Dr. Roberto Portillo Lara, Research Associate at the Imperial College London, Faculty of Engineering, Department of Bioengineering
Dr. Roberto Portillo Lara leads the "Living Electrode" project aimed at the development of tissue-engineered neural interfaces for implantable bioelectronics. He presented an overview of the current and emerging bioengineering strategies to develop superior neural interfaces for implantable bioelectronics. The objective of this approach is to overcome the inflammatory immune response provoked by synthetic materials, and it is hoped that bioinspired strategies will offer a safer forms of neural engineering.
Dr. Portillo Lara also addressed key ethical and policy dimensions of neural interfaces, including questions related to (1) the impact on agency and identity of devices that can alter patients’ perceptual and other capacities, (2) privacy, cybersecurity and consent, (3) responsibility for actions influenced by neural devices, and (4) justice, in terms of access to technology and the enhancement uses of neural devices. He noted the history of the collective caution regarding recombinant DNA technology as a useful historical lesson for cautious development of neural devices. He also addressed the importance of broad stakeholder participation in product development as a part of responsible engineering.
Some of the themes emerging in the subsequent discussion involved:
-The benefits of broad stakeholder engagement in bioengineering projects.
-The importance of avoiding hype regarding these technologies, and adopting a balanced and cautious approach.
-The need to clarify the legal conceptualization of neural devices. This is perhaps particularly the case with those devices that are designed to integrate most effectively with the user’s own tissues, making the body/artifact distinction more difficult to draw.
-The possibility of using biodegradable electrodes, such that when the device has done its job, it will disappear, and some concerns caused by persistent forms may be reduced.
Portillo-Lara, R., Goding, J. A. & Green, R. A. (2021). Adaptive biomimicry: design of neural interfaces with enhanced biointegration. Current Opinion in Biotechnology, 72, 62-68. https://doi.org/10.1016/j.copbio.2021.10.004
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Dr. Richard Heersmink, Assistant Professor, Department of Philosophy, Tilburg University
Dr. Heersmink presented and discussed his work "Heersmink, R. (2021), Varieties of Artifacts: Embodied, Perceptual, Cognitive, and Affective. Top. Cogn. Sci., 13: 573-596. https://doi.org/10.1111/tops.12549"
He provided a comprehensive overview and analysis of the various relations between material artifacts and the embodied mind and identified some of the trends in the design and use of artifacts. Based on their functional properties, he identifies four categories of artifacts co-opted by the embodied mind, namely (a) embodied artifacts, (b) perceptual artifacts, (c) cognitive artifacts, and (d) affective artifacts. These categories can overlap and so some artifacts are members of more than one category. He also identified some of the techniques we use when interacting with artifacts. Identifying these categories of artifacts and techniques allows us to map the landscape of relations between embodied minds and the artifactual world. He then outlined some of the trends in the design and use of artifacts, focusing on neuroprosthetics, brain-computer interfaces, and personalization algorithms nudging their users toward particular epistemic paths of information consumption.
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Cassandra J. Thomson, Rebecca A. Segrave, Paul B. Fitzgerald, Karyn E. Richardson, Eric Racine, & Adrian Carter.
A discussion with Drs. Cassandra Thomson and Adrian Carter of Monash University regarding their qualitative study with patients and caregivers of the personal and relationship changes following DBS for depression.
Objective: Deep brain stimulation (DBS) and whether it alters patient personality is a much-debated topic within academic literature, yet rarely explored with those directly involved. This study qualitatively examined how DBS for treatment-resistant depression impacts patient personality, self-concept and relationships from the perspectives of both patients and caregivers.
Methods: A prospective qualitative design was used. Eleven participants were included (six patients, five caregivers). Patients were enrolled in a clinical trial of DBS of the bed nucleus of the stria terminalis. Semi-structured interviews were conducted with participants before DBS-implantation and 9-months after stimulation-initiation. The 21 interviews were thematically analysed.
Results: Three primary themes were identified: (a) impact of mental illness and treatment on self-concept; (b) device acceptability and usability, and (c) relationships and connection. Severe refractory depression had profoundly impacted who patients were, how they viewed themselves, and the quality and functioning of their relationships. Patients who benefited from DBS felt reconnected with their premorbid self, yet still far from their ideal self. While reductions in depression were broadly beneficial for relationships, the process of adjusting relationship dynamics created new challenges. All patients reported recharging difficulties and challenges adapting to the device.
Conclusions: Therapeutic response to DBS is a gradual and complex process that involves an evolving self-concept, adjusting relationship dynamics, and growing connection between body and device. This is the first study to provide in-depth insight into the lived experience of DBS for treatment-resistant depression. Patient and caregiver narrative accounts should be routinely collected to guide more person-centred DBS clinical interventions.
Professor Muireann Quigley and Dr. Laura Downey, University of Birmingham Law School
Professor Quigley and Dr. Downey presented their recent chapter* on the legal challenges posed by integrated medical devices. The binary approach of the common law to conceptualizing person (legal subject) and device (object) results in fundamental conceptual and normative problems for emerging everyday cyborgs – people with attached and implanted medical devices.
The authors draw on Graeme Laurie’s work on the liminal analysis of law, arguing that the law should be transformed to account for the missing ‘spaces in-between’ so that it can account for the hybrid status of integrated medical devices. They use Laurie’s approach to liminal spaces to critique the manner in which medical research is regulated. This results in multiple overlapping regulatory regimes that are formed around legally constructed ‘ bounded objects’ i.e ‘tissues’, ‘data’ and ‘embryos’, that focus on objects rather than research subjects. This results in inefficient and fragmented regulatory ‘silos.’
Quigley and Downey also point to medical device regulation – particularly regulation of integrated health devices – which treats devices narrowly as products or commodities to be regulated for safety purposes. The Cumberlege Review (Independent Medicines and Medical Devices Safety Review), found that patient voices and experiences have been decentred and marginalized. This undermined informed choice and reporting of adverse events. They suggest that the liminal analytical approach helps to reorient regulatory attention to bring in the patient’s voice and experiences. The focus becomes the integrated person, in which device and person have a conjoined future, rather than the device or object.
The authors also address Graeme Laurie’s processual approach to regulation, which acknowledges enduring relationships between subjects and objects, acknowledges the fluidity within these categories, and recognizes the identity implications of these relationships. This too is useful in addressing the regulation of integrated medical devices in a way that captures the importance of those devices for patients and provides more room for their voices. They concluded by making concrete and much needed proposals for UK national regulations such as entrusting an independent body like a patient safety commissioner to act as a guide to healthcare system and patients, respond to crisis more swiftly and even prevent them and provide opportunity for coproduction of regulation along with enabling meaningful engagement of subjects to the process as recommended in the Cumberlege Review.
Some of the themes emerging in the subsequent discussion involved:
* Muireann Quigley and Laura Downey. (2022). Integrating the Biological and the Technological: Time to Move Beyond Law’s Binaries?. In Dove, E.S. & Nic Shuibhne, N. (Eds.) Law and Legacy in Medical Jurisprudence: Essays in Honour of Graeme Laurie. Cambridge University Press
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