{"id":"https://openalex.org/W4379600971","doi":"https://doi.org/10.1155/2023/6724656","title":"Strategies for Medical Device Development: User and Stakeholder Perceptions","display_name":"Strategies for Medical Device Development: User and Stakeholder Perceptions","publication_year":2023,"publication_date":"2023-01-01","ids":{"openalex":"https://openalex.org/W4379600971","doi":"https://doi.org/10.1155/2023/6724656","pmid":"https://pubmed.ncbi.nlm.nih.gov/37284489","pmcid":"https://www.ncbi.nlm.nih.gov/pmc/articles/10241585"},"language":"en","primary_location":{"id":"doi:10.1155/2023/6724656","doi":"https://doi.org/10.1155/2023/6724656","is_oa":true,"landing_page_url":"https://doi.org/10.1155/2023/6724656","pdf_url":"https://downloads.hindawi.com/journals/jhe/2023/6724656.pdf","source":{"id":"https://openalex.org/S36625193","display_name":"Journal of Healthcare Engineering","issn_l":"2040-2295","issn":["2040-2295","2040-2309"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["cwts-core","poland-20"],"host_organization":"https://openalex.org/P4310319869","host_organization_name":"Hindawi Publishing Corporation","host_organization_lineage":["https://openalex.org/P4310319869","https://openalex.org/P4310320595"],"host_organization_lineage_names":["Hindawi Publishing Corporation","Wiley"],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Journal of Healthcare Engineering","raw_type":"journal-article"},"volume":null,"type":"article","is_traditional":true,"indexed_in":["crossref","pubmed"],"open_access":{"is_oa":true,"oa_status":"hybrid","oa_url":"https://downloads.hindawi.com/journals/jhe/2023/6724656.pdf","any_repository_has_fulltext":true},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5008600369","display_name":"I-Ching Tsai","orcid":"https://orcid.org/0009-0003-4831-5474","observed_orcids":["https://orcid.org/0009-0003-4831-5474"]},"institutions":[{"id":"https://openalex.org/I91807558","display_name":"National Cheng Kung University","ror":"https://ror.org/01b8kcc49","country_code":"TW","type":"education","lineage":["https://openalex.org/I91807558"]}],"countries":["TW"],"is_corresponding":false,"raw_author_name":"I-Ching Tsai","raw_affiliation_strings":["Department of Biomedical Engineering, National Cheng Kung University, No. 1, University Road, Tainan City 701, Taiwan","Department of Biomedical Engineering, National Cheng Kung University, No. 1, University Road, Tainan City 701"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Biomedical Engineering, National Cheng Kung University, No. 1, University Road, Tainan City 701, Taiwan","institution_ids":["https://openalex.org/I91807558"]},{"raw_affiliation_string":"Department of Biomedical Engineering, National Cheng Kung University, No. 1, University Road, Tainan City 701","institution_ids":["https://openalex.org/I91807558"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5022405935","display_name":"Ching-Da Wang","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I91807558","display_name":"National Cheng Kung University","ror":"https://ror.org/01b8kcc49","country_code":"TW","type":"education","lineage":["https://openalex.org/I91807558"]}],"countries":["TW"],"is_corresponding":false,"raw_author_name":"Ching-Da Wang","raw_affiliation_strings":["Department of Biomedical Engineering, National Cheng Kung University, No. 1, University Road, Tainan City 701, Taiwan","Department of Biomedical Engineering, National Cheng Kung University, No. 1, University Road, Tainan City 701"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Biomedical Engineering, National Cheng Kung University, No. 1, University Road, Tainan City 701, Taiwan","institution_ids":["https://openalex.org/I91807558"]},{"raw_affiliation_string":"Department of Biomedical Engineering, National Cheng Kung University, No. 1, University Road, Tainan City 