According to Axendia, regulatory compliance continues to constrain\nimprovement in MD&D manufacturing efficiency and productivity. \u201cOur primary\nresearch shows that medical device companies list regulators\/government\nagencies as the top business disruptor,\u201d says Daniel R. Matlis, president of\nAxendia. The United States Food and Drug Administration (US FDA) and the new European\nUnion Medical Device Regulations (EU MDR) are driving new requirements.\nSpecifically, the US FDA is shifting regulatory focus to product quality versus\ntraditional compliance, while the EU Commission\u2019s proposal for the regulations\non medical devices establish a modernized and more robust legislative framework\nto ensure better production of public health and patient safety. Both efforts\npresent new challenges for operations in their respective geographies.<\/p>\n\n\n\n
Regulatory inspections are disruptive. Companies are finding\nit difficult to manage and respond to inquiries, and product recalls are still\nrising. With social media and consumer engagement, the repercussions of recalls\nwill be more damaging to medical device company brands.<\/p>\n\n\n\n
Here are a few key insights related to these trends:<\/p>\n\n\n\n
New manufacturing challenges that affect a MD&D\ncompany\u2019s digital technologies are arising in relation to these new regulatory\nschemes:<\/p>\n\n\n\n
Quality inspections will become more difficult to manage.\n<\/strong>When product traceability is hidden in paper records and downstream data is\nnot integrated into the product master record, it is impossible to properly\nconduct root-cause analysis and define preventive actions, resulting in\nregulatory agency actions or recalls.<\/p>\n\n\n\n Manufacturers must collect data throughout the product\nlifecycle. <\/strong>Manufacturers in the US will be required to expand the data\ncollected across the product lifecycle and respond to the FDA Regulatory\nFramework for the Total Product Lifecycle (TPLC). Medical device companies will\ncollect data, including concept, prototype, feasibility, stability, clinical,\ndesign transfer, manufacturing, in-process testing, product release, quality\ninspections, nonconformance reports (NCRs), corrective and preventive action (CAPA),\nfield actions, adverse events, post-market surveillance, complaints and\nobsolescence.<\/p>\n\n\n\n Quality and compliance are often confused. <\/strong>Medical\ndevice companies focus on compliance activities because the FDA guidance\ndemands it. Compliance does not equal quality and having great compliance does\nnot ensure high-quality products. Quality and compliance are often confused.<\/p>\n\n\n\n Manufacturers need to understand the FDA\u2019s quality\nmetrics guidance. <\/strong>\u201cOur primary research on the medtech industry\u2019s ability\nto build a culture of quality and innovation shows only 62 percent of\nmanufacturers are familiar with FDA\u2019s Medical Device Industry Consortium (MDIC)\nCase for Quality,\u201d says Matlis. The agency recognizes manufacturers who are\nhigh performers and will shift their resources to products\/areas that need more\nattention. Manufacturers should learn about and become active in the FDA\u2019s Case\nfor Quality.<\/p>\n\n\n\n The EU MDR contains a series of important improvements to\nmodernize the current system. They include:<\/p>\n\n\n\n Focusing on product quality and compliance<\/strong><\/p>\n\n\n\n The MES automatically controls the manufacturing environment\naccording to product and process definitions, while simultaneously collecting\nas-built data. Although the opportunities for errors, NCRs and field failures\nare dramatically reduced, compliance becomes a by-product of a digitally\ncontrolled process. Managing inspections is greatly simplified, reducing the\ntime and overhead of producing documented evidence with technology solutions\nthat provide rich, timely and accurate data.<\/p>\n\n\n\n Manufacturers must leverage MES to automatically create\ndevice history records, accelerating their ability to respond to inspections\nand more intelligently prevent quality issues.<\/p>\n\n\n\n Access to real-time data and full traceability allow better\ndecision-making and predictive analytics across the product lifecycle. MES\nprovides this source of data for TPLC.<\/p>\n\n\n\n Ultimately, using MES supports the FDA\u2019s case for quality.\nThe FDA is looking for manufacturers to adopt technologies like MES to allow them\nto focus on efforts that improve product quality, rather than focusing on\ndocumenting compliance. Medical device manufacturers that adopt MES will be in\na much stronger position to reduce the amount of regulatory scrutiny relative\nto manufacturers that don\u2019t.<\/p>\n\n\n\n As with FDA regulations, using MES is critical for supporting EU regulatory requirements. Using MES enables you to automatically record as-built data, providing visibility into useful manufacturing data that can add to the entire product lifecycle from R&D to manufacturing to patient (post market) and back using closed-loop feedback.<\/p>\n\n\n\n