{"id":"https://openalex.org/W1966973035","doi":"https://doi.org/10.1109/agile.2009.50","title":"Adopting Agile in an FDA Regulated Environment","display_name":"Adopting Agile in an FDA Regulated Environment","publication_year":2009,"publication_date":"2009-08-01","ids":{"openalex":"https://openalex.org/W1966973035","doi":"https://doi.org/10.1109/agile.2009.50","mag":"1966973035"},"language":"en","primary_location":{"id":"doi:10.1109/agile.2009.50","is_oa":false,"landing_page_url":"https://doi.org/10.1109/agile.2009.50","pdf_url":null,"source":null,"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"2009 Agile Conference","raw_type":"proceedings-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":null,"display_name":"Rod Rasmussen","orcid":null},"institutions":[{"id":"https://openalex.org/I4210088555","display_name":"Abbott (United States)","ror":"https://ror.org/0052svj16","country_code":"US","type":"company","lineage":["https://openalex.org/I4210088555"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Rod Rasmussen","raw_affiliation_strings":["Abbott, Abbott Park, IL, USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Abbott, Abbott Park, IL, USA","institution_ids":["https://openalex.org/I4210088555"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5103028586","display_name":"Tim Hughes","orcid":"https://orcid.org/0000-0002-0923-9937"},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Tim Hughes","raw_affiliation_strings":["AgileTek LLC, Des Plaines, IL, USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"AgileTek LLC, Des Plaines, IL, USA","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5064597285","display_name":"J.R. Jenks","orcid":null},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"J.R. Jenks","raw_affiliation_strings":["AgileTek LLC, Des Plaines, IL, USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"AgileTek LLC, Des Plaines, IL, USA","institution_ids":[]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5085494692","display_name":"John Skach","orcid":null},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"John Skach","raw_affiliation_strings":["AgileTek LLC, Des Plaines, IL, USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"AgileTek LLC, Des Plaines, IL, USA","institution_ids":[]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":4,"corresponding_author_ids":[],"corresponding_institution_ids":[],"apc_list":null,"apc_paid":null,"fwci":2.7557,"has_fulltext":false,"cited_by_count":53,"citation_normalized_percentile":{"value":0.89133645,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":{"min":90,"max":99},"biblio":{"volume":null,"issue":null,"first_page":"151","last_page":"155"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T13280","display_name":"Biomedical and Engineering Education","score":0.9873999953269958,"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":0.9873999953269958,"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"}},{"id":"https://openalex.org/T10430","display_name":"Software Engineering Techniques and Practices","score":0.9366000294685364,"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"}}],"keywords":[{"id":"https://openalex.org/keywords/agile-software-development","display_name":"Agile software development","score":0.9247263669967651},{"id":"https://openalex.org/keywords/food-and-drug-administration","display_name":"Food and drug administration","score":0.7344788312911987},{"id":"https://openalex.org/keywords/agile-unified-process","display_name":"Agile Unified Process","score":0.6877381205558777},{"id":"https://openalex.org/keywords/agile-usability-engineering","display_name":"Agile usability engineering","score":0.5014395713806152},{"id":"https://openalex.org/keywords/computer-science","display_name":"Computer science","score":0.489300936460495},{"id":"https://openalex.org/keywords/best-practice","display_name":"Best