Since its founding in 2002, New Orleans based MaxiFlex LLC remains the only company with FDA approval to produce and market single-use and limited-use endoscopes in the U.S. These low cost high quality devices, called flexible ureteroscopes, cost approximately 70 percent less than other devices that have been in use for over 20 years in the surgical field. They greatly reduce the cost of surgery for removing kidney stones, and can be adapted to other specialties. These low cost devices have increased healthcare access to developing countries that cannot afford such high cost equipment, and market share is rapidly increasing. MaxiFlex’s Vice President Nicholas Gerbo shares the company’s Louisiana innovation story:
[Q] What inspired the launch of MaxiFlex?
[A] The company was founded in 2002 by Gary Ventrella, who was developing the SemiFlex Scope™. The idea of a low cost scope was mentioned during a case Ventrella was attending with Raju Thomas, MD, who is now Chairman of Urology at Tulane Medical Center. While training a resident, Dr. Thomas was telling Ventrella that these devices were extremely fragile and expensive, and if he could find a way to make one of these devices that cost less and offer the same user characteristics, it would be monumental. Ten years later the SemiFlex Scope™ was launched.
[Q] Why did you pick Louisiana to develop MaxiFlex?
[A] Being a native of Louisiana and an entrepreneur, Louisiana offers some unique opportunities. Both the Louisiana Emerging Technology Center located on the Louisiana State University campus and the New Orleans BioInnovation Center offer investment opportunities, IP guidance, facility and utility sharing, and more for start up biotech companies. These facilities are waypoints for the biotech industry here in Louisiana. We are happy these facilities exist and are keys to attracting more biotech companies to the state.
[Q] When did you realize that MaxiFlex would be a success?
[A] We have developed what we believe is a disruptive technology and now have the opportunity to distribute it on a global basis. The largest measure of success for us is making a minimally invasive procedure available to patients globally where ordinarily an invasive procedure would have been performed for purely economic reasons. For the first time, surgeons in these areas are able to perform a procedure utilizing this now affordable technology.
We believe competitors’ reactions to our device can be the best barometer of success. In countries where our product sales are rapidly increasing, we are now seeing a significant change in marketing and pricing strategy from one of the largest manufacturers and global competitors.
[Q] What would you say to an aspiring Louisiana entrepreneurs and innovators?
[A] If they want to start a medical device manufacturing business, they better be in it for the duration. One should expect a minimum of 10 to 12 years of hard work before any returns are made due to the regulatory challenges and the inherent complexity of the distribution network. Financial resources will be necessary to carry you through that time. Knowledge of the global healthcare market is critically important. Knowing the regulatory process in all countries you want to do business in is a must. The real reward is knowing that the device your company makes is being used to successfully treat patients around the globe who may have not had access otherwise.