Towards Open Source Medical Devices

Current Situation, Inspiring Advances and Challenges

Arti Ahluwalia

, Carmelo De Maria

, Andrés Díaz Lantada

, Licia Di Pietro

, Alice Ravizza

Mannan Mridha

, June Madete

, Philippa Ngaju Makobore

, Alvo Aabloo

Risto Kitsing

and Arni Leivobits

University of Pisa, Pisa, Italy

Universidad Politécnica de Madrid, Madrid, Spain

Kungliga Tekniska Högskolan, Stockholm, Sweden

Kenyatta University, Nairobi, Kenya

Uganda Industrial Research Institute, Kampala, Uganda

Tartu Ulikool, Tartu, Estonia

Agileworks, Tallin, Estonia

Keywords: Open Source Medical Devices, Collaborative Design, Biomedical Engineering, Regulatory Harmonization.

Abstract: Open Source Medical Devices may be part of the solution towards the democratization of medical

technologies pursuing Universal Health Coverage as part of the Sustainable Development Goals for United

Nations. Recent technological advances, especially in information and communication technologies,

combined with innovative collaborative design methodologies and manufacturing techniques allow for the

mass-personalization of biodevices and help to optimize the related development times and costs, while

keeping safety in the foreground through the whole life cycle of medical products. These advantages can be

further promoted by adequately fostering collaboration, communication, high value information exchange,

and sustainable partnerships and by extending the employment of open source strategies. To this end, within

the UBORA project, we are developing a framework for training the biomedical engineers of the future in

open-source collaborative design strategies and for supporting the sharing of information and the assessment

of safety and efficacy in novel biodevices. An essential part of this open-source collaborative framework is

the UBORA e-infrastructure, which is presented in this study, together with some initial success cases. Main

future challenges, connected with regulatory harmonization, with educational issues and with accessible and

open design and manufacturing resources, among others, are also presented and discussed.

1 INTRODUCTION

Universal Health Care (UHC) is still a dream, even

if all United Nations Member States have agreed to

pursue the achievement of universal health coverage

by 2030 (UN General Assembly, 2012), as part of

the Sustainable Development Goals. Currently,

around 60 countries offer health care to all their

citizens, but vast regions of North and South

America, Africa and Asia, accounting for more than

the 80% of the World’s population, still live without

the desired coverage. In the case of Africa, the

scarcity of quality healthcare is linked, not only to

the lack of resources, but also to the shortage of

adequately trained biomedical engineers.

Capacity building in this sector is needed for

progress and for the establishment of a sustainable

healthcare system. Excluding South Africa, apart

from a few singular initiatives (i.e. in Nigeria and

Ghana), no university in sub-Saharan Africa offers a

complete Biomedical Engineering (BME) graduate

& post-graduate programme (Nkuma-Udah and

Mazi, 2007). Considering that Africa has one of the

youngest demographics, targeting students may be a

key to rapidly and efficiently promote healthcare

improvements. One way of reaching this goal is to

Ahluwalia, A., Maria, C., Lantada, A., Pietro, L., Ravizza, A., Mridha, M., Madete, J., Makobore, P., Aabloo, A., Kitsing, R. and Leibovits, A.

Towards Open Source Medical Devices - Current Situation, Inspiring Advances and Challenges.

DOI: 10.5220/0006586501410149

In Proceedings of the 11th International Joint Conference on Biomedical Engineering Systems and Technologies (BIOSTEC 2018) - Volume 1: BIODEVICES, pages 141-149

ISBN: 978-989-758-277-6

141

use the immediacy and high information content

offered by the internet combined with the open

source approach to teach design and fabrication of

biomedical devices at university level, hence

focusing on the biomedical engineers of the future.

Creating open source medical devices (OSMD)

means developing these devices by sharing ideas and

concepts, design files, documentation, source-code,

blueprints and prototypes, testing results and all

collected data, with other professional medical

device designers. These interactions should benefit

the whole life cycle of the devices or products under

development and, in the context of BME, there is a

need for a high level of supervision, to control the

final quality and to guarantee the respect to

standards and regulations, hence promoting the final

safety of OSMD (De Maria et al., 2015).

