{"id":12670,"date":"2026-05-05T16:09:39","date_gmt":"2026-05-05T14:09:39","guid":{"rendered":"https:\/\/www.healtis.com\/?p=12670"},"modified":"2026-05-05T16:15:31","modified_gmt":"2026-05-05T14:15:31","slug":"numerical-modelling-reliability-experience-and-dedicated-tools","status":"publish","type":"post","link":"https:\/\/www.healtis.com\/en\/numerical-modelling-reliability-experience-and-dedicated-tools\/","title":{"rendered":"Numerical modeling: reliability, experience and dedicated tools"},"content":{"rendered":"\r\n\r\n\r\n<p><em>(article updated on May, 5th 2026)<\/em><\/p>\r\n<h1>What is the role of numerical simulation for medical device heating in MRI environments?<\/h1>\r\n<h2>Introduction<\/h2>\r\n<p>In an MRI environment, radiofrequency (RF) electromagnetic fields can induce significant heating of implanted medical devices, posing a risk to patients.<\/p>\r\n<p>This heating is often localized, dependent on numerous parameters (type of implant, configuration, positioning, patient anatomy, MRI sequence, etc.), and highly variable from one situation to another. Consequently, it is generally impossible to reliably identify a &#8220;worst-case&#8221; configuration through simple theoretical reasoning or experimental testing alone.<\/p>\r\n<p>In this context, numerical simulations serve as a key tool for understanding, anticipating, and controlling these complex phenomena.<\/p>\r\n<h2>Evaluation of RF heating on passive implantable medical devices: a multi-step approach<\/h2>\r\n<p>Generally, the evaluation of RF-induced heating in MRI relies on three main complementary steps:<\/p>\r\n<ol>\r\n<li><strong>1.Numerical simulations: identifying the worst-case<\/strong><br \/>An initial numerical modeling study makes it possible to identify the most unfavorable device configuration, taking into account, where relevant, the surrounding tissues and realistic implantation scenarios.<br \/><br \/><\/li>\r\n<li><strong>2.RF Heating testing according to the ASTM F2182 standard<\/strong><br \/>The device identified as the worst-case is then subjected to ASTM testing (specifically ASTM F2182) in a phantom filled with conductive gel. These tests measure the temperature rise under reproducible and standardized conditions.<br \/><br \/><\/li>\r\n<li><strong>3.Complementary study: &#8220;in-vivo scaling&#8221; under realistic clinical conditions<\/strong><br \/>When necessary, an additional numerical study is conducted to transpose the results obtained in the ASTM phantom to an estimate of heating within the human body under realistic clinical conditions (<em>in vivo)<\/em>.<\/li>\r\n<\/ol>\r\n<p><img decoding=\"async\" class=\"alignnone  wp-image-18595\" src=\"https:\/\/www.healtis.com\/w2020\/wp-content\/uploads\/2023\/10\/Capture-decran-2026-05-05-151235.png\" alt=\"\" width=\"691\" height=\"210\" srcset=\"https:\/\/www.healtis.com\/w2020\/wp-content\/uploads\/2023\/10\/Capture-decran-2026-05-05-151235.png 1127w, https:\/\/www.healtis.com\/w2020\/wp-content\/uploads\/2023\/10\/Capture-decran-2026-05-05-151235-600x182.png 600w, https:\/\/www.healtis.com\/w2020\/wp-content\/uploads\/2023\/10\/Capture-decran-2026-05-05-151235-1000x303.png 1000w, https:\/\/www.healtis.com\/w2020\/wp-content\/uploads\/2023\/10\/Capture-decran-2026-05-05-151235-768x233.png 768w\" sizes=\"(max-width: 691px) 100vw, 691px\" \/><\/p>\r\n<h2>Worst-case identification<\/h2>\r\n<p data-path-to-node=\"3\">At Healtis, we provide a team of experts and <a href=\"https:\/\/www.healtis.com\/en\/prestation\/numerical-modeling\/\">advanced numerical modeling tools<\/a> specifically dedicated to evaluating RF-induced heating in MRI. For passive implantable medical devices, numerical modeling notably allows for:<\/p>\r\n<ul>\r\n<li data-path-to-node=\"4,0,0\">Identifying a worst-case configuration within complex product ranges (sizes, geometries, materials, variants);<\/li>\r\n<li data-path-to-node=\"4,0,0\">Locating &#8220;hot spots&#8221; likely to exhibit the highest temperature rises;<\/li>\r\n<\/ul>\r\n<p data-path-to-node=\"5\">These critical points identified through simulation will subsequently be monitored during real-world testing.