The Regenerating Body: An ethical analysis of personalized regenerative implants

A new generation of personalized regenerative implants is being developed for use in healthcare. These implants break down after implantation and facilitate tissue regeneration. While these innovations hold the promise to improve many lives, they also raise important ethical questions and concerns. The aim of this dissertation is to identify the ethical implications of personalized regenerative implants and to evaluate how these implants can be developed and used in an ethically responsible manner. We focus on implants that treat cleft palate, joint defects, and heart valve defects. The first part of the dissertation examines diverse ethical implications concerning personalized regenerative implants. A literature review identifies nine different ethical themes: digitalization, irreversibility, responsibility, gender, first-in-human trials, N-of-1 studies, commercialization, human identity and embodiment, and the ontological status of personalized regenerative implants. A focus group study with patients, parents of children, and professional experts highlights two important themes: patient-centered research and care and ambivalent attitudes towards personalized regenerative implants. The second part of the dissertation explores the importance of the intimate relationship between humans and technology for the responsible development and use of these implants. Drawing from phenomenological literature, we aim to understand how the embodied experience of implant recipients might be affected by living with regenerative implants. We argue that the interwoven and intimate relationship of people living with regenerative implants should be understood in terms of entanglement. This entangled relationship can lead to implant recipients feeling alienated or could promote their embodied experience. After this, we reflect on the Intimate Implant project, in which we engaged with the arts and a broader public to explore the implications of these implants for the relationship with our bodies. The third part of the dissertation outlines an inclusive approach to personalized regenerative implants. We begin to discuss the importance of considering gender in various facets of healthcare. By focusing on an example within the field of 3D bioprinting, we demonstrate that accounting for sex and gender differences is crucial in mitigating bias during the development of new technologies. Then, we explore various strategies for preventing biases. Biases often stem from overlooking or incorrectly considering differences between people. To prevent this, we argue that if medical devices are tailored to different groups, differences should be defined by specific and morally significant characteristics rather than using broader categories as proxies, and the causal explanations for the significance of such specific differences should be scrutinized for biases. We then explore the requirements for inclusive design of regenerative implants. Regenerative implants should be designed to account for relevant user differences, be affordable and suitable for global distribution, and be developed by inclusive design teams using inclusive communication and engaging users. Overall, this thesis provides an ethical analysis of personalized regenerative implants, contributing to their responsible development and use

Personalized 3D printed scaffolds:The ethical aspects

Personalized 3D printed scaffolds are a new generation of implants for tissue engineering and regenerative medicine purposes. Scaffolds support cell growth, providing an artificial extracellular matrix for tissue repair and regeneration and can biodegrade once cells have assumed their physiological and structural roles. The ethical challenges and opportunities of these implants should be mapped in parallel with the life cycle of the scaffold to assist their development and implementation in a responsible, safe, and ethically sound manner. This article provides an overview of these relevant ethical aspects. We identified nine themes which were linked to three stages of the life cycle of the scaffold: the development process, clinical testing, and the implementation process. The described ethical issues are related to good research and clinical practices, such as privacy issues concerning digitalization, first-in-human trials, responsibility and commercialization. At the same time, this article also creates awareness for underexplored ethical issues, such as irreversibility, embodiment and the ontological status of these scaffolds. Moreover, it exemplifies how to include gender in the ethical assessment of new technologies. These issues are important for responsible development and implementation of personalized 3D printed scaffolds and in need of more attention within the additive manufacturing and tissue engineering field. Moreover, the insights of this review reveal unresolved qualitative empirical and normative questions that could further deepen the understanding and co-creation of the ethical implications of this new generation of implants.</p

A value hierarchy for inclusive design of heart valve implants in regenerative medicine

Aim: This paper investigates the conditions for inclusive design of regenerative medicine interventions from a bioethical perspective, taking regenerative valve implants as a showcase. Methods: A value hierarchy is construed to translate the value of justice into norms and design requirements for inclusive design of regenerative valve implants. Results: Three norms are proposed and translated into design requirements: regenerative valve implants should be designed to promote equal opportunity to good health for all potential users; equal respect for all potential users should be shown; and the implants should be designed to be accessible to everyone in need. Conclusion: The norms and design requirements help to design regenerative valve implants that are appropriate, respectful and available for everyone in need.</p

A value hierarchy for inclusive design of heart valve implants in regenerative medicine

Aim: This paper investigates the conditions for inclusive design of regenerative medicine interventions from a bioethical perspective, taking regenerative valve implants as a showcase. Methods: A value hierarchy is construed to translate the value of justice into norms and design requirements for inclusive design of regenerative valve implants. Results: Three norms are proposed and translated into design requirements: regenerative valve implants should be designed to promote equal opportunity to good health for all potential users; equal respect for all potential users should be shown; and the implants should be designed to be accessible to everyone in need. Conclusion: The norms and design requirements help to design regenerative valve implants that are appropriate, respectful and available for everyone in need.</p

