Project based Learning and Biomedical Devices:

The UBORA Approach towards an International Community of

Developers Focused on Open Source Medical Devices

Andres Diaz Lantada

Mechanical Engineering Department, ETSI Industriales,

Universidad Politecnica de Madrid, c/ José Gutiérrez Abascal, 2, 28006 Madrid, Spain

Keywords: Project-based Learning, Biomedical Engineering (BME), Open Source Medical Devices (OSMD), Service

Learning, Collaborative Design, Co-creation, Collective Intelligence.

Abstract: The engineering design of successful medical devices relies on several key factors and constitutes an

extremely challenging process, which requires from multidisciplinary collaboration. In consequence,

preparing engineers in general and biomedical engineers in particular to work in the medical industry, in

connection with biodevice development, is complex. The teaching learning processes, through which the

trainees should acquire a broad overview of the medical field and biomedical industry, a well-balanced

combination of general and specific knowledge according to the chosen specialization, several technical

abilities linked to modern engineering tools and a wide set of professional skills, have to be strategically

planned and implemented. Among the existing teaching-learning methodologies that can be employed for

providing such holistic training, project-based learning is presented here and illustrated by means of

successful experiences. Trends in the field of collaboratively developed open source medical devices

(OSMDs) are presented and main current R&D challenges analyzed. To illustrate the OSMD field, the

“UBORA” project (meaning “excellence in Swahili) is highlighted as a paradigmatic example, in which

research and training aspects are importantly interwoven. In fact, this Euro-African initiative is focused on

the promotion of OSMDs by means of innovation through education, by the creation of a sort of

“Wikipedia” of medical devices, the “UBORA e-infrastructure”, which also guides designers in the

engineering design process and supports online collaboration through the process, and by the constitution of

an international community of developers devoted to OSMDs. Results from project-based learning activities

within the UBORA project, which include competitions, design schools and final degree theses, are

presented. The “UBORA e-infrastructure”, with more than 100 open source biodevices concepts and

prototypes already developed in collaboration by a global community of around 350 users, and shared

through such online platform, are also analyzed.

1 INTRODUCTION

The engineering design of successful medical

devices relies on several key factors, including:

orientation to patients’ needs, collaboration with

healthcare professionals throughout the whole

development process and the compromise of multi-

disciplinary research and development (R&D) teams

formed by well-trained professionals, especially

biomedical engineers, capable of understanding the

connections between science, technology and health

and guiding such developments. Preparing engineers

in general and biomedical engineers in particular to

work in the medical industry, in connection with

biodevice development, is a challenging process,

through which the trainee should acquire a broad

overview of the medical field and biomedical

industry, a well-balanced combination of general

and specific knowledge, according to the chosen

specialization, several technical abilities linked to

modern engineering tools and professional skills.

Among the varied existing teaching-learning

methodologies that can be employed for providing

such a holistic training, project-based learning

(PBL), especially in connection with the CDIO

“conceive-design-implement-operate” approach

applied to the biomedical field (Crawley, et al.,

2007, CDIO standards), is discussed here and

illustrated by means of successful experiences.

Diaz Lantada, A.

Project based Learning and Biomedical Devices: The UBORA Approach towards an International Community of Developers Focused on Open Source Medical Devices.

DOI: 10.5220/0008345600070013

In Proceedings of the 12th International Joint Conference on Biomedical Engineering Systems and Technologies (BIOSTEC 2019), pages 7-13

ISBN: 978-989-758-353-7

Besides, new approaches to the development of

innovative medical devices, including open source

and collaborative engineering design strategies,

which are bound to impact the medical industry in a

relevant way in the very near future and to support

the democratization of medical technology, need to

be considered for training the “biomedical engineers

of the future”. Trends in the field of collaboratively

developed open source medical devices (OSMDs)

are also presented along this document (De Maria, et

al., 2014 & 2015, Ahluwalia, et al., 2018).

To illustrate the OSMD field, the “UBORA”

project is put forward as a recent paradigmatic

example. This Euro-African initiative is focused on

the promotion of OSMDs by means of innovation

through education, by the creation of a “Wikipedia”

of medical devices, the “UBORA e-infrastructure”,

which also guides designers in the engineering

design process and supports online collaboration

through the process, and by the constitution of an

international community of developers devoted to

OSMDs. The varied project-based learning activities

performed within the first couple of years of

UBORA project’s endeavors are presented and some

results illustrated. Besides, the “UBORA e-

infrastructure” and the more than 100 open source

biodevices concepts and prototypes developed in

collaboration by a global community of around 350

users, and shared through such online infrastructure,

are also analyzed, focusing on advances since its

official presentation (Ahluwalia, et al., 2018a,

2018b, 2018c). Finally, some potentials and

challenges in the OSMD field are discussed.

