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.
Connected devices already enable remote patient monitoring by collecting real-time data, such as injection date and time. With time, these benefits are likely to grow. Following are three areas where manufacturers are exploring new uses of digitalization in drug delivery to better understand the needs of patients and healthcare professionals and create more effective devices.
The Food and Drug Omnibus Reform Act (FDORA) authorized FDA to conduct remote device facility inspections. While it will take time for the FDA to take the necessary steps to start performing remote inspections, industry can look to remote regulatory assessments as a potential model.
Unified communication systems can improve staff efficiency, while enhancing patient outcomes and staff and patient safety.
Cybersecurity in health care is anything but simple. But significant changes can be expected in the coming years.
Data integrity issues have plagued the pharma industry since its inception. Blockchain, with its potential to assist in processes from product serialization to data flow tracking, could be the best solution yet.
“The solution provider that builds the device and creates the algorithm should consider integration and accountability among multiple other challenges. But meeting the needs of the third element in the equation, the doctors, is key.”
LinkedIn has become the go-to social media platform for professionals to build their personal brands, promote their expertise and grow their careers or businesses. Following are key content characteristics and strategies shared by the leading medtech voices on LinkedIn that can help you harness the potential of the platform.
The world of medicine has long centered on the central maxim laid out in the Hippocratic Oath, “Do no harm.” When we look at the growth of AI in health care, I say let’s also include a 21st-century addendum, “Do not deceive.”
More and more, the quality of real-world evidence (RWE)—gathered from remote patient monitoring data, product and disease registry data, and patient feedback—determines whether a medical device is approved and, in some instances, for how long. Yet some medical device manufacturers are missing an important opportunity to collaborate with clinical registries in capturing this data and driving value.