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.
Is technology replacing the human element in hospitals and clinics, or enhancing it? In this AAMI Research Review, a pair of newly published studies exemplify how accounting for the humans that use a technology can enhance its effectiveness… and vice versa.
Not talking, doing is the mantra of the medtech professionals behind Diversity by Doing (DxD), an organization committed to helping small- to mid-sized medtech companies build a foundation of diversity, equity and inclusion into their companies’ DNA.
Next-generation, predictive analytic patient monitoring lowers healthcare costs, improves clinical outcomes and enhances the patient experience in hospital-at-home, post-acute care and chronic care management.
Data analytics can provide a more streamlined view of your customers and simplify the complex challenges faced by medical device commercial operations teams.
Randomized clinical trials are the gold standard for conducting clinical research. They are, however, fraught with issues and come with burdens to the patient, site and sponsor. Decentralized trials (DCTs) allow for a novel, agile and more cost-effective approach to an industry standard and traditional methodology. Here’s how to determine if a full or hybrid DCT is a good option for your clinical trial.
Numerous studies have explored the challenge of helping patients adhere to their medication regimens. One promising solution is “smart” medication blister packs with embedded sensors that enable caregivers to remotely monitor if—and when—doses are removed. But they can only be used if they are cyber-hardened against today’s dangerous and ever-evolving cybersecurity risks.
Old justifications or business reasons for security gaps are obsolesced. We need robust medical device cybersecurity, but we need it in a manner that is workable by both MDMs and HDOs.
The upcoming revision to ISO 10993-17 proposes the use of release kinetics data to support toxicological risk assessments. Manufacturers should expect that this data will be needed to help mitigate the risks identified in exhaustive extraction studies.
Rapid developments in healthcare technology, combined with improved data collection, pandemic pressures and increased consumer demand for tech-enabled and virtual health care, are fueling innovation and transformation in the digital health space.