2 PROJECT-BASED LEARNING

AND BIOMEDICAL DEVICES

Biomedical engineering (BME) has been since its

origins a truly transformative field of engineering,

which may even lead to equitable access to

healthcare technologies and universal health

coverage in the near future, according to World

Health Organization’s objectives (United Nations

General Assembly, 2012). However, this field and

related transformations rely on the collaboration of

engineers from all fields, whose training should

make them successful developers of effective,

efficient, safe, replicable, cost competitive, ethically

responsible, sustainable and regulation compliant

medical devices. Project-based learning, connected

to the development of real medical devices, is

arguably the best strategy for training engineers,

from a wide set of environments, towards successful

professional practice in the medical industry.

Some guidelines, proposals and ideas for the

straightforward successful design, implementation

and operation of PBL experiences in the biomedical

engineering field and focused on the design,

manufacturing and testing of biodevices, based on

author’s experience and recommendations from key

references (King, 1999, King, et al., 2003, 2006,

Krishnan, et al., 2011, Morss Clyne, et al., 2016), are

provided in the following subsections.

2.1 Planning the Learning Objectives

When planning project-based teaching-learning

experiences, it is interesting to start by analyzing the

purpose and by listing down the learning objectives

envisioned for the concrete course or programme of

studies. Asking ourselves how our students may be

involved in the medical industry in their future

career paths and what we would like them to master,

as regards the development life cycle of innovative

medical devices seems a good start option. A set of

high-level learning objectives for any bioengineering

design course focused on training students through

the complete development process of medical

technologies may include the following:

O.1. Ability to conceive, design, produce and

operate innovative medical devices by applying

systematic engineering-design methodologies for

improved results when addressing global health

concerns.

O.2. Ability to promote research and innovation

strategies in biomedical engineering and in the

medical device industry, so as to better take into

consideration the voice of patients, associations and

healthcare professionals.

O.3. Understanding the fundamental relevance of

standardization and the need for considering existing

regulatory paths, so as to achieve safe and compliant

prototypes of medical devices ready for production.

O.4. Capability to create value proposals linked to

innovative medical devices or technologies and to

generate viable entrepreneurial activities within the

biomedical industry.

O.5. Capability to learn for researching and

developing innovative technologies and to mentor

their application to innovative medical devices with

improved performance, usability and societal

impact, as compared with current gold standards.

Once the learning objectives are defined, the

context and boundaries need to be established, in

accordance with the temporal framework and

available resources for our course and considering

the overall objectives and desired outcomes of the

complete engineering programme.

BIOSTEC 2019 - 12th International Joint Conference on Biomedical Engineering Systems and Technologies

2.2 Establishing the Context: PBL and

Service Learning

Student and professor motivation are the keys of

success in engineering education and establishing a

motivating context of shared dreams is essential,

towards truly successful and career inspiring PBL

experiences, especially in such a transformative field

as BME: Our students should always understand that

engineering must aim at improving the world and

our global society. Medical technologies are part of

this process of change, in connection with the UN

Global Goal number 3 on “Good health and well-

being”, but also linked to numbers 8 on “Decent

work and economic growth” and 9 on “Industry,

innovation and infrastructure” among others.

In consequence, PBL experiences in the BME

field, if possible, should be contextualized in

connection with relevant health concerns and try to

respond to the needs of patients and healthcare

professionals. Ideally, when external advisors from

hospitals, associations, companies or NGOs working

in low-resource settings are involved, the context

and ideas for the projects, to be developed by

student groups within the PBL experience, can be

linked to real specific needs or concrete challenges,

hence transforming the PBL experience into a

service learning challenge, in which ethical issues

can be additionally developed in class.

Evidently the context is marked also by the

background of our students and by the global

objectives and outcomes of the whole programme: A

medical device engineering design course within a

robotics engineering programme may concentrate on

medical robotics projects (i.e. design of surgical

manipulators or artificial hands); while student

projects in a mechanical engineering programme

may focus on the design and manufacturing of

implants (i.e. prostheses for articular repair or

artificial valves). At the same time, biomedical PBL

experiences in materials science programmes may

even connect with the field of biofabrication,

through the design of scaffolding materials and other

artificial constructs (at least conceptually); while

PBL tasks in industrial organization engineering

may tackle supply chain problems or focus on

quality and risk management, in connection with

real production processes, to cite some examples.

