Important lessons can be learned from the COVID-19 pandemic, which after more than two years of worldwide suffering is still among us. First, we now better understand that global health concerns cannot be tackled and solved individually and verify that the dream for universal health care is far from being fulfilled. Besides, biomedical technologies and medical devices, despite their transformative potential, cannot always reach those urgently needing them, due to centralized production, supply chain issues, intellectual property restrictions, and lack of raw materials and resources close to the point of care, which calls for a renovation of the biomedical industry aimed at sustainability and equity. To make matters worse, unethical behaviors of governments, companies, and citizens, from which the ongoing pandemic has provided plenty of examples, also endanger the already challenging progress toward the Sustainable Development Goals (SDGs), including “Goal 3” on “Good Health and Well Being.”
In my personal view , engineering may be defined as: “The development and application of scientific and technical knowledge to the discovery, creation and mentoring of technologies, capable of transforming human societies and environments, for increased well-being and life quality and, hence, necessarily following sustainability and equity principles.” Arguably, biomedical engineers should transform health care toward good health and well-being and take the lead in fostering the mentioned SDG-3 . To this end, mastering sustainable development principles applied to biomedical technologies and being capable of dealing with complex ethical dilemmas should become fundamental learning outcomes of any modern Biomedical engineering (BME) program of studies. However, technological issues dominate the programs, while ethical, legal, and social aspects or issues Ethical, legal and social aspects/issues (ELSA/ELSI) of medical technology are seldom addressed in detail. In fact, despite the relevance of ethics and sustainability for accreditation bodies like American Board for Engineering and Technology (ABET) or European Accredited Engineer (EURACE) and for contemporary approaches to engineering education (i.e., Conceive-Design-Implement-Operate (CDIO) initiative and related standards), it is still challenging to find a BME program with courses on “ethics for biomedical engineers,” “social and legal issues of bioengineering,” or “sustainable and human-centered design in biomedicine.”
In addition, technology evolves at an extremely rapid and unforeseen pace, enabling not only innovative health care solutions, but also new ways of interacting with the human body and mind, in manners that might even reshape the human condition very soon. For example, the first time I heard about health affective technologies, wearables that read emotions and brain–machine interfaces, despite their potential benefits, I could not avoid experiencing an uncanny feeling of discomfort. I was not only thinking of related privacy issues and dual uses of these technologies (like targeted advertisements), but also considering potential infringements in the freedom of thought, which have been also recently described in detail . One could easily imagine parallel advances leading to personalized biofeedback, for instance aimed at making users feel cheerier (through drugs and other external stimuli) when the technology decides that the user is living through a moment of sadness or loneliness. This would be just one step away from technologies checking the moral rightness of users’ thoughts, which could lead to the death of creativity. What would happen if literary giants like Stephen King or Camila Läckberg would be prosecuted, in an Orwellian way or as more recently exemplified in Minority Report, just because of their wild imagination, understanding of horror, and capability to imagine crimes? What would be the implications for any of us monitored by such “intelligent” technologies?
All this may sound a bit exaggerated, but the prevalent and worrying biases of artificial intelligence, to cite an example, already warn us and help to put forward the pressing need for further fostering ethics guided technological research, especially in the biomedical arena. New unknowns emerge with progresses in fields like biofabrication, synthetic biology, living machines, and engineered living materials. Biohybrid systems are already common in several areas of research and, consequently, the frontiers between the living and the synthetic progressively fall apart. Like old alchemists in their search for the philosopher’s stone, new age gurus work on reverting aging and pursuing human immortality, a dream dating back to the Epic of Gilgamesh, the earliest surviving written tale. Once made possible, I wonder who would be the privileged, able to pay for such treatments, and what would happen to our already devastated planet, if humans put an end to the cycle of life. The current sanitary situation asks for more modesty and sympathy.
Extremely multifaceted ethical, legal, and social concerns arise in all these cutting-edge research topics and, although some may argue that ethics and sustainability should not hinder progress and that mankind has always been able to manage the consequences of technological advance, a wide set of indicators tell us that current revolutions are radically different from previous ones and that a more careful mentoring of the innovation pipeline is immediately required. Changes are needed, and any strategy dealing with impactful transformations should rely on rethinking education, involving educators, and training the future champions of sustainable change.
