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Now is the best time to improve your medical device packaging, says Abhishek Gautam, before you retest your products to ensure compliance with the European Union\u2019s Medical Device Regulation (EU MDR).<\/span><\/p>\n Gautam spoke on Tuesday, June 4, at the <\/span>IME South<\/a><\/span> event, which includes SouthPack, MD&M South, and other co-located shows. He is the Executive Engineer with <\/span>DDL Inc.<\/a><\/span>, a leading medical device and materials testing laboratory and consulting company.<\/span><\/p>\n Gautam is a medical device insider, having worked within the industry for nearly 20 years. Prior to working at DDL, Gautam has held leadership positions at Teleflex, DePuy, Edwards Life Sciences, ConMed, and Medtronic.<\/span><\/p>\n During his \u201cEU MDR Extension \u2013 Creating $ Value-Add\u201d presentation, Gautam makes a solid case for taking advantage of the EU MDR extension to update the packaging of your medical devices \u2014 \u00a0when it makes business sense. You\u2019ll be able to improve user experience, lower costs, boost revenue, and streamline production.<\/span><\/p>\n But how do you know when it makes business sense?<\/span><\/p>\n \u201cMedical device manufacturers face challenges in prioritizing EU MDR compliance amidst their regular operations, especially for older products,\u201d Gautam says. \u201cThe extension of EU MDR deadlines offers relief, particularly for MDMs struggling to meet the new standards. Despite this, significant gaps persist, complicating prioritization and leading to costly decisions to retest legacy products. MDMs can leverage the extension to refine their strategies, enhance compliance efforts, and potentially differentiate their offerings, gaining a competitive edge and driving profitability.\u201d<\/span><\/p>\n In this this 45-minute presentation, Gautam gives an overview of the European Union\u2019s Medical Device Regulation (EU MDR) and its extension, explains the challenges faced by medical device manufacturers (MDMs), describes how to do a gap assessment, and offers the following advice:<\/span><\/p>\n Allocate resources strategically:<\/span><\/span> Prioritize resources effectively to balance compliance efforts with ongoing business operations.<\/span><\/p>\n Mitigate risk:<\/span><\/span> Implement robust risk management strategies to mitigate potential compliance failures and associated business risks.<\/span><\/p>\n Leverage the extension period:<\/span><\/span> Use the extended transition period to fully comply with EU MDR without compromising market presence or patient safety.<\/span><\/p>\n Plan proactively and adapt:<\/span><\/span> Continuously adapt to regulatory changes and maintain proactive planning to stay ahead in the compliance journey.<\/span><\/p>\n Gautam offers a step-by-step game plan (see images in the slideshow).<\/span><\/p>\n He recommends mapping out your products based on risk and revenue, high and low (see slide # in slideshow).<\/span><\/p>\n Once you know where a product falls, you can better decide to update the packaging or not. For example:<\/span><\/p>\n \u2022 Low revenue, low risk products may only need feasibility testing.<\/span> Companies have between 18 months to four years for the EU MDR transition. With most medical packaging projects able to be completed in nine to 18 months, there\u2019s a window here for proactive redesign and innovation. Using this time effectively can prevent product\/package failures, protect revenue and market share, and drive competitive advantage (see slide # in slideshow).<\/span><\/p>\n Listen to the presentation here:<\/span><\/p>\n
\u2022 High revenue, low risk products require minor changes to avoid risking revenue.<\/span>
\u2022 Low revenue, high risk products might be discontinued or phased out.<\/span>
\u2022 High revenue, high risk products need careful retesting with minor changes to ensure they meet compliance and minimize failure risk.<\/span><\/p>\n