Laying the Groundwork for an AI Breakthrough
Digital transformation requires a clear vision, buy-in at every level, and significant investment. Here are three steps to streamline the process.
Tag Archives: Focus Article – Homepage
Contamination Control: Practical Steps to Compliance with EU GMP Annex 1
Revised EU GMP Annex 1 requirements must be fulfilled by August 2023. Designed to protect and increase confidence in the sterility of these products, the new specifications are significant and wide-ranging, spanning the Quality system and the manufacturing process itself. Anna Cluet of Rephine discusses the practical specifics of designing and delivering a fit-for-purpose contamination control strategy.
Microbattery Advancements Will Unlock a New Wave of MedTech Innovation
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.
How Health Tech Can Combat the High Cost of Lifestyle Choices
We’ve all dabbled with apps that affect various parts of our health and wellness, but never in a holistic way. This is an opportunity for the tech sector to help patients drive better health outcomes and reduce overall healthcare costs by showing them how to embark on a path of wellness. It’s just a matter of pulling it together into the right user experience.
From Art to Science: How Machine Learning Is Changing the Surgical Landscape
Anthony Fernando, CEO and president of Asensus Surgical, discusses the potential benefits of augmented intelligence in robotic surgery for both patients and physicians.
Why Human Factors Engineering Matters in Medical Device Packaging
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.
Preparing for a Data-first Regulatory World
As data, rather than document-based dossiers, become the focus for regulatory processes, regulatory affairs managers need to consider whether team skill sets need to be refreshed to reflect new ways of working.
Nudging Towards Safer Decision Making
There is an increased need to foster effective and improved dynamics between people, processes, knowledge and technology to generate an output of safety. “Nudges,” which can help optimize choices by encouraging safer and healthier behaviors, are a promising option.
Improving Image Integrity in Clinical Research
Including figures and images in clinical research enables researchers to illustrate their findings in a clear, effective and engaging way. Yet, it can be difficult to manually check images for accuracy, introducing the risk of integrity issues. Following we look at best practices and new tools developed to ensure image integrity in clinical research.
The Real Impact of IVDR on Clinical Evidence Requirements
One of the biggest stumbling blocks for manufacturers, particularly those with legacy devices, is clinical evidence under IVDR. Carlos Galamba, former technical reviewer and current VP of Intelligence and Innovation at RQM+, discusses the challenges and opportunities of the more stringent evidence requirements facing diagnostics developers.