Unhappy with current textbooks and resources for regulatory professionals, Elijah Wreh, Professor of Regulatory Science and Senior Manager Regulatory Affairs at Boston Scientific, authored his own book for industry and future regulators.
Registration is now open for the MedTech Regulatory Intelligence Summit in Washington, DC, May 16-17. Join us as we take a closer look at strategies and best practices in developing an effective and sustainable regulatory strategy for today’s global market.
How innovators in the femtech space can protect their inventions and defend market share.
As surgeries become increasingly complex and involve more sophisticated technology, the mental and physical demands on surgeons and their teams are expected to increase. As an industry, we need to thoughtfully consider how each piece of technology introduced into operating rooms will impact existing surgical workflow and workloads.
Imagine a patient undergoing therapy being relaxed and enjoying the treatment, or receiving rewards for taking medicine religiously and on time. Creating a game-like experience can change patient perception of medical devices from boring or scary to engaging and attractive. This article covers ways to integrate gaming features into your medical devices, why games are so enticing and how they impact human behavior.
More and more, the quality of real-world evidence (RWE)—gathered from remote patient monitoring data, product and disease registry data, and patient feedback—determines whether a medical device is approved and, in some instances, for how long. Yet some medical device manufacturers are missing an important opportunity to collaborate with clinical registries in capturing this data and driving value.
Rama Chellappa, PhD, John Hopkins University Bloomberg Distinguished Professor in electrical, computer, and biomedical engineering, and co-author of “Can We Trust AI?” looks at the promise of AI in health care and how we can best utilize this extraordinary tool to save lives and improve health equity.
MedTech IoT start-ups and early-stage innovators often launch with a minimum viable product, or MVP, a version with just enough features and stability to be used in clinical or field-testing. With the right MVP, companies can prove technical feasibility and position themselves for success with investors. Here is how to get there.
Connected sensors are a key component to improving patient access to and patient retention in clinical trials. Following are considerations for developers and sponsors when designing and selecting sensors for use in trials.
Digital transformation requires a clear vision, buy-in at every level, and significant investment. Here are three steps to streamline the process.