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.
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.
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.
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.
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.
The deeper insights provided by a single source of truth help regulatory teams pinpoint and address gaps in data collection during each trial phase. By mitigating potential risks earlier in the process, teams generate more robust evidence and stronger submissions, which often means a shorter approval process.
Leslie Storms, U.S. president of Ethicon, Martha Shadan, chairwoman of Brilliant Springs Therapeutics, and Kristine Ilaria, vice president of Corporate Development at Smith+Nephew, share lessons learned from their panel “Making Acquisition Strategy Succeed: Perspectives from Both Sides of The Deal.”
The reality of biased data is becoming all too clear, which raises important questions for clinicians as well as device and drug developers. In a world full of biased data what are the most ethical practices to achieve equitable health care?
Connected medical devices have many advantages but require a higher level of security. If the medical industry doesn’t improve its cybersecurity posture, it could endanger patient privacy and lives.
Taking these compliance challenges into account will allow healthcare organizations to prepare for compliance audits, but more importantly it will help institutions address issues that result in a negative patient outcome.
