{"id":"https://openalex.org/W4322502875","doi":"https://doi.org/10.3390/s23052578","title":"Medical Devices with Embedded Sensor Systems: Design and Development Methodology for Start-Ups","display_name":"Medical Devices with Embedded Sensor Systems: Design and Development Methodology for Start-Ups","publication_year":2023,"publication_date":"2023-02-26","ids":{"openalex":"https://openalex.org/W4322502875","doi":"https://doi.org/10.3390/s23052578","pmid":"https://pubmed.ncbi.nlm.nih.gov/36904782"},"language":"en","primary_location":{"id":"doi:10.3390/s23052578","is_oa":true,"landing_page_url":"https://doi.org/10.3390/s23052578","pdf_url":"https://www.mdpi.com/1424-8220/23/5/2578/pdf?version=1677656539","source":{"id":"https://openalex.org/S101949793","display_name":"Sensors","issn_l":"1424-8220","issn":["1424-8220"],"is_oa":true,"is_in_doaj":true,"is_core":true,"host_organization":"https://openalex.org/P4310310987","host_organization_name":"Multidisciplinary Digital Publishing Institute","host_organization_lineage":["https://openalex.org/P4310310987"],"host_organization_lineage_names":["Multidisciplinary Digital Publishing Institute"],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Sensors","raw_type":"journal-article"},"type":"article","indexed_in":["crossref","doaj","pubmed"],"open_access":{"is_oa":true,"oa_status":"gold","oa_url":"https://www.mdpi.com/1424-8220/23/5/2578/pdf?version=1677656539","any_repository_has_fulltext":true},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5091014608","display_name":"Nerea Arandia","orcid":"https://orcid.org/0000-0003-2679-8068"},"institutions":[{"id":"https://openalex.org/I4210136402","display_name":"Tekniker","ror":"https://ror.org/033vryh36","country_code":"ES","type":"nonprofit","lineage":["https://openalex.org/I4210136402"]}],"countries":["ES"],"is_corresponding":true,"raw_author_name":"Nerea Arandia","raw_affiliation_strings":["Tekniker, Basque Research and Technology Alliance (BRTA), 20600 Eibar, Spain"],"raw_orcid":"https://orcid.org/0000-0003-2679-8068","affiliations":[{"raw_affiliation_string":"Tekniker, Basque Research and Technology Alliance (BRTA), 20600 Eibar, Spain","institution_ids":["https://openalex.org/I4210136402"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5054407704","display_name":"Jos\u00e9 Ignacio G\u00e1rate","orcid":"https://orcid.org/0000-0003-0343-6320"},"institutions":[{"id":"https://openalex.org/I169108374","display_name":"University of the Basque Country","ror":"https://ror.org/000xsnr85","country_code":"ES","type":"education","lineage":["https://openalex.org/I169108374"]}],"countries":["ES"],"is_corresponding":false,"raw_author_name":"Jose Ignacio Garate","raw_affiliation_strings":["Department of Electronics Technology, University of the Basque Country (UPV/EHU), 48080 Bilbao, Spain"],"raw_orcid":"https://orcid.org/0000-0003-0343-6320","affiliations":[{"raw_affiliation_string":"Department of Electronics Technology, University of the Basque Country (UPV/EHU), 48080 Bilbao, Spain","institution_ids":["https://openalex.org/I169108374"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5035176775","display_name":"Jon Mabe","orcid":"https://orcid.org/0000-0002-0211-842X"},"institutions":[{"id":"https://openalex.org/I4210136402","display_name":"Tekniker","ror":"https://ror.org/033vryh36","country_code":"ES","type":"nonprofit","lineage":["https://openalex.org/I4210136402"]}],"countries":["ES"],"is_corresponding":false,"raw_author_name":"Jon Mabe","raw_affiliation_strings":["Tekniker, Basque Research and Technology Alliance (BRTA), 20600 Eibar, Spain"],"raw_orcid":"https://orcid.org/0000-0002-0211-842X","affiliations":[{"raw_affiliation_string":"Tekniker, Basque Research and Technology Alliance (BRTA), 20600 