Student background should be also considered,

perhaps leaving more conceptual projects to the first

engineering courses and those requiring more

technical design, manufacturing and experimental

skills to the final year of the Bachelor’s degrees or to

the Master’s and even PhD levels.

2.3 Defining Contents and Boundaries

With the previously listed high-level learning

objectives in mind (Sect. 2.1 O.1-O.5), for any

bioengineering design course focused on training

students through the complete development process

of medical technologies or biodevices, the following

basic contents are proposed. They can serve as

topics for lessons or modules depending on the

available time and temporal framework of the

concrete course. They can act as structuring

elements for PBL experiences, which can range

from just one week to even a whole academic year,

as previous examples have shown (Ahluwalia, et al.

2018b). The proposed basic contents include:

-Engineering design methodologies for biodevices.

-Conceptual design and creativity promotion tools.

-Design for usability and risk mitigation.

-Design considering standards and regulations.

-Prototyping and testing of biodevices.

-Mass-personalization and mass-production options.

-Commercialization paths and supply chain issues.

-Sustainable development of biodevices.

-Ethical issues in the biomedical industry.

These basic contents can be completed with

specific modules for adapting a generic or sort of

“universal” bioengineering design course to the

specific needs of completely varied engineering

programmes. For instance, a module on “biosignals”

may adapt and reinforce these contents for a

electronic engineering programme, while a module

on “biomechanics and biomaterials” may be

adequate for completing a course for a materials

science or mechanical engineering programme. In

some cases, specific training for transversal skills

may be provided, including seminars on teamwork

abilities, project and time management skills, and

communication techniques, among others.

Regarding the scope and boundaries of the PBL

experience, depending also on the available time and

resources, the projects may focus just on the

specification and conceptual stages, or reach up to

the design, prototyping and testing phases.

2.4 Implementing and Assessing

A good definition of objectives, context and contents

typically leads to straightforwardly implementable

PBL experiences, although some unforeseen events

may always take place. Counting with well-

maintained manufacturing resources, with rapid

responding suppliers and with software licenses,

renewed with enough time before the start of the

courses, are among the good practices we can cite.

Project based Learning and Biomedical Devices: The UBORA Approach towards an International Community of Developers Focused on

Open Source Medical Devices

Promotion of communication between professors

and students, with monthly face-to-face meetings

and tutorials and with intermediate presentation of

results and through a consistent plan of distributed

deliverables, is also advisable.

Regarding evaluation, involving students in their

own assessment, especially through peer-review

activities within the working groups, may be

considered as an additional control tool for

successful PBL. However the promotion of positive

interdependence, by making students work in

complex enough projects, and some degree of

individual assessment, i.e. through specific questions

in oral presentations or by means of additional

deliverables or evaluation tasks, are the more basic

options for achieving a good ambience of

collaboration within the teams, without losing

individual control upon students that may fade away

in teamwork activities (Díaz Lantada, et al, 2013).

3 THE UBORA OPEN SOURCE

COLLABORATIVE MODEL

The UBORA research, development and training

model for transforming the biomedical industry

towards equitable healthcare technologies derives

from experiences conceived, designed, performed

and validated within the H2020 “UBORA: Euro-

African Open Biomedical Engineering e-Platform

for Innovation through Education” project (GA-

731053) during years 2017 and 2018, which have

counted with the fundamental support of the

UBORA e-infrastructure, an open-access design

environment envisioned for the co-creation of open-

source medical technologies according to real needs,

as detailed below.

3.1 Open Source Medical Devices

UBORA focuses on the promotion of research and

training activities in BME pursuing the collaborative

development of open-source medical devices

(OSMDs). These devices are developed by sharing

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 ideally lead to safer performance,

thanks to increased peer-review through the co-

creation process (De Maria et al., 2015, Ravizza, et

al., 2017, Ahluwalia, et al., 2018a).

3.2 UBORA: Much More than a

“Wikipedia” of Biodevices

The UBORA e-infrastructure, implemented for

supporting the nascent OSMD community in

research, co-creation/-design and teaching-learning

tasks (see: https://ubora-kahawa.azurewebsites.net/)

includes features such as: a) a section for specifying

medical needs, through which patients and

healthcare professionals can ask for technological

solutions; b) a section for sharing technological

solutions, through which engineers can showcase

their proposals for the future of medical care; c) a

meta-structure for supporting biomedical engineers,

engineering students and professors in the field to

guide the development of innovative medical

technologies, in a step-by-step process following

systematic engineering-design processes, answering

and filling in the questions and sections provided by

the e-infrastructure; d) a community with already

more than 350 co-creators; and e) a section for

sharing open teaching materials.