practice","score":0.4824988842010498},{"id":"https://openalex.org/keywords/engineering-management","display_name":"Engineering management","score":0.4764585793018341},{"id":"https://openalex.org/keywords/realization","display_name":"Realization (probability)","score":0.44992929697036743},{"id":"https://openalex.org/keywords/extreme-programming-practices","display_name":"Extreme programming practices","score":0.44722241163253784},{"id":"https://openalex.org/keywords/software","display_name":"Software","score":0.3953593969345093},{"id":"https://openalex.org/keywords/process-management","display_name":"Process management","score":0.3842920958995819},{"id":"https://openalex.org/keywords/software-engineering","display_name":"Software engineering","score":0.334244966506958},{"id":"https://openalex.org/keywords/knowledge-management","display_name":"Knowledge management","score":0.3333398103713989},{"id":"https://openalex.org/keywords/engineering","display_name":"Engineering","score":0.29531681537628174},{"id":"https://openalex.org/keywords/risk-analysis","display_name":"Risk analysis (engineering)","score":0.264196515083313},{"id":"https://openalex.org/keywords/software-development","display_name":"Software development","score":0.257377028465271},{"id":"https://openalex.org/keywords/business","display_name":"Business","score":0.23012149333953857},{"id":"https://openalex.org/keywords/software-development-process","display_name":"Software development process","score":0.2065817415714264},{"id":"https://openalex.org/keywords/management","display_name":"Management","score":0.10214096307754517}],"concepts":[{"id":"https://openalex.org/C14185376","wikidata":"https://www.wikidata.org/wiki/Q30232","display_name":"Agile software development","level":2,"score":0.9247263669967651},{"id":"https://openalex.org/C3018890749","wikidata":"https://www.wikidata.org/wiki/Q204711","display_name":"Food and drug administration","level":2,"score":0.7344788312911987},{"id":"https://openalex.org/C87813535","wikidata":"https://www.wikidata.org/wiki/Q956418","display_name":"Agile Unified Process","level":5,"score":0.6877381205558777},{"id":"https://openalex.org/C36837802","wikidata":"https://www.wikidata.org/wiki/Q17011481","display_name":"Agile usability engineering","level":5,"score":0.5014395713806152},{"id":"https://openalex.org/C41008148","wikidata":"https://www.wikidata.org/wiki/Q21198","display_name":"Computer science","level":0,"score":0.489300936460495},{"id":"https://openalex.org/C184356942","wikidata":"https://www.wikidata.org/wiki/Q830382","display_name":"Best practice","level":2,"score":0.4824988842010498},{"id":"https://openalex.org/C110354214","wikidata":"https://www.wikidata.org/wiki/Q6314146","display_name":"Engineering management","level":1,"score":0.4764585793018341},{"id":"https://openalex.org/C2781089630","wikidata":"https://www.wikidata.org/wiki/Q21856745","display_name":"Realization (probability)","level":2,"score":0.44992929697036743},{"id":"https://openalex.org/C170291536","wikidata":"https://www.wikidata.org/wiki/Q5422448","display_name":"Extreme programming practices","level":5,"score":0.44722241163253784},{"id":"https://openalex.org/C2777904410","wikidata":"https://www.wikidata.org/wiki/Q7397","display_name":"Software","level":2,"score":0.3953593969345093},{"id":"https://openalex.org/C195094911","wikidata":"https://www.wikidata.org/wiki/Q14167904","display_name":"Process management","level":1,"score":0.3842920958995819},{"id":"https://openalex.org/C115903868","wikidata":"https://www.wikidata.org/wiki/Q80993","display_name":"Software engineering","level":1,"score":0.334244966506958},{"id":"https://openalex.org/C56739046","wikidata":"https://www.wikidata.org/wiki/Q192060","display_name":"Knowledge management","level":1,"score":0.3333398103713989},{"id":"https://openalex.org/C127413603","wikidata":"https://www.wikidata.org/wiki/Q11023","display_name":"Engineering","level":0,"score":0.29531681537628174},{"id":"https://openalex.org/C112930515","wikidata":"https://www.wikidata.org/wiki/Q4389547","display_name":"Risk