{"id":702251,"date":"2023-07-26T16:08:44","date_gmt":"2023-07-26T14:08:44","guid":{"rendered":"https:\/\/www.capgemini.com\/?p=940858"},"modified":"2026-02-24T02:05:24","modified_gmt":"2026-02-24T07:05:24","slug":"how-a-system-based-modular-approach-minimizes-risk-and-accelerates-samd-go-to-market","status":"publish","type":"post","link":"https:\/\/www.capgemini.com\/us-en\/insights\/expert-perspectives\/how-a-system-based-modular-approach-minimizes-risk-and-accelerates-samd-go-to-market\/","title":{"rendered":"\u200bHow a system-based modular approach minimizes risk and accelerates\u00a0SaMD\u00a0go-to-market\u200b"},"content":{"rendered":"\n<p>\u200b<\/p>\n\n\n\n<header class=\"wp-block-cg-blocks-hero-blogs header-hero-blogs\"><div class=\"container\"><div class=\"hero-blogs\"><div class=\"hero-blogs-content-wrapper\"><div class=\"row\"><div class=\"col-12\"><div class=\"header-title\"><h1>How a system-based modular approach minimizes risk and accelerates\u00a0SaMD\u00a0go-to-market\u200b<\/h1><\/div><\/div><\/div><\/div><div class=\"hero-blogs-bottom\"><div class=\"header-author\"><div class=\"author-img\"><img decoding=\"async\" src=\"\/wp-content\/themes\/capgemini2020\/assets\/images\/cg-logo.png?w=200&amp;quality=10\" alt=\"Capgemini\" loading=\"lazy\"\/><\/div><div class=\"author-name-date\"><h5 class=\"author-name\">Capgemini<\/h5><h5 class=\"blog-date\">27 Jul 2023<\/h5><\/div><\/div><div class=\"brand-image\"><img decoding=\"async\" loading=\"lazy\" src=\"\/wp-content\/themes\/capgemini2020\/assets\/images\/capgemini-engineering-white.svg\" alt=\"capgemini-engineering\"\/><\/div><\/div><\/div><\/div><\/header>\n\n\n\n<section class=\"wp-block-cg-blocks-intro-para undefined section section--intro\"><div class=\"intro-para\"><div class=\"container\"><div class=\"row\"><div class=\"col-12 col-md-1\"><nav class=\"article-social\"><ul class=\"social-nav\"><li class=\"ip-order-fb\"><a href=\"https:\/\/www.facebook.com\/sharer\/sharer.php?u=https:\/\/www.capgemini.com\/us-en\/insights\/expert-perspectives\/940858-2\/\" target=\"_blank\" rel=\"noopener noreferrer\" title=\"opens in a new window\"><i aria-hidden=\"true\" class=\"icon-fb\"><\/i><span class=\"sr-only\">Facebook<\/span><\/a><\/li><li class=\"ip-order-li\"><a href=\"https:\/\/www.linkedin.com\/sharing\/share-offsite\/?url=https:\/\/www.capgemini.com\/us-en\/insights\/expert-perspectives\/940858-2\/\" target=\"_blank\" rel=\"noopener noreferrer\" title=\"opens in a new window\"><i aria-hidden=\"true\" class=\"icon-li\"><\/i><span class=\"sr-only\">Linkedin<\/span><\/a><\/li><\/ul><\/nav><\/div><div class=\"col-12 col-md-11 col-lg-10\"><h2 class=\"intro-para-title\">In the field of healthcare systems\u00a0compliance, the difference between 99% and 100% is a chasm.\u00a0\u00a0\u200b\u00a0<\/h2><\/div><\/div><\/div><\/div><\/section>\n\n\n\n<section class=\"wp-block-cg-blocks-group undefined section section--article-content\"><div class=\"article-main-content\"><div class=\"container\"><div class=\"row\"><div class=\"col-12 col-md-11 col-lg-10 offset-md-1 offset-lg-1\"><div class=\"article-text article-quote-text\">\n<p>\u201cSoftware defect.\u201d \u201cFalse upstream alarms.\u201d \u201cFirmware error.\u201d \u201cLogin error.\u201d \u201cSoftware bug.\u201d \u201cSensor failure.\u201d \u201cCybersecurity vulnerability.\u201d The FDA list of&nbsp;<a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfres\/res.cfm\" target=\"_blank\" rel=\"noreferrer noopener\">software-related&nbsp;recalls<\/a>&nbsp;is sobering reading. We see the story behind each event \u2013 the teams that worked overtime designing and building a new device, quality assurance professionals checking&nbsp;each and every&nbsp;vulnerability, last-minute adjustments, the elation of a seemingly successful release\u2026 And all the while a tiny flaw lay hidden from sight, with the power to&nbsp;derail everything compromising safety and&nbsp;exposing liabilities.&nbsp;\u200b<\/p>\n\n\n\n<p>As a <a href=\"https:\/\/www.capgemini.com\/solutions\/capgemini-as-your-legal-manufacturer-for-samd\/\">legal manufacturer<\/a>, we specialize in safety and compliance for Software as a Medical Device (SaMD). It\u2019s a fast-growing field, with risks hiding in every nook and cranny.