{"id":"https://openalex.org/W4205693127","doi":"https://doi.org/10.1561/1000000040","title":"High-Confidence Medical Device Software Development","display_name":"High-Confidence Medical Device Software Development","publication_year":2015,"publication_date":"2015-12-10","ids":{"openalex":"https://openalex.org/W4205693127","doi":"https://doi.org/10.1561/1000000040"},"language":"en","primary_location":{"id":"doi:10.1561/1000000040","is_oa":false,"landing_page_url":"https://doi.org/10.1561/1000000040","pdf_url":null,"source":{"id":"https://openalex.org/S138962964","display_name":"Foundations and Trends\u00ae in Electronic Design Automation","issn_l":"1551-3939","issn":["1551-3939","1551-3947"],"is_oa":false,"is_in_doaj":false,"is_core":true,"host_organization":"https://openalex.org/P4310318575","host_organization_name":"Now Publishers","host_organization_lineage":["https://openalex.org/P4310318575"],"host_organization_lineage_names":["Now Publishers"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Foundations and Trends\u00ae in Electronic Design Automation","raw_type":"journal-article"},"type":"article","indexed_in":["crossref"],"open_access":{"is_oa":false,"oa_status":"closed","oa_url":null,"any_repository_has_fulltext":false},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5053473939","display_name":"Zhihao Jiang","orcid":"https://orcid.org/0000-0002-6730-6915"},"institutions":[{"id":"https://openalex.org/I36788626","display_name":"California University of Pennsylvania","ror":"https://ror.org/01spssf70","country_code":"US","type":"education","lineage":["https://openalex.org/I36788626"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Zhihao Jiang","raw_affiliation_strings":["University of Pennsylvania ,","University of Pennsylvania, USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"University of Pennsylvania ,","institution_ids":["https://openalex.org/I36788626"]},{"raw_affiliation_string":"University of Pennsylvania, USA","institution_ids":["https://openalex.org/I36788626"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5009445756","display_name":"Rahul Mangharam","orcid":"https://orcid.org/0000-0002-3388-8283"},"institutions":[{"id":"https://openalex.org/I36788626","display_name":"California University of Pennsylvania","ror":"https://ror.org/01spssf70","country_code":"US","type":"education","lineage":["https://openalex.org/I36788626"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Rahul Mangharam","raw_affiliation_strings":["University of Pennsylvania ,","University of Pennsylvania, USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"University of Pennsylvania ,","institution_ids":["https://openalex.org/I36788626"]},{"raw_affiliation_string":"University of Pennsylvania, USA","institution_ids":["https://openalex.org/I36788626"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":1,"corresponding_author_ids":[],"corresponding_institution_ids":["https://openalex.org/I36788626"],"apc_list":null,"apc_paid":null,"fwci":0.5321,"has_fulltext":false,"cited_by_count":6,"citation_normalized_percentile":{"value":0.69246446,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":{"min":90,"max":96},"biblio":{"volume":"9","issue":"4","first_page":"309","last_page":"391"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T13280","display_name":"Biomedical and Engineering Education","score":0.8844000101089478,"subfield":{"id":"https://openalex.org/subfields/2204","display_name":"Biomedical Engineering"},"field":{"id":"https://openalex.org/fields/22","display_name":"Engineering"},"domain":{"id":"https://openalex.org/domains/3","display_name":"Physical Sciences"}},"topics":[{"id":"https://openalex.org/T13280","display_name":"Biomedical and Engineering Education","score":0.8844000101089478,"subfield":{"id":"https://openalex.org/subfields/2204","display_name":"Biomedical