This article examines present and near-term opportunities for liquid biopsy, as well as what’s needed to elevate this innovative diagnostic tool to a standard of care.
The U.S. Food and Drug Administration’s Premarket Submissions for Management of Cybersecurity in Medical Devices draft guidance appears to draw inspiration from CaCPA and the EU’s General Data Protection Regulation (GDPR) – is the FDA merely a follower, or is it leading the way in medtech cybersecurity regulation?
Rather than 12 days of gifts, here are 12 months of suggestions to assist you in helping your organization bring its quality efforts and programs to the next level. As you think about where you want to be in 2019, consider these thoughts as strategies for building more credibility, cachet, and value around quality.
This is the first in a two-part article describes a change management model derived from the concept of co-creation, a process in which brands and consumers work together to create better ideas, products, and services. This first part discusses the tools and methodologies that provide a foundation for improving change management.
Advances in sensors, smartphones, communications, and analytics give developers new tools to build creative and powerful applications that promise to improve health outcomes and reduce healthcare costs.
As component sizes for medical devices shrink to micron size, conventional machining may not be the most efficient or consistent method for manufacturing. Learn why Micro-MIM is preferred for components with tight tolerances at high volumes.
Sustaining engineering enables the developer to plan ahead, getting the development and design of the device done right the first time, and smoothing the transition to manufacturing. KMC's executive director of engineering, Scott Leon, weighs in on the subject.
The business pain of switching suppliers, both in terms of costs and revalidation time, heightens the importance of making the right decision the first time.
Micromolding requires a high level of intimacy and attention to detail to be successful over the long run, so it’s important to work with micromolder with the capability, scalability, and sustainability to get a product from the design stage all the way to high-quality mass production.