{"id":1103,"date":"2020-04-06T06:22:24","date_gmt":"2020-04-06T10:22:24","guid":{"rendered":"https:\/\/blogs.sw.siemens.com\/siemens-opcenter\/?p=1103"},"modified":"2026-03-26T04:59:56","modified_gmt":"2026-03-26T08:59:56","slug":"medical-device-manufacturing-why-digitalization-is-changing-everything","status":"publish","type":"post","link":"https:\/\/blogs.sw.siemens.com\/opcenter\/medical-device-manufacturing-why-digitalization-is-changing-everything\/","title":{"rendered":"Medical Device Manufacturing: Why Digitalization is Changing Everything"},"content":{"rendered":"\n<iframe src=\"https:\/\/medical-technology.nridigital.com\/medical_technology_oct19\/siemens_company_insight\" style=\"height:100%;width:100%;min-height:1000px;\"><\/iframe>\n\n\n\n<h2 class=\"wp-block-heading\">Text Version: Leveraging on Medical Device Manufacturing Digitalization to drive growth<\/h2>\n\n\n\n<p>It\u2019s impossible to exaggerate how profoundly the digital revolution has already impacted our lives, from banking, shipping, home-buying to the way we communicate, get news, and perform our work. Digitalization has opened up new and more efficient ways to get products, and has forever changed consumer expectations as well as supply chain demands. When applied the complex world of medical devices, what implications should manufacturers be aware of and preparing for?<\/p>\n\n\n\n<p>First, digitalization is changing the\npatient\u2019s expectations. Patients have access to more medical information than\never before, enabling them to self-diagnose and \u201cshop around\u201d for providers and\ntreatment options. Patients are becoming more critical of the value received\nfor their healthcare money. <\/p>\n\n\n\n<p>Add to this the growing complexity of\nmedical technology itself. The Internet of Medical Things, connected\ndiagnostics, next-generation implants, customized orthopedics, personalized\nmedicine \u2013 these complexities are creating new challenges for medical device\nmanufacturers not only from the treatment itself, but from the data generated\nthroughout. It is an increasingly Big Data conundrum.<\/p>\n\n\n\n<p>This reality is changing the way medical\ndevice manufacturers are running their business. Today, best-in-class\ndigitalized med-tech companies are 4 times more likely to monitor intelligent\nanalytics. 66.7% of med-tech executives perceive intelligent analytics as one of\nthe major opportunities for growth (Frost and Sullivan). 64% of providers\nperceive consumer feedback as a vital benefit of operations within IoMT\nprograms (Accenture Consulting). In short \u2013 medical device companies must have\nan infrastructure to support the analysis and application of this big data, and\nuse it to better meet patient expectations.<\/p>\n\n\n\n<p>The FDA and other regulatory agencies are expecting\nmedical device manufacturers to do this. They have shifted their regulatory\nparadigm from compliance to quality. They are rewarding manufacturing behavior\nthat applies intelligence and best practices to improve product quality. The\nFDA states, \u201cFrom 2009 to 2014, there was a 3x increase in adverse events and a\n50% increase in product recalls. These numbers will rise without proper digital\nprocesses implemented across all business segments within a given medical\ndevice organization.\u201d<\/p>\n\n\n\n<p>So, what are the most important things\nmedical device manufacturers should be doing (if they aren\u2019t already) to\noperate in a world changed by digitalization?<\/p>\n\n\n\n<p>First, manufacturers must leverage the\ncapabilities of digital manufacturing systems to empower every phase of the\ninnovation process. That requires connected, collaborative, intelligent systems\nacross the manufacturing enterprise. At Siemens, we call this connectivity the\n\u201cDigital Thread.\u201d It is leveraged by a single platform with a common data model\nto create a powerful foundation for speed, quality, and cost efficiency.<\/p>\n\n\n\n<p>In addition, \u201cDigital Twins,\u201d or digital representations\nof the physical world, can be used to predict and optimize quality and\nperformance of devices from design to development to production to utilization.\nBefore large investments are made in producing particular designs, setting up\nplants, assembly lines, and fabrication work cells, performance can be\nsimulated and improved in the digital realm, where mistakes are much less\ncostly.<\/p>\n\n\n\n<p>When you get feedback from manufacturing\noperations, Digital Twins enable you act on that feedback by comparing the\npredicted performance against the actual performance, and based on that\ninsight, make adjustments in the device design and the manufacturing processes.