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.
AI can support device innovation and surgical training, but it requires data and collaboration.
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.
The second part of this two-article series on digital therapeutics (DTx) sheds light on challenges faced by the companies in the DTx market and outlines hurdles that must be overcome to achieve success.
Nondisclosure agreements (NDAs) can help protect trade secrets and build a framework for better cooperation and understanding between parties. Following are some key areas to consider when creating an NDA.
Digital therapeutics (DTx) have the potential to lower healthcare costs and improve patient compliance, outcomes and access to care. In the first part of this two-article series we look at the current and potential applications for this growing sector of digital health as well as key considerations for technology developers.
On the journey to full-scale production for medical devices incorporating optics, a series of steps early in the process can make all the difference for successfully launching new products and introducing next-generation upgrades. This article discusses four considerations for a successful product launch.