Therefore, the core curriculum for biomedical

engineering should also include courses on

biomedical device regulations and standards and

focus on the promotion of collaborative design

strategies and on the potentials and challenges of

OSMD, as we discuss further on. This approach may

prove beneficial, not only in developing countries,

but also in countries, in which UHC is already

implemented. Taking account of the current situation

of our World, in which new healthcare challenges

are appearing due to shifting demographics and

changing lifestyles, new strategies are needed.

In fact, the relevance of OSMD has been already

put forward by inspiring projects and achieved very

interesting results showing their transformative

potentials. Among these influential proposals, we

can cite the 3D printed hand prostheses developed in

a personalized way (and for free) by the e-NABLE

Community, the sharing of good practices within the

Patient Innovation forum (Oliveira et al., 2017),

pioneering projects for promoting open-source

bioengineering (De Maria et al., 2014; 2015,

Ravizza et al., 2017) and educational experiences

searching for more democratic paradigms, as

summarized previously (Díaz Lantada, 2016).

However, additional and systematic efforts are

needed for achieving global impacts and for making

OSMD a key turning point for the future of a more

socially oriented medical industry. In the following

sections we describe the concept and approach of the

UBORA project and some recent advances achieved

during its preparation and along its first year of

endeavor.

Fundamental issues including: i) the promotion

of collaborative biomedical design methodologies

oriented to global health concerns, ii) the

development of open-access e-infrastructures for

global action, iii) Education for all approaches, iv)

harmonization of medical regulations and v)

international partnerships are part of the strategy

deployed within UBORA. Preliminary success

stories and current challenges are analyzed.

2 CONCEPT AND APPROACH OF

THE UBORA PROJECT

To encourage the shift towards OSMD and the

democratization of medical technology, the EU

funded “UBORA:Euro-African Open Biomedical

Engineering e-Platform for Innovation through

Education”project (H2020 research and innovation

programme GA 731053) aims at implementing an e-

infrastructure, UBORA, for open source co-design

of new solutions to face the current and future

healthcare challenges of Europe and Africa.

UBORA (“excellence” in Swahili) brings together

European and African universities and their

technological hubs (supporting biomedical design

and prototyping laboratories and incubators) to

develop and establish a new methodology for

designing biomedical devices in a collaborative and

open source way.

The UBORA e-infrastructure is aimed at taking

engineers and engineering students through a

process of needs identification, device classification

and regulation, computer-aided modeling, rapid

prototyping and final preparation of production, in

which each stage is vetted and monitored by experts

to ensure that safety criteria are met during the

design process.

Throughout the project, we are exploiting and

reinforcing networking, disseminating knowledge on

rapid prototyping of new ideas and sharing

information about the performance and the gathered

quality data, in order to maximize innovation and

minimize waste along the life cycle of the

biodevices being collaboratively developed, which

are also providing open-access content to the

UBORA e-infrastructure. The UBORA project is

supported by policymakers and stakeholders

covering the whole life cycle of biomedical product

development, as well as propelled by a series of

design schools and design competitions connected

with the aforementioned formative efforts.

The UBORA design schools are inspired by the

pioneering UNECA (United Nations Economic

Commission for Africa) funded Innovator Summer

Schools (ISS). Since 2013 the themes of these ISS

have focused on the co-development of biomedical

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142

devices based on local needs and materials. Table 1

lists the Summer Schools held so far on different

topics related to Biomedical Engineering.

Thanks to UNECA the ISS bring together a

community of African universities committed to

developing a joint and well balanced curriculum in

Biomedical Engineering and to achieving reliable

results in this field from an academic point of view.

Underlying this ambition is the awareness that

quality healthcare is the key to well-being and

importantly helps to promote wealth as well. With

UNECA’s support, 13 universities in Africa have

joined to form “ABEC” the African Biomedical

Engineering Consortium. UBORA was born out of

these initiatives, and seeks to extend the ISS through

the creation of an OSMD co-creation platform: the

mentioned UBORA e-infrastructure. The results

from its first implementation and cases of success

are detailed in the next section.

Table 1: ISS (Innovator Summer Schools) held since

2013. All ISS were funded by UNECA.

Innovator

Summer

School

Hosting

Institution

Period

Topic

Nairobi, Kenya

Kenyatta

University,

2013

August

- 16

Introduction to

BME regulations

and rapid

prototyping

Dar Es Salaam,

Tanzania

Muhimbili

University of

Health and

Allied Science

2014

December

- 12

From making to

marketing

Addis Ababa,

Ethiopia

Addis Ababa

Institute

of Technology

2016

January

- 15

Application of

mobile phones in

healthcare

product

development

Cairo, Egypt

Cairo

University

2017

January

-27

Biomedical and

clinical data and

informatics for

development in

Africa

3 IMPLEMENTATION OF THE

UBORA e-INFRASTRUCTURE

The UBORA e-infrastructure, developed for the

collaborative design of open-source medical devices,

is the key tool for making our project’s data

available, promoting impacts and helping to support

OSMD. Once completely ready, the platform will

incorporate developed projects, publications,

teaching materials and will be made open to the

public for being used as reference collaborative

design resource in the biomedical industry.

At present, a first preliminary version is already

working and is being used by UBORA project’s

partners and by the students taking part in the

UBORA design competitions, whose research and

development results are being also incorporated to

the platform for generating relevant content before

public disclosure. The main features of this online

platform for OSMD are described further on.

3.1 Overall Structure of UBORA

The UBORA e-infrastructure is implemented in a

user-friendly way and clearly oriented to biomedical

engineers and designers, medical professionals,

patients and patients’ associations, medical device

manufacturers and potential collaborators, as main

stakeholders. The access to the e-infrastructure is

obtained after free registration and the homepage

gives the following basic possibilities: i) registration

or entrance for registered users; ii) search for a

medical solution; iii) proposal of ideas or solutions

for relevant medical needs; and iv) consultation of

existing public projects (see Figure 1).

Regarding UBORA as tool for the collaborative

development of medical devices, it is necessary to

highlight that the lifecycle of a medical device has

numerous phases, which go from needs assessment

to the manufacture, sales and disposal. UBORA will

specially focus on and support the first stages of the

process (up to pre-production), which include:

identification of needs, specification, conceptual

design and creativity promotion, geometrical design,

materials selection and virtual and rapid prototyping,

which are the most relevant phases for encouraging

the generation of novel solutions. Conception and

development are channeled following European

biomedical device directives and each step of the

process takes account of European regulations, as a

first step towards global harmonization.

Towards Open Source Medical Devices - Current Situation, Inspiring Advances and Challenges

143

Figure 1: Structure of the UBORA e-infrastructure.

The projects are structured according to the phases of

systematic product development methodologies.

As a collaborative design resource, the UBORA

e-infrastructure has been implemented considering

the mentioned lifecycle of medical devices and the

related relevant steps. Users of this online platform

can create and manage biodevice development

projects, whose relevant information is uploaded,

organized according to the systematic development

phases (see Figure 1) and made accessible to the

users of UBORA.

3.2 Data Management within UBORA

The UBORA e-infrastructure is implemented

following “FAIR” (findable, accessible, inter-

operable and re-usable) data management principles,

according to current recommendations from the EU

and the Horizon 2020 Programme.

Once the UBORA e-infrastructure is loaded with

hundreds of projects, towards the end of the project

by 2019, it will be necessary to count with

adequately implemented search mechanisms for

easily reaching the medical solutions and, hence,

promoting its friendly usability and popularization,

as a tool medical professionals, for medical device

innovators, for policy makers and for patients and

patient associations.

In order to make such data findable, the UBORA

e-infrastructure is designed with interactive tabs,

which help to organize the generated projects and

the uploaded information and data. The projects are

being currently created and organized answering the

following questions:

A) Which clinical area does your solution belong

to?

B) What kind of technology do you propose?

C) Which clinical needs do you address?

Once the fields from previous questions A, B & C

are ordered and numbered, such numbers may be

used as identification coordinates for classifying the

different projects according to the type of medical

device being developed, to the medical area

involved and to the clinical need being addressed. At

present we are also considering the use of the Global

Medical Device Nomenclature (GMDN) or the

Universal Medical Device Nomenclature System

although the use of these privately developed

taxonomies requires the payment of fees, which is

controversial with the open-source and free-

available developments we are pursuing, so

additional reflections are needed.

