Personalized 3D printed scaffolds: The ethical aspects

New Biotechnology, vol. 78, pp. 116–122

Abstract

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.

Authors 4

1. Manon van Daal corresponding

   Utrecht University · University Medical Center Utrecht

   Affiliation as printed

   Department of Bioethics and Health Humanities, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands. Electronic address: m.vandaal@umcutrecht.nl

   Department of Bioethics and Health Humanities, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, 3508 GA Utrecht, Utrecht University, Utrecht, the Netherlands

2. Anne-Floor J. de Kanter

   Utrecht University · University Medical Center Utrecht

   Affiliation as printed

   Department of Bioethics and Health Humanities, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands

   Department of Bioethics and Health Humanities, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, 3508 GA Utrecht, Utrecht University, Utrecht, the Netherlands

3. Annelien L. Bredenoord

   Erasmus University Rotterdam

   Affiliation as printed

   Erasmus School of Philosophy, Erasmus University Rotterdam, Rotterdam, the Netherlands

   Erasmus School of Philosophy, Erasmus University Rotterdam, 3062 PA Rotterdam, the Netherlands

4. Nienke de Graeff Aachen Department of Medical Ethics and Health Law

   Leiden University · Utrecht University · Leiden University Medical Center · University Medical Center Utrecht

   Affiliation as printed

   Department of Medical Ethics and Health Law, Leiden University Medical Center, Leiden University, Leiden, the Netherlands

   Department of Bioethics and Health Humanities, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, 3508 GA Utrecht, Utrecht University, Utrecht, the Netherlands