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PFD Patch Development
Dr. Biesman’s Fun Success Story About An Idea that Made Its Way From Lunch to an FDA-Approved Product
A little less than two years ago, while attending a laser meeting, I was invited to lunch with a very small startup company. One of the founders of the company I had known for many years, and the others I met for the first time that day. We talked about a new product that the company thought might make laser-assisted tattoo removal (and possibly other treatments) more efficient and successful. During the course of the meal, I outlined some suggestions of how the company might go about testing the product and ultimately bring it to market. One of the biggest obstacles, as I saw it, facing the young company was that the product would need FDA clearance, a frequently insurmountable barrier. (I have had dozens of such conversations over the years and, for a variety of reasons, most don’t end up going to the next level.) Somewhat to my surprise, several months later I received follow-up communication from the ON Light Sciences that they wished to move forward with the project we discussed!
I consulted with my research team and, in collaboration with ON Light Sciences, we started our first project. While I did the high-level planning, the real “heavy lifting” was done by our research coordinator Melissa Boudreau, LPN CCRC, and Cara Costner, RN, FNP-C. I credit Cara with discovering the nuances involved in getting best results with the patch and she will soon be featured in an educational video explaining her technique.
Our first project was to demonstrate that the product (a clear patch infiltrated with a special solution) enhances the efficiency of laser-assisted tattoo removal. As shown in the photographs, we were able to achieve this goal. Our next objective was to prove to the satisfaction of the FDA that this product is safe. I worked directly with the FDA and the ON Light Sciences team to design a project that would be acceptable to FDA if successful. After reaching consensus, our team executed the study without delay and less than three months after receiving our data, the FDA granted clearance for the product which will now be used worldwide to assist in the treatment of tattoos and other laser procedures. It’s not very often that we get to help launch a new FDA-approved product, but it is gratifying and fun when those opportunities present themselves. I am so proud of our team!