Considering that UBORA will turn out to be,

using a metaphor, a sort of “collaborative Wikipedia

of medical devices”, the contents uploaded will be

made available to the community, in principle

resorting to different types of Creative Commons

Licenses (https://creativecommons.org). In all cases,

attribution to the designer or to the developing team

has to be granted (CC BY).

We will analyse other possible additions to the

basic mentioned CC BY license, including “share-

alike”, “non-derivatives”, “non-commercial”, among

others, although this may well be a final decision of

the designer or developer, as happens in

collaborative environments for sharing documents

and blueprints such as: Wikimedia Commons,

Thingiverse, Grabcad, among others.

Accessibility to the UBORA e-infrastructure

requires registration, which the users achieve by

introducing basic personal and contact data. Users

accept the terms of usability expressed in the “terms

and conditions” section of the e-infrastructure for

registration. Once registered, users have access to

the projects of innovative medical devices uploaded

to UBORA and to their data and metadata. Search of

desired data is supported by keywords and by the

classifications of clinical areas, medical technologies

and clinical needs previously detailed. Users are

responsible for the veracity of the information

uploaded to UBORA (or modified within UBORA

by them) and the managers of the UBORA e-

infrastructure retain the right to expel users that do

not adequately use the information shared.

Interoperability will be achieved by using

standard file formats and by taking account of the

existing compatibilities among design programmes

and files. A support document for users of the

UBORA is included within the e-infrastructure. It is

important to note that each project within UBORA is

collaboratively developed by a different team of

international designers and collaborators, which will

probably choose among the existing options of

computer-aided design, modeling and manufacturing

software, so the file types used are varied.

It is also necessary to highlight that the final

version of the UBORA e-infrastructure will count on

a group of mentors or managers, i.e. partners from

the UBORA project motivated about the long-term

viability of the e-infrastructure and colleagues with

international impact in bioengineering, who will

advise users of the e-infrastructure about the

preferred file formats for improved interoperation.

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Regarding re-usability of the generated data, the

biodevice development projects validated in the e-

infrastructure by the UBORA mentors or managers

and reviewed as potentially beneficial for solving

global healthcare concerns, once completed, will be

archived in the protected servers of the UBORA e-

infrastructure and will be made available to users

during the whole life of the e-infrastructure or until

the developer, together with the team of mentors and

managers of UBORA, decide to replace it by a better

solution or to eliminate it due to existing alternatives

performing better.

3.3 Ethical Issues and Security

Concerns within UBORA

During the UBORA project’s lifespan (2017-2019),

the medical devices developed rely solely on healthy

volunteers for being tested in vitro and in laboratory

environments, hence being “prototypes for the

assessment of functionality”.

These devices are in most cases consequence of

partners’ dedication to the UBORA project or the

result of students’ developments within the design

competitions and the design schools. No device

potentially harmful for users will be tested in

humans during the project. In any case, ethical

approval from local ethical committees will be

obtained prior to commencing any assessments.

Regarding privacy, it is UBORA’s policy to

respect users’ privacy regarding any information that

the e-infrastructure may collect. Accordingly, the

shared through UBORA e-infrastructure, is outlined

in a clear way in a specific section of the website.

3.4 Some Initial Development Cases

within UBORA

The First UBORA Design Competition counted with

a total of 113 submitted projects, from which 60

were selected for a second round. After the second

round, 40 projects and their teams have been

assessed and chosen as finalists. The best 24 teams

of finalists receive travel and full-board sponsorship

(for one team member) to attend the First UBORA

Design School, to be held in Kenyatta University

(Nairobi, Kenya) from the 11

to the 15

December 2017, whose main topic is the systematic

and collaborative development of innovative

biomedical engineering solutions to reduce child

mortality, which was the topic for the competition.

Among presented projects and solutions we can

cite: biodevices for detecting malaria, coolers for

vaccines, systems for the sterilization of surgical

instruments, incubators for premature babies,

devices for monitoring pregnancy, breast pumps

with cooling and preservation systems, 4D printed

splints (3D printed and then personally modified to

suit patients), polymeric devices for treating

clubfoot, CPAP devices or preventive methods for

malaria, to mention just a few examples. Such

projects are already being incorporated to the

UBORA e-infrastructure, as complete examples.