Educating the biomedical engineers of the future
The fact that few BME programs dedicate whole traditional courses, based on lectures, to ethics and sustainability is not surprising, as these complex interconnected topics may require more holistic educational strategies and supporting “learning by doing” methods. Often, program directors may interact with accreditation bodies and explain that different courses synergically contribute to the training in ethics and sustainability, but rarely are these synergies clearly presented or strategically conceived. In the end, the Ethical, legal, social (ELS) issues tend to be understood and crafted during the professional life of biomedical engineers, possibly with a narrower view (focusing on a very specific sector or concrete device type), than could be initially trained at universities. These aspects have been extensively discussed in previous studies, leading to highly interesting proposals of good practices for promoting ethics ,  and sustainability .
Here, a personal alternative focusing on five pillars for jointly nurturing ethics and sustainability in BME is advanced, in which different educational paradigms and teaching techniques are combined. Figure 1 schematically illustrates the proposal, and the pillars are explained as follows.
- Ethics fundamentals for BME professional practice: Basic principles of justice, beneficence and nonmaleficence, objectivity and autonomy, integrity and loyalty, veracity, accountability, among others, should be transmitted to students, not only by means of example, but through theoretical–practical approaches and guided debate. Dedicating a course or course module, supported by cases studies, or a series of introductory seminars, may be good practices for incorporating these fundamentals into the BME programs.
- Safe medical devices and technologies: The “do no significant harm” principle and the concept of “risk-ratio benefit” are essential for developing successful medical devices and biomedical technologies, and related analyses are required by regulatory bodies for medical device certification purposes. In consequence, aspects like classifying biodevices according to risk, finding and applying relevant standards throughout their development processes, and risk minimization and evaluation techniques are basic for BME practitioners. These issues can be trained through introductory lessons oriented to hands-on activities in project-based learning courses, CDIO-style experiences, capstone courses, and final degree theses dealing with the design and manufacturing of medical devices.
- Sustainable medical devices and technologies: In connection with the above, safe technologies for users should be also sustainable for the environment. Again, all kinds of (problem-, project-, challenge-, service-)based learning activities may place students in real life scenarios and help orient them toward sustainability. Frequently, educational projects dealing with the development of medical technologies include the elaboration of a business plan, delivered as a report together with the final prototypes, through which students learn about how to evaluate the economical viability of engineering results. Reporting about environmental impacts, through life cycle analyses, and examining the main ethical, legal and social aspects, surrounding any technology developed by our students, should be considered as relevant as an entrepreneurial plan, and become part of the evaluation.
- Achieving technological equity and universal health care: Achieving affordable medical technologies for all, capable of reaching everywhere, is challenging but possible. BME students should be aware of innovative strategies for the cocreation of open-source medical devices, through which the whole development cycle and supply chain can be reformulated, as has already happened with more conventional product development and the advent of the makers’ movement . Safety and regulatory compliance are essential for Do-it-yourself (DIY) medical devices, usually manufactured closer to the point of care and using emerging technologies, for which educational and mentoring resources, like the UBORA e-infrastructure , are necessary. Educational initiatives with practical activities in international contexts can be considered best practices for introducing these topics into the BME programs.
- Ethics applied to BME’s future research challenges: As for the future, BME students and educators should also find space for fruitful debate around the future trends of BME and related ELS aspects, if possible, in connection with social and industrial agents. University extension activities like visits and internships at biomedical companies, participation in research and development projects, and even the participation in extracurricular seminars, can importantly contribute to performing multistakeholder analyses.
Ethical, legal, and social aspects should become central to BME education and practice, and progressively gain in relevance, according to the radical transformations that health care technology is expected to promote in years to come. In an environment of continuous technological revolutions, unforeseen impacts will arise, and these may not always be positive for the ecosystem or for societal well-being. Through ethics and sustainability centered BME education, the biomedical engineers of the future will count with the background and skills needed, to adequately mentor technological advances and more successfully face the ethical, legal, and social dilemmas ahead, in the quest for sustainable, equitable, and safe medical technologies.
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- C. De Maria et al., “Open-source medical devices,” in Clinical Engineering Handbook, E. Iadanza, Ed., 2nd ed. Amsterdam, The Netherlands: Elsevier, 2019.