{"id":"https://openalex.org/W2922492442","doi":"https://doi.org/10.5220/0007483102070214","title":"Techniques for Usability Risk Assessment during Medical Device Design","display_name":"Techniques for Usability Risk Assessment during Medical Device Design","publication_year":2019,"publication_date":"2019-01-01","ids":{"openalex":"https://openalex.org/W2922492442","doi":"https://doi.org/10.5220/0007483102070214","mag":"2922492442"},"language":"en","primary_location":{"id":"doi:10.5220/0007483102070214","is_oa":true,"landing_page_url":"https://doi.org/10.5220/0007483102070214","pdf_url":null,"source":null,"license":"cc-by-nc-nd","license_id":"https://openalex.org/licenses/cc-by-nc-nd","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Proceedings of the 12th International Joint Conference on Biomedical Engineering Systems and Technologies","raw_type":"proceedings-article"},"type":"conference-paper","indexed_in":["crossref"],"open_access":{"is_oa":true,"oa_status":"gold","oa_url":"https://doi.org/10.5220/0007483102070214","any_repository_has_fulltext":null},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5097494719","display_name":"Design Ravizza","orcid":null},"institutions":[{"id":"https://openalex.org/I177477856","display_name":"Politecnico di Torino","ror":"https://ror.org/00bgk9508","country_code":"IT","type":"education","lineage":["https://openalex.org/I177477856"]}],"countries":["IT"],"is_corresponding":false,"raw_author_name":"Design Ravizza","raw_affiliation_strings":["DIMEAS, Politecnico di Torino, Torino and Italy, --- Select a Country ---"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"DIMEAS, Politecnico di Torino, Torino and Italy, --- Select a Country ---","institution_ids":["https://openalex.org/I177477856"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5076945258","display_name":"Federico Sternini","orcid":"https://orcid.org/0000-0002-5510-2296"},"institutions":[{"id":"https://openalex.org/I177477856","display_name":"Politecnico di Torino","ror":"https://ror.org/00bgk9508","country_code":"IT","type":"education","lineage":["https://openalex.org/I177477856"]}],"countries":["IT"],"is_corresponding":false,"raw_author_name":"Federico Sternini","raw_affiliation_strings":["DIMEAS, Politecnico di Torino, Torino and Italy, --- Select a Country ---"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"DIMEAS, Politecnico di Torino, Torino and Italy, --- Select a Country ---","institution_ids":["https://openalex.org/I177477856"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5082691724","display_name":"Andr\u00e9s D\u00edaz Lantada","orcid":"https://orcid.org/0000-0002-0358-9186"},"institutions":[{"id":"https://openalex.org/I88060688","display_name":"Universidad Polit\u00e9cnica de Madrid","ror":"https://ror.org/03n6nwv02","country_code":"ES","type":"education","lineage":["https://openalex.org/I88060688"]}],"countries":["ES"],"is_corresponding":false,"raw_author_name":"Andres Lantada","raw_affiliation_strings":["ETSI Industriales, Universidad Politecnica de Madrid, Madrid and Spain, --- Select a Country ---"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"ETSI Industriales, Universidad Politecnica de Madrid, Madrid and Spain, --- Select a Country ---","institution_ids":["https://openalex.org/I88060688"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5091844209","display_name":"Luis S\u00e1nchez","orcid":"https://orcid.org/0000-0001-6747-3150"},"institutions":[{"id":"https://openalex.org/I88060688","display_name":"Universidad Polit\u00e9cnica de Madrid","ror":"https://ror.org/03n6nwv02","country_code":"ES","type":"education","lineage":["https://openalex.org/I88060688"]}],"countries":["ES"],"is_corresponding":false,"raw_author_name":"Luis S\u00e1nchez","raw_affiliation_strings":["ETSI Industriales, Universidad Politecnica de Madrid, Madrid and Spain, --- Select a Country ---"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"ETSI Industriales, Universidad Politecnica de Madrid, Madrid and Spain, --- Select a Country ---","institution_ids":["https://openalex.org/I88060688"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5076945258","display_name":"Federico