701","institution_ids":["https://openalex.org/I91807558"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5000625354","display_name":"Peng-Ting Chen","orcid":"https://orcid.org/0000-0002-7758-5399","observed_orcids":["https://orcid.org/0000-0002-7758-5399"]},"institutions":[{"id":"https://openalex.org/I91807558","display_name":"National Cheng Kung University","ror":"https://ror.org/01b8kcc49","country_code":"TW","type":"education","lineage":["https://openalex.org/I91807558"]}],"countries":["TW"],"is_corresponding":true,"raw_author_name":"Peng-Ting Chen","raw_affiliation_strings":["Department of Biomedical Engineering, National Cheng Kung University, No. 1, University Road, Tainan City 701, Taiwan","International Institute of Medical Device Innovation, National Cheng Kung University, No. 1, University Road, Tainan City 701, Taiwan","Department of Biomedical Engineering, National Cheng Kung University, No. 1, University Road, Tainan City 701","International Institute of Medical Device Innovation, National Cheng Kung University, No. 1, University Road, Tainan City 701"],"raw_orcid":"https://orcid.org/0000-0002-7758-5399","affiliations":[{"raw_affiliation_string":"Department of Biomedical Engineering, National Cheng Kung University, No. 1, University Road, Tainan City 701, Taiwan","institution_ids":["https://openalex.org/I91807558"]},{"raw_affiliation_string":"International Institute of Medical Device Innovation, National Cheng Kung University, No. 1, University Road, Tainan City 701, Taiwan","institution_ids":["https://openalex.org/I91807558"]},{"raw_affiliation_string":"Department of Biomedical Engineering, National Cheng Kung University, No. 1, University Road, Tainan City 701","institution_ids":["https://openalex.org/I91807558"]},{"raw_affiliation_string":"International Institute of Medical Device Innovation, National Cheng Kung University, No. 1, University Road, Tainan City 701","institution_ids":["https://openalex.org/I91807558"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":1,"corresponding_author_ids":["https://openalex.org/A5000625354"],"corresponding_institution_ids":["https://openalex.org/I91807558"],"apc_list":{"value":2375,"currency":"USD","value_usd":2375},"apc_paid":{"value":2375,"currency":"USD","value_usd":2375},"fwci":4.6442,"has_fulltext":true,"cited_by_count":21,"citation_normalized_percentile":{"value":0.9534669,"is_in_top_1_percent":false,"is_in_top_10_percent":true},"cited_by_percentile_year":{"min":93,"max":99},"biblio":{"volume":"2023","issue":"1","first_page":"6724656","last_page":"6724656"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T14396","display_name":"Healthcare Regulation","score":0.392300009727478,"subfield":{"id":"https://openalex.org/subfields/2739","display_name":"Public Health, Environmental and Occupational Health"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},"topics":[{"id":"https://openalex.org/T14396","display_name":"Healthcare Regulation","score":0.392300009727478,"subfield":{"id":"https://openalex.org/subfields/2739","display_name":"Public Health, Environmental and Occupational Health"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T13690","display_name":"Quality and Safety in Healthcare","score":0.16940000653266907,"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"}},{"id":"https://openalex.org/T14306","display_name":"Technology Assessment and Management","score":0.16349999606609344,"subfield":{"id":"https://openalex.org/subfields/1405","display_name":"Management of Technology and Innovation"},"field":{"id":"https://openalex.org/fields/14","display_name":"Business, Management and Accounting"},"domain":{"id":"https://openalex.org/domains/2","display_name":"Social Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/medical-device-development","display_name":"medical device