Home-Made, Adapted and Modified Devices in Surgical Practice

Campbell, Bruce

doi:10.1308/003588408x285685

Cited by 3 publications

(1 citation statement)

References 7 publications

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“…Two distinct types of modification were evident from descriptions of surgical procedures: a change to a single aspect (for example a technical modification) of an existing procedure which may lead to an entirely new procedure or multiple, cumulative changes to different aspects of a procedure (including new indication, combining of established techniques) 39 , 40 . In contrast, device modifications were broadly described as either: manufacturer-led modifications that were primarily design-focused and clinician-led modifications that focused on addressing a clinical need 31 , 41 .…”

Section: Resultsmentioning

confidence: 99%

Development of a conceptual framework for reporting modifications in surgical innovation: scoping review

et al. 2023

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Background Innovative surgical procedures and devices are often modified throughout their development and introduction into clinical practice. A systematic approach to reporting modifications may support shared learning and foster safe and transparent innovation. Definitions of ‘modifications’, and how they are conceptualized and classified so they can be reported and shared effectively, however, are lacking. This study aimed to explore and summarize existing definitions, perceptions, classifications and views on modification reporting to develop a conceptual framework for understanding and reporting modifications. Methods A scoping review was conducted in accordance with PRISMA Extension for Scoping Reviews (PRISMA-ScR) guidelines. Targeted searches and two database searches were performed to identify relevant opinion pieces and review articles. Included were articles relating to modifications to surgical procedures/devices. Data regarding definitions, perceptions and classifications of modifications, and views on modification reporting were extracted verbatim. Thematic analysis was undertaken to identify themes, which informed development of the conceptual framework. Results Forty-nine articles were included. Eight articles included systems for classifying modifications, but no articles reported an explicit definition of modifications. Some 13 themes relating to perception of modifications were identified. The derived conceptual framework comprises three overarching components: baseline data about modifications, details about modifications and impact/consequences of modifications. Conclusion A conceptual framework for understanding and reporting modifications that occur during surgical innovation has been developed. This is a first necessary step to support consistent and transparent reporting of modifications, to facilitate shared learning and incremental innovation of surgical procedures/devices. Testing and operationalization is now needed to realize the value of this framework.

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Section: Resultsmentioning

confidence: 99%

Development of a conceptual framework for reporting modifications in surgical innovation: scoping review

et al. 2023

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The use of non-orthopaedic devices for orthopaedic procedures

George¹,

Abdulkareem

Bould

et al. 2013

The Surgeon

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Designing medical technology for resilience: integrating health economics and human factors approaches

Borsci

Uchegbu

Buckle

et al. 2017

Expert Review of Medical Devices

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The slow adoption of innovation into healthcare calls into question the manner of evidence generation for medical technology. This paper identifies potential reasons for this including a lack of attention to human factors, poor evaluation of economic benefits, lack of understanding of the existing healthcare system and a failure to recognise the need to generate resilient products. Areas covered: Recognising a cross-disciplinary need to enhance evidence generation early in a technology's life cycle, the present paper proposes a new approach that integrates human factors and health economic evaluation as part of a wider systems approach to the design of technology. This approach (Human and Economic Resilience Design for Medical Technology or HERD MedTech) supports early stages of product development and is based on the recent experiences of the National Institute for Health Research London Diagnostic Evidence Co-operative in the UK. Expert commentary: HERD MedTech i) proposes a shift from design for usability to design for resilience, ii) aspires to reduce the need for service adaptation to technological constraints iii) ensures value of innovation at the time of product development, and iv) aims to stimulate discussion around the integration of pre- and post-market methods of assessment of medical technology.

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Home-Made, Adapted and Modified Devices in Surgical Practice

Cited by 3 publications

References 7 publications

Development of a conceptual framework for reporting modifications in surgical innovation: scoping review

Development of a conceptual framework for reporting modifications in surgical innovation: scoping review

The use of non-orthopaedic devices for orthopaedic procedures

Designing medical technology for resilience: integrating health economics and human factors approaches

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