In mid-January, Johnson & Johnson announced that it would begin sharing clinical trial data for its devices and diagnostics via the Yale University Open Data Access (YODA) Project. Since 2011, the YODA Project has operated as a third-party independent reviewer … Continue reading →

The second edition of the Biodesign textbook is now available for pre-order. Here’s how the publisher, Cambridge University Press, is describing the new version: This step-by-step guide to medical technology innovation, now in full color, has been rewritten to reflect … Continue reading →

“Biodesign is on the forward edge of one of the most exciting new frontiers of health care. This impressive and engaging work provides a thorough look at the innovation process.  But this is certainly not just for the scientific innovators: … Continue reading →

Many thanks to Aaron Lu of the University of Virginia for bringing two important updates to our attention regarding medical device regulation in China: (1) In 4.2  Regulatory Basics, we say that a device must receive marketing approval in its … Continue reading →

In the United States, Medicare allows payment of routine costs of care furnished to Medicare beneficiaries in certain categories of Investigational Device Exemption (IDE) studies.  In order to determine whether billing of routine costs (and in some cases the cost of the … Continue reading →

The recently announced National Medical Device Curriculum includes a series of fictional case studies designed to help academic institutions and science and technology innovators understand FDA’s medical device regulatory processes. The FDA believes that better understanding of its regulatory pathways will accelerate the … Continue reading →