J LEE MANAGEMENT, INC.

In 2006, while talking with a doctor, Maureen L. Mulvihill, Ph.D. realized that there is a market need for an agile business with actuation (i.e., electronically controlled motion) expertise. Actuated Medical, Inc. (AMI) was born with a mission to integrate motion into medical devices to improve patient outcