This article provides an analysis of bioprinting personalised medical device technology and its ethical challenges to regulation and research ethics. I argue the inclusion of bioprinting applications within existing regulatory frameworks does not adequately address the technologies disruption to the traditionally siloed activities of research and treatment. Using the conceptual framework of liminality, I offer a meaningful way to engage with this technology and address some identified concerns with how it will be categorised and the appropriate recognition of its evidentiary (...) thresholds. I demonstrate these concerns through the exploration of limited conventional research methodologies tasked with the production of generalisable knowledge, specifically population-based evidence that is derived from Randomised Clinical Trials. I use Australian regulatory amendments introduced in 2021 as an example of current regulatory trajectories and highlight why I believe this approach to be insufficient. The significance of this argument will be to demonstrate the disruption of bioprinting applications to current approaches in medical policy, and how various jurisdictions are enacting regulation that is not fit for purpose. (shrink)

Technology corporations and the emerging digital health market are exerting increasing influence over the public healthcare agendas forming around the application of mobile medical devices. By promising quick and cost-effective technological solutions to complex healthcare problems, they are attracting the interest of funders, researchers, and policymakers. They are also shaping the public facing discourse, advancing an overwhelmingly positive narrative predicting the benefits of wearable medical devices to include personalised medicine, improved efficiency and quality of care, the empowering of under-resourced communities, (...) and delivery of health services previously unavailable to the citizens of developing countries. Typically techno-optimist in their description, the key barriers to this impending inflection point in healthcare are identified as technical issues such as short battery life and a lack of data protection. However, this tech innovation narrative is consistent with problematic ethical, social, and political assumptions that have practical and normative effects, and risk, one, undermining the real clinical potential of wearable devices and, two, designing social inequality and injustice into our mobile health interventions in global healthcare. I argue that the foundational assumptions dealing with the just distribution of healthcare ‘goods’, the individual as part of society, and the political framing of future healthcare policy devalue equity and despite what they promise cannot meet the distinctive needs of individuals and groups that do not conform to a standardised concept of care-receiver. (shrink)