Towards Open Source Medical Devices - Current Situation, Inspiring Advances and Challenges

145

Figure 2: Open-source solar autoclave. Computer-aided

design of final solution and low-cost prototype. Designed

by: O. Blanco, A. García, L. Martín, L. Jiménez, D. Pérez-

Urruti & P. Isla. Mentors: A. Díaz, J. Jiménez & A. Ros.

It is important to highlight that these examples,

in their current state, are just helping to test the

developed e-infrastructure and to provide cases of

study for teaching-learning tasks, towards active

education paradigms linked to OSMD, which is a

fundamental issue for transforming the medical field

in developing countries. Successful OSMD would

probably be manufactured with alternative methods,

for instance taking benefit of distributed fab-labs

and rapid prototyping techniques nearer to the end

users and searching for personalization.

By means of example, Figure 2 includes the

computer-aided design and the low-cost prototype of

an open-source solar autoclave and Figure 3 includes

the final design of a premature baby incubator with

autonomous temperature regulation and the related

functional prototype.

Figure 3: Open-source premature baby incubator.

Computer-aided design and functional prototype.

A. Tomás. Mentors: A. Díaz, J. Jiménez & A. Ros.

Figure 4 shows the conceptual computer-aided

design of a system for cooling and preservation of

breast milk, based on the thermodynamic of water

evaporation. Inspired by pot-in-pot refrigerators,

students selected appropriate materials and device

size, with the final aim of promoting the use of

breastmilk, as means for reinforcing the immune

system of newborns (WHO, 2016).

Figure 4: Cooling and preservation system for breast milk.

3.5 UBORA Design School Structure

With the aim at providing students with a clear

overview of the whole life cycle of a medical device,

from the conceptual and planning stages, through the

design and implementation, towards the operation

and life, the UBORA design school will provide a

combination of experts’ lessons, cases of study and

Conceived – Design – Implement – Operate(CDIO)

teamwork activities (Crawley et al., 2007).

Lessons will cover aspects such as: introduction

to the medical industry, methodologies for the

development of biodevices, safety issues and

standardization, creativity promotion, conceptual

design, materials selection strategies, advanced

design and manufacturing resources. Inspiring

keynote presentation by outstanding speakers will

present global healthcare issues as well as future

trends in biomedical engineering. Practical

workshops on electronics, software and physical

rapid prototyping, on signal acquisition and data

analysis complete the programme of the school.

4 CURRENT CHALLENGES AND

FUTURE RESEARCH

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The UBORA project is EU funded and developed

among a group of European and African partners

and the already implemented first version of the

UBORA e-infrastructure for OSMD is now open to

the project partners, to colleagues from the ABEC

consortium and to participants from the First

UBORA. However our approach is truly global and

the second release of the e-infrastructure will be

opened to collaborators worldwide along the first

half of 2018. In order to obtain the desired impact

and to enable OSMD to truly make a change for the

better, in the path towards universal health coverage,

there are some current challenges, which still require

additional efforts.

The UBORA e-infrastructure itself may

relevantly contribute to finding satisfactory answers

to these issues, which will in any case require the

support of well-established long-term partnerships,

as detailed in the following subsections.

4.1 Sustainability Issues of OSMD

Open-source and collaborative developments of

biodevices are aimed at reaching every single patient

potentially benefiting from the novel technology,

regardless of their social-economical status.

However successful open-source and freely

available (for the patients) solutions rely also on

their potential of generating wealth, of involving the

local populations for more efficient supply chains

and of sustainably growing, both environmentally

and socioeconomically, while benefiting both the

patients and all stakeholders involved in the lifecycle

of the biodevice. To this end, educators, researchers,

medical professionals, patients and associations,

device manufacturers, policy makers, experts in

regulation, fundraisers, patrons and sponsoring

bodies have to interact (and the UBORA e-

infrastructure constitutes a powerful resource for

such collaboration) and work together for the

sustainability of OSMD.

Regarding these issues, after the project’s life, in

the long-term life of the UBORA e-infrastructure,

UBORA mentors or managers will not be

responsible for the use given to the open-access

online resources of the e-infrastructure and it will be

the responsibility of the potential manufacturers,

taking inspiration on the projects available in the e-

infrastructure, to fulfil pre-market approvals and to

respond to potential failures of the products they

decide to produce and commercialize.

