{"id":36030,"date":"2019-10-10T04:30:23","date_gmt":"2019-10-10T11:30:23","guid":{"rendered":"https:\/\/www.jamasoftware.com\/?p=36030"},"modified":"2023-01-19T13:02:48","modified_gmt":"2023-01-19T21:02:48","slug":"jama-connect-helps-ossur-improve-the-mobility-of-millions","status":"publish","type":"post","link":"https:\/\/www.jamasoftware.com\/legacy\/blog\/2019\/10\/10\/jama-connect-helps-ossur-improve-the-mobility-of-millions\/","title":{"rendered":"A Developing Story: Jama Connect Helps \u00d6ssur Improve the Mobility of Millions"},"content":{"rendered":"

\"Ossur<\/p>\n

In medical device development, control of quality and risk is heavily driven by regulatory requirements. Compliance with international medical device standards like ISO 13485<\/a> and ISO 14971<\/a> can drain resources and reduce operational agility if the means of demonstrating compliance are not agile themselves.<\/p>\n

The more complex the project, the higher the risk. And the higher the risk, the more stringent the medical device compliance procedures. Managing hundreds of requirements in a document-based system without traceability becomes a major chore.<\/p>\n

\u00d6ssur, a global leader in non-invasive orthopedics, had for several years been relying on an internally developed document-based process to manage its product requirements. While their system had been working as intended, they felt there was an opportunity to streamline procedures and compliance tasks.<\/p>\n

The Costs of a Rigid Requirements System in Medical Device Development<\/h2>\n

Continually evolving its processes has always been a key to success for \u00d6ssur, whose cutting-edge prosthetics technologies have been showcased in publications like Popular Science<\/a> and have been worn in competition in the Olympic Games. They examined their development cycle for inefficiencies and noted their requirements process unfolded in a sequential manner that was costing them an enormous amount of time and effort.<\/p>\n

In specifying a highly complex<\/a> \u00d6ssur medical device, several engineers would collaborate on drafting requirements and compiling the requirements document. The document would then be circulated for review. Once approved, the requirements would be verified. If any requirement needed to be added or changed, however, the entire review and approval cycle had to be repeated.<\/p>\n

“Our old system was very rigid,” said David Langlois, Director of R&D for Bionic Solutions at \u00d6ssur. “The minimum effort was always quite high, which means the overhead was also high.”<\/p>\n

\u00d6ssur knew it was time for a change. They wanted something that was as close to a turn-key solution as possible \u2014 one that would provide traceability<\/a> and dynamic content management, and would be scalable across their organization. Plus, it needed to be capable of handling the complete development chain \u2014 from requirements through verification and validation, along with easing the path to compliance to ISO standards like ISO 13485<\/a> and ISO 14971<\/a> \u2014 for a diverse product line.<\/p>\n

After evaluating several alternatives, including some designed specifically for medical device development, \u00d6ssur chose Jama Connect\u2122.<\/p>\n

\u00a0Learn more about how Jama Connect helps teams improve medical device development.<\/a><\/p><\/blockquote>\n

Replacing Process Rigidity with Speed and Agility<\/h2>\n

\u00d6ssur began using Jama Connect in 2018, starting with a small group of developers working on bionic lower-limb prosthetics. They immediately began seeing dramatic improvements in their process, especially in the areas of traceability, impact analysis, and test management.<\/p>\n

As soon as they began importing their data into Jama Connect, \u00d6ssur\u2019s engineers saw they had traceability gaps. “Catching these gaps would probably have taken hours or days in our old system,” says Langlois. “With Jama, it became obvious in a matter of minutes.”<\/p>\n

With Jama Connect\u2019s impact analysis, teams can quickly gain an accurate understanding of the implications of a proposed change. So, in turn, they can make better informed business decisions. “That brings a lot of value when you’re trying to run a review, and you want to know whether you have gaps in your test coverage,” says Langlois. “With Jama, it’s a five-minute question instead of one that takes hours.”<\/p>\n

In addition, \u00d6ssur feels Jama Connect’s test coverage and built-in metrics are making its testing process far more predictable and efficient. \u201cOne thing that\u2019s very powerful about Jama Connect is that, after a few test runs, you can actually quantify pretty accurately what sort of effort is required,” Langlois says. \u201cJama provides all these metrics that allow you to identify where your bottlenecks are, giving you a better understanding of where the time is going and where you\u2019re losing money.\u201d<\/p>\n

Leveraging Jama Connect\u2019s Flexibility for a Faster, More Flexible Future<\/h2>\n

As \u00d6ssur branches Jama out into other areas of its organization, it plans to allow individual teams to configure Jama Connect in a way that best suits how they work. And \u00d6ssur is already thinking about ways to integrate with some of the other solutions it\u2019s currently using.<\/p>\n

