As with most industries experiencing steady growth, the medtech market faces several challenges, including supply chain issues, price inflation on materials and energy, labor shortages and increasing regulations. Adopting cloud-based digital solutions can help address these challenges. For companies investigating new solutions, the State of Manufacturing Technology survey can serve as a valuable benchmarking tool.
On October 30, President Biden issued an Executive Order establishing new standards for artificial intelligence (AI). The order focuses on safety and security, privacy protections, advancement of equity and civil rights, promotion of innovation and competition and advancing American leadership in AI.
Timely firmware updates are only one part of the hardware-related security equation. Whether it’s a hematology analyzer, CT scanner or any other networked medical device, the ability to withstand as well as recover from a malicious attack begins with the contract manufacturer that builds the embedded system. Here are five questions to ask your hardware integrator to be sure that your devices are equipped with maximum protection both before and after delivery.
Change control plans for AI/ML, remanufacturing of devices and medical device shortages are among the guidances the FDA Center for Devices and Radiological Health (CDRH) is prioritizing in 2024. The agency is seeking stakeholder feedback on the list of guidance documents it intends to publish in the coming year.
Understanding the latest trends, tools and challenges in access management empowers cybersecurity professionals to make better choices in safeguarding their systems. Following we look at emerging trends, regulatory requirements and how shifts in the workplace are impacting the risk of cyber attacks.
The FDA announced that on October 1, 2023, it would begin to Refuse to Accept (RTA) medical device premarket submissions that do not comply with PATCH Act requirements. Erez Kaminski, former head of AI with Amgen and founder of Ketryx, and Paul Jones, former FDA official and Executive Vice President of Ketryx, provide an overview of challenges companies face as they work to comply with the new cybersecurity regulations and standards.
Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions provides recommendations on what information to include in premarket submissions and emphasizes that cybersecurity is a component of quality system regulation.
On August 11, the FDA released a Final Guidance on Off-the-Shelf Software Use in Medical Devices, which supersedes Off-The-Shelf Software Use in Medical Devices issued September 27, 2019.
Healthcare cyberattacks are becoming more common and more costly—both financially and to patient care continuity. Internet-connected IoMT devices and equipment remain a security concern for healthcare delivery organizations. Deeper collaboration between HDOs, medical device manufacturers and security providers is needed to reduce risk and vulnerability.
The use of artificial intelligence in medical device design is already transforming health care. In this article we look at areas of greatest promise as well as the challenges that must be addressed to realize the promise of AI in device design and engineering.