Engineering"},"field":{"id":"https://openalex.org/fields/22","display_name":"Engineering"},"domain":{"id":"https://openalex.org/domains/3","display_name":"Physical Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/computer-science","display_name":"Computer science","score":0.500985860824585},{"id":"https://openalex.org/keywords/software","display_name":"Software","score":0.42825838923454285},{"id":"https://openalex.org/keywords/software-development","display_name":"Software development","score":0.4213230013847351},{"id":"https://openalex.org/keywords/software-engineering","display_name":"Software engineering","score":0.35807856917381287},{"id":"https://openalex.org/keywords/operating-system","display_name":"Operating system","score":0.15650129318237305}],"concepts":[{"id":"https://openalex.org/C41008148","wikidata":"https://www.wikidata.org/wiki/Q21198","display_name":"Computer science","level":0,"score":0.500985860824585},{"id":"https://openalex.org/C2777904410","wikidata":"https://www.wikidata.org/wiki/Q7397","display_name":"Software","level":2,"score":0.42825838923454285},{"id":"https://openalex.org/C529173508","wikidata":"https://www.wikidata.org/wiki/Q638608","display_name":"Software development","level":3,"score":0.4213230013847351},{"id":"https://openalex.org/C115903868","wikidata":"https://www.wikidata.org/wiki/Q80993","display_name":"Software engineering","level":1,"score":0.35807856917381287},{"id":"https://openalex.org/C111919701","wikidata":"https://www.wikidata.org/wiki/Q9135","display_name":"Operating system","level":1,"score":0.15650129318237305}],"mesh":[],"locations_count":2,"locations":[{"id":"doi:10.1561/1000000040","is_oa":false,"landing_page_url":"https://doi.org/10.1561/1000000040","pdf_url":null,"source":{"id":"https://openalex.org/S138962964","display_name":"Foundations and Trends\u00ae in Electronic Design Automation","issn_l":"1551-3939","issn":["1551-3939","1551-3947"],"is_oa":false,"is_in_doaj":false,"is_core":true,"host_organization":"https://openalex.org/P4310318575","host_organization_name":"Now Publishers","host_organization_lineage":["https://openalex.org/P4310318575"],"host_organization_lineage_names":["Now Publishers"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Foundations and Trends\u00ae in Electronic Design Automation","raw_type":"journal-article"},{"id":"pmh:oai:aleph.bib-bvb.de:BVB01-033259222","is_oa":false,"landing_page_url":null,"pdf_url":null,"source":null,"license":null,"license_id":null,"version":"submittedVersion","is_accepted":false,"is_published":false,"raw_source_name":null,"raw_type":"text"}],"best_oa_location":null,"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/W2476117260","https://openalex.org/W2770531922","https://openalex.org/W1845068655","https://openalex.org/W4321354308","https://openalex.org/W3118244000","https://openalex.org/W3121161786","https://openalex.org/W2290299503","https://openalex.org/W3029851195","https://openalex.org/W2046884474","https://openalex.org/W2183585111"],"abstract_inverted_index":{"The":[0,33,66,269],"design":[1,54,349,360],"of":[2,39,69,96,147,168,183,200,230,244,265,272,282,289,295,335,366],"bug-free":[3],"and":[4,36,60,108,118,126,128,171,186,207,233,247,262,302,308,323,341,362,380],"safe":[5],"medical":[6,71,384],"device":[7,72,78,191,313],"software":[8,45,73,368],"is":[9,17,74,114,145,374],"challenging,":[10],"especially":[11],"in":[12,189],"complex":[13,117,324],"implantable":[14,162],"devices.":[15],"This":[16,372],"due":[18],"to":[19,43,75,135,177,225,254,338],"the":[20,25,37,77,82,97,133,136,141,157,161,172,175,184,201,205,227,231,241,245,266,318,352,359,364,388],"device\u2019s":[21],"closed-loop":[22,64,169,214,267,305,353],"interaction":[23],"with":[24,63,195,387