By the time you read this, Robert M. Califf, MD, a recognized global leader in cardiology, clinical research, and medical economics, will have been installed as the U.S. Food and Drug Administration’s new Commissioner of Food and Drugs. As the top official of the FDA, he is committed to strengthening programs and policies that enable the agency to carry out its mission to protect and promote the public health.

One of the first things on his plate is a call for increased diversity of patients enrolled in clinical trials. Recognizing that women, the elderly, and racial/ethnic minorities have been underrepresented in trials, the FDA has named 2016 the year of more diversity in clinical trials, and is planning a variety of tools and activities to push for greater inclusion, including more minority participation.

In addition, the FDA’s Office of Regulatory Affairs (ORA) has also named a new Ombudsman, Jessica Zeller, to serve as an unbiased third party dedicated to assist industry with assessing and resolving problems. She can be reached at This email address is being protected from spambots. You need JavaScript enabled to view it..

Speaking of new—if you’re a subscriber who is involved directly in manufacturing, production, and/or quality control—you’ll find our new exclusive, demographic supplement, Medical Manufacturing & Fabrication, bound into the center of this issue. Packed chock-full of exciting feature articles, briefs, and new products and services, Medical Manufacturing & Fabrication is targeted to roughly half of Medical Design Briefs’ subscribers.

In survey after survey, our readers have told us is that manufacturing is the subject they’d like to see covered more thoroughly in MDB. So, in addition to more opportunities throughout the year in our Editorial Calendar, we’ve added this twice-yearly supplement. Medical Manufacturing & Fabrication features in-depth coverage of the tools and techniques that companies are using to create the latest medical components and systems—from advanced laser welding, to CAM programming, to milling and machining, to augmented reality to improve medical manufacturing—you’ll find this and more in our premier issue. Should you not be a part of this demographic audience but still want to enjoy the content, it will all be available on the MDB website .

Through a special arrangement, copies of this issue with Medical Manufacturing & Fabrication will also be distributed at Mfg4— Manufacturing 4 the Future, May 3-5, in Hartford, CT; Rapid 2016, May 16- 19, in Orlando, FL; and at MD&M East June 14-16 in New York, NY. The next manufacturing supplement will appear in the October issue.