Sternini","orcid":"https://orcid.org/0000-0002-5510-2296"},"institutions":[{"id":"https://openalex.org/I177477856","display_name":"Politecnico di Torino","ror":"https://ror.org/00bgk9508","country_code":"IT","type":"education","lineage":["https://openalex.org/I177477856"]}],"countries":["IT"],"is_corresponding":false,"raw_author_name":"Federico Sternini","raw_affiliation_strings":["DIMEAS, Politecnico di Torino, Torino and Italy, --- Select a Country ---"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"DIMEAS, Politecnico di Torino, Torino and Italy, --- Select a Country ---","institution_ids":["https://openalex.org/I177477856"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5097494719","display_name":"Design Ravizza","orcid":null},"institutions":[{"id":"https://openalex.org/I177477856","display_name":"Politecnico di Torino","ror":"https://ror.org/00bgk9508","country_code":"IT","type":"education","lineage":["https://openalex.org/I177477856"]}],"countries":["IT"],"is_corresponding":false,"raw_author_name":"Design Ravizza","raw_affiliation_strings":["DIMEAS, Politecnico di Torino, Torino and Italy, --- Select a Country ---"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"DIMEAS, Politecnico di Torino, Torino and Italy, --- Select a Country ---","institution_ids":["https://openalex.org/I177477856"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5023946271","display_name":"Cristina Bignardi","orcid":"https://orcid.org/0000-0002-7065-2552"},"institutions":[{"id":"https://openalex.org/I177477856","display_name":"Politecnico di Torino","ror":"https://ror.org/00bgk9508","country_code":"IT","type":"education","lineage":["https://openalex.org/I177477856"]}],"countries":["IT"],"is_corresponding":false,"raw_author_name":"Cristina Bignardi","raw_affiliation_strings":["DIMEAS, Politecnico di Torino, Torino and Italy, --- Select a Country ---"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"DIMEAS, Politecnico di Torino, Torino and Italy, --- Select a Country ---","institution_ids":["https://openalex.org/I177477856"]}]}],"institutions":[],"countries_distinct_count":2,"institutions_distinct_count":2,"corresponding_author_ids":[],"corresponding_institution_ids":[],"apc_list":null,"apc_paid":null,"fwci":2.8483,"has_fulltext":false,"cited_by_count":11,"citation_normalized_percentile":{"value":0.89082969,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":{"min":94,"max":97},"biblio":{"volume":null,"issue":null,"first_page":null,"last_page":null},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T13690","display_name":"Quality and Safety in Healthcare","score":0.9340000152587891,"subfield":{"id":"https://openalex.org/subfields/3607","display_name":"Medical Laboratory Technology"},"field":{"id":"https://openalex.org/fields/36","display_name":"Health Professions"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},"topics":[{"id":"https://openalex.org/T13690","display_name":"Quality and Safety in Healthcare","score":0.9340000152587891,"subfield":{"id":"https://openalex.org/subfields/3607","display_name":"Medical Laboratory Technology"},"field":{"id":"https://openalex.org/fields/36","display_name":"Health Professions"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/usability","display_name":"Usability","score":0.8842006325721741},{"id":"https://openalex.org/keywords/computer-science","display_name":"Computer science","score":0.7246018648147583},{"id":"https://openalex.org/keywords/toolbox","display_name":"Toolbox","score":0.6839256286621094},{"id":"https://openalex.org/keywords/risk-analysis","display_name":"Risk analysis (engineering)","score":0.6143386363983154},{"id":"https://openalex.org/keywords/heuristic-evaluation","display_name":"Heuristic evaluation","score":0.526416003704071},{"id":"https://openalex.org/keywords/user-interface","display_name":"User interface","score":0.48115408420562744},{"id":"https://openalex.org/keywords/risk-assessment","display_name":"Risk assessment","score":0.45154568552970886},{"id":"https://openalex.org/keywords/cognitive-walkthrough","display_name":"Cognitive