3.3 Arranging and Training a Global

Community Focused on OSMDs

When planning to arrange and train a global

community of designers and developers of OSMDs,

in which international collaboration should play a

central role for the near future, it became clear for

the UBORA consortium that PBL should be used as

overall teaching-learning strategy. Consequently,

different types and formats of PBL experiences have

been conceived and carried out in the last two years,

which have involved around 30 mentors and well-

beyond 300 students (now engineers), leading to a

collaborative community of more than 350 members

from some 30 countries distributed through Africa,

America, Asia and Europe and interacting through

the UBORA e-infrastructure.

UBORA PBL experiences include: thematic

medical device design competitions, one-week

medical device design schools and final degree

theses linked to biodevice development. In 2017 the

UBORA Design Competition (online, February-

June) and Design School (Nairobi, December)

focused on child and maternal health, while in 2018

the UBORA Design Competition (online, January-

May) and Design School (Pisa, September) focused

on ageing-related issues. More than 100 participants

have taken part in each of the competitions, while 40

students have participated in each design school,

which follow an “express PBL approach, from

concept to prototype in 5 days”.

BIOSTEC 2019 - 12th International Joint Conference on Biomedical Engineering Systems and Technologies

These PBL activities are now performed on an

annual basis and additional ones (mainly UBORA

competitions and UBORA design schools) can be ad

hoc conceived and implemented for focusing on

more specific topics, health issues, contexts or

locations, for colleagues and institutions interested

in exploring open source approaches to the

development of medical technology. Besides, the

UBORA e-infrastructure is already supporting the

development of different medical technology design

courses, within different engineering programmes at

the universities involved in the UBORA project

consortium. Its use as teaching-learning environment

for fostering PBL methodologies in bioengineering

programmes is open to all colleagues interested in

learning-by-doing with their students.

3.4 Some Cases of Success

When exploring the OSMDs developed within the

UBORA e-infrastructure it is possible to find

technological concepts and prototype solutions for

most medical technology missions, including:

prevention, diagnosis, surgery, therapy and

monitoring. Besides, most medical areas are already

being covered, from pediatrics to geriatrics, from

internal medicine, through general surgery, to

traumatology and orthopedics.

Here, by means of example, we present some

selected cases of study mentored by the author and

developed together with his students during their

final degree projects and during their participation in

different courses, in which PBL is used as driving

methodology for teaching medical technology

development and promoting BME in Spain.

Figure 1 illustrates the personalized design and

the 3D printed prototype of a shoulder splint for

injured joint immobilization. Computer-aided design

is performed, after optical scanning of the healthy

volunteer, by using surface based design operation

with Siemens NX-11 design software and final

meshing with Autodesk Meshmixer. 3D printing for

ergonomic validation is accomplished using a BCN-

Sigma 3D printer and white poly(lactic acid) (PLA)

filament. Figure 2 schematically presents the

development of a portable cooler for vaccines based

on the use of Peltier cells. The circuit design, based

on the use of open source electronics (Arduino

control board) and the preliminary 3D printed

prototype, with the Peltier cell and refrigerator

mounted upon the cooler top and isolating panels

placed inside the printed cage, are shown. Additional

information on these devices is shared through the

UBORA e-infrastructure.

Figure 1: Personalized design and 3D printed prototype of

a shoulder splint for injured joint immobilization.

Designer: Eduardo Martínez. Collaborator: Marina

Maestro. Mentor: Andrés Díaz Lantada.

Figure 2: Circuit design and preliminary prototype of a

portable cooler for vaccines using Peltier cells. Designers:

Isabel Álvarez and Elena Crespo. Mentor: Andrés Díaz

Lantada.

Project based Learning and Biomedical Devices: The UBORA Approach towards an International Community of Developers Focused on

Open Source Medical Devices

4 FUTURE PERSPECTIVES

4.1 Main Potentials

Open source medical devices are here to stay as a

changing force, towards a more equitable medical

industry and accessible medical technologies. Their

benefits for the democratization of these solutions,

aiming at global health coverage in the near future,

can be understood, if we consider examples from

other industries (i.e. electronics and software)

already transformed through open source software

and hardware.