Our model implies manufacturers perceiving the

access to UBORA’s developments as a support to

their reaching more rapidly the users (hence

minimizing their R&D costs by using open-designs

developed following safe design procedures and

supervised by a team of experts) and, subsequently,

wishing to reinvest in the e-infrastructure. We also

pursue that the educational aspects of UBORA will

be understood by institutions and used as massive-

open-online resources, which will also serve to

support the sustainability of the e-infrastructure.

Inspiring cases of success, such as Wikipedia,

Firefox, Linux and other open-source initiatives

from the software industry provide clear examples

about the feasibility of open-source strategies.

Let’s apply similar development principles to the

Biomedical Engineering field.

4.2 Towards Regulatory

Harmonization

Continued and systematic work aimed at the global

harmonization of regulations, which should also take

account of the particular aspects present in

collaboratively developed devices, constitute

additional keys for the success of OSMD. In fact

collaboratively developed projects may well result in

safer devices if the correct design principles are

followed (Ravizza et al., 2017).

Ideally, the standards used by the biomedical

designers during their development processes should

be also generated and shared using collaborative and

open-source strategies, if the impact of OSMD is to

be promoted in a methodic way. Considering the

current costs of accessing standards, unbearable for

many designers worldwide, the designers of richer

countries and multinationals “play with loaded

dice”, and this should be corrected.

4.3 Biomedical Engineering Education

for All

Biomedical Engineering Education for all should be

promoted and access to validated and reliable

teaching-learning resources and materials should be

made widely available. Connection of potential

students to networks of educators with a background

in this field should be also encouraged. We consider

that the UBORA e-infrastructure can again

constitute a relevant tool for sharing educational

resources, as the First UBORA Design School will

demonstrate. All this gathering of genius, hopefully

unaffected by reasons linked to social status, race,

religion, political opinions, sex or sexual orientation,

may prove to be transformative for the Biomedical

Engineering field and its industry.

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147

5 CONCLUSIONS

OSMD may be part of the global solution towards

the democratization of medical technologies,

pursuing Universal Health Coverage, as part of the

Sustainable Development Goals for United Nations.

Recent technological advances, especially in

information and communication technologies,

combined with innovative collaborative design

methodologies and manufacturing techniques allow

for the mass-personalization of biodevices and help

to optimize the related development times and costs,

while keeping safety in the foreground through the

whole life cycle of medical products, as has been

discussed in this study.

Main future challenges, linked to regulatory

harmonization, to educational issues and to

accessible and open design and manufacturing

resources, among others, have been also presented

and analyzed. We propose the use of EU standards,

as they are currently recognized in many African

countries, at least as a starting point towards

commercialization, but harmonization is a key yet

unsolved issue, as mentioned before.

It is important to highlight that the advantages of

OSMD can be further promoted by adequately

fostering collaboration, communication, high value

information exchange, and sustainable partnerships

and by extending the employment of open source

strategies. To this end, within the UBORA project,

we are developing a framework for training the

biomedical engineers of the future in open-source

collaborative design strategies and for supporting the

sharing of information and the assessment of safety

and efficacy in novel biodevices.

An essential part of this open-source and

collaborative design framework is the UBORA e-

infrastructure, which has been also presented in this

study, together with some initial success cases.

In short, the UBORA e-Infrastructure is a new

and powerful tool for biomedical engineers to drive

medical innovation forward, in the quest to a better

world with Universal Health Coverage, where access

to the most advanced medical technologies may not

just be for the privileged few. With this UBORA e-

infrastructure the worldwide biomedical community

can generate and share data and blueprints of

biomedical devices, accompanied by the required

procedures for respecting quality assurance, and

assess performance and safety. When properly

implemented, and guaranteed by authorized

competent authorities, these biomedical devices may

safely be used in hospitals and on patients

throughout the World.

Being the UBORA project focused on the

establishment of international partnerships, we

welcome all comments and support. Please contact

us or visit: http://ubora-biomedical.org for updated

information about progress on OSMD.

ACKNOWLEDGEMENTS

The UBORA “Euro-African Open Biomedical

Engineering e-Platform for Innovation through

Education” project has received funding from the

European Union’s “Horizon 2020” research and

innovation programme under grant agreement No

731053.

The authors thank UNECA for their continued

support and Pehr Wessmark for designing the logo

of UBORA:

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