\nWe call this \u201cClosed-loop Manufacturing.\u201d It is the culmination of digital\ntransformation in manufacturing.<\/p>\n\n\n\n<p>Central to\nthis platform is the point at which the digital realm intersects with the\nphysical realm \u2013 manufacturing operations. Manufacturing operations management\n(MOM) systems play a key role in translating digital optimization processes\ninto reality. Some of the key capabilities include<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>Integration between PLM and Automation<\/strong>, facilitating a smooth transfer of virtual product and production information from the design and engineering departments to the shop floor and manufacturing operations.<\/li><li><strong>Orchestration<\/strong>, or MOM as the digital brain of manufacturing and quality operations. MOM collects production orders from ERP and BoM\/BoP from PLM and \u2013 using its digital intelligence \u2013 orchestrates all the manufacturing activities based on the best schedule and real-time shop floor information.<\/li><li><strong>Data contextualization and closed loop feedbacks<\/strong> <strong>&#8211; <\/strong>The digital intelligence of MOM enriches production and product data with manufacturing information, transforming them from simple data into actionable information that can be re-used by the right departments at the right time. MOM closes the loop between reality and virtual environments enriching virtual production and virtual products with augmented and contextualized data. <\/li><li><strong>Connection to product lifecycle analytics &#8211; <\/strong>Manufacturing contextualized&nbsp; data are also fed into a complete analytics platform that spans the product lifecycle to enrich Big Data IoT-based information.<\/li><\/ul>\n\n\n\n<p>Finding the right platform for\nmanufacturing will make or break med-tech companies in the not-to-distant\nfuture. With digitalization changing everything, manufacturers must brace for\nchange in their industry by leveraging digitalization in their own operations.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Text Version: Leveraging on Medical Device Manufacturing Digitalization to drive growth It\u2019s impossible to exaggerate how profoundly the digital revolution&#8230;<\/p>\n","protected":false},"author":29114,"featured_media":1086,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"spanish_translation":"","french_translation":"","german_translation":"","italian_translation":"","polish_translation":"","japanese_translation":"","chinese_translation":"","footnotes":""},"categories":[236],"tags":[173,81,265,119,51,288,56],"industry":[225],"product":[],"coauthors":[],"class_list":["post-1103","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-learning-resources","tag-diagnostics","tag-digital-enterprise","tag-digital-transformation","tag-digitalization","tag-industry-4-0","tag-manufacturing-execution-system-mes","tag-smart-manufacturing","industry-medical-devices-pharmaceuticals"],"featured_image_url":"https:\/\/blogs.sw.siemens.com\/wp-content\/uploads\/sites\/3\/2020\/03\/Med_dev_pharma-product-quality.jpg","_links":{"self":[{"href":"https:\/\/blogs.sw.siemens.com\/opcenter\/wp-json\/wp\/v2\/posts\/1103","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.sw.siemens.com\/opcenter\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.sw.siemens.com\/opcenter\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.sw.siemens.com\/opcenter\/wp-json\/wp\/v2\/users\/29114"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.sw.siemens.com\/opcenter\/wp-json\/wp\/v2\/comments?post=1103"}],"version-history":[{"count":4,"href":"https:\/\/blogs.sw.siemens.com\/opcenter\/wp-json\/wp\/v2\/posts\/1103\/revisions"}],"predecessor-version":[{"id":1328,"href":"https:\/\/blogs.sw.siemens.com\/opcenter\/wp-json\/wp\/v2\/posts\/1103\/revisions\/1328"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/blogs.sw.siemens.com\/opcenter\/wp-json\/wp\/v2\/media\/1086"}],"wp:attachment":[{"href":"https:\/\/blogs.sw.siemens.com\/opcenter\/wp-json\/wp\/v2\/media?parent=1103"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.sw.siemens.com\/opcenter\/wp-json\/wp\/v2\/categories?post=1103"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.sw.siemens.com\/opcenter\/wp-json\/wp\/v2\/tags?post=1103"},{"taxonomy":"industry","embeddable":true,"href":"https:\/\/blogs.sw.siemens.com\/opcenter\/wp-json\/wp\/v2\/industry?post=1103"},{"taxonomy":"product","embeddable":true,"href":"https:\/\/blogs.sw.siemens.com\/opcenter\/wp-json\/wp\/v2\/product?post=1103"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/blogs.sw.siemens.com\/opcenter\/wp-json\/wp\/v2\/coauthors?post=1103"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}