SCALE 19x venue
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Los Angeles, CA
July 2022

The Freespireco Project: A free-libre open-source respiratory medical device ecosystem

Audience:
Topic:

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.

Room:
Los Angeles C
Time:
Saturday, July 30, 2022 - 11:30 to 12:30