analysis (engineering)","level":1,"score":0.264196515083313},{"id":"https://openalex.org/C529173508","wikidata":"https://www.wikidata.org/wiki/Q638608","display_name":"Software development","level":3,"score":0.257377028465271},{"id":"https://openalex.org/C144133560","wikidata":"https://www.wikidata.org/wiki/Q4830453","display_name":"Business","level":0,"score":0.23012149333953857},{"id":"https://openalex.org/C180152950","wikidata":"https://www.wikidata.org/wiki/Q2904257","display_name":"Software development process","level":4,"score":0.2065817415714264},{"id":"https://openalex.org/C187736073","wikidata":"https://www.wikidata.org/wiki/Q2920921","display_name":"Management","level":1,"score":0.10214096307754517},{"id":"https://openalex.org/C162324750","wikidata":"https://www.wikidata.org/wiki/Q8134","display_name":"Economics","level":0,"score":0.0},{"id":"https://openalex.org/C199360897","wikidata":"https://www.wikidata.org/wiki/Q9143","display_name":"Programming language","level":1,"score":0.0},{"id":"https://openalex.org/C105795698","wikidata":"https://www.wikidata.org/wiki/Q12483","display_name":"Statistics","level":1,"score":0.0},{"id":"https://openalex.org/C33923547","wikidata":"https://www.wikidata.org/wiki/Q395","display_name":"Mathematics","level":0,"score":0.0}],"mesh":[],"locations_count":1,"locations":[{"id":"doi:10.1109/agile.2009.50","is_oa":false,"landing_page_url":"https://doi.org/10.1109/agile.2009.50","pdf_url":null,"source":null,"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"2009 Agile Conference","raw_type":"proceedings-article"}],"best_oa_location":null,"sustainable_development_goals":[{"id":"https://metadata.un.org/sdg/17","score":0.46000000834465027,"display_name":"Partnerships for the goals"}],"awards":[],"funders":[],"has_content":{"grobid_xml":false,"pdf":false},"content_urls":null,"referenced_works_count":0,"referenced_works":[],"related_works":["https://openalex.org/W1497203923","https://openalex.org/W4376498447","https://openalex.org/W2607592281","https://openalex.org/W3082577432","https://openalex.org/W2169992518","https://openalex.org/W2113109691","https://openalex.org/W2184909477","https://openalex.org/W3099012432","https://openalex.org/W2534333789","https://openalex.org/W2108509292"],"abstract_inverted_index":{"This":[0,77],"paper":[1],"is":[2,86],"an":[3,83],"experience":[4,78],"report":[5],"describing":[6],"Abbottpsilas":[7],"adoption":[8,51],"of":[9,33,52,57,63,93],"agile":[10,28,53,84],"software":[11],"development":[12,92],"practices":[13,54],"in":[14],"its":[15],"molecular":[16],"diagnostics":[17],"division.":[18],"We":[19,47],"will":[20,48],"compare":[21],"two":[22],"medical":[23,95],"device":[24],"projects;":[25],"one":[26,30],"before":[27],"and":[29,44,68,70,74],"after.":[31],"Both":[32],"these":[34],"projects":[35],"required":[36],"submission":[37],"to":[38,60,66,72,91],"the":[39,50,58,61,87],"FDA":[40],"(the":[41],"U.S.":[42],"Food":[43],"Drug":[45],"Administration).":[46],"describe":[49],"from":[55],"realization":[56],"need":[59],"selection":[62],"a":[64],"mentor":[65],"implementation":[67],"fine-tuning":[69],"finally":[71],"results":[73],"lessons":[75],"learned.":[76],"has":[79],"convinced":[80],"us":[81],"that":[82],"approach":[85,88],"best":[89],"suited":[90],"FDA-regulated":[94],"devices.":[96]},"counts_by_year":[{"year":2025,"cited_by_count":1},{"year":2023,"cited_by_count":2},{"year":2022,"cited_by_count":1},{"year":2021,"cited_by_count":6},{"year":2020,"cited_by_count":2},{"year":2019,"cited_by_count":3},{"year":2018,"cited_by_count":4},{"year":2017,"cited_by_count":6},{"year":2016,"cited_by_count":5},{"year":2015,"cited_by_count":3},{"year":2014,"cited_by_count":1},{"year":2013,"cited_by_count":7},{"year":2012,"cited_by_count":7}],"updated_date":"2026-06-11T09:08:48.828518","created_date":"2025-10-10T00:00:00"}