The Freespireco Project: A free-libre open-source respiratory medical device ecosystem
The COVID-19 pandemic has demonstrated a clear and present need for a
complete, free-libre open-source, easily repairable, widely usable,
safe and effective respiratory support medical device ecosystem. By
“complete ... respiration system," we mean all of the composable
components needed to medically and therapeutically assist people
having trouble breathing for whatever reason. By “free-libre
open-source,” we mean that ordinary people with ordinary skills can
construct each component in the art of making electromechanical
devices with the help of clear and already-published designs, plans,
instructions, and regulatory documentation free for all to use and
share. By "easily repairable" we mean that the owners of equipment
have both the legal right and technical information to make safe
repairs. Furthermore, those plans can be legally improved upon, so
long as those improvements are shared under the same principles. By
“safe and effective,” we mean there is a large, compelling,
clearly-published body of evidence that proves the designs are safe
and effective. By “widely usable,” we mean that makers have put in
significant effort to ensure these devices are usable in low-resource,
non-mainstream, or high-stress environments -- such as by people in
rural communities, people with little money, people who speak less
widely spoken languages, and people in emergency situations.
The Problem
The COVID-19 pandemic taught us that our lives depend on a fragile
international supply chain which cannot always adapt to disruption or
acute demands. The most startling example of this was the shortage of
Personal Protective Equipment (PPE) worldwide. The shortage of
mechanical ventilators was at times another example. Writing currently
in March of 2021, the lack of therapeutic oxygen is a pressing
problem. Masks, ventilators, and oxygen concentrators are simple
devices whose basic operation has been known for decades -- but simple
does not mean easy. Because these devices are all life-critical
devices in different ways, great care must be taken to make them safe
and effective. Generally the marketing of such devices requires
regulatory approval from a national body tasked with ensuring that
quality. When a shortage arises, people die. Nonetheless, our planet
has a vast manufacturing capability. How can it be that this
manufacturing cannot be quickly repurposed to supply the demand and
save lives? Within a given community or nation there may be a lack of
financial resources. In some cases, there may be sufficient money to
make the devices, but there may not be the know-how needed to do
so. There may be the manufacturing know-how, but there may not be
designs available. There may be designs available, but there may be
legal impediments. It may be possible to make the devices, but it may
not be possible to make devices that have regulatory approval allowing
distribution and use.
The Solution
Public Invention proposes to create The Freespireco Project to create
a complete, free-libre open-source, widely usable, safe and effective
respiration system. By making this system free, open, and
transparent, any nation, firm, community or person will have the legal
right to construct a full range of safe and effective respiration
support devices. Most nations regulate the marketing of such
devices. Freespireco will make obtaining regulatory approval of these
devices easier by providing a large, transparent body of designs and
tests. By organizing a large community of persons, firms, nonprofits
and NGOs participating in Freespireco, a reliable and reusable body of
human know-how will be made sharable and freely accessible to
all. This is analogous to free-libre open source software projects
which have conferred similar benefits to humanity in the realm of
software, such as the GNU/Linux operating system, and some
microcontrollers, such as the Arduino microcontroller family, both of
which are based on the principles of free and open sharing. Creating
a system of composable, interoperating, and cooperating devices has
enormous benefits. Today we may think in terms of individual devices
to provide a particular medical function, although even now these
devices have accessories and are composed in different ways to add
different functionality. Particularly with respect to respiration,
there are many features which are composable and cross-cutting
concerns.. By thinking holistically of the whole system of respiratory
support possibilities as a cooperating system or ecosystem, we can
make treatment safer and more effective. A set of cooperating
projects that support respiration may make respiration support cheaper
and more accessible globally.
Standards Support Modularization
The fundamental insight that all mechanical ventilators consist of
three separable modules, the air drive, the sensing module, and the
control module, allow us to modularize the mechanical ventilator. With
proper standardization, we can allow hot-swappability of these
modules. This allows local manufacture of ventilators and an
unprecedented level of repairability. Data standards are key to this
modularization. A Suite of Medical Devices So in terms of medical
devices, The Freespireco Project plans to develop designs for
different but related kinds of devices: An invasive ventilator, An
non-invasive ventilator, A transport ventilator, A BPAP machine, A
CPAP machine, An anesthesia machine, and A PAPR. However, it will do
so by making four cooperating modules: An Air Drive, A Sense Module, A
Controller, and A User Interface. These modules will be sufficiently
configurable to support use in any of the six respiration support
machines. Testing, Transparency, and Trust Testing is paramount to
The Freespireco Project. Public Invention developed the VentMon
Monitor/Test before developing any air production components as an
expression of this principle: Testing drives development. The
Freespireco Project will develop special test equipment (such as the
VentMon) and test harnesses, not listed as components. Nevertheless,
test equipment is of equal or greater importance than the devices
being tested. We take trust through transparency as a basic
principle. Code which can be freely studied and highly instrumented
machines provide trustworthiness. By using extensive instrumentation
and logging, the normally hidden function of the machine is fully
exposed, building trust. Moreover, extensive testing of both expected
and unusual cases and complete published transparency of those test
results is crucial to building trust.
What Success Would Mean
Let us imagine a world in which the Freespireco Project has succeeded
spectacularly, and another pandemic occurs that requires us, as a
planet, to treat an acute quintupling of patients with respiratory
distress. Because of Freespireco, anyone in the world can examine a
complete set of plans and other documents explaining how to make safe
and effective devices. Because these devices have been developed
transparently in the open and large amounts of test and regulatory
documentation are available, their safety and effectiveness is easy to
judge and evaluate. Application for the approval to market such
devices is relatively easy because of the transparent nature of the
design history of these devices. Because they are developed in an
ecosystem, it is easy to understand how these devices work together
when they need to. Innumerable business opportunities to manufacture
and market these devices widely are created. Because they are part of
a free and transparent ecosystem, quickly training people to use the
devices is relatively easy. Training materials may already be
available, and nothing encumbers the quick production of new training
materials -- for example, in a new language to meet a need in one
geographic region. The devices are not gratis or free-as-in-free
lunch -- they have a cost. However, because they are
free-as-in-speech, nobody has a monopoly or oligopoly on them.