walkthrough","score":0.4235779345035553},{"id":"https://openalex.org/keywords/failure-mode-and-effects-analysis","display_name":"Failure mode and effects analysis","score":0.4161864221096039},{"id":"https://openalex.org/keywords/usability-goals","display_name":"Usability goals","score":0.41605710983276367},{"id":"https://openalex.org/keywords/human\u2013computer-interaction","display_name":"Human\u2013computer interaction","score":0.35906803607940674},{"id":"https://openalex.org/keywords/reliability-engineering","display_name":"Reliability engineering","score":0.30998632311820984},{"id":"https://openalex.org/keywords/engineering","display_name":"Engineering","score":0.2129804790019989},{"id":"https://openalex.org/keywords/computer-security","display_name":"Computer security","score":0.11783576011657715}],"concepts":[{"id":"https://openalex.org/C170130773","wikidata":"https://www.wikidata.org/wiki/Q216378","display_name":"Usability","level":2,"score":0.8842006325721741},{"id":"https://openalex.org/C41008148","wikidata":"https://www.wikidata.org/wiki/Q21198","display_name":"Computer science","level":0,"score":0.7246018648147583},{"id":"https://openalex.org/C2777655017","wikidata":"https://www.wikidata.org/wiki/Q1501161","display_name":"Toolbox","level":2,"score":0.6839256286621094},{"id":"https://openalex.org/C112930515","wikidata":"https://www.wikidata.org/wiki/Q4389547","display_name":"Risk analysis (engineering)","level":1,"score":0.6143386363983154},{"id":"https://openalex.org/C3255780","wikidata":"https://www.wikidata.org/wiki/Q1616517","display_name":"Heuristic evaluation","level":3,"score":0.526416003704071},{"id":"https://openalex.org/C89505385","wikidata":"https://www.wikidata.org/wiki/Q47146","display_name":"User interface","level":2,"score":0.48115408420562744},{"id":"https://openalex.org/C12174686","wikidata":"https://www.wikidata.org/wiki/Q1058438","display_name":"Risk assessment","level":2,"score":0.45154568552970886},{"id":"https://openalex.org/C87105883","wikidata":"https://www.wikidata.org/wiki/Q1107002","display_name":"Cognitive walkthrough","level":4,"score":0.4235779345035553},{"id":"https://openalex.org/C66283442","wikidata":"https://www.wikidata.org/wiki/Q1389268","display_name":"Failure mode and effects analysis","level":2,"score":0.4161864221096039},{"id":"https://openalex.org/C62993174","wikidata":"https://www.wikidata.org/wiki/Q2928808","display_name":"Usability goals","level":4,"score":0.41605710983276367},{"id":"https://openalex.org/C107457646","wikidata":"https://www.wikidata.org/wiki/Q207434","display_name":"Human\u2013computer interaction","level":1,"score":0.35906803607940674},{"id":"https://openalex.org/C200601418","wikidata":"https://www.wikidata.org/wiki/Q2193887","display_name":"Reliability engineering","level":1,"score":0.30998632311820984},{"id":"https://openalex.org/C127413603","wikidata":"https://www.wikidata.org/wiki/Q11023","display_name":"Engineering","level":0,"score":0.2129804790019989},{"id":"https://openalex.org/C38652104","wikidata":"https://www.wikidata.org/wiki/Q3510521","display_name":"Computer security","level":1,"score":0.11783576011657715},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.0},{"id":"https://openalex.org/C111919701","wikidata":"https://www.wikidata.org/wiki/Q9135","display_name":"Operating system","level":1,"score":0.0},{"id":"https://openalex.org/C199360897","wikidata":"https://www.wikidata.org/wiki/Q9143","display_name":"Programming language","level":1,"score":0.0}],"mesh":[],"locations_count":1,"locations":[{"id":"doi:10.5220/0007483102070214","is_oa":true,"landing_page_url":"https://doi.org/10.5220/0007483102070214","pdf_url":null,"source":null,"license":"cc-by-nc-nd","license_id":"https://openalex.org/licenses/cc-by-nc-nd","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Proceedings of the 12th International Joint Conference on Biomedical Engineering Systems and Technologies","raw_type":"proceedings-article"}],"best_oa_location":{"id":"doi:10.5220/0007483102070214","is_oa":true,"landing_page_url":"https://doi.org/10.5220/0007483102070214","pdf_url":null,"source":null,"license":"cc-by-nc-nd","license_id":"https://openalex.org/licenses/cc-by-nc-nd","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Proceedings