has steadily progressed to a point where production pilots are nearly possible, as their most recent progress report explains.
Artificial Pancreas Systems
An Artificial Pancreas System is a device for type 1 diabetics which mimics the insulin-production of a functioning pancreas. While some commercial APS are being developed and others are awaiting regulatory approval, OpenAPS has made their position clear with their social media hashtag: #WeAreNotWaiting.
OpenAPS is a simplified version of commercial APS (most of which are in clinical trials) that is designed to be used with existing medical devices for diabetics. Rather than rely on more complicated algorithms, it uses a heuristic-algorithm to automate the same math the patient would use to do their own blood sugar calculations.
Along with an algorithm which can be easily understood by the consumer, the OpenAPS team provides extensive documentation and reference materials for building and operating the system. The beginning of their reference design provides an excellent summary:
OpenAPS differs from other APS currently in clinical trials in two significant ways.
First, it is designed to use existing approved medical devices, commodity hardware, and open source software.
Secondly, it is designed
primarily for safety, understandability, and interoperability with
existing treatment approaches and existing devices.
On their outcomes page, they have the self reported OpenAPS data from 2016, as well as a list of studies conducted between 2018-2021. The latest scientific paper on APS (called automated insulin dosing or AID in the paper) is a review of 21 studies between 2018-2021. The review concludes, "Commercially developed and open-source AID systems represent effective
and safe treatment options for PwD [people with diabetes] of several age groups and genders."
Conclusion
Just as open source software has not yet replaced proprietary software, and 3D printing has not yet replaced conventional manufacturing, it is unlikely that we will see the medical system make a complete transition to open source models anytime soon. However, as we have seen, the past six years have brought us significant advances in open source medicine.
It remains possible that as information technology continues to decentralize everything from our mail to our money, the coming decades may bring a return to the age-old mutual aid healthcare system, with the high-tech spin we've come to expect of 21st century.