In 1996, Cranial Technologies’ founder, Jeanne Pomatto, was looking to find a way to eliminate the need to cast a baby’s head with plaster of Paris in order to fabricate her new medical device, the DOC Band®.A patent attorney introduced the two of us, and shortly thereafter I joined Cranial Technologies as the Director of R&D. My primary goals were to develop a 3D imaging system to replace the current method of plaster casting, as well as create a custom software application that would replicate the manual, truly savant-like process Jeanne would go through in making each baby’s medical device. These have been realized in the Company’s DSi® Imaging System, and Sentient3D® proprietary software programs.Shortly after joining the company, I was also given the opportunity to secure FDA clearance for the product, which up until that time had been considered a ‘custom made’ medical device. This was the first device of its kind, and despite our attempts to demonstrate substantial equivalence to other known devices, our 510(k) application failed. Fortunately, at that time (1998), the FDA had just introduced the new DeNovo Petition process, and the DOC Band became the first device to successfully navigate these waters. As a result, a new medical device category, the cranial orthosis, was created by the Agency.Jeanne and I shared a passion for research, and in collaboration with several well-known craniofacial and pediatric neurosurgeons, we published over 30 peer-reviewed journal articles, and presented over a hundred podium presentations which helped to get the word out about this new treatment option (and developed my enjoyment for public speaking). Over the past twenty years, I also created the Company’s Quality System, and led numerous successful FDA inspections. I oversee the Company’s intellectual property portfolio, and still maintain a leadership role in the Company’s research & development efforts.

My first job at Phoenix Keratek is something I would not have changed for the world. Great people, and an exciting new medical device. Phoenix Keratek was a startup founded by serial entrepreneur Russ Kopenick. Russ hired me directly out of graduate school, sight unseen (I suspect largely due more to my persistence than skill set). The company won a spot and seed funding from the Arizona Technology Incubator (ATI) in Scottsdale in 1994, and within a year had won the National Incubator Company of the Year. The company’s medical device was known as a microkeratome, and was used to temporarily excise the front of the cornea at a time when LASIK was just beginning to replace Radial Keratotomy (RK) as the refractive surgery (vision correction) of choice.In this position I had the opportunity to literally ‘do it all’ (or at least try it all). I was involved with the design of the medical device, setting up and running manufacturing, creating the quality system, doing sales at tradeshows, servicing and supporting the installed systems, and also wrote my first peer-reviewed article published in Biomedical Optics. Looking back, my favorite part was working with some truly world-class refractive surgeons who were pushing the envelope to introduce this new concept called LASIK, and the camaraderie of our small team of employees who shared this common vision.As with many technologies, the microkeratome was replaced with a newer and improved technology, in this case a laser, resulting in a safer and more precise procedure.