{"id":30898,"date":"2018-10-23T05:59:49","date_gmt":"2018-10-23T12:59:49","guid":{"rendered":"https:\/\/www.jamasoftware.com\/?post_type=press&p=30898"},"modified":"2021-12-29T08:53:34","modified_gmt":"2021-12-29T16:53:34","slug":"jama-software-introduces-product-enhancements-and-new-service-capabilities-to-help-companies-navigate-the-growing-complexity-of-medical-device-development","status":"publish","type":"press","link":"https:\/\/www.jamasoftware.com\/legacy\/company\/press\/jama-software-introduces-product-enhancements-and-new-service-capabilities-to-help-companies-navigate-the-growing-complexity-of-medical-device-development\/","title":{"rendered":"Jama Software Introduces Product Enhancements and New Service Capabilities to Help Companies Navigate the Growing Complexity of Medical Device Development"},"content":{"rendered":"

Jama Software, the leading product development platform provider for building complex products and integrated systems, today announced the launch of the Jama Connect\u2122 Risk Management Center and Jama Medical Device Services \u2013 designed to ease the path to regulatory compliance for product development teams, while enabling them to reach product milestones faster.<\/p>\n

Medical device companies are under increasing pressure to release safe, regulatory-compliant devices on-time, on-budget and at a competitive price point \u2013 while continuing to innovate. At the same time, medical device product failures are on the rise.\u00a0According to the Stericycle Expert Solutions Recall Index<\/a> report, recalls increased 126 percent in the first quarter of 2018 alone.\u00a0These statistics represent the medical device industry\u2019s highest number of recalls since 2005.\u00a0Software issues are cited as the number one cause of these recalls.<\/p>\n

“Working with more than 160 medical device manufacturers globally, we have a deep understanding of the challenges they face in developing products in a regulated landscape. Identifying product risks, such as hazards and potential harm to a patient, is a fundamental part of the product development process,” said Scott Roth, Jama Software’s CEO. “A solution that gives individuals and teams the ability to make the risk management process a living document, while incorporating medical device best practices for risk management and product definition, is absolutely critical in today’s environment.”<\/p>\n

\u201cFrom a systems engineering point of view, over half of the requirements for medical device development pertain to risk mitigation,\u201d said Randy Armstrong, Chief Technology Officer for Velentium, a leading medical device consultancy. \u201cJama\u2019s new product enhancements bring much needed ease and simplicity to a highly complex product development process, while helping medical device companies adhere to standards such as ISO 14971 Annex E. We anticipate a quick and smooth transition to Jama\u2019s solution for those still relying on Excel spreadsheets.\u201d<\/p>\n

The product enhancements and new service capabilities build on Jama\u2019s ongoing investment in\u00a0the Jama Product Development Platform<\/a>,\u00a0with\u00a0the inclusion of\u00a0risk and hazard analysis.<\/p>\n

The Jama Connect Risk Management Center incorporates and enhances the risk analysis process within Jama Connect. As a result, teams can view and properly mitigate risks with confidence, enabling them to quickly move to the next phase of development. Further, development teams can:<\/p>\n