In the News: Driving Improvement Through Innovation and Technology


Healthcare is known for using cutting-edge technology to drive patient care. Today, an increasing number of healthcare organizations are establishing innovation centers to implement and test new modes of care. At the same time, they are reevaluating existing manufacturing processes and material regulations to identify areas for patient safety improvement.

This month’s news roundup explores examples of how healthcare organizations are using — and modifying — technology to enhance patient care and safety.

FDA Posts Final Guidance on Remanufacturing Medical Devices

The Food and Drug Administration (FDA) recently published final guidance on medical device remanufacturing — specifically, to clarify the distinction between remanufacturing and servicing. The final rule incorporated an additional section on the regulatory requirements for manufacturers, based on feedback from groups like Advamed. This change aimed to simplify the guidance so entities that are less familiar with regulatory terminology can fully understand their responsibilities.

Why Healthcare Organizations Are Launching Innovation Centers

An increasing number of healthcare organizations are opening innovation centers to develop and test new technologies to improve patient care. UC San Diego Health’s Jacobs Center for Health Innovation (JCHI), for instance, significantly impacted patient care by deploying an artificial intelligence (AI) sepsis prediction algorithm that reduced sepsis deaths by 17%. In a similar push for modernization, Emory Healthcare recently launched an innovation hub and partnered with Verizon to build a 5G network that allows the hub to explore augmented reality and virtual reality applications.

Phasing Out PFAS: Next Steps for Medical Device Manufacturers

The European Chemicals Agency (ECHA) is reviewing a proposal to ban PFAS, highly biopersistent substances used extensively in medical devices for their resistance to friction, infection, and blood clots. While PFAS are crucial for many MedTech products, there is increasing regulatory pressure to find alternatives due to their environmental and health risks. Companies are encouraged to start the redesign process now to avoid future disruptions and ensure compliance with healthcare regulations.

3D Printed Medical Device Market Set to Skyrocket to $16.5 Billion by 2034

The 3D printed medical device market is projected to grow from $4.5 billion in 2023 to $16.5 billion by 2034, driven by advancements in personalized medical solutions, especially in prosthetics, audiology, and dental care. See how this technology is revolutionizing healthcare reducing costs, and improving patient outcomes.

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