Women in Medtech: FDA Commissioner Margaret Hamburg

[Editor's note: This is the last installment in MD+DI's 10-part "Women in Medtech" series.]

As commissioner of the FDA, Margaret Hamburg has a tough job. Part of her role is to walk the thin line between protecting patients and giving them access to innovative, lifesaving products.

She brings to the task her background as a physician as well as years spent working in public health. Hamburg has served as FDA commissioner since 2009, and she is just the second woman to be nominated for the agency's top spot.

MD+DI: How did you first become involved in the medtech industry?

Margaret Hamburg: As a medical professional I have obviously been exposed to medical technology issues. However, prior to becoming FDA commissioner I had never really been involved directly with the industry. In my role I’m now uniquely positioned to see various aspects of the development and regulatory process that impacts the medtech industry. I am often struck by how dynamic an industry it is and how many different specialty areas and discipline areas are involved. It is a field that is evolving very, very rapidly and has a model that is somewhat different from the model I am more familiar with, which is the pharmaceutical industry model.

MD+DI: What do you think are the most important challenges the industry will face over the next five years?

Hamburg: I think it is going to be a very active and dynamic field where there are going to be a number of important breakthroughs. We are going to see more complex technologies being developed. The IT area is going to be a burgeoning area. In particular, the advances in hand-held technology are going to start to merge with the medical device area, and we are already seeing this.

There will be a lot of opportunities, but also a lot of challenges in terms of how to best assess and assure safety and efficacy of these products. I think we are also seeing increasing overlap between products that traditionally been viewed as medical devices and products that have traditionally been viewed as drugs. We are going to see both combination products in the sense things that will be able to deliver care in new ways.

At the same time, we all recognize that this is a time of intense economic pressures and that this is an industry is responding to those pressures and we all recognize that this is a very important industry that matters to the health and well-being of patients. The agency is also well aware of the need for this industry to function efficiently if it is to play a significant role in maintaining and improving the quality of our healthcare system.

MD+DI: Are there barriers to women entering the medtech field?

Hamburg: I’d rather turn this around and talk about the opportunities that exist for women entering the medtech field. Women have the opportunity to provide leadership in both new companies and in existing companies. This is field where women can come in and really marry an interest and commitment to serving patients with helping to develop new medical technologies.

MD+DI: How can we encourage more women to get involved in the medtech industry?

Hamburg: I think one potential concern here is that we are not seeing enough young women going into science and technology as a professional, in particular, the harder science areas such as engineering, IT, and physics. Traditionally, they are more represented in the life sciences, but I think we really need to focus on ensuring that our educational system from the earliest ages are really teaching and engaging girls and young women in the science and math arenas. We all need to work together to expose young women to the opportunities and career paths that exist within the medtech industry.

MD+DI: What advice do you have for women starting out in the medtech industry?

Hamburg: My advice is to plunge in. The science and technology sectors offer many meaningful opportunities for women that will allow them to combine a range of skills and participate in what I hope are the next great advances in medicine that will help shape the future of health care.

For more from Hamburg, check out her TEDMED 2012 talk:


—Jamie Hartford is the associate editor of MD+DI. Follow her on Twitter @readMED.