{"id":1490,"date":"2020-01-22T02:08:00","date_gmt":"2020-01-22T07:08:00","guid":{"rendered":"http:\/\/www.spartasystems.com\/?post_type=resources&p=1490"},"modified":"2024-08-13T10:47:22","modified_gmt":"2024-08-13T14:47:22","slug":"managing-quality-within-the-medical-device-supply-chain","status":"publish","type":"resources","link":"https:\/\/www.spartasystems.com\/resources\/managing-quality-within-the-medical-device-supply-chain\/","title":{"rendered":"Managing Quality Within the Medical Device Supply Chain"},"content":{"rendered":"\n

For medical device manufacturers<\/a>, confidence in the quality of outsourced or offshored components or raw materials is crucial. <\/p>\n\n\n\n

Supply chain factors\u2014such as nonconforming materials or processes\u2014have been noted as contributing to the errors that led to a 126 percent spike in medical device recalls<\/a> early in 2018.<\/p>\n\n\n\n

Yet a large proportion of medical device manufacturers lack visibility<\/a> into their (often complex) supply chains. <\/p>\n\n\n\n

Gaining this end-to-end quality insight\u2014and better yet, integration\u2014will be even more important as new EU medical device regulations go into effect this year.  <\/p>\n\n\n\n

Outsourcing on the Rise <\/h2>\n\n\n\n

Outsourcing in the medical device industry is here to stay, it seems. <\/p>\n\n\n\n

According to Acumen Research and Consulting, outsourcing is a growing solution for medical device manufacturers looking for scalability and cost efficiency in design, assembly, and packaging. <\/p>\n\n\n\n

Acumen predicts that this outsourcing market will top $190 billion within the next five years. <\/p>\n\n\n\n

But while outsourcing may deliver benefits, it also adds significant complexity to the supply chain. <\/p>\n\n\n\n

Multiple suppliers increase the challenge of gaining visibility into critical quality information, but real-time (or near-real-time) access to that information is necessary for manufacturing quality managers to make proactive decisions.  <\/p>\n\n\n\n

Increasing Regulatory Pressure  <\/h2>\n\n\n\n

With regulatory agencies creating additional compliance guidelines and demands, end-to-end insight becomes even more important.  <\/p>\n\n\n\n