Medical Design and Outsourcing

FDA now inspects device makers by risk. Supplier audit programs still built on fixed rotations and one-size-fits-all checklists stand out fast, and for the wrong reasons. By Binitkumar Vaghani, Siemens Healthineers Ask any supplier quality team whether their audit program is risk-based and they’ll say, “Yes, the procedure says so.” Then look at the audit…

Siemens Embedded Solutions address the challenge of developing medical devices through an integrated suite of software that includes: Proven operating systems and middleware Quick, easy, and secure cloud connectivity Comprehensive built-in security Best-in-class security vulnerability monitoring Pre-certified software components and quality artifacts that enable safety certification Professional services Sponsored content by Siemens

NEWS RELEASE: New reactive polymer technology enables SLS printing of high-temperature amorphous components BlueSky Polymers, Insight Polymers and ALM join forces to produce an SLS-printable reactive polyetherimide (xPEI) that offers design and process flexibility for high-temperature, high-performance engineering parts. Kingsport, Tenn. — BlueSky Polymers, Insight Polymers and Advanced Laser Materials (ALM) have developed an amorphous, reactive…

Guardant Health’s Shield blood test for colorectal cancer screening has taken home the prize for best medical technology at the 2026 Prix Galien USA awards. Held at the American Museum of Natural History in New York City, the 20th annual winner was selected from 23 entrants spanning radiosurgery systems, medical implants, diagnostics and pocket-sized devices.…

Becton, Dickinson and Co. (BD) is using technology developed for space in its HemoSphere Stream Module noninvasive monitoring technology, which BD says enables continuous blood pressure monitoring with accuracy comparable to an arterial line. “If you’re building products for the in-hospital setting, it has to be to that [arterial] standard,” BD Worldwide President of Advanced…