of the 12th International Joint Conference on Biomedical Engineering Systems and Technologies","raw_type":"proceedings-article"},"sustainable_development_goals":[],"awards":[],"funders":[],"has_content":{"pdf":false,"grobid_xml":false},"content_urls":null,"referenced_works_count":0,"referenced_works":[],"related_works":["https://openalex.org/W2150599767","https://openalex.org/W2155602934","https://openalex.org/W2130660484","https://openalex.org/W2085749886","https://openalex.org/W2163058110","https://openalex.org/W2772000347","https://openalex.org/W2016022053","https://openalex.org/W2587266006","https://openalex.org/W147331940","https://openalex.org/W4210309199"],"abstract_inverted_index":{"Human":[0],"errors":[1],"during":[2,88],"the":[3,12,15,33,37,49,52,143,163,172,187,194,224,273],"use":[4],"of":[5,14,39,51,72,91,117,145,162,171,174,201,205,226,258],"medical":[6],"devices,":[7],"due":[8],"to":[9,20,23,26,48,77,152,196,218,241],"pitfalls":[10],"in":[11,119,203,279],"design":[13,53,122],"user":[16,40,140],"interface,":[17],"may":[18,44,75],"lead":[19,76],"substantial":[21],"risk":[22,202,210,227,234,259,268,274],"users":[24],"and":[25,35,62,64,68,103,114,128,136,160,178,216,249,251,282],"patients.":[27],"There":[28],"are":[29,81,108,155],"multiple":[30],"techniques":[31,80,107,167],"for":[32,36,84,110,158,253],"identification":[34],"assessment":[38,275],"related":[41],"risks,":[42],"that":[43,272],"be":[45,153,169,181,214,219,238,263,277],"chosen":[46],"according":[47,240],"step":[50,188],"(preliminary":[54],"feasibility":[55],"studies,":[56],"minimum":[57],"viable":[58],"product":[59],"assessment,":[60],"verification":[61,159],"validation)":[63],"considering":[65],"cognitive":[66],"processes":[67],"information":[252],"processing":[70],"mechanisms":[71],"users,":[73],"which":[74],"errors.":[78],"Some":[79],"more":[82,112,120],"adequate":[83,109,157],"a":[85,111,125,175,198,266,280],"quick-and-dirty":[86],"approach,":[87,132],"early":[89],"stages":[90],"design:":[92],"these":[93],"include":[94],"expert":[95],"reviews,":[96],"discussions":[97],"among":[98],"focus":[99],"groups,":[100],"standard":[101],"reviews":[102],"heuristic":[104],"analyses.":[105,138],"Other":[106],"detailed":[113],"systematic":[115],"analysis":[116,130,166],"risk,":[118],"advanced":[121],"stages,":[123],"with":[124,142],"failure":[126],"mode":[127],"effect":[129],"(FMEA)":[131],"including":[133],"time-and-motion":[134],"studies":[135],"task":[137],"Lastly,":[139],"tests":[141],"help":[144],"rapid":[146],"prototypes,":[147],"perhaps":[148],"involving":[149],"alternative":[150],"embodiments":[151],"studied,":[154],"very":[156],"validation":[161],"interface.":[164],"Usability":[165],"should":[168,180,192,237,262],"part":[170],"toolbox":[173],"biomedical":[176],"engineer":[177],"they":[179],"carefully":[182],"chosen.":[183],"Each":[184,256],"technique,":[185],"regardless":[186],"it":[189],"is":[190],"used,":[191],"allow":[193],"designers":[195],"define":[197],"precise":[199],"level":[200],"terms":[204],"probability,":[206],"severity.":[207],"Moreover,":[208],"usability":[209,233],"minimisation":[211,235,260],"measures":[212,236],"shall":[213],"measurable":[215,267],"able":[217],"quantified,":[220],"as":[221,223,244],"well":[222],"impact":[225],"mitigation":[228],"strategies.":[229],"For":[230],"this":[231],"reason,":[232],"classified":[239],"regulatory":[242,283],"requirements":[243],"safe":[254],"by":[246],"design;":[247],"alarms":[248],"protections":[250],"use.":[255],"class":[257],"measure":[261],"then":[264],"given":[265],"reduction":[269],"score,":[270],"so":[271],"can":[276],"completed":[278],"repeatable":[281],"compliant":[284],"way.":[285]},"counts_by_year":[{"year":2025,"cited_by_count":3},{"year":2024,"cited_by_count":2},{"year":2023,"cited_by_count":2},{"year":2022,"cited_by_count":2},{"year":2020,"cited_by_count":2}],"updated_date":"2026-07-29T14:22:42.915294","created_date":"2025-10-10T00:00:00"}
