Diagnostic manufacturers and pharmaceutical sponsors with therapeutics that rely on biomarker identification or companion diagnostics should adjust their commercialization and partnership strategies to fit the new regulatory environment.
An analysis from the Life Sciences legal team at Hogan Lovells.
Medical Device Original Equipment Manufacturers (OEMs) are increasingly seeking sophisticated thermal solutions to improve medical device performance. How does the transition from traditional heaters to advanced, layered heater technologies impacts device design?
Information Sharing and Analysis Centers (ISACs), developed to help critical infrastructure industries prevent and become more resilient to cyber and physical security attacks, are expanding their strategies to meet ever-evolving threats. Errol Weiss, Chief Security Officer of the Health-ISAC, discusses how these groups work to protect industry, emerging threats and how device developers and healthcare organizations are working together to protect patients.
The Home as a Health Care Hub will bring together patients, providers and device developers with the goal of making health care in the home environment an integral part of the healthcare system, and advancing health equity for all people in the U.S.
Typically, costs are reduced by using less material and floor space, and eliminating any specialty equipment required for handling large or heavy parts. For miniature devices, the equation is reversed.
The new equity guide provides implementation steps to help developers and users implement the AHRQ Digital Healthcare Equity Framework to ensure new technologies ameliorate, rather than exacerbate, inequities in health care.
The push to use smaller packages can be counterproductive. The better solution may be to reduce the size of external components or eliminate them entirely and integrate their functionality into highly integrated ICs.
Automation and digitization of quality processes can improve efficiency, reduce costs, and enhance product quality in manufacturing, allowing for more informed decisions that will contribute to long-term success.
“In the future, CDRH intends to increase the breadth of the dataset of chemicals and RRF information it makes publicly available, and to add other detection methodologies such as liquid chromatography (LC).”