The co-creation processes, in which these

OSMDs rely, also turn out to be very positive for

patients and healthcare professionals, due to the

promotion of bottom-up innovation. All these

beneficial aspects of open source biodevices can be

multiplied by means of adequate training strategies,

aimed at the creation of a cohort of designers and

developers, capable of mentoring this emergent area

of open source medical technologies and focused on

international, intersectoral and interdisciplinary

collaboration throughout the whole innovation

chain.

4.2 Key Challenges

Among the more relevant challenges to tackle in this

novel open source medical technology co-creation

paradigm, it is important to highlight: i) the need for

solutions to guarantee the traceability of materials,

design files and manufactured components in open

design and production lines; ii) the need for

resources to systematically and safely track design

changes in collaborative design environments and e-

infrastructures; iii) the need for changes in existing

regulations and for new standards adequately

considering and guiding developers, within these

collaborative and open design and manufacturing

approaches to biodevice innovation.

Capacity building in low-resource settings, by

creating a workforce of biomedical engineering and

BME professors, in places where access to medical

technology is more urgent and where the co-creation

with healthcare professionals and patients can be of

special relevance, is another fundamental issue.

We expect that all these issues will be solved in

the near future through collaboration using co-

creation environments, such as the UBORA e-

infrastructure, which is open to all medical

technology designers and users, as well as educators,

for constructive interactions.

5 CONCLUSIONS

Innovation through education (one of the mottos of

the UBORA project and community) is an excellent,

sustainable and responsible strategy for transforming

any industry and for walking towards the fulfilment

of the United Nations Global Goals for Sustainable

Development. Within BME, training engineers for

working in international teams and for collaborating

in the development of open source medical

technologies can constitute a very relevant driver of

change in years to come.

The highlighted UBORA e-infrastructure, a

recently created collaborative environment for the

co-creation of medical devices, and related UBORA

teaching-learning experiences provide pioneering

examples of collaborative research and education in

BME, as a way for establishing the foundations of

the OSMD field.

ACKNOWLEDGEMENTS

This document summarizes the Biodevices 2019

keynote speech presented by Prof. Andrés Díaz

Lantada, who acknowledges the consideration of the

Conference Chairs for their kind invitation.

Besides, author acknowledges the UBORA

“Euro-African Open Biomedical Engineering e-

Platform for Innovation through Education” project,

funded by the European Union’s “Horizon 2020”

research and innovation programme, under grant

agreement No 731053, and all colleagues from the

UBORA consortium, inspiringly led by Prof. Arti

Ahluwalia from the University of Pisa.

BIOSTEC 2019 - 12th International Joint Conference on Biomedical Engineering Systems and Technologies

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BRIEF BIOGRAPHY

Andrés Díaz Lantada is Associate

Professor in the Department of

Mechanical Engineering at the

Industrial Engineering School of

Universidad Politécnica de

Madrid (UPM). He finished his

6-year Industrial Engineering

Degree in 2005 and his PhD

Thesis in Mechanical Engineering and

Manufacturing in 2009, which received the

Extraordinary PhD Award by UPM and the 2nd PhD

Award by the Council of Industrial Engineers of

Madrid. His research interests are linked to the

development of mechanical systems and biomedical

devices with improved capabilities, thanks to the

incorporation of smart materials, special geometries

and complex functional surfaces and structures,

mainly attainable by means of high-precision

additive manufacturing processes.

He is currently UPM Contact Researcher at the

“EU Virtual Institute of Knowledge-Based Multi-

functional Materials”, UPM Leader at the “UBORA:

Euro-African Open Biomedical Engineering e-

Platform for Innovation through Education” project,

funded by the EU H2020 programme within the

“Support to policy and international cooperation”

call, and Director of the UPM Product Development

Laboratory. He has also led the research activities of

UPM within the “TOMAX: Tool-less manufacturing

of complex structures” project, funded by the EU

H2020 programme within the “Factories of the

future” call.

Andrés has directed 2PhD Theses and more than

100MSc and BSc final degree theses. He has

received the “UPM Teaching Innovation Award” in

2014, the “UPM Young Researcher Award” in 2014,

and the “Medal to Researchers under 40” by the

“Spanish Royal Academy of Engineering” in 2015.

Since January 2016 he has the honour of being

Member of the Editorial Advisory Board of the

International Journal of Engineering Education. His

current research dedication is to the field of open

source medical devices for the democratization of

medical technology, in connection with the UBORA

community and with the UBORA e-infrastructure,

and to the development of innovative teaching-

learning methodologies in the BME field.

Project based Learning and Biomedical Devices: The UBORA Approach towards an International Community of Developers Focused on

Open Source Medical Devices