This #FDAFriday series consists of mini-interviews with former FDA regulators. Our goals are twofold: (1) help students and professionals interested in Regulatory Affairs see what career paths are possible, and (2) talk about some of the various roles at FDA to demonstrate the diversity of responsibilities at the Agency. If you are a former FDA employee and would like to participate, please email us at email@example.com.
This is our last post until the new year! We're taking next week off to enjoy the holidays and spend time in the company of family and friends. Thank you for following along and being part of our community here. We'll see you in 2018!
Laura received degrees in Bioengineering and Biomedical Engineering before working in R&D for such companies as Smith & Nephew and Abbott Vascular. She started at FDA in 2012 where she reviewed premarket applications. Laura was one of the founding members of the Additive Manufacturing Working group at FDA. She continues to support medical device manufacturers in her current role as Global Medical Business Development Manager at EOS in Austin, TX.
Tell us a little bit about your responsibilities at FDA.
During my time at the FDA I was in the Division of Orthopedic Devices II Branch with the main responsibilities of reviewing 510k applications for large and small joint orthopedic implants and instruments. I was also a founding member of the Additive Manufacturing Working group which continues to be led by co-founders, Matthew Di Prima and James Colburn
What experience do you think helped you be a successful regulator at FDA?
I had experience within the orthopedic device industry prior to my time at the FDA, mainly in research and development. I had working knowledge of how a medical device company approached design, development, testing, and interpreting the standards set by the FDA. I believe the experience I had from both sides helped me close any gaps in understanding with the companies whose products I reviewed because I also understood their perspective and objectives.
What are you up to now?
Today I work for EOS, the leader in industrial additive manufacturing, as the Global Medical Business Development Manager. In this role I work with medical device companies worldwide helping them implement additive manufacturing into their business.
So what's additive manufacturing? Asking for a friend...
Additive Manufacturing refers to a process by which digital 3D design data is used to build up a component in layers by depositing material. The term "3D printing" is increasingly used as a synonym for Additive Manufacturing. However, the latter is more accurate in that it describes a professional production technique which is clearly distinguished from conventional methods of material removal. Instead of milling a workpiece from solid block, for example, Additive Manufacturing builds up components layer by layer using materials which are available in fine powder form. A range of different metals, plastics and composite materials may be used.
What's something that you learned from FDA that helped you in your current position at EOS?
Because additive manufacturing is a fairly new process for medical device and instrument production, many of our customers have questions on the regulatory framework. While the guidance document, “Technical Considerations for Additive Manufactured Medical Devices” was finalized in early December 2017, my background and work as a reviewer at the FDA has given me insight into what types of questions and scope of information the FDA is asking for devices made through this manufacturing technique. It is very rewarding to be able to help our customers gain confidence and move forward with their innovative ideas through new design possibilities gained using this technology.
What do you think is a common misconception about the additive manufacturing industry?
The most common misconception about additive manufacturing for the general public is that it is only used for prototyping. In fact, the FDA recently disclosed that over 100 medical devices manufactured by additive manufacturing have been cleared to date. There are acetabular cups and revision shoulders, for example, produced by additive manufacturing that have already been implanted into patients. More and more medical device companies are using the technology for serial production.
What is some advice you can give to a person interested in regulatory affairs?
This is actually advice I would give to anyone interested in the medical device industry: Be curious. There is so much to learn about medicine and so many innovative companies and physicians creating new processes, materials, or surgical techniques. Be open to possibilities you never thought you’d find; it’s an exciting diverse field!
More about Laura Gilmour
For more information about Laura and her colleagues’ work at EOS, please visit the following link: https://www.eos.info/en
And check out this really cool video on 3D printed micro parts from EOS!