The industry’s heavy reliance on waterfall project management has resulted in long, siloed, and high-risk product development cycles. This model does not accommodate evolving regulations, shifting geopolitical realities, or fast-changing healthcare needs.
Titanium has become a vital material in modern medicine due to its strength, light weight, corrosion resistance, and exceptional biocompatibility with high long-term success rates and minimal risk of rejection. Its non-ferromagnetic nature makes it MRI-safe, and its durability supports better healing outcomes compared to materials like stainless steel. Though more expensive, titanium’s costs are becoming more manageable, and demand is expected to surge with the aging population. Innovations like beta-titanium alloys, surface treatments, and 3D-printed implants continue to expand its medical potential.
For over four decades, the medical device industry has wrestled with fragmented data exchange and proprietary integrations. HL7’s Device Interoperability FHIR Accelerator initiative offers a vendor-neutral framework to finally achieve plug-and-play interoperability—unlocking scalable, AI-powered MedTech innovation and improving patient outcomes.
FDA-Cleared Nanotechnology developed by Nanovis is planned for use to enhance Medtronic PEEK interbody fusion devices used in Spine Surgery.
In the healthcare industry where patient lives are at stake, quality culture is a cornerstone principle extending beyond operational efficiency. It has profound effects on patient outcomes. As tech continues to disrupt healthcare, how do technology companies build a robust quality culture to succeed in healthcare?
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.
In a document updated for the first time since 2017, AAMI released new guidance for EO material compatibility and including new alternatives.
In the medical device industry, engineering quality is paramount. This is a high-stakes field, and the FDA has zero tolerance for violations. A robust development process not only enhances quality, compliance and efficiency but also boosts profitability.
How can drug delivery devices manage competing priorities – reducing overall carbon footprint without expense to patient and practitioner safety or treatment efficacy. Sustainability strategies must account for commercial and budgetary pressures.
Because of the environmental and health risks that PFAS ─ per- and polyfluoroalkyl substances ─ pose, they are subject to a potential ban across the European Union. Such a ban would introduce a need for medical device manufacturers to identify and discontinue the sale of products containing PFAS, while also developing safe and effective alternatives. How will suppliers across the EU approach the impending shift away from these “forever chemicals”?