],"patient\u2019s":[26],"organs,":[27],"which":[28],"are":[29,101,356],"stochastic":[30],"physical":[31],"environments.":[32],"life-critical":[34],"nature":[35],"lack":[38],"existing":[40],"industry":[41],"standards":[42],"enforce":[44],"validation":[46,379],"make":[47],"this":[48,347],"an":[49,85,166],"ideal":[50],"domain":[51],"for":[52,57,258,279,300,310,344,383],"exploring":[53],"automation":[55],"challenges":[56,185],"integrated":[58],"functional":[59,263],"formal":[61,259],"modeling":[62,106,109],"analysis.":[65],"primary":[67],"goal":[68],"high-confidence":[70],"guarantee":[76],"will":[79],"never":[80],"drive":[81],"patient":[83],"into":[84],"unsafe":[86],"condition":[87],"even":[88],"though":[89],"we":[90,180,250,291],"do":[91],"not":[92],"have":[93],"complete":[94],"understanding":[95],"physiological":[98],"plant.":[99],"There":[100],"two":[102,153],"major":[103],"differences":[104],"between":[105,143,152],"physiology":[107,113],"man-made":[110,122],"systems:":[111],"first,":[112],"much":[115],"more":[116],"less":[119],"well-understood":[120],"than":[121,150],"systems":[123,386],"like":[124],"cars":[125,154],"airplanes,":[127],"spans":[129],"several":[130,182],"scales":[131],"from":[132,210,369],"molecular":[134],"entire":[137],"human":[138],"body.":[139],"Secondly,":[140],"variability":[142],"humans":[144],"orders":[146],"magnitude":[148],"larger":[149],"that":[151,298],"coming":[155],"off":[156],"assembly":[158],"line.":[159],"Using":[160],"cardiac":[163],"pacemaker":[164,248,312],"as":[165,174,316,327],"example":[167],"device,":[170,249],"heart":[173,246,319],"organ":[176],"be":[178],"modeled,":[179],"present":[181,251],"early":[187],"results":[188],"model-based":[190,348],"validation.":[192],"We":[193],"begin":[194],"detailed":[196],"timed":[197],"automata":[198],"model":[199,226,260,306,333],"pacemaker,":[202],"based":[203],"on":[204,286],"specifications":[206],"algorithm":[208],"descriptions":[209],"Boston":[211],"Scientific.":[212],"For":[213],"evaluation,":[215],"a":[216,252,280,287,293,375,378],"real-time":[217],"Virtual":[218],"Heart":[219],"Model":[220],"(VHM)":[221],"has":[222,276],"been":[223,277],"developed":[224],"electrophysiological":[228],"operation":[229],"functioning":[232],"malfunctioning":[234],"(i.e.,":[235],"during":[236],"arrhythmia)":[237],"hearts.":[238],"By":[239],"extracting":[240],"timing":[242],"properties":[243,355],"methodology":[253],"construct":[255],"timed-automata":[256],"models":[257,337],"checking":[261,307],"testing":[264,309,340,381],"system.":[268],"VHM\u2019s":[270],"capability":[271],"generating":[273],"clinically-relevant":[274],"response":[275],"validated":[278],"variety":[281],"common":[283],"arrhythmias.":[284],"Based":[285],"set":[288],"requirements,":[290],"describe":[292],"framework":[294],"Abstraction":[296],"Trees":[297],"allows":[299],"interactive":[301],"physiologically":[303],"relevant":[304],"basic":[311],"operations":[314],"such":[315,326],"maintaining":[317],"rate,":[320],"atrial-ventricle":[321],"synchrony":[322],"conditions":[325],"avoiding":[328],"pacemaker-mediated":[329],"tachycardia.":[330],"Through":[331],"automatic":[332],"translation":[334],"abstract":[336],"simulation-based":[339],"code":[342],"generation":[343],"platform-level":[345],"testing,":[346],"approach":[350,382],"ensures":[351],"safety":[354],"retained":[357],"through":[358],"toolchain":[361],"facilitates":[363],"development":[365],"verified":[367,370],"models.":[371],"system":[373],"step":[376],"toward":[377],"cyber-physical":[385],"patient-in-the-loop.":[389]},"counts_by_year":[{"year":2025,"cited_by_count":1},{"year":2021,"cited_by_count":2},{"year":2018,"cited_by_count":2},{"year":2016,"cited_by_count":1}],"updated_date":"2026-05-21T06:26:12.895304","created_date":"2025-10-10T00:00:00"}