<\/p>\r\n<p data-path-to-node=\"5\"><img decoding=\"async\" class=\"alignnone size-full wp-image-18598\" src=\"https:\/\/www.healtis.com\/w2020\/wp-content\/uploads\/2023\/10\/Image1.png\" alt=\"\" width=\"664\" height=\"392\" srcset=\"https:\/\/www.healtis.com\/w2020\/wp-content\/uploads\/2023\/10\/Image1.png 664w, https:\/\/www.healtis.com\/w2020\/wp-content\/uploads\/2023\/10\/Image1-593x350.png 593w\" sizes=\"(max-width: 664px) 100vw, 664px\" \/><\/p>\r\n<h2 data-path-to-node=\"5\">Consideration of multi-configurations and biological tissues<\/h2>\r\n<p>In accordance with the FDA guidance &#8220;Assessment of Radiofrequency Induced Heating in the Magnetic Resonance (MR) Environment for Multi-Configuration Passive Medical Devices,&#8221; a statistical approach is recommended when the number of possible configurations is very high (variability in dimensions, coatings, assemblies, offsets, etc.).<\/p>\r\n<p>This method reduces the number of configurations to be tested experimentally while ensuring a sufficient level of safety.<\/p>\r\n<p>Furthermore, when devices are implanted in or near tissues with electrical or thermal properties that differ significantly from the ASTM gel (such as bone), the FDA requires these tissues to be explicitly accounted for in the heating assessment. Numerical simulations are therefore the most suitable tool to integrate this complexity.<\/p>\r\n<p>We invite you to <a href=\"https:\/\/www.healtis.com\/en\/contact\/\">consult with us<\/a> to determine the specific requirements for your medical device.<\/p>\r\n<p><img decoding=\"async\" class=\"alignnone size-full wp-image-18601\" src=\"https:\/\/www.healtis.com\/w2020\/wp-content\/uploads\/2023\/10\/image_os_260505.png\" alt=\"\" width=\"290\" height=\"399\" srcset=\"https:\/\/www.healtis.com\/w2020\/wp-content\/uploads\/2023\/10\/image_os_260505.png 290w, https:\/\/www.healtis.com\/w2020\/wp-content\/uploads\/2023\/10\/image_os_260505-254x350.png 254w\" sizes=\"(max-width: 290px) 100vw, 290px\" \/><\/p>\r\n<h2>RF Heating testing in accordance with ASTM F2182<\/h2>\r\n<p>Radiofrequency-induced heating is caused by the absorption of RF energy by the conductive materials of medical devices. As specified above, the intensity of this phenomenon depends on numerous factors.<\/p>\r\n<p><a href=\"https:\/\/www.healtis.com\/en\/astm-f2182-rf-test-method-for-mri-implants-principle-limitations-and-clinical-relevance\/\">The ASTM F2182 standard<\/a> describes a reference method for evaluating this heating in passive implantable devices. This approach is based on several steps:<\/p>\r\n<ul>\r\n<li>Immersion of the device in a gel that replicates the electrical and thermal properties of the human body;<\/li>\r\n<li>Measurement of the temperature rise at locations likely to be hot spots around the device, as well as at a distant reference point;<\/li>\r\n<li>Repetition of measurements without the device present, in order to characterize the local RF exposure at the various measurement points.<\/li>\r\n<\/ul>\r\n<p>These tests characterize the thermal behavior of the implant within a standardized environment. However, they do not always allow for the direct prediction of heating under real-world clinical conditions, which justifies the use of complementary approaches.<\/p>\r\n<p><img decoding=\"async\" class=\"alignnone size-full wp-image-18604\" src=\"https:\/\/www.healtis.com\/w2020\/wp-content\/uploads\/2023\/10\/Image3.jpg\" alt=\"\" width=\"252\" height=\"336\" \/><\/p>\r\n<h2>Complementary study: in-vivo extrapolation<\/h2>\r\n<p data-path-to-node=\"3\">The ASTM F2182 standard specifies that the manufacturer is responsible for establishing the link between:<\/p>\r\n<ul data-path-to-node=\"4\">\r\n<li>\r\n<p data-path-to-node=\"4,0,0\">the temperature rise measured in the ASTM phantom,<\/p>\r\n<\/li>\r\n<li>\r\n<p data-path-to-node=\"4,1,0\">and the expected temperature rise in the patient under defined exposure conditions.<\/p>\r\n<\/li>\r\n<\/ul>\r\n<p data-path-to-node=\"5\">Experimental results can thus be used as input data for a numerical model to estimate the in-vivo temperature rise.