Eibar, Spain","institution_ids":["https://openalex.org/I4210136402"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":2,"corresponding_author_ids":["https://openalex.org/A5091014608"],"corresponding_institution_ids":["https://openalex.org/I4210136402"],"apc_list":{"value":2400,"currency":"CHF","value_usd":2673},"apc_paid":{"value":2400,"currency":"CHF","value_usd":2673},"fwci":6.1632,"has_fulltext":true,"cited_by_count":14,"citation_normalized_percentile":{"value":0.96248669,"is_in_top_1_percent":false,"is_in_top_10_percent":true},"cited_by_percentile_year":{"min":94,"max":98},"biblio":{"volume":"23","issue":"5","first_page":"2578","last_page":"2578"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T10430","display_name":"Software Engineering Techniques and Practices","score":0.994700014591217,"subfield":{"id":"https://openalex.org/subfields/1710","display_name":"Information Systems"},"field":{"id":"https://openalex.org/fields/17","display_name":"Computer Science"},"domain":{"id":"https://openalex.org/domains/3","display_name":"Physical Sciences"}},"topics":[{"id":"https://openalex.org/T10430","display_name":"Software Engineering Techniques and Practices","score":0.994700014591217,"subfield":{"id":"https://openalex.org/subfields/1710","display_name":"Information Systems"},"field":{"id":"https://openalex.org/fields/17","display_name":"Computer Science"},"domain":{"id":"https://openalex.org/domains/3","display_name":"Physical Sciences"}},{"id":"https://openalex.org/T14306","display_name":"Technology Assessment and Management","score":0.9887999892234802,"subfield":{"id":"https://openalex.org/subfields/2213","display_name":"Safety, Risk, Reliability and Quality"},"field":{"id":"https://openalex.org/fields/22","display_name":"Engineering"},"domain":{"id":"https://openalex.org/domains/3","display_name":"Physical Sciences"}},{"id":"https://openalex.org/T13280","display_name":"Biomedical and Engineering Education","score":0.9649999737739563,"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/risk-analysis","display_name":"Risk analysis (engineering)","score":0.5264859199523926},{"id":"https://openalex.org/keywords/computer-science","display_name":"Computer science","score":0.5171739459037781},{"id":"https://openalex.org/keywords/key","display_name":"Key (lock)","score":0.4761602580547333},{"id":"https://openalex.org/keywords/wearable-computer","display_name":"Wearable computer","score":0.46577852964401245},{"id":"https://openalex.org/keywords/certification","display_name":"Certification","score":0.45986413955688477},{"id":"https://openalex.org/keywords/new-product-development","display_name":"New product development","score":0.4572041630744934},{"id":"https://openalex.org/keywords/systems-engineering","display_name":"Systems engineering","score":0.44183436036109924},{"id":"https://openalex.org/keywords/design-methods","display_name":"Design methods","score":0.42625537514686584},{"id":"https://openalex.org/keywords/medical-device","display_name":"Medical device","score":0.4228309094905853},{"id":"https://openalex.org/keywords/manufacturing-engineering","display_name":"Manufacturing engineering","score":0.38964903354644775},{"id":"https://openalex.org/keywords/engineering","display_name":"Engineering","score":0.3828311562538147},{"id":"https://openalex.org/keywords/embedded-system","display_name":"Embedded system","score":0.33631977438926697},{"id":"https://openalex.org/keywords/computer-security","display_name":"Computer security","score":0.14512234926223755},{"id":"https://openalex.org/keywords/business","display_name":"Business","score":0.10610014200210571}],"concepts":[{"id":"https://openalex.org/C112930515","wikidata":"https://www.wikidata.org/wiki/Q4389547","display_name":"Risk analysis (engineering)","level":1,"score":0.5264859199523926},{"id":"https://openalex.org/C41008148","wikidata":"https://www.wikidata.org/wiki/Q21198","display_name":"Computer science","level":0,"score":0.5171739459037781},{"id":"https://openalex.org/C26517878","wikidata":"https://www.wikidata.org/wiki/Q228039","display_name":"Key (lock)","level":2,"score":0.4761602580547333},{"id":"https://openalex.org/C150594956","wikidata":"https://www.wikidata.org/wiki/Q1334829","display_name":"Wearable