Smart textiles: transforming the practice of medicalisation and health care

Joyce, Kelly

doi:10.1111/1467-9566.12871

Cited by 24 publications

(16 citation statements)

References 29 publications

(37 reference statements)

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“…Rich, Miah and Lewis 2019 ). However, while various social-science research has drawn attention to the pressure exerted by digital health technologies on the socio-legally constructed boundary between lifestyle and medical products (Lucivero and Prainsack 2015 ; Faulkner 2018 ; Joyce 2019 ; Geiger and Kjellberg 2021 ), the role of regulators in attempting to position DHT across this boundary has hardly been studied from a social-science angle.…”

Section: Discussionmentioning

confidence: 99%

“…Intended to be deployed both within a medical context as well as ‘at home,’ the launch of the Mobile MIM Software app challenged the (institutionalized) boundary between consumer and medical device products. While numerous social scientists have pointed to the complex hybrid (both medical and lifestyle) character of digital health technologies and the difficulties this might entail for QSS (Lucivero and Prainsack 2015 ; Faulkner 2018 ; Joyce 2019 ; Geiger and Kjellberg 2021 ), the MIM Software events actually translated this concern into practical difficulties. For one thing, do we allow them to be used in a medical context?…”

Section: The Making Of the Fda’s Digital Health Standardizationmentioning

confidence: 99%

“…However, walking a fine line between lifestyle consumer products and the rigid (densely regulated) world of medical professionals, pharmaceutical and medical device companies, insurance companies, and patient organizations, DHT prompted more significant governance adjustments over the years (Lucivero and Prainsack 2015 ; Faulkner 2018 ; Blassimme, Vayena and Van Hoyweghen 2019 ; Joyce 2019 ; Geiger and Kjellberg 2021 ). Sleep applications are a case in point.…”

Section: Introductionmentioning

confidence: 99%

“…As such, DHT are the product of a process of ‘medicalization’ and ‘lifestylization’ at the same time: they enable the entry of lifestyle data (e.g. sleep tracking information, step counting, and dietary habits) into the medical sphere, while medicalizing people’s lifestyle choices at home (Lucivero and Prainsack 2015 ; Joyce 2019 ; McFall, Meyers and Van Hoyweghen 2020 ).…”

Section: Introductionmentioning

confidence: 99%

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The FDA’s standard-making process for medical digital health technologies: co-producing technological and organizational innovation

2021

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As digital health technologies (DHT) have been embraced as a ‘panacea’ for health care systems, they have evolved from a buzzword into a high priority objective for health policy across the globe. In the realm of quality and safety standards for medical devices, the US Food and Drug Administration (FDA) has been a frontrunner in adapting its regulatory framework to DHT. However, despite the utmost relevance of quality and safety standards and their role for sustaining the innovation pathway of DHT, their actual making has not yet been subjected to in-depth social-science scrutiny. Drawing on the conceptual repertoires of Science and Technology Studies (STS), this article investigates how digital health evolved from a buzzword into an ‘object of government’, or gained material meaning and transformed into a regulatable object, by charting the standard-making process of FDA’s medical digital health policy between 2008 and 2018. From this, we reflect on the mutually sustaining dynamics between technological and organizational innovation, as the FDA’s attempts to standardize medical DHT not only shaped the lifestyle/medical boundary for DHT. It also led to significant reconfigurations within the FDA itself, while fostering a broader shift toward the uptake of alternative forms of evidence in regulatory science.

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Section: Discussionmentioning

confidence: 99%

Section: The Making Of the Fda’s Digital Health Standardizationmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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The FDA’s standard-making process for medical digital health technologies: co-producing technological and organizational innovation

2021

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“…Textile technologies, also known as “electronic textiles” and “e-textiles” [ 6 , 9 , 10 , 11 ] are fabrics made of filaments woven together in different ways that are capable of interacting with an external environment, such as the human body. “Smart textiles” is a further term [ 12 , 13 , 14 ], which is the one adopted by this research, highlighting the dedicated, or assistive, functions that regular textiles cannot fulfil [ 6 ].…”

Section: Introductionmentioning

confidence: 99%

Smart Textiles for Improved Quality of Life and Cognitive Assessment

Oatley¹,

Choudhury²,

Buckman³

2021

Sensors

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Smart textiles can be used as innovative solutions to amuse, meaningfully engage, comfort, entertain, stimulate, and to overall improve the quality of life for people living in care homes with dementia or its precursor mild cognitive impairment (MCI). This concept paper presents a smart textile prototype to both entertain and monitor/assess the behavior of the relevant clients. The prototype includes physical computing components for music playing and simple interaction, but additionally games and data logging systems, to determine baselines of activity and interaction. Using microelectronics, light-emitting diodes (LEDs) and capacitive touch sensors woven into a fabric, the study demonstrates the kinds of augmentations possible over the normal manipulation of the traditional non-smart activity apron by incorporating light and sound effects as feedback when patients interact with different regions of the textile. A data logging system will record the patient’s behavioral patterns. This would include the location, frequency, and time of the patient’s activities within the different textile areas. The textile will be placed across the laps of the resident, which they then play with, permitting the development of a behavioral profile through the gamification of cognitive tests. This concept paper outlines the development of a prototype sensor system and highlights the challenges related to its use in a care home setting. The research implements a wide range of functionality through a novel architecture involving loosely coupling and concentrating artifacts on the top layer and technology on the bottom layer. Components in a loosely coupled system can be replaced with alternative implementations that provide the same services, and so this gives the solution the best flexibility. The literature shows that existing architectures that are strongly coupled result in difficulties modeling different individuals without incurring significant costs.

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