Over the past decade, global regulations for medical technology have skyrocketed from around 500 to over 8000. Navigating the complexities of regulatory compliance is a daunting task—especially when faced with orthogonal aspects of regulations.
The future of healthcare depends on cross-sector collaboration among regulatory, commercial, R&D, and business development teams. This integrated approach is crucial to avoiding siloed decisions that could hinder long-term progress. Sustainability must be embedded throughout the product life cycle—from design and manufacturing to distribution and use—ensuring products not only restore sight but also address pressing environmental and logistical challenges.
The European Commission’s Green Deal sets specific sustainability targets across the EU, while policies like the German Supply Chain Act (LkSG) of 2023 are setting standards domestically. TÜV SÜD explains how hospital operators and medical device manufacturers can position themselves sustainably in the market.
The pilot program launched by Baxter International and Northwestern Medicine in Chicago resulted in the recycling of more than 170,000 IV bags. Baxter is now working to expand the program in the Chicago area to further validate the process and economic viability of the program.
Stefano Vicenzetto, Design Systems Engineer at Flex, shares his insights on how Circular Economy principles can be applied within the MedTech industry to reduce environmental impact by shifting away from the linear take, make and waste approach.
The MedTech industry has grown too comfortable with “essential use” exemptions and is ignoring the growing liability, supply chain and regulatory risk of PFAS use in medical devices and manufacturing facilities.
A recent study from Ethicon and the Cleveland Clinic outlined opportunities and barriers to better sustainability practices in operating rooms. We spoke with Vishnu Kalra, President, U.S. Ethicon, to learn more about the study’s findings, Ethicon’s efforts to develop more sustainable products and practices, and how other companies can get started.
At Device Talks Boston in May, Ronald Kurz, Sr. Director and GM at Canon Virginia, Kathryn Unger, Sr. Mgr. of Global ESG Communications at Boston Scientific, and David Ettl, COO at Gradian Health System, addressed the question, how can we make medical products sustainable?
Only one third of “The State of ESG in Manufacturing” survey respondents have high confidence in the quality and accuracy of their supply chain data. This article summarizes the risks of poor data, the seven elements that contribute to siloed data, and the associated regulatory risks.
New directives and guidance aim to connect patients, physicians and other stakeholders across the healthcare ecosystem with a consistently up-to-date information source for product and safety information that isn’t dependent on paper. Schlafender Hase’s Peter Muller explores the promise of e-labeling and practical next steps required to deliver on these directives.
