LSI Solutions’ Scaling Medical Device Production: Local cleanroom, global impact!
Guest post from Greater Rochester Chamber member LSI Solutions
At the end of 2021, LSI Solutions® (7796 Victor-Mendon Road) initiated the design and construction of the new state-of-the-art cleanroom on their 60-acre headquarters in Victor, NY!
LSI Solutions is a medical devices company that specializes in developing minimally invasive surgical devices to enable better patient outcomes around the world. The President & CEO, Jude S. Sauer M.D., started the company in 1986 but it has grown significantly over the past 37 years. LSI now employs over 500 people including Medical Doctors, Engineers, Regulatory professionals, domestic and international Sales professionals, and many more. LSI is based in the United States but maintains a European subsidiary (LSI Europe) in Dusseldorf, Germany.
After much thought and planning, LSI’s new cleanroom is specifically designed to maximize the space and optimize the workflow efficiency for the assembly of their high-volume cardiac surgery products (Cor-Knot® and Cor-Knot Mini®). These products are used in over 80 countries every day, and as the demand continues to increase, LSI is adapting to provide more of these life-saving tools.
The preparation for the new cleanroom space was completed in September of 2022. The foundation & steel supports, built within one of their preexisting buildings, were completed at the beginning of 2023 and quickly followed by the installation of the walls & ceiling. Once the filtration systems, flooring, and other cleanroom necessities are installed, LSI Solutions® will undertake the task of officially qualifying and classifying the space as a cleanroom. A DEKRA certification followed by a Grand Opening are expected near the end of 2023.
LSI Solutions® anticipates commencing production in their new, state-of-the-art cleanroom in early 2024.