Medical devices are ubiquitous — from thermometers, bandages, and dental floss to blood glucose meters, hearing aids, and complex implantable devices such as pacemakers. The latest cutting-edge examples even extend to apps on tablets and PCs that physicians use to help monitor and treat patients. Before a medical device can be put on the market,...
Medical device development must address some unique challenges that have grown over the last decade due to increasing medical device complexity, a more complex regulatory framework catching up with the industry, and an established and variable standard clinical practice to compete with: These factors have a major impact on the medical device development cycle, which...
Software as a medical device (SaMD) has emerged as a class of devices for collecting, processing and analyzing healthcare data to manage disease. Powered by analytics, SaMD accelerates the diagnosis and treatment of a wide range of medical conditions and is automating certain aspects of patient care, saving time and improving health outcomes. Because the...
Medical devices play an increasingly critical role in the health and quality of life for millions of people worldwide. While clinical trials for medical devices have many similarities to those for pharmaceuticals, the regulatory evaluation of devices is distinct from that of drugs – and there are critical differences in the way the device trials...
As those working in the development of combination products likely know, the Food and Drug Administration (FDA) issued two new draft guidances in December 2019. The guidances – Requesting FDA Feedback on Combination Products and Bridging for Drug-Device and Biologic-Device Combination Products– were published in response to the 21st Century Cures Act and Prescription Drug...
For medical device developers seeking to enter the diverse, complex Asia-Pacific (APAC) market, having a well-planned reimbursement strategy is critical for commercial success. Thoughtful consideration of coverage, coding, and payment should be factored into the product development cycle at its earliest stages, and understanding the reimbursement landscape in all the countries in which you intend...
The EU Medical Devices Regulation (MDR) was published on May 5, 2017. The impetus behind these new, more rigorous regulations was in part to reflect the substantial technological and scientific advances made by the medical device sector and in part a response to the need for regulations that would significantly tighten the controls around medical...
As medical device regulations evolve and global, multi-center studies become increasingly common, a growing number of sponsors are turning to independent committees such as Data Monitoring Committees (DMCs) or Clinical Endpoint Committees (CECs) for assistance with clinical trial oversight. However, given that neither the U.S. Food and Drug Administration (FDA) nor the European Medicines Agency...
It isn’t difficult to see how technology has changed our lives for the better over the last century. From self-driving cars to smartphones, numerous innovations have made our lives safer and much more convenient. Of course, one of the most robust categories where the quality of life has improved is medicine thanks to ongoing technological...
We were reviewing a study protocol for a maker of medical devices, and there was one provision that just didn’t make sense. The sponsor specified a need for regular data monitoring committee meetings, but we didn’t see the need and couldn’t justify the effort. It was a short study involving few sites. In all likelihood,...