development","score":0.9990000128746033},{"id":"https://openalex.org/keywords/stakeholder-perspectives","display_name":"stakeholder perspectives","score":0.7509999871253967},{"id":"https://openalex.org/keywords/user-safety","display_name":"user safety","score":0.6830000281333923},{"id":"https://openalex.org/keywords/medical-device-regulation","display_name":"medical device regulation","score":0.6169999837875366},{"id":"https://openalex.org/keywords/development-strategy","display_name":"development strategy","score":0.4490000009536743},{"id":"https://openalex.org/keywords/user-centered-design","display_name":"user-centered design","score":0.6259999871253967},{"id":"https://openalex.org/keywords/resource-allocation","display_name":"resource allocation","score":0.5329999923706055},{"id":"https://openalex.org/keywords/medical-device-industry","display_name":"medical device industry","score":0.5759999752044678},{"id":"https://openalex.org/keywords/development-pathways","display_name":"development pathways","score":0.3330000042915344}],"concepts":[{"id":"https://openalex.org/C201305675","wikidata":"https://www.wikidata.org/wiki/Q852998","display_name":"Stakeholder","level":2,"score":0.6197778582572937},{"id":"https://openalex.org/C26760741","wikidata":"https://www.wikidata.org/wiki/Q160402","display_name":"Perception","level":2,"score":0.5257152915000916},{"id":"https://openalex.org/C56739046","wikidata":"https://www.wikidata.org/wiki/Q192060","display_name":"Knowledge management","level":1,"score":0.41232192516326904},{"id":"https://openalex.org/C41008148","wikidata":"https://www.wikidata.org/wiki/Q21198","display_name":"Computer science","level":0,"score":0.4116297662258148},{"id":"https://openalex.org/C144133560","wikidata":"https://www.wikidata.org/wiki/Q4830453","display_name":"Business","level":0,"score":0.3968130052089691},{"id":"https://openalex.org/C195094911","wikidata":"https://www.wikidata.org/wiki/Q14167904","display_name":"Process management","level":1,"score":0.3528890311717987},{"id":"https://openalex.org/C15744967","wikidata":"https://www.wikidata.org/wiki/Q9418","display_name":"Psychology","level":0,"score":0.27760571241378784},{"id":"https://openalex.org/C39549134","wikidata":"https://www.wikidata.org/wiki/Q133080","display_name":"Public relations","level":1,"score":0.22965297102928162},{"id":"https://openalex.org/C17744445","wikidata":"https://www.wikidata.org/wiki/Q36442","display_name":"Political science","level":0,"score":0.12372052669525146},{"id":"https://openalex.org/C169760540","wikidata":"https://www.wikidata.org/wiki/Q207011","display_name":"Neuroscience","level":1,"score":0.0}],"mesh":[],"locations_count":3,"locations":[{"id":"doi:10.1155/2023/6724656","doi":"https://doi.org/10.1155/2023/6724656","is_oa":true,"landing_page_url":"https://doi.org/10.1155/2023/6724656","pdf_url":"https://downloads.hindawi.com/journals/jhe/2023/6724656.pdf","source":{"id":"https://openalex.org/S36625193","display_name":"Journal of Healthcare Engineering","issn_l":"2040-2295","issn":["2040-2295","2040-2309"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["cwts-core","poland-20"],"host_organization":"https://openalex.org/P4310319869","host_organization_name":"Hindawi Publishing Corporation","host_organization_lineage":["https://openalex.org/P4310319869","https://openalex.org/P4310320595"],"host_organization_lineage_names":["Hindawi Publishing Corporation","Wiley"],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Journal of Healthcare Engineering","raw_type":"journal-article"},{"id":"pmh:oai:pubmedcentral.nih.gov:10241585","doi":null,"is_oa":true,"landing_page_url":"https://www.ncbi.nlm.nih.gov/pmc/articles/10241585","pdf_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC10241585/pdf/JHE2023-6724656.pdf","source":{"id":"https://openalex.org/S2764455111","display_name":"PubMed