&nbsp;How do we make sure we catch and neutralize every risk? How do we ensure safety and compliance, without sacrificing speed? Let\u2019s dive in.&nbsp;\u200b<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Compliance&nbsp;and agility by design\u200b<\/h3>\n\n\n\n<p>There\u2019s a common fear that&nbsp;<a href=\"https:\/\/www.google.com\/url?sa=t&amp;rct=j&amp;q=&amp;esrc=s&amp;source=web&amp;cd=&amp;cad=rja&amp;uact=8&amp;ved=2ahUKEwjxmfqb1ZqAAxVaJRAIHUCNBfIQFnoECA0QAQ&amp;url=https%3A%2F%2Fwww.capgemini.com%2Fus-en%2Fsolutions%2Fregulatory-affairs-compliance-and-quality%2F&amp;usg=AOvVaw19dPeb4ry8An6i_HpvzuVR&amp;opi=89978449\" target=\"_blank\" rel=\"noreferrer noopener\">safety and compliance<\/a>&nbsp;slow&nbsp;down go to market. A justified concern? Yes and no. Of course, extra steps take extra time. That\u2019s why, wherever&nbsp;possible, we work to engrain safety and compliance considerations into every process. For example, a remote patient monitoring system that records patient data needs to do&nbsp;many things, some are basic functions; others cross over into the \u201csafety\u201d category.&nbsp;Safety and compliance are mandatory and are integrated into the development process.&nbsp;Pharma and MedTech companies will&nbsp;speed development and improve quality if they adopt two changes: agile processes combined with modularity by design. To see how&nbsp;modularity adds value, let\u2019s look closer at the challenges&nbsp;SaMD&nbsp;teams face.\u200b<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-challenges-of-connected-systems-nbsp\">Challenges of connected systems&nbsp;\u200b<\/h3>\n\n\n\n<p>With today&#8217;s more connected and complex systems, the boundaries of what constitutes \u201cSoftware as a Medical Device\u201d are often blurred. For example, when the system is&nbsp;distributed, with parts of an application running on a wearable,&nbsp;mobile phone, or in the cloud, and&nbsp; a combination of medical and non-medical functions, is the whole system&nbsp;SaMD? How do we manage&nbsp;a combination of&nbsp;safety and non-safety, administrative and&nbsp;other&nbsp;functions that&nbsp;all need to work together to fulfill a medical purpose? If&nbsp;the system&nbsp;is&nbsp;developed as monolithic, this&nbsp;increases effort to get regulatory approval and places additional compliance effort to modify, improve or add functions after the system has&nbsp;received initial market authorization. What\u2019s the solution?\u200b<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">The benefits of modularization&nbsp;for connected health&nbsp;\u200b<\/h3>\n\n\n\n<p>A pragmatic approach to accelerate&nbsp;SaMD&nbsp;development, manage safety and regulatory complexity, and&nbsp;maintain flexibility, is modularization. We segregate&nbsp;SaMD&nbsp;products&nbsp;by&nbsp;function and by risk category (high, medium and low risk). This makes it possible to apply the&nbsp;appropriate level of risk control and&nbsp;testing measures in each case. Using&nbsp;pre-built,&nbsp;ready-to-use&nbsp;SaMD&nbsp;modules&nbsp;developed under certified processes and&nbsp;qualified tools,&nbsp;assures reliable, fast and&nbsp;compliant&nbsp;software.&nbsp;\u200b<\/p>\n\n\n\n<p>Modularization reduces regulatory complexity and \u2013 together with agile development models \u2013&nbsp;speeds up the time to market,\u202fwhile providing the flexibility we need to&nbsp;continuously adapt functions. Most critically, it reduces risk. The \u201chidden flaw\u201d we talked about earlier \u2013 in a modular system there\u2019s no place to hide, and agile development&nbsp;makes it possible to and correct flaws early in the development cycles.\u200b<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Reducing risk and regulatory complexity\u200b<\/h3>\n\n\n\n<p>We believe that risk is best managed when technical and regulatory responsibility go&nbsp;hand-in-hand. The closer a development team is to the consequences of success or failure&nbsp;\u2013 the more skin they have in the game \u2013 the more we count on them to scrupulously&nbsp;manage risk.&nbsp;We\u2019d&nbsp;been working in the&nbsp;SaMD&nbsp;field from the start, at the intersection of&nbsp;software, life sciences and regulatory, so taking regulatory responsibility for our work was a natural step. How to manage regulatory compliance is an important question for&nbsp;every innovator \u2013 a far-reaching question with many dimensions. For us, most crucial is the link between technical and regulatory responsibility.\u200b<br>\u200bYou can find more about <a href=\"https:\/\/www.capgemini.com\/solutions\/intelligent-products-systems-engineering-for-medtech\/\" target=\"_blank\" rel=\"noreferrer noopener\">our offer<\/a> and <a href=\"https:\/\/www.capgemini.com\/solutions\/capgemini-as-your-legal-manufacturer-for-samd\/\">our Legal Manufacturer capabilities<\/a> on our webpage, and&nbsp;we\u2019re&nbsp;also available to consult on any aspect of risk and compliance.<\/p>\n\n\n\n<p>When your innovations hit the market, dozens of factors affect their success. Avoidable mistakes&nbsp;should not&nbsp;be one of them.&nbsp;Let\u2019s&nbsp;make your products flawless.&nbsp;&nbsp;<\/p>\n\n\n\n<p><\/p>\n<\/div><\/div><\/div><\/div><\/div><\/section>\n\n\n\n<section class=\"section section--expert-slider wrapper-people-slider wp-block-cg-blocks-wrapper-people-slider undefined\"><div class=\"container\"><div class=\"content-title\"><h2 data-maxlength=\"34\" class=\"people-heading-title\">Meet our experts<\/h2><\/div><\/div><div class=\"slider slider-boxed\"><div class=\"container\"><div class=\"slider-window\"><div class=\"slider-list\">\n\n\t\t<div class=\"slide\">\n\t\t\t<div class=\"box\">\n\t\t\t\t<div class=\"row\">\n\t\t\t\t\t<div class=\"col-md-6 col-lg-4 box-img-wrapper\">\n\t\t\t\t\t\t<img decoding=\"async\" loading=\"lazy\" src=\"https:\/\/www.capgemini.com\/us-en\/wp-content\/themes\/capgemini2025\/assets\/images\/mockup.png\" alt=\"Events\"\/>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div class=\"col-md-6 col-lg-8 box-inner\">\n\t\t\t\t\t\t<div class=\"row title-social-media-header\">\n\t\t\t\t\t\t\t<div class=\"col-md-12 col-lg-6 mbl-social-icon\">\n\t\t\t\t\t\t\t\t<ul class=\"social-nav\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"col-md-12 col-lg-6 box-container\">\n\t\t\t\t\t\t\t\t<div class=\"box-title\">\n\t\t\t\t\t\t\t\t\t<h3 class=\"people-profile-title\">Events<\/h3>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"col-md-12 col-lg-6 social-box-container dkt-social-icon\">\n\t\t\t\t\t\t\t\t<ul class=\"social-nav\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div><\/div><\/div><div class=\"slider-nav\"><button class=\"slider-prev inactive\" aria-label=\"Slider-previous\" tabindex=\"-1\"><\/button><ul class=\"slider-paginator\"><\/ul><button class=\"slider-next\" aria-label=\"Slider-next\"><\/button><\/div><\/div><\/section>\n","protected":false},"excerpt":{"rendered":"<p>In the field of healthcare systems compliance, the difference between 99% and 100% is a chasm.<\/p>\n","protected":false},"author":282,"featured_media":759355,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"cg_dt_proposed_to":[],"cg_seo_hreflang_relations":"[]","cg_seo_canonical_relation":"","cg_seo_hreflang_x_default_relation":"{\"uuid\":\"9c9ffef2-4f91-484d-b463-cc97f99e8bd2\",\"blogId\":\"\",\"domain\":\"\",\"sitePath\":\"\",\"postLink\":\"\",\"postId\":null,\"isSaved\":true,\"isCrossLink\":false,\"hasCrossLink\":false}","cg_dt_approved_content":true,"cg_dt_mandatory_content":false,"cg_dt_notes":"","cg_dg_source_changed":true,"cg_dt_link_disabled":false,"_yoast_wpseo_primary_brand":"135","_jetpack_memberships_contains_paid_content":false,"footnotes":"","featured_focal_points":"{\"x\":0.32,\"y\":0.54}"},"categories":[1],"tags":[391],"brand":[135],"service":[],"industry":[73],"partners":[],"blog-topic":[396],"content-group":[],"class_list":["post-702251","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized","tag-life-sciences","brand-capgemini-engineering","industry-life-sciences","blog-topic-technology"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v22.8 (Yoast SEO v22.8) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>\u200bHow a system-based modular approach minimizes risk and accelerates\u00a0SaMD\u00a0go-to-market\u200b - Capgemini USA<\/title>\n<meta name=\"description\" content=\"In the field of healthcare systems compliance, the difference between 99% and 100% is a chasm. 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