{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,28]],"date-time":"2026-08-28T04:16:57Z","timestamp":1787890617270,"version":"build-2784847793"},"reference-count":27,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2026,8,3]],"date-time":"2026-08-03T00:00:00Z","timestamp":1785715200000},"content-version":"vor","delay-in-days":2,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2026,8,1]],"date-time":"2026-08-01T00:00:00Z","timestamp":1785542400000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/501100001780","name":"RMIT University","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100001780","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100015539","name":"Australian Government","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100015539","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Numer Methods Biomed Eng"],"published-print":{"date-parts":[[2026,8]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>\n                    Digital twins have transformed design and verification workflows in engineering, yet their adoption within medical device development remains limited. Conventional build\u2010and\u2010test approaches restrict design space exploration and often delay identification of mechanically critical risks. This paper presents a case study on the development of a calibrated, design\u2010phase behavioral digital twin for a capsule\u2010based biomedical delivery system used in dentistry, with the annular snap\u2010fit nozzle\u2010to\u2010body interface selected as a representative mechanically sensitive feature. Empirical testing, analytical snap\u2010fit theory and nonlinear Finite Element Analysis (FEA) were integrated to characterize mating force, strain and structural safety during assembly. Strong pre\u2010calibration agreement was observed between the analytical and numerical models and back\u2010calculation of an effective polymer\u2010to\u2010polymer coefficient of friction (\n                    <jats:italic>\u03bc<\/jats:italic>\n                    \u2009=\u20090.12) reduced prediction error relative to empirical measurements to within experimental repeatability, establishing a validated behavioral digital twin. Design optimization employed a Taguchi orthogonal array to efficiently explore strain\u2010constrained geometric variation. Results identified undercut depth, governed by nozzle inner diameter, as the dominant contributor to retention strength. An optimized configuration achieved a 65%\u201375% increase in mating force relative to the baseline design while remaining within permissible strain limits. Numerical verification predicted peak mating force of 190\u2009N and identified localized stress concentrations in the nozzle neck region, highlighting reinforcement requirements before production tooling. Physical verification and validation of the optimized system confirmed the predicted increase in structural performance. Consistent with the digital twin maturity continuum, the framework is positioned as a design\u2010phase, behavioral digital twin. It operates with offline one\u2010way physical\u2010to\u2010digital data flow during the product realization stage, with automated bidirectional synchronization identified as the next stage of development. These findings demonstrate how digital twins can shift biomedical device development from reactive validation towards predictive, manufacturability\u2010aware design, strengthening patient safety, clinician confidence and regulatory assurance in Class II medical devices.\n                  <\/jats:p>","DOI":"10.1002\/cnm.70203","type":"journal-article","created":{"date-parts":[[2026,8,4]],"date-time":"2026-08-04T01:25:56Z","timestamp":1785806756000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Development of Design\u2010Phase Digital Twin for Structural Optimization of a Biomedical Device"],"prefix":"10.1002","volume":"42","author":[{"ORCID":"https:\/\/orcid.org\/0009-0000-6797-0448","authenticated-orcid":false,"given":"Tanguy Ren\u00e9","family":"Pinol","sequence":"first","affiliation":[{"name":"Biomedical Engineering, School of Engineering, STEM College RMIT University  Melbourne Victoria Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9131-5889","authenticated-orcid":false,"given":"Leon Hugh","family":"Prentice","sequence":"additional","affiliation":[{"name":"SDI Limited  Bayswater Victoria Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8090-3215","authenticated-orcid":false,"given":"Kate","family":"Fox","sequence":"additional","affiliation":[{"name":"Biomedical Engineering, School of Engineering, STEM College RMIT University  Melbourne Victoria Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4766-3042","authenticated-orcid":false,"given":"Toh Yen","family":"Pang","sequence":"additional","affiliation":[{"name":"Biomedical Engineering, School of Engineering, STEM College RMIT University  Melbourne Victoria Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,8,3]]},"reference":[{"key":"e_1_2_13_2_1","doi-asserted-by":"publisher","DOI":"10.3390\/jfb15020048"},{"key":"e_1_2_13_3_1","volume-title":"Dentistry\u2014Pre\u2010Capsulated Dental Amalgam, ISO 20749:2023","year":"2023"},{"key":"e_1_2_13_4_1","unstructured":"Bayer Material Science LLC \u201cSnap\u2010Fit Joints for Plastics\u2013A Design Guide \u201d(2013)."},{"key":"e_1_2_13_5_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10796\u2010024\u201010536\u20104"},{"key":"e_1_2_13_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.heliyon.2023.e19390"},{"key":"e_1_2_13_7_1","doi-asserted-by":"publisher","DOI":"10.1007\/s44174\u2010025\u201000469\u20100"},{"key":"e_1_2_13_8_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41746\u2010024\u201001073\u20100"},{"key":"e_1_2_13_9_1","doi-asserted-by":"publisher","DOI":"10.3390\/jpm12081255"},{"key":"e_1_2_13_10_1","volume-title":"Medical Devices\u2014Quality Management Systems\u2014Requirements for Regulatory Purposes, ISO 13485:2016","year":"2016"},{"key":"e_1_2_13_11_1","volume-title":"Medical Devices\u2014Application of Risk Management to Medical Devices, ISO 14971:2019","year":"2019"},{"key":"e_1_2_13_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.identj.2024.08.005"},{"key":"e_1_2_13_13_1","doi-asserted-by":"publisher","DOI":"10.4103\/jioh.Jioh_11_21"},{"key":"e_1_2_13_14_1","doi-asserted-by":"publisher","DOI":"10.14429\/dlsj.9.19439"},{"key":"e_1_2_13_15_1","doi-asserted-by":"publisher","DOI":"10.1002\/cnm.70113"},{"key":"e_1_2_13_16_1","doi-asserted-by":"publisher","DOI":"10.1002\/cnm.70174"},{"key":"e_1_2_13_17_1","doi-asserted-by":"publisher","DOI":"10.1002\/cnm.70175"},{"key":"e_1_2_13_18_1","doi-asserted-by":"publisher","DOI":"10.1109\/24.387375"},{"key":"e_1_2_13_19_1","volume-title":"Digital Twin\u2014Concepts and Terminology, ISO\/IEC 30173:2023","year":"2023"},{"key":"e_1_2_13_20_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ifacol.2018.08.474"},{"key":"e_1_2_13_21_1","doi-asserted-by":"publisher","DOI":"10.2196\/69544"},{"key":"e_1_2_13_22_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.hcc.2025.100340"},{"key":"e_1_2_13_23_1","doi-asserted-by":"publisher","DOI":"10.1002\/sys.70078"},{"key":"e_1_2_13_24_1","volume-title":"Metallic Materials\u2014Calibration and Verification of Static Uniaxial Testing Machines, ISO 7500\u20101:2018","year":"2018"},{"key":"e_1_2_13_25_1","volume-title":"Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions, FDA\u2010D\u20100980","year":"2021"},{"key":"e_1_2_13_26_1","volume-title":"Introduction to Statistical Quality Control","author":"Montgomery D. 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