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.
Peter O’Blenis, CEO of Evidence Partners, discusses the growing role—and challenges –of literature reviews in the medtech market.
Remote care in the home relies both on the quality of patient monitoring and on the insights provided to the care team. There is a real danger that data overload and alert fatigue will undermine otherwise well-designed remote patient monitoring (RPM) and Hospital at Home programs. The software platform and algorithms tasked with integrating and evaluating data must identify the data that matters, when it matters.
Gain insight into the notified body approach to assessing biological equivalence and how manufacturers can make sure their equivalence justifications pass notified body review.
Companies can make mistakes during drug and device development and in the post-marketing maintenance phase, but all too often, organizations apply a temporary solution to the problem and move on. In this article, Helen Lowe at Arriello addresses how Corrective and Preventive Action (CAPA) management provides a better approach to discover the root cause of the problem.
Before product developers can more confidently design RWE studies and venture away from the traditional path of lengthy prospective studies, industry must overcome several challenges. This article provides insight on these barriers and perspective on how industry might fully realize the promise of RWE in the near-term to advance health care.