Stayce Beck at the FDA: Helping to Assure the Safety and Quality of Medical Devices Used by Millions of Diabetics
Daily life for people with diabetes can be complicated by various risks and challenges associated with the medical condition. But in her role as Chief, Diabetes Diagnostics Devices Branch of the Food and Drug Administration (FDA), Stayce Beck, Ph.D., M.P.H., is playing a key role in improving the quality of life for such individuals by advancing the safety and effectiveness of the devices that diabetics and medical professionals use to manage the disease.
Diabetes is a condition in which the body either doesn’t make enough insulin (a hormone produced by the pancreas that helps glucose, or sugar, get into our cells for energy) or can’t use its own insulin as well as it should. This causes sugars to build up in the blood. Diabetes can cause serious health complications including heart disease, blindness, kidney failure, and lower-extremity amputations.
In her branch office, which is under the direction of the FDA´s Center for Devices and Radiological Health, Stayce oversees scientific and medical matters involved in assuring that new and existing diabetes devices manufactured by companies and made available to the public meet the FDA´s strict standards for safety and quality. This rigorous process includes monitoring these products from the time they are developed until (and after) the product is placed on the market.
Says Stayce: “This is not an easy task and it requires that the manufacturer have a clearly defined process for making the device, even after all the preliminary tests, studies and clinical trials for it have been done. We must continue to follow it to make sure the product is indeed safe for the people who will be using it.”
A highly important federal government agency with far-reaching responsibilities, the FDA, in addition to overseeing the quality of medical devices, is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation. “The FDA mission is to protect and promote the public health — and we take this mission very seriously, “ says Stayce.
It is her job´s impact on the human side of product safety and quality that especially appeals to her. “I started out going to graduate school where I did basic science research which I really enjoyed,” Stayce recalls, “but I wanted to get into research that had more direct impact on helping patients. So I then I applied for an FDA fellowship that allowed me to continue with basic science research but also the opportunity to learn the regulatory side of it and how this impacts the humans that stand to benefit.”
This explains why in her current post at FDA that she also sees her role as being an advocate for diabetics. “In my job, I am aware of the complexities that these individuals face each day, ranging from dealing with hypo- and hyperglycemia [low and high blood sugar rates] to the longer term complications that can develop.” In addition to these health risks, she says, there are other challenges that they must also deal with daily, such as having to carry a meter, pump, a CGM (a blood sugar testing device), and a lancet (a device that draws blood for testing) “In addition, many diabetics have to do a lot of math calculations just to know when and what to eat, how much insulin to take and whether they can exercise or not.”
To help lessen these challenges, Stayce and other colleagues at the FDA are working with medical device companies to help develop and approve devices that will make daily living for diabetics less complex, thereby adding to quality of life.
Stayce earned her Ph.D. in Biomedical Sciences from the University of California, San Diego; her Masters of Public Health degree in Epidemiology from the University of Maryland, Baltimore, and her Bachelor of Science in Chemical Engineering from the University of Texas at Austin.
For more information, please visit https://diabetesadvocates.org/masterlab-2014/dr-stayce-beck/