Central","issn_l":null,"issn":null,"is_oa":true,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1299303238","host_organization_name":"National Institutes of Health","host_organization_lineage":["https://openalex.org/I1299303238"],"host_organization_lineage_names":[],"type":"repository"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"J Healthc Eng","raw_type":"Text"},{"id":"pmid:37284489","doi":null,"is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/37284489","pdf_url":null,"source":{"id":"https://openalex.org/S4306525036","display_name":"PubMed","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1299303238","host_organization_name":"National Institutes of Health","host_organization_lineage":["https://openalex.org/I1299303238"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Journal of healthcare engineering","raw_type":"Journal Article"}],"best_oa_location":{"id":"doi:10.1155/2023/6724656","doi":"https://doi.org/10.1155/2023/6724656","is_oa":true,"landing_page_url":"https://doi.org/10.1155/2023/6724656","pdf_url":"https://downloads.hindawi.com/journals/jhe/2023/6724656.pdf","source":{"id":"https://openalex.org/S36625193","display_name":"Journal of Healthcare Engineering","issn_l":"2040-2295","issn":["2040-2295","2040-2309"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["cwts-core","poland-20"],"host_organization":"https://openalex.org/P4310319869","host_organization_name":"Hindawi Publishing Corporation","host_organization_lineage":["https://openalex.org/P4310319869","https://openalex.org/P4310320595"],"host_organization_lineage_names":["Hindawi Publishing Corporation","Wiley"],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Journal of Healthcare Engineering","raw_type":"journal-article"},"sustainable_development_goals":[{"display_name":"Good health and well-being","score":0.8371999859809875,"id":"https://metadata.un.org/sdg/3"}],"study_designs":[],"awards":[{"id":"https://openalex.org/G7885719340","display_name":"The Strategic Analysis Model for Biomedical Technology Startups: the Resource Allocation Strategy from Organizational Barrier Perspective","funder_award_id":"MOST108-2221-E006-063","funder_id":"https://openalex.org/F4320322795","funder_display_name":"Ministry of Science and Technology, Taiwan"},{"id":"https://openalex.org/G7974754855","display_name":"The R&D and Commericialization Analysis Model and Resource Allocation Strategy of Artificial Intelligence in Software as a Medical Device","funder_award_id":"MOST109-2410-H006-045-MY2","funder_id":"https://openalex.org/F4320322795","funder_display_name":"Ministry of Science and Technology, Taiwan"}],"funders":[{"id":"https://openalex.org/F4320322795","display_name":"Ministry of Science and Technology, Taiwan","ror":"https://ror.org/02kv4zf79"},{"id":"https://openalex.org/F4320329099","display_name":"Medical Device Innovation Center","ror":"https://ror.org/03nxzs866"}],"has_content":{"pdf":true,"grobid_xml":true},"content_urls":{"pdf":"https://content.openalex.org/works/W4379600971.pdf","grobid_xml":"https://content.openalex.org/works/W4379600971.grobid-xml"},"referenced_works_count":56,"referenced_works":["https://openalex.org/W33981300","https://openalex.org/W1965574250","https://openalex.org/W1971543333","https://openalex.org/W1972798031","https://openalex.org/W2001833428","https://openalex.org/W2009171817","https://openalex.org/W2016377862","https://openalex.org/W2017067922","https://openalex.org/W2035050686","https://openalex.org/W2041567225","https://openalex.org/W2062228572","https://openalex.org/W2067404301","https://openalex.org/W2101813937","https://openalex.org/W2122859025","https://openalex.org/W2128506806","https://openalex.org/W2484237608","https://openalex.org/W2576868625","https://openalex.org/W2589150736","https://openalex.org/W2614051393","https://openalex.org/W2617583700","https://openalex.org/W2781585085","https://openalex.org/W2793087850","https://openalex.org/W2794544590","https://openalex.org/W2795835276","https://openalex.org/W2800959660","https://openalex.org/W2805231511","https://openalex.org/W2806872747","https://openalex.org/W2811167785","https://openalex.org/W2883522797","https://openalex.org/W2887690325","https://openalex.org/W2907342835","https://openalex.org/W2922498032","https://openalex.org/W2942647258","https://openalex.org/W2944336814","https://openalex.org/W2951512847","https://openalex.org/W2961116122","https://openalex.org/W2969297811","https://openalex.org/W2972464767","https://openalex.org/W2972551632","https://openalex.org/W2978011250","https://openalex.org/W2979070716","https://openalex.org/W2983449830","https://openalex.org/W3005655862","https://openalex.org/W3021916629","https://openalex.org/W3080742623","https://openalex.org/W3123184067","https://openalex.org/W3125999116","https://openalex.org/W3128926672","https://openalex.org/W3212114143","https://openalex.org/W4205168051","https://openalex.org/W4205451601","https://openalex.org/W4211200711","https://openalex.org/W4211201417","https://openalex.org/W4225773244","https://openalex.org/W4283827340","https://openalex.org/W4294577542"],"related_works":["https://openalex.org/W2128506806","https://openalex.org/W2519347070","https://openalex.org/W2212726445","https://openalex.org/W4283461380","https://openalex.org/W7098653828","https://openalex.org/W6997202236","https://openalex.org/W4323056331","https://openalex.org/W3089249311","https://openalex.org/W3034205849","https://openalex.org/W4200026893"],"abstract_inverted_index":{"Medical":[0],"device":[1,17,57,74,83,109,156,172],"development":[2,32,37,58,110,121,160,173],"involves":[3],"user":[4,147],"safety,":[5],"and":[6,27,36,65,91,111,136,139,162,181],"it":[7,97],"is":[8],"governed":[9],"by":[10,132],"specific":[11],"regulations.":[12],"The":[13,152],"failure":[14],"of":[15,23,47,68,81,122,149,183],"medical":[16,48,56,73,82,108,123,150,155,171],"developers":[18,157,168],"to":[19,44,102,145,166],"consider":[20],"the":[21,25,34,45,55,69,79,104,120,146,179,184],"influence":[22],"users,":[24],"environment,":[26,138],"related":[28],"organizations":[29],"on":[30],"product":[31],"during":[33],"design":[35],"process":[38],"can":[39],"result":[40],"in":[41,169],"added":[42],"risks":[43],"use":[46,137],"technologies.":[49],"Although":[50],"many":[51],"studies":[52],"have":[53],"examined":[54],"process,":[59],"there":[60],"has":[61],"been":[62],"no":[63],"systematic":[64],"comprehensive":[66],"assessment":[67],"key":[70,105],"factors":[71,106],"affecting":[72,107],"development.":[75],"This":[76],"research":[77],"synthesized":[78],"value":[80],"industry":[84,94],"stakeholders'":[85],"experiences":[86],"through":[87],"a":[88],"literature":[89],"review":[90],"interviews":[92],"with":[93,127,158],"experts.":[95],"Then,":[96],"establishes":[98],"an":[99],"FIA-NRM":[100],"model":[101],"identify":[103],"suggests":[112],"appropriate":[113],"pathways":[114,161],"for":[115,186],"improvement.":[116],"Results":[117],"indicate":[118],"that":[119],"devices":[124],"should":[125,142],"begin":[126],"stabilizing":[128],"organizational":[129],"characteristics,":[130],"followed":[131],"strengthening":[133],"technical":[134],"capability":[135],"finally,":[140],"consideration":[141],"be":[143],"given":[144],"action":[148],"devices.":[151],"results":[153],"provide":[154],"optimal":[159],"resource":[163],"allocation":[164],"recommendations":[165],"support":[167],"developing":[170],"strategies":[174],"as":[175,177],"well":[176],"ensuring":[178],"safety":[180],"effectiveness":[182],"products":[185],"end":[187],"users.":[188]},"counts_by_year":[{"year":2026,"cited_by_count":6},{"year":2025,"cited_by_count":9},{"year":2024,"cited_by_count":4},{"year":2023,"cited_by_count":2}],"updated_date":"2026-11-07T11:25:07.637180","created_date":"2023-06-08T00:00:00"}