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.
The dramatic increase of medical devices in patient care has yielded many benefits. However, this technology also carries various risks, including risks to patient privacy, that must be addressed.
The recently announced “Refuse to Accept Policy” signed into law under section 524B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) gives the FDA more traction to encourage the medical device manufacturing industry to utilize software bills of materials that help to incorporate supply chain security. The ISA/IEC 62443 series of standards defines a secure product lifecycle process that can be adopted by medical device manufacturers to identify and manage the security risks of all external components used within the product.
When it comes to testing, the most significant difference between CSV and CSA is that CSV focuses on a “test everything” approach, while CSA encourages us to use critical thinking to test more effectively. The following article outlines how companies can identify the appropriate degree of testing rigor for risk-based CSA validation to ensure the least burdensome approach.
Smart hospitals are revolutionizing health care with the help of AI, IoT and robotics. Following are the latest technology and data analytics tools and trends that are helping these hospitals of the future provide safer, more personalized care.
Regulatory requirements for computer systems validation (CSV) have long been in place, but their compliance requires considerable time and resources. In the life sciences industry, traditional validation processes add to project timelines and costs, affecting time to market and preventing the deployment of newer versions of software. In addition to improving accuracy and coverage, automated CSV processes can create the same artifacts as manual execution and expedite the upgrade timeline.
Internet-enabled medical technologies have significantly improved the standard of care. They have also introduced a range of challenges for healthcare practitioners, administrators, and patients. The good news is these issues can be mitigated—or, in some cases, eliminated—in the engineering and design phase. Following are five key considerations for manufacturers to help foster connected healthcare’s continued acceleration.
MedTech is evolving from siloed products and devices to increasingly multi-functional and integrated digital systems, and device manufacturers are faced with significant challenges in bringing these connected solutions to market. Slow and expensive development lifecycles, complex and inflexible device architectures, and the need for increased cybersecurity, are among the key challenges. The solution lies in a new generation of devices powered by intelligent software data flow.