Staying a Step Ahead of the Competition

In 2003, while attending a hip surgery for a new implant, the local distributor asked me to meet with a Foot & Ankle surgeon at this prominent academic institution to discuss a new opportunity. At the time our company had no plans to develop any foot and ankle products. The focus was large joints, namely knee, hip and shoulder. After spending time with the surgeon discussing the limitations of the existing treatments and missing my flight in the process, it was clear that there was an unmet clinical need ripe for the taking. Upon my return to the office, I investigated market size, reimbursement and the competitive landscape. The analysis was clear. It was time to develop a new product for the toe. The product was launched less than a year later and became our #1 unit seller after just one year. It was critical in getting the company to reach breakeven in 2009 right at the height of the worst financial depression in US history. This new product essentially saved the company.

Prior to 2004 arthritis, hallux rigidus or hallux limitus of the first metatarsal joint (MTP) was primarily addressed using fusion, a hinged silicone implant or a concave, cup shaped implant placed on the phalangeal or socket side of the joint. Fusions addressed the pain but restricted, silicone resulted in problematic foreign body reactions and because arthritis starts on the metatarsal head and not the phalanx the existing implants were being placed on the wrong side of the diseased joint. With the issues identified, a new implant was designed that not only went on the metatarsal side but it also included multiple curvatures to restore the articulating surface. The new implant was unique in that it allowed the sesamoids to move again and with time a modular implant for the opposing side of the joint was developed, added thereby creating the first anatomic total toe. Since the introduction of the new device, fusion is no longer considered the gold standard for arthritis treatment. The rest of the Foot and Ankle industry has followed with their versions of metatarsal based implants and toe implants are now considered a normal part of the treatment algorithm.