computer","level":2,"score":0.46577852964401245},{"id":"https://openalex.org/C46304622","wikidata":"https://www.wikidata.org/wiki/Q374814","display_name":"Certification","level":2,"score":0.45986413955688477},{"id":"https://openalex.org/C19351080","wikidata":"https://www.wikidata.org/wiki/Q1395034","display_name":"New product development","level":2,"score":0.4572041630744934},{"id":"https://openalex.org/C201995342","wikidata":"https://www.wikidata.org/wiki/Q682496","display_name":"Systems engineering","level":1,"score":0.44183436036109924},{"id":"https://openalex.org/C138852830","wikidata":"https://www.wikidata.org/wiki/Q2292993","display_name":"Design methods","level":2,"score":0.42625537514686584},{"id":"https://openalex.org/C3020535179","wikidata":"https://www.wikidata.org/wiki/Q6554101","display_name":"Medical device","level":2,"score":0.4228309094905853},{"id":"https://openalex.org/C117671659","wikidata":"https://www.wikidata.org/wiki/Q11049265","display_name":"Manufacturing engineering","level":1,"score":0.38964903354644775},{"id":"https://openalex.org/C127413603","wikidata":"https://www.wikidata.org/wiki/Q11023","display_name":"Engineering","level":0,"score":0.3828311562538147},{"id":"https://openalex.org/C149635348","wikidata":"https://www.wikidata.org/wiki/Q193040","display_name":"Embedded system","level":1,"score":0.33631977438926697},{"id":"https://openalex.org/C38652104","wikidata":"https://www.wikidata.org/wiki/Q3510521","display_name":"Computer security","level":1,"score":0.14512234926223755},{"id":"https://openalex.org/C144133560","wikidata":"https://www.wikidata.org/wiki/Q4830453","display_name":"Business","level":0,"score":0.10610014200210571},{"id":"https://openalex.org/C136229726","wikidata":"https://www.wikidata.org/wiki/Q327092","display_name":"Biomedical engineering","level":1,"score":0.0},{"id":"https://openalex.org/C199539241","wikidata":"https://www.wikidata.org/wiki/Q7748","display_name":"Law","level":1,"score":0.0},{"id":"https://openalex.org/C17744445","wikidata":"https://www.wikidata.org/wiki/Q36442","display_name":"Political science","level":0,"score":0.0},{"id":"https://openalex.org/C162853370","wikidata":"https://www.wikidata.org/wiki/Q39809","display_name":"Marketing","level":1,"score":0.0},{"id":"https://openalex.org/C78519656","wikidata":"https://www.wikidata.org/wiki/Q101333","display_name":"Mechanical engineering","level":1,"score":0.0}],"mesh":[{"descriptor_ui":"D000076251","descriptor_name":"Wearable Electronic Devices","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D000076251","descriptor_name":"Wearable Electronic Devices","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D000076251","descriptor_name":"Wearable Electronic Devices","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D055986","descriptor_name":"Vital Signs","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D055986","descriptor_name":"Vital Signs","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D055986","descriptor_name":"Vital Signs","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false}],"locations_count":6,"locations":[{"id":"doi:10.3390/s23052578","is_oa":true,"landing_page_url":"https://doi.org/10.3390/s23052578","pdf_url":"https://www.mdpi.com/1424-8220/23/5/2578/pdf?version=1677656539","source":{"id":"https://openalex.org/S101949793","display_name":"Sensors","issn_l":"1424-8220","issn":["1424-8220"],"is_oa":true,"is_in_doaj":true,"is_core":true,"host_organization":"https://openalex.org/P4310310987","host_organization_name":"Multidisciplinary Digital Publishing Institute","host_organization_lineage":["https://openalex.org/P4310310987"],"host_organization_lineage_names":["Multidisciplinary Digital Publishing Institute"],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Sensors","raw_type":"journal-article"},{"id":"pmid:36904782","is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/36904782","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,"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":"Sensors (Basel, Switzerland)","raw_type":null},{"id":"pmh:oai:addi.ehu.eus:10810/60337","is_oa":true,"landing_page_url":"http://hdl.handle.net/10810/60337","pdf_url":"http://addi.ehu.es/bitstream/10810/60337/1/sensors-23-02578-v2.pdf","source":{"id":"https://openalex.org/S4306401964","display_name":"Communities in ADDI (University of the Basque Country)","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"host_organization":"https://openalex.org/I169108374","host_organization_name":"University of the Basque Country","host_organization_lineage":["https://openalex.org/I169108374"],"host_organization_lineage_names":[],"type":"repository"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"submittedVersion","is_accepted":false,"is_published":false,"raw_source_name":"","raw_type":"info:eu-repo/semantics/article"},{"id":"pmh:oai:pubmedcentral.nih.gov:10007284","is_oa":true,"landing_page_url":"https://www.ncbi.nlm.nih.gov/pmc/articles/10007284","pdf_url":null,"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,"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":"submittedVersion","is_accepted":false,"is_published":false,"raw_source_name":"Sensors (Basel)","raw_type":"Text"},{"id":"pmh:oai:doaj.org/article:657648226c534b0fa891b9c4bc926a69","is_oa":true,"landing_page_url":"https://doaj.org/article/657648226c534b0fa891b9c4bc926a69","pdf_url":null,"source":{"id":"https://openalex.org/S4306401280","display_name":"DOAJ (DOAJ: Directory of Open Access Journals)","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"host_organization":null,"host_organization_name":null,"host_organization_lineage":[],"host_organization_lineage_names":[],"type":"repository"},"license":"cc-by-sa","license_id":"https://openalex.org/licenses/cc-by-sa","version":"submittedVersion","is_accepted":false,"is_published":false,"raw_source_name":"Sensors, Vol 23, Iss 5, p 2578 (2023)","raw_type":"article"},{"id":"pmh:oai:mdpi.com:/1424-8220/23/5/2578/","is_oa":true,"landing_page_url":"https://dx.doi.org/10.3390/s23052578","pdf_url":null,"source":{"id":"https://openalex.org/S4306400947","display_name":"MDPI (MDPI AG)","issn_l":null,"issn":null,"is_oa":true,"is_in_doaj":false,"is_core":false,"host_organization":"https://openalex.org/I4210097602","host_organization_name":"Multidisciplinary Digital Publishing Institute (Switzerland)","host_organization_lineage":["https://openalex.org/I4210097602"],"host_organization_lineage_names":[],"type":"repository"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"submittedVersion","is_accepted":false,"is_published":false,"raw_source_name":"Sensors","raw_type":"Text"}],"best_oa_location":{"id":"doi:10.3390/s23052578","is_oa":true,"landing_page_url":"https://doi.org/10.3390/s23052578","pdf_url":"https://www.mdpi.com/1424-8220/23/5/2578/pdf?version=1677656539","source":{"id":"https://openalex.org/S101949793","display_name":"Sensors","issn_l":"1424-8220","issn":["1424-8220"],"is_oa":true,"is_in_doaj":true,"is_core":true,"host_organization":"https://openalex.org/P4310310987","host_organization_name":"Multidisciplinary Digital Publishing Institute","host_organization_lineage":["https://openalex.org/P4310310987"],"host_organization_lineage_names":["Multidisciplinary Digital Publishing Institute"],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Sensors","raw_type":"journal-article"},"sustainable_development_goals":[{"display_name":"Industry, innovation and infrastructure","score":0.5,"id":"https://metadata.un.org/sdg/9"}],"awards":[{"id":"https://openalex.org/G2457834208","display_name":null,"funder_award_id":"CER-20211003","funder_id":"https://openalex.org/F4320321043","funder_display_name":"Centro para el Desarrollo Tecnol\u00f3gico Industrial"}],"funders":[{"id":"https://openalex.org/F4320321043","display_name":"Centro para el Desarrollo Tecnol\u00f3gico