Mobile technology and wearables have been hailed by many as the golden future for operational efficiency and patient retention in clinical studies. Digital engagement expert Tim Davis discusses the pitfalls of selecting a one-size-fits-all strategy and waiting for trial processes and regulators to catch up.

As patient safety emerges as a top priority in health care, there's been a steady stream of new regulations and heightened oversight designed to satisfy concerns that the right things are being done to ensure the safety of medical products. For medical device manufacturers, this atmosphere has intensified scrutiny of product design, a trend that could become even more acute later this year when the Association for the Advancement of Medical Instrumentation releases a new set of best practices for Human Factors engineering.

The Agency for Healthcare Research and Quality's new head of the CERTs program, Anne Trontell, MD, MPH, embodies the joint interests of AHRQ and the Food & Drug Administration in the research centers-or as some people refer to it, the parent and godparent status of the two agencies to the centers.

It's been just over a year since the Food & Drug Administration started down the Critical Path to drug development reform, and senior agency staffers are already exuding confidence that at least one of its first showcase projects will be a winner.