Christopher G Scully, Pras Pathmanathan, Chathuri Daluwatte, Farid Yaghouby, Richard A Gray, Sandy Weininger, Tina M Morrison, Bahram Parvinian
{"title":"Applying a Computational Model Credibility Framework to Physiological Closed-loop Controlled Medical Device Testing.","authors":"Christopher G Scully, Pras Pathmanathan, Chathuri Daluwatte, Farid Yaghouby, Richard A Gray, Sandy Weininger, Tina M Morrison, Bahram Parvinian","doi":"10.1109/lsc.2018.8572270","DOIUrl":"https://doi.org/10.1109/lsc.2018.8572270","url":null,"abstract":"<p><p>Physiological closed-loop controlled medical devices are safety-critical systems that combine patient monitors with therapy delivery devices to automatically titrate therapy to meet a patient's current need. Computational models of physiological systems can be used to test these devices and generate pre-clinical evidence of safety and performance before using the devices on patients. The credibility, utility, and acceptability of such model-based test results will depend on, among other factors, the computational model used. We examine how a recently developed risk-informed framework for establishing the credibility of computational models in medical device applications can be applied in the evaluation of physiological closed-loop controlled devices.</p>","PeriodicalId":92787,"journal":{"name":"IEEE Life Sciences Conference. Life Sciences Conference","volume":"2018 ","pages":"130-133"},"PeriodicalIF":0.0,"publicationDate":"2018-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1109/lsc.2018.8572270","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39410326","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}