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.
Cevian Capital increased its position in Smith & Nephew to a 5% stake in the British medical equipment maker, making it Smith & Nephew’s second largest shareholder according to reports by Reuters.
Nearly 2/3 of device makers say their regulatory intelligence may be insufficient and they lack the resources to complete all product compliance needs this year. See the executive summary of this MedTech Intelligence audience research.
Payers demand robust evidence that molecular diagnostics and AI/ML technologies demonstrate clear ability to improve overall patient health or healthcare economics even if the technologies themselves don’t directly deliver the final outcome. This disconnect between a technology’s function and the desired long-term impact creates a hurdle for [innovators] to overcome when convincing payers of their value proposition.
San Diego-based medical tech company, Cue Health, announced Monday that it is laying off its entire staff. Similar industry reports indicate a complete shuttering of operations.
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.
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.
Stefano Vicenzetto, Design Systems Engineer at Flex, shares his insights on how Circular Economy principles can be applied within the MedTech industry to reduce environmental impact by shifting away from the linear take, make and waste approach.
