Dr B
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This blog from Matthew Bacon, CEO of TCC-CASEMIX Ltd, looks at why a multi-factorial dataset is needed to create holistic understanding of medical device performance and is the only effective means for determining the multi-factorial causes of failure. -
Content ArticleTCC-CASEMIX has created a unique infrastructure to provide total traceability of medical device performance. This infrastructure is supported by The Association of British HealthTech Industries [ABHI]. We refer to it as an 'Open Registry Infrastructure' for medical devices. It is 'open', because unlike existing clinically focused registries, which are 'closed', we enable wide searches across the registries connected into it. It is 'open' because registries will 'declare the content' (I don't know what I don't know, so how can I search for what I don't know?) Access to this infrastructure is through a Data Access Portal which is being configured for the specific needs of each stakeholder group. We are seeking interest from patient groups who would like to join an Advisory Board to help specify how data should be presented to patients in a way that is relevant and meaningful. Our vision is to link this portal into an enhanced pre-operative assessment process, and to transform patient informed consent.
