Connectivity in medical devices creates new diagnostic and treatment opportunities, yet at the same time increases the risks of cyberattacks—including their consequences for patient safety and data privacy. Now the new IEC 81001-5-1 standard provides clear technical requirements for manufacturers and developers to ensure the cybersecurity of their products across their life cycle.
“The Liver-Chip detected nearly 7 out of every 8 drugs that proved hepatoxic in clinical use despite having been deemed to have an appropriate therapeutic window by animal models.”
Digital transformation requires a clear vision, buy-in at every level, and significant investment. Here are three steps to streamline the process.
The acquisition expands Veranex’s footprint for product design engineering services across the U.S., with combined company offices now in the Eastern, Central, and Western regions
The acquisition expands MilliporeSigma’s portfolio to a full range of bioreactors, from 2ml to 2000L, and adds to the company’s expertise in monoclonal antibody (mAb) process development.
There are several challenges and opportunities on the road to a truly connected, hospital to home healthcare system. Stuart Long, CEO of InfoBionics, discusses new innovations as well as what’s needed to move connected care and remote patient monitoring to the next level of adoption.
Microbatteries are on the cusp of a new era as solid-state lithium technology arrives to pack more energy into smaller form factors. These batteries will enable the products they power to be offered in smaller sizes and more comfortable shapes, with enormous implications for future medtech product designs and capabilities, from the convergence of hearables and OTC hearing aids to wearable devices that are used for remote health monitoring and fitness tracking.
Neurosurgeons Adel Malek, M.D., Ph.D., and Carl Heilman, M.D., were recognized for their eShunt System, which is the first minimally invasive treatment for communicating hydrocephalus.
Anthony Fernando, CEO and president of Asensus Surgical, discusses the potential benefits of augmented intelligence in robotic surgery for both patients and physicians.
By applying HFE principles early on, packaging design can evolve beyond usability evaluations in product development cycles to ultimately ensure a better user experience and safe execution.
