Cybersecurity in health care is anything but simple. But significant changes can be expected in the coming years.
Hägen, who was a contributor to Medtech Intelligence, spent 28 years building BlackHägen Design to support clients in the development of “mission-critical” products. He was pivotal in the advocacy of human factors and good design practices for medical devices and was at the forefront of patient safety initiatives, helping to found the Industrial Designers Society of America (IDSA) Patient Safety Committee.
A new guide from the Healthcare and Public Health Sector Coordinating Council recommends cybersecurity strategies that manufacturers and health providers can implement for legacy medical technology as a shared responsibility in the clinical environment, and provides insights for designing future devices that are more secure.
Point of care 3D printing of medical devices has abundant potential. However, many regulatory uncertainties remain.
The Gushu facility in Shenzhen, China, achieved the accreditation after meeting the rigorous audit requirements set by MedAccred subscribing members, including Baxter, BD, Boston Scientific, Edwards Lifesciences, Johnson & Johnson, Medtronic, Philips, Roche Diagnostics and Stryker.
How innovators in the femtech space can protect their inventions and defend market share.
As surgeries become increasingly complex and involve more sophisticated technology, the mental and physical demands on surgeons and their teams are expected to increase. As an industry, we need to thoughtfully consider how each piece of technology introduced into operating rooms will impact existing surgical workflow and workloads.
The acquisition brings MAXIS’ expertise in pre-clinical engineering, design validation and verification, regulatory affairs, field clinical services, and trial management to Avania’s contract research and MedTech development capabilities.
The doctrine of assignor estoppel is intended to prevent an inventor who has sold or “assigned” a patent from then challenging the patent’s validity. Mauricio Uribe, a patent lawyer with Knobbe Martens, discusses what medical device inventors and acquiring companies should do to ensure they comply with the Supreme Court and Federal Circuit’s clarification of assignor estoppel.
“This report validates the broad applicability—and true value—of computational modeling and simulation as a critical engineering discipline. Tangible cost, quality and performance improvements are being realized by the early adopters.”