Industrial","ror":"https://ror.org/0124x7055"}],"has_content":{"grobid_xml":false,"pdf":true},"content_urls":{"pdf":"https://content.openalex.org/works/W4322502875.pdf"},"referenced_works_count":41,"referenced_works":["https://openalex.org/W1486782512","https://openalex.org/W1545785109","https://openalex.org/W2004873752","https://openalex.org/W2037889871","https://openalex.org/W2073053192","https://openalex.org/W2134062730","https://openalex.org/W2165500415","https://openalex.org/W2181712710","https://openalex.org/W2284252859","https://openalex.org/W2498583220","https://openalex.org/W2499640337","https://openalex.org/W2506856518","https://openalex.org/W2530254210","https://openalex.org/W2539177311","https://openalex.org/W2603732955","https://openalex.org/W2605890780","https://openalex.org/W2765437775","https://openalex.org/W2793067277","https://openalex.org/W2793518681","https://openalex.org/W2870704319","https://openalex.org/W2907560629","https://openalex.org/W2921306725","https://openalex.org/W2921408567","https://openalex.org/W2922083361","https://openalex.org/W3095763442","https://openalex.org/W3099030530","https://openalex.org/W3118464080","https://openalex.org/W3123713150","https://openalex.org/W3129781879","https://openalex.org/W3137010999","https://openalex.org/W3197509362","https://openalex.org/W4231675101","https://openalex.org/W4283693271","https://openalex.org/W4300681202","https://openalex.org/W4312196203","https://openalex.org/W6682495112","https://openalex.org/W6685904288","https://openalex.org/W6789814316","https://openalex.org/W6791686937","https://openalex.org/W6801190317","https://openalex.org/W6831071378"],"related_works":["https://openalex.org/W2899084033","https://openalex.org/W2329452785","https://openalex.org/W2356380379","https://openalex.org/W2363925233","https://openalex.org/W2366284060","https://openalex.org/W1794016765","https://openalex.org/W1457512362","https://openalex.org/W2350180741","https://openalex.org/W2028482608","https://openalex.org/W2110476174"],"abstract_inverted_index":{"Embedded":[0],"systems":[1],"have":[2],"become":[3],"a":[4,29,43,112],"key":[5],"technology":[6],"for":[7,115,131],"the":[8,14,54,58,72,94,109,120,128,132,146],"evolution":[9],"of":[10,74,111],"medical":[11,36,50],"devices.":[12],"However,":[13],"regulatory":[15],"requirements":[16],"that":[17],"must":[18],"be":[19],"met":[20],"make":[21],"designing":[22],"and":[23,47,62,80,83],"developing":[24],"these":[25],"devices":[26,37,51,133],"challenging.":[27],"As":[28],"result,":[30],"many":[31],"start-ups":[32],"attempting":[33],"to":[34,45],"develop":[35,48],"fail.":[38],"Therefore,":[39],"this":[40,88],"article":[41],"presents":[42],"methodology":[44,68,98],"design":[46],"embedded":[49],"while":[52],"minimising":[53],"economic":[55],"investment":[56],"during":[57],"technical":[59],"risk":[60],"stages":[61],"encouraging":[63],"customer":[64],"feedback.":[65],"The":[66,97,123],"proposed":[67,129,147],"is":[69,89,101,119,142],"based":[70],"on":[71],"execution":[73],"three":[75],"stages:":[76],"Development":[77],"Feasibility,":[78],"Incremental":[79],"Iterative":[81],"Prototyping,":[82],"Medical":[84],"Product":[85],"Consolidation.":[86],"All":[87],"completed":[90],"in":[91,107],"compliance":[92],"with":[93],"applicable":[95],"regulations.":[96],"mentioned":[99],"above":[100],"validated":[102],"through":[103],"practical":[104],"use":[105,125],"cases":[106,126],"which":[108],"development":[110],"wearable":[113],"device":[114],"monitoring":[116],"vital":[117],"signs":[118],"most":[121],"relevant.":[122],"presented":[124],"sustain":[127],"methodology,":[130],"were":[134],"successfully":[135],"CE":[136],"marked.":[137],"Moreover,":[138],"ISO":[139],"13485":[140],"certification":[141],"obtained":[143],"by":[144],"following":[145],"procedures.":[148]},"counts_by_year":[{"year":2026,"cited_by_count":1},{"year":2025,"cited_by_count":5},{"year":2024,"cited_by_count":6},{"year":2023,"cited_by_count":2}],"updated_date":"2026-07-22T07:51:19.307946","created_date":"2025-10-10T00:00:00"}