<\/p>\r\n<p data-path-to-node=\"5\"><img decoding=\"async\" class=\"alignnone size-full wp-image-18607\" src=\"https:\/\/www.healtis.com\/w2020\/wp-content\/uploads\/2023\/10\/invivo_1.png\" alt=\"\" width=\"564\" height=\"267\" \/> <img decoding=\"async\" class=\"alignnone size-full wp-image-18610\" src=\"https:\/\/www.healtis.com\/w2020\/wp-content\/uploads\/2023\/10\/invivo_2.png\" alt=\"\" width=\"538\" height=\"424\" srcset=\"https:\/\/www.healtis.com\/w2020\/wp-content\/uploads\/2023\/10\/invivo_2.png 538w, https:\/\/www.healtis.com\/w2020\/wp-content\/uploads\/2023\/10\/invivo_2-444x350.png 444w\" sizes=\"(max-width: 538px) 100vw, 538px\" \/> <img decoding=\"async\" class=\"alignnone size-full wp-image-18613\" src=\"https:\/\/www.healtis.com\/w2020\/wp-content\/uploads\/2023\/10\/invivo_3.png\" alt=\"\" width=\"409\" height=\"713\" srcset=\"https:\/\/www.healtis.com\/w2020\/wp-content\/uploads\/2023\/10\/invivo_3.png 409w, https:\/\/www.healtis.com\/w2020\/wp-content\/uploads\/2023\/10\/invivo_3-201x350.png 201w, https:\/\/www.healtis.com\/w2020\/wp-content\/uploads\/2023\/10\/invivo_3-344x600.png 344w\" sizes=\"(max-width: 409px) 100vw, 409px\" \/><\/p>\r\n<p data-path-to-node=\"6\">At Healtis, in addition to ASTM F2182 testing, we offer these numerical extrapolation models with the objective of translating experimentally measured temperatures into an estimate of the temperature within the human body.<\/p>\r\n<p data-path-to-node=\"7\">These studies can rely on:<\/p>\r\n<ul>\r\n<li data-path-to-node=\"8,0,0\">CAD models of the implant;<\/li>\r\n<li data-path-to-node=\"8,0,0\">The use of multiple realistic human body models;<\/li>\r\n<li data-path-to-node=\"8,0,0\">Specific implantation scenarios;<\/li>\r\n<li data-path-to-node=\"8,0,0\">Various &#8220;birdcage&#8221; coils and body positions within the MRI;<\/li>\r\n<li data-path-to-node=\"8,0,0\">FDA-qualified tools (MDDT): IMAnalytics, MRIxViP, and BCLib.<\/li>\r\n<\/ul>\r\n<h2>From a regulatory perspective<\/h2>\r\n<p>In 2016, the FDA published a guidance specifically dedicated to the assessment of RF-induced heating in MRI, strongly encouraging the use of numerical simulations\u2014particularly for multi-configuration passive devices (such as joint or spinal implants, or any device where the final configuration may vary).<\/p>\r\n<p>The numerical modeling services offered by Healtis are fully aligned with these recommendations, enabling you to conduct rigorous, well-documented studies that are defensible from a regulatory standpoint.<\/p>\r\n<p>By leveraging our expertise, you ensure the safety of your patients while securing both your testing processes and your regulatory submissions.<\/p>\r\n<p>Would you like to learn more about MRI numerical simulations or our services?<\/p>\r\n<p>Contact us via <a href=\"https:\/\/www.healtis.com\/en\/contact\/\">our contact form<\/a>, email us at sales@healtis.com, or visit our website to discover how numerical modeling can support the development and certification of your medical devices.<\/p>\r\n","protected":false},"excerpt":{"rendered":"<p>(article updated on May, 5th 2026) What is the role of numerical simulation for medical device heating in MRI environments? Introduction In an MRI environment, radiofrequency (RF) electromagnetic fields can induce significant heating of implanted medical devices, posing a risk to patients. This heating is often localized, dependent on numerous parameters (type of implant, configuration, [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":18610,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[50],"tags":[],"class_list":["post-12670","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-simulations-numeriques-2"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.6 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Numerical modeling: reliability, experience and dedicated tools - Healtis MRI Safety<\/title>\n<meta name=\"description\" content=\"Discover how numerical modeling can support the development and certification of your medical devices in MRI environment.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.healtis.com\/en\/numerical-modelling-reliability-experience-and-dedicated-tools\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Numerical modeling: reliability, experience and dedicated tools - 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