As demand for POC diagnostic platforms continues to grow, product development to achieve CLIA waiver is becoming increasingly necessary for IVD manufacturers.

The rate of change within the healthcare and diagnostics landscapes are unprecedented, presenting both challenges and opportunities for IVD manufacturers.

A user-focused product development process enables IVD manufacturers to accurately identify and understand the problems a device must address before looking for solutions through product definition.

A recap of the presentation Cece O’Connor, Invetech’s Global Director of UX Strategy & Design, gave at the 24th International Molecular Medicine Tri-Conference.

At this year’s AACC Annual Meeting & Expo, we continued our Lab of the Future Series with discussions on adopting agile principles for product development.

Integrating planning of production scale-up and associated automation early and throughout the design process will help enable a seamless transfer to manufacture.

Best practices for evaluating the design trade-offs that may need to be made to achieve acceptable levels of accuracy, sensitivity, cost, and time to result and best match the needs for a particular test.

Representatives from Haemonetics, Quidel and Alameda Health Systems Highland Hospital discuss the future of point of care testing during a webinar hosted by AACC.

Invetech program manager Magnus Ahlstrom shares some of his observations on trends in wearable medical devices after attending Medica 2015.

The IVD industry has the opportunity to not only address world poverty, but also achieve strong commercial return.