Class 1 recalls are at a 15-year high. To reduce the number of recalls and nonconformances, medtech manufacturers need quality management and traceability processes that go beyond documenting and tracking changes to effectively connect people, processes and data.
Bob Tilling, VP of Global Sales at Kallik, delves into dupe culture and its link to counterfeit drugs, and explains how developments in label management can foil illicit traders.
Patient adherence is critical to maximizing the benefits of medical wearables. In this article, we look at the key challenges to patient adherence in clinical trials and healthcare settings, and how device developers, researchers and providers can collaborate to harness the full benefits of wearables.
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.
Timely firmware updates are only one part of the hardware-related security equation. Whether it’s a hematology analyzer, CT scanner or any other networked medical device, the ability to withstand as well as recover from a malicious attack begins with the contract manufacturer that builds the embedded system. Here are five questions to ask your hardware integrator to be sure that your devices are equipped with maximum protection both before and after delivery.
Researchers found that mechanical stress caused by implants leads immune cells to activate RAC2 and other proteins, which then summon additional immune cells, including types that can combine to attack a large invader. These findings may help improve the design and safety of implants.
Instructional materials help users grasp how to use a device safely. Renée Bailey, Certified Instructional Technologist (CIT), explains how effective instructional materials are vital for the medtech design process, and shares necessary considerations to produce instructions that are coherent, easy to understand and aligned with the human factors engineering process.
For “Systematic Testing of a Ventilator Remote Control System Towards Safe Use in Tele-Critical Care and Prolonged Care,” researchers developed a prototype system for network-based far remote-control of the NKV-550 critical care ventilator, with the goals of identifying and implementing foundational remote-control capabilities, and exploring essential performance, interoperability, and cybersecurity requirements.
As VP of Product Marketing for a MedTech startup, my role is to champion pioneering medical technology, strategically spark interest and drive it out of the design lab and into the field where it will ultimately change, or even save lives. Over the last two decades, I’ve seen the industry evolve in interesting ways, and I’ve learned some enduring lessons about market introduction and launch of market-making technologies post-FDA clearance.
When considering use cases and data classification methods for machine learning, image quality, power consumption and latency must be considered.
