OPEN-SOURCE HARDWARE MAY ADDRESS THE SHORTAGE IN MEDICAL DEVICES FOR PATIENTS
WITH LOW-INCOME AND CHRONIC RESPIRATORY DISEASES IN LOW-RESOURCE COUNTRIES
Ramon Farré
Unitat de Biofísica i Bioenginyeria, Facultat de Medicina
Universitat de Barcelona, Barcelona, Spain.
The problem
Industrial R&D and clinical research have made available very
sophisticated and effective medical devices.
However, such advanced and expensive devices are not affordable
for most patients in low- and middle-income countries (LMICs)
Billions of inhabitants in low-resource regions have scarce or no
access to life-saving medical equipment.
Example:
Mechanical ventilators for
acute respiratory failure.
Such inequity in access to life-saving solutions prompts a uniquely
important question in global health:
how to reduce this access inequality problem besides passively
waiting under the wishful thinking that economic differences
among countries will progressively disappear?
Some useful but limited solutions
▪ Philanthropic donations of commercially available medical
devices:
Limitations: Very high costs involved (thus, inefficient use of
donations), and short functioning time (lack of maintenance and
repair).
▪ Construction and donation of custom-made devices by
university teams in developed countries:
Limitations: Hardly sustainable because it requires long-term
commitments to ensure appropriate maintenance of the devices.
▪ Production by local companies in LMICs, specifically
building “frugal” medical devices:
Limitations: Costs in any industrial process, even in not-for-profit
companies in LMICs, may result in prices still not affordable for many
patients in LMICs.
www.open-source-medical-devices.com
The open-source approach…
The open-source approach is a way to design and distribute the
technical information required for building devices such that anybody
can freely and unrestrictedly use the know-how to replicate the device
or modify the design for improvement or adaptation to different
applications.
Open source hardware is currently facilitated by:
▪ 3D printing
▪ Simple electronic platforms (e.g., Arduino, Raspberry Pi)
▪ Affordable sensors, actuators and electronic components
▪ E-commerce (e.g., Amazon, Alibaba)
…for medical devices in LMICs
The open-source approach may contribute to facilitating the provision
of affordable medical devices for patients in LMICs.
How to successfully implement it:
Interdisciplinarity: Medical devices are built by technical teams
linked to hospitals or to associated engineering schools.
Local involvement: LMICs professionals fully involved to ensure that
the project is suitable for implementation under local conditions, and
to promote local industry in each ecosystem.
Clinical involvement: Medical experts actively participate in the
design and evaluation of the devices on the bench and in patients.
No competition with the conventional market:
The conventional market is actually not operating in LMICs (with the
exception of providing products for a small minority of wealthy
patients), and this situation is not expected to change in the upcoming
decades given the huge gap between costs and prices in developed
countries and financial capabilities in LMICs.
Open-source medical devices do not compete with the conventional
market, they are aimed to fill the inequality gap in accessibility.
CONVENTIONAL MARKET OPEN SOURCE, LOW-COST
Highest performance, with many non- High performance on the essential
fundamental “vanity” functions functions for diagnosis and therapy
Difficult to run and repair in LMICs Easy to run and repair in LMICs
Non-robust in difficult environments Robust in difficult environments
Very high cost, not affordable in LMICs Low cost, affordable in LMICs
An example
“Low-cost, easy-to-build noninvasive pressure support ventilator for
under-resourced regions: open source hardware description,
performance and feasibility testing”
Eur Respir J 2020; 55: 2000846
▪ Retail cost of ventilator
components <75 US$.
▪ Clinically tested:
similar performance as
a commercial ventilator
Safety issues
A fundamental issue to be addressed regarding the local fabrication of
medical devices is their safety and patient protection:
Conventional approach in developed countries:
Labeling with FDA or EC marks to ensure device safety. However, this
is extremely expensive for LMICs.
Requiring FDA or CE mark in LMICs is in practice equivalent to:
▪ prohibiting most inhabitants from receiving potentially life-
saving treatments
▪ hampering the development of a local industry of medical
devices.
A simpler and effective approach for LMICs:
Local approval of devices by hospital/regional Ethics Boards
incorporating internal or external technical professionals. This is the
same approval approach currently used for clinical trials and the one
initially used for medical devices in developed countries.
Conclusions
The relatively novel, free open-source approach may be useful
for facilitating affordable medical devices for patients in LMICs
who otherwise would not have access to tools that, in some
cases, enable life-saving diagnosis and treatment.