Search

Abstract Background Tissue engineering is a multidisciplinary field that combines principles from cell biology, bioengineering, material sciences, medicine and surgery to create functional and viable bioproducts that can be used to repair or replace damaged or diseased tissues in the human body. The complexity of tissue engineering can affect the prospects of efficiently translating scientific discoveries in the field into scalable clinical approaches that could benefit patients. Organizational challenges may play a key role in the clinical translation of tissue engineering for the benefit of patients. Methods To gain insight into the organizational aspects of tissue engineering that may create impediments to efficient clinical translation, we conducted a retrospective qualitative case study of one tissue engineering multi-site translational project on knee cartilage engineered tissue grafts. We collected qualitative data using a set of different methods: semi-structured interviews, documentary research and audio-visual content analysis. Results Our study identified various challenges associated to first-in-human trials in tissue engineering particularly related to: logistics and communication; research participant recruitment; clinician and medical student participation; study management; and regulation. Conclusions While not directly generalizable to other types of advanced therapies or to regenerative medicine in general, our results offer valuable insights into organizational barriers that may prevent efficient clinical translation in the field of tissue engineering.

Abstract Digital health innovation is expected to transform healthcare, but it also generates ethical and societal concerns, such as privacy risks, and biases that can compound existing health inequalities. While such concerns are widely recognized, existing regulatory principles, oversight methods and ethical frameworks seem out of sync with digital health innovation. New governance and innovation best practices are thus needed to bring such principles to bear with the reality of business, innovation, and regulation. To grant practical insight into best practices for responsible digital health innovation, we conducted a qualitative study based on an interactive engagement methodology. We engaged key stakeholders (n = 46) operating at the translational frontier of digital health. This approach allowed us to identify three clusters of governance and innovation best practices in digital health innovation: i) inclusive co-creation, ii) responsive regulation, and iii) value-driven innovation. Our study shows that realizing responsible digital health requires diverse stakeholders’ commitment to adapt innovation and regulation practices, embracing co-creation as the default modus operandi for digital health development. We describe these collaborative practices and show how they can ensure that innovation is neither slowed by overregulation, nor leads to unethical outcomes.

Abstract In the age of Machine Learning Algorithms, Artificial Intelligence and Natural Language Processing, digital technologies have become interwoven in various aspects of society, including in our practices for ethical deliberation and decision-making. In this study, we present a systematic mapping and taxonomy of digital tools designed explicitly for this purpose and published between 2010 and 2023. By providing a comprehensive overview of the landscape, we identify the key features and mechanisms employed to facilitate ethical deliberation. This research enhances our understanding of the potential role that digital tools can play in supporting ethical decision-making processes, offering valuable insights for ethicists, educators, government organizations, and private institutions seeking to develop, deploy, or utilize such tools.

In the evolving landscape of digital medicine, digital biomarkers have emerged as a transformative source of health data, positioning them as an indispensable element for the future of the discipline. This necessitates a comprehensive exploration of the ethical complexities and challenges intrinsic to this cutting-edge technology. To address this imperative, we conducted a scoping review, seeking to distill the scientific literature exploring the ethical dimensions of the use of digital biomarkers. By closely scrutinizing the literature, this review aims to bring to light the underlying ethical issues associated with the development and integration of digital biomarkers into medical practice.

Abstract Over the last decade, bioengineering has seen a sustained growth in scientific publications, patents, and clinical trials. As the field attempts to bridge the gap between discovery and clinical application, a broader societal dialogue is needed to build public trust and address potential ethical, societal, and regulatory challenges. In this essay, we discuss societal aspects linked to the clinical use of biomedical engineering approaches and technologies, with a specific focus on molecular systems engineering. Drawing on data from interviews with 24 scientists, we identified four key aspects for fostering societal support for translational efforts in this domain: (1) effective science communication and internal awareness; (2) open societal dialogue; (3) fair and equitable access to new technologies; and (4) adequate science and technology policies. We conclude that molecular systems engineering would benefit from anticipating future challenges with the view of building a robust bond of trust with lay publics, regulators, and society at large.

Bottom-up Synthetic Biology (buSynBio) is an approach focused on the artificial making of minimal functional biosynthetic systems by recombining existent biochemical modules or manufacturing them from scratch. Over the last decade, this emerging orientation has gained new momentum with the development of new bioengineering tools, theories, and technologies. Despite the growing acceptance of buSynBio, few studies have dedicated attention to the analysis of its organizational aspects. This article offers the first systematic investigation of emerging research initiatives in buSynBio and their meaning to bioengineering research. Our analysis is based on a multi-method qualitative study, including expert literature review, bibliometric research and a documentary analysis of online materials such as reports and project descriptions available in official grant data repositories. Our study found that publications of specialized articles on “bottom-up synthetic biology” have increased, both in absolute numbers and normalized to total number of publications. We show how that might be enabled by novel mechanisms of organization that reposition material, intellectual and political resources in synthetic biology. Drawing on theoretical analyses within Science and Technology Studies (STS), we examine 14 research initiatives in 5 selected countries (Germany, United Kingdom, United States, Netherlands, and Switzerland). The bottom-up approach is supported by a variety of “tentative regimes” of scientific governance in different stages of consolidation, but holding in common the establishment of novel basic research in Chemistry, Biology, Engineering and Physics. The study aims to contribute to social science research in synthetic biology by shedding light on the implications of buSynBio as trend driving the current organizational change of bioengineering research.

Abstract A new active substance called “dersimelagon” (MT-7117) is being tested as an alternative treatment option for Erythropoietic protoporphyria (EPP). At the moment, dersimelagon is being tested both in the US and in Europe in a phase III placebo-controlled RCT. However, given the availability of an already approved treatment option for EPP the use of a placebo arm is questionable from an ethics point of view. We analyze the issue and suggest that a noninferiority active-control trial without placebo is an ethically and scientifically more valid design to test the efficacy of dersimelagon as well as other EPP treatments.

Background: Organ chips are microfabricated devices containing living engineered organ substructures in a controlled microenvironment. Research on organ chips has increased considerably over the past two decades.Aim: This paper offers an overview of the emerging knowledge ecosystem of organ chip research in Europe. Method: This study is based on queries and analyses undertaken through the bibliometric software Dimensions.ai.Results: Organ chip research has been rapidly growing in Europe in recent years, supported by robust academic science consortia, public-private initiatives, dedicated funding, and science policy instruments. Our data shows that previous investment in basic and fundamental research in centers of excellence in bioengineering science and technology are relevant to future investment in organ chips. Moreover, organ chip research in Europe is characterized by collaborative infrastructures to promote convergence of scientific, technical, and clinical capabilities.Conclusion: According to our study, the knowledge ecosystem of organ chip research in Europe has been growing sustainably. This growth is due to relevant institutional diversity, public-private initiatives, and ongoing research collaborations supported by robust funding schemes.

Spurred by recent advances in machine learning and electronic hardware, digital health promises to profoundly transform medicine. At the same time, however, it raises conspicuous ethical and regulatory issues. This has led to a growing number of calls for responsible digital health. Based on stakeholder engagement methods, this paper sets out to identify core impediments hindering responsible digital health in Switzerland. We developed a participatory research methodology to access stakeholders' fragmented knowledge of digital health, engaging 46 digital health stakeholders over a period of five months (December 2020–April 2021). We identified ineffective stakeholder collaboration, lack of ethical awareness among digital health innovators, and lack of relevant regulation as core impediments to responsible digital health. The stakeholders' accounts indicate that ethical concerns may considerably slow the pace of digital health innovation – implying that responsible innovation is a core catalyst for the progress of digital health overall.

IntroductionArtificial intelligence (AI) has the potential to transform clinical decision-making as we know it. Powered by sophisticated machine learning algorithms, clinical decision support systems (CDSS) can generate unprecedented amounts of predictive information about individuals' health. Yet, despite the potential of these systems to promote proactive decision-making and improve health outcomes, their utility and impact remain poorly understood due to their still rare application in clinical practice. Taking the example of AI-powered CDSS in stroke medicine as a case in point, this paper provides a nuanced account of stroke survivors', family members', and healthcare professionals' expectations and attitudes towards medical AI.MethodsWe followed a qualitative research design informed by the sociology of expectations, which recognizes the generative role of individuals' expectations in shaping scientific and technological change. Semi-structured interviews were conducted with stroke survivors, family members, and healthcare professionals specialized in stroke based in Germany and Switzerland. Data was analyzed using a combination of inductive and deductive thematic analysis.ResultsBased on the participants' deliberations, we identified four presumed roles that medical AI could play in stroke medicine, including an administrative, assistive, advisory, and autonomous role AI. While most participants held positive attitudes towards medical AI and its potential to increase accuracy, speed, and efficiency in medical decision making, they also cautioned that it is not a stand-alone solution and may even lead to new problems. Participants particularly emphasized the importance of relational aspects and raised questions regarding the impact of AI on roles and responsibilities and patients' rights to information and decision-making. These findings shed light on the potential impact of medical AI on professional identities, role perceptions, and the doctor-patient relationship.ConclusionOur findings highlight the need for a more differentiated approach to identifying and tackling pertinent ethical and legal issues in the context of medical AI. We advocate for stakeholder and public involvement in the development of AI and AI governance to ensure that medical AI offers solutions to the most pressing challenges patients and clinicians face in clinical care.

Machine learning has become a key driver of the digital health revolution. That comes with a fair share of high hopes and hype. We conducted a scoping review on machine learning in medical imaging, providing a comprehensive outlook of the field's potential, limitations, and future directions. Most reported strengths and promises included: improved (a) analytic power, (b) efficiency (c) decision making, and (d) equity. Most reported challenges included: (a) structural barriers and imaging heterogeneity, (b) scarcity of well-annotated, representative and interconnected imaging datasets (c) validity and performance limitations, including bias and equity issues, and (d) the still missing clinical integration. The boundaries between strengths and challenges, with cross-cutting ethical and regulatory implications, remain blurred. The literature emphasizes explainability and trustworthiness, with a largely missing discussion about the specific technical and regulatory challenges surrounding these concepts. Future trends are expected to shift towards multi-source models, combining imaging with an array of other data, in a more open access, and explainable manner.

There are intense discussions about the ethical and societal implications of biomedical engineering, but little data to suggest how scientists think about the ethics of their work. The aim of this study is to describe how scientists frame the ethics of their research, with a focus on the field of molecular systems engineering. Semi-structured qualitative interviews were conducted during 2021–2022, as part of a larger study. This analysis includes a broad question about how participants view ethics as related to their work, with follow up probes about the topics they consider most important. Interviews were transcribed, inductively coded by two researchers to consensus, and analyzed thematically. Twenty-four scientists participated in the study. Interviewees hold positions as professors, principal investigators, and senior staff researchers in universities or research institutes in the United States and Europe. Among those scientists who reported reflecting on ethical considerations in their work, many equated ethics with research ethics topics (e.g., safety, replicability), or with regulation and guidelines. Participants expressed the view that ethical issues are primarily relevant for clinical trials of bioengineered products, or for those working with animal or human subjects. Scientists described their research as "too early" or "not examining anything living" with regard to ethical reflection. Finally, many felt that ethics is seen as territory for experts and therefore beyond scientists' competencies. Molecular systems engineering scientists currently focus on regulatory aspects as the framework for their ethical analyses. They describe using a framework to define when life arises, as a means to determine when further ethical engagement is warranted. Further research is needed to investigate how scientists relate to the ethics of their scientific work, and build consensus around concepts of life, autonomous behavior, and physiological relevance of bioengineered systems. [ABSTRACT FROM AUTHOR]

Digital health innovation is expected to transform healthcare, but it also generates ethical and societal concerns, such as privacy risks, and biases that can compound existing health inequalities. While such concerns are widely recognized, existing regulatory principles, oversight methods and ethical frameworks seem out of sync with digital health innovation. New governance and innovation best practices are thus needed to bring such principles to bear with the reality of business, innovation, and regulation. To grant practical insight into best practices for responsible digital health innovation, we conducted a qualitative study based on an interactive engagement methodology. We engaged key stakeholders (n = 46) operating at the translational frontier of digital health. This approach allowed us to identify three clusters of governance and innovation best practices in digital health innovation: i) inclusive co-creation, ii) responsive regulation, and iii) value-driven innovation. Our study shows that realizing responsible digital health requires diverse stakeholders' commitment to adapt innovation and regulation practices, embracing co-creation as the default modus operandi for digital health development. We describe these collaborative practices and show how they can ensure that innovation is neither slowed by overregulation, nor leads to unethical outcomes. [ABSTRACT FROM AUTHOR]

Over the last decade, bioengineering has seen a sustained growth in scientific publications, patents, and clinical trials. As the field attempts to bridge the gap between discovery and clinical application, a broader societal dialogue is needed to build public trust and address potential ethical, societal, and regulatory challenges. In this essay, we discuss societal aspects linked to the clinical use of biomedical engineering approaches and technologies, with a specific focus on molecular systems engineering. Drawing on data from interviews with 24 scientists, we identified four key aspects for fostering societal support for translational efforts in this domain: (1) effective science communication and internal awareness; (2) open societal dialogue; (3) fair and equitable access to new technologies; and (4) adequate science and technology policies. We conclude that molecular systems engineering would benefit from anticipating future challenges with the view of building a robust bond of trust with lay publics, regulators, and society at large. [ABSTRACT FROM AUTHOR]

Recent research has challenged the notion that dementia is an inevitable outcome of age-related cognitive decline, highlighting the possibility of preventing or delaying onset by addressing specific risk factors. This paradigm shift suggests that prevention through lifestyle modifications and early interventions is possible, potentially averting millions of cases worldwide. This study explores the translation of scientific evidence on dementia prevention into public health policy in Switzerland. Combining the analysis of official policy documents and qualitative interviews with stakeholders, the study explores potential barriers and challenges to implementing preventive intervenions or programs, as well as opportunities for improvement. Results indicate a significant gap in incorporating emerging scientific evidence on dementia prevention into health policies and disseminating information to the public in Switzerland. This study underscores the need for a collaborative and coordinated approach to address these barriers and effectively translate scientific findings into preventive policies and campaigns. These insights can inform policy and targeted programs in Switzerland both at the federal and the cantonal level, eventually serving as a model for other countries seeking to translate evidence-based dementia prevention strategies into public health policies. By bridging the gap between research and policy, significant progress can be made in preventing or delaying the onset of dementia, providing significant benefits to individuals, families, and society. [ABSTRACT FROM AUTHOR]