Personalized 3D printed scaffolds: The ethical aspects

Personalized 3D printed scaffolds are a new generation of implants for tissue engineering and regenerative medicine purposes. Scaffolds support cell growth, providing an artificial extracellular matrix for tissue repair and regeneration and can biodegrade once cells have assumed their physiological and structural roles. The ethical challenges and opportunities of these implants should be mapped in parallel with the life cycle of the scaffold to assist their development and implementation in a responsible, safe, and ethically sound manner. This article provides an overview of these relevant ethical aspects. We identified nine themes which were linked to three stages of the life cycle of the scaffold: the development process, clinical testing, and the implementation process. The described ethical issues are related to good research and clinical practices, such as privacy issues concerning digitalization, first-in-human trials, responsibility and commercialization. At the same time, this article also creates awareness for underexplored ethical issues, such as irreversibility, embodiment and the ontological status of these scaffolds. Moreover, it exemplifies how to include gender in the ethical assessment of new technologies. These issues are important for responsible development and implementation of personalized 3D printed scaffolds and in need of more attention within the additive manufacturing and tissue engineering field. Moreover, the insights of this review reveal unresolved qualitative empirical and normative questions that could further deepen the understanding and co-creation of the ethical implications of this new generation of implants

Embodiment and regenerative implants: a proposal for entanglement

Regenerative Medicine promises to develop treatments to regrow healthy tissues and cure the physical body. One of the emerging developments within this field is regenerative implants, such as jawbone or heart valve implants, that can be broken down by the body and are gradually replaced with living tissue. Yet challenges for embodiment are to be expected, given that the implants are designed to integrate deeply into the tissue of the living body, so that implant and body become one. In this paper, we explore how regenerative implants may affect the embodied experience of implant recipients. To this end, we take a phenomenological approach. First, we explore what insights the existing phenomenological and empirical literature on embodiment offers regarding the experience of illness and of living with regular (non-regenerative) implants and organ transplants. Second, we apply these insights to better understand how future implant recipients might experience living with regenerative implants. Third, we conclude that concepts and considerations from the existing phenomenological literature do not sufficiently address what it might be like to live with an implantable technology that, over time, becomes one with the living body. We argue that the interwovenness and intimate relationship of people living with regenerative implants should be understood in terms of ‘entanglement’. Entanglement allows us to explore the complexities of human-technology relations, acknowledging the inseparability of humans and implantable technologies. Our theoretical foundations regarding the role of embodiment may be tested empirically once more people will be living with regenerative implants

A value hierarchy for inclusive design of heart valve implants in regenerative medicine

Aim: This paper investigates the conditions for inclusive design of regenerative medicine interventions from a bioethical perspective, taking regenerative valve implants as a showcase. Methods: A value hierarchy is construed to translate the value of justice into norms and design requirements for inclusive design of regenerative valve implants. Results: Three norms are proposed and translated into design requirements: regenerative valve implants should be designed to promote equal opportunity to good health for all potential users; equal respect for all potential users should be shown; and the implants should be designed to be accessible to everyone in need. Conclusion: The norms and design requirements help to design regenerative valve implants that are appropriate, respectful and available for everyone in need

Patient, parent and professional expert perspectives on personalized regenerative implants: a qualitative focus group study

Background: Perspectives of patients, parents and professional experts on personalized regenerative implants for regenerative medicine purposes are largely unknown. Method: To better understand these perspectives, we conducted four focus groups with professional experts of mixed European nationality (n = 8), Dutch patients with regular implants (n = 8), Dutch and Belgian (n = 5) and Spanish (n = 8) parents of children with cleft palate. Results: Two overarching themes were identified: ‘patient-centered research and care’ and ‘ambivalent attitudes toward personalized regenerative implants’. Discussion: The results reveal that stakeholders should adopt a participatory rather than an impairment discourse and address the ambivalence among professional experts, patients and parents. Conclusion: Considering stakeholder perspectives facilitates ethical and responsible development and use of personalized regenerative implants

Embodiment and regenerative implants:a proposal for entanglement

Regenerative Medicine promises to develop treatments to regrow healthy tissues and cure the physical body. One of the emerging developments within this field is regenerative implants, such as jawbone or heart valve implants, that can be broken down by the body and are gradually replaced with living tissue. Yet challenges for embodiment are to be expected, given that the implants are designed to integrate deeply into the tissue of the living body, so that implant and body become one. In this paper, we explore how regenerative implants may affect the embodied experience of implant recipients. To this end, we take a phenomenological approach. First, we explore what insights the existing phenomenological and empirical literature on embodiment offers regarding the experience of illness and of living with regular (non-regenerative) implants and organ transplants. Second, we apply these insights to better understand how future implant recipients might experience living with regenerative implants. Third, we conclude that concepts and considerations from the existing phenomenological literature do not sufficiently address what it might be like to live with an implantable technology that, over time, becomes one with the living body. We argue that the interwovenness and intimate relationship of people living with regenerative implants should be understood in terms of ‘entanglement’. Entanglement allows us to explore the complexities of human-technology relations, acknowledging the inseparability of humans and implantable technologies. Our theoretical foundations regarding the role of embodiment may be tested empirically once more people will be living with regenerative implants.</p