\u201cAs a software developer, I think Jama Connect\u2019s integration with Jira<\/a> is going to be very useful for me,\u201d says Matth\u00edas Kristj\u00e1nsson, Product Lead Designer at \u00d6ssur. \u201cToday, we actually make duplicates of our requirements into the Jira system. Being able to connect them straight to Jama and remove that step \u2014 so they\u2019re directly connected to a requirement or specification \u2014 will be valuable.\u201d<\/p>\n

Read the full case study<\/a> to learn more about how \u00d6ssur is using Jama Connect to grow more agile and efficient and assure compliance with relevant regulatory standards.<\/em><\/strong><\/p><\/blockquote>\n","protected":false},"excerpt":{"rendered":"

See how medical device development company \u00d6ssur uses Jama Connect to comply with with international medical device standards like ISO 13485 and ISO 14971. <\/p>\n","protected":false},"author":4,"featured_media":45795,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[853],"tags":[411,33,40,41,27],"industry":[574],"class_list":["post-36030","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-customer-spotlight","tag-a-developing-story","tag-compliance","tag-medical-device-compliance","tag-medical-device-development","tag-traceability","industry-medical-devices"],"acf":[],"yoast_head":"\nJama Connect Helps Medical Device Company \u00d6ssur - Jama Software<\/title>\n<meta name=\"description\" content=\"See how medical device development company \u00d6ssur uses Jama Connect to comply with with international medical device standards like ISO 13485 and ISO 14971.\" \/>\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.jamasoftware.com\/blog\/2019\/10\/10\/jama-connect-helps-ossur-improve-the-mobility-of-millions\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Jama Connect Helps \u00d6ssur Improve the Mobility of Millions\" \/>\n<meta property=\"og:description\" content=\"See how medical device development company \u00d6ssur uses Jama Connect to comply with with international medical device standards like ISO 13485 and ISO 14971.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.jamasoftware.com\/blog\/2019\/10\/10\/jama-connect-helps-ossur-improve-the-mobility-of-millions\/\" \/>\n<meta property=\"og:site_name\" content=\"Jama Software\" \/>\n<meta property=\"article:published_time\" content=\"2019-10-10T11:30:23+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2023-01-19T21:02:48+00:00\" \/>\n<meta name=\"author\" content=\"Jama Software\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:title\" content=\"Jama Connect Helps \u00d6ssur Improve the Mobility of Millions\" \/>\n<meta name=\"twitter:description\" content=\"See how medical device development company \u00d6ssur uses Jama Connect to comply with with international medical device standards like ISO 13485 and ISO 14971. v\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Jama Software\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"4 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.jamasoftware.com\\\/blog\\\/2019\\\/10\\\/10\\\/jama-connect-helps-ossur-improve-the-mobility-of-millions\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.jamasoftware.com\\\/blog\\\/2019\\\/10\\\/10\\\/jama-connect-helps-ossur-improve-the-mobility-of-millions\\\/\"},\"author\":{\"name\":\"Jama Software\",\"@id\":\"https:\\\/\\\/www.jamasoftware.com\\\/#\\\/schema\\\/person\\\/59a942565a528aa5f56b240c9342fc7f\"},\"headline\":\"A Developing Story: Jama Connect Helps \u00d6ssur Improve the Mobility of Millions\",\"datePublished\":\"2019-10-10T11:30:23+00:00\",\"dateModified\":\"2023-01-19T21:02:48+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.jamasoftware.com\\\/blog\\\/2019\\\/10\\\/10\\\/jama-connect-helps-ossur-improve-the-mobility-of-millions\\\/\"},\"wordCount\":798,\"image\":{\"@id\":\"https:\\\/\\\/www.jamasoftware.com\\\/blog\\\/2019\\\/10\\\/10\\\/jama-connect-helps-ossur-improve-the-mobility-of-millions\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.jamasoftware.com\\\/media\\\/2019\\\/10\\\/A-Developing-Story-without-logo-1.jpg\",\"keywords\":[\"A Developing Story\",\"compliance\",\"Medical Device Compliance\",\"medical device development\",\"traceability\"],\"articleSection\":[\"Customer Spotlight\"],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.jamasoftware.com\\\/blog\\\/2019\\\/10\\\/10\\\/jama-connect-helps-ossur-improve-the-mobility-of-millions\\\/\",\"url\":\"https:\\\/\\\/www.jamasoftware.com\\\/blog\\\/2019\\\/10\\\/10\\\/jama-connect-helps-ossur-improve-the-mobility-of-millions\\\/\",\"name\":\"Jama Connect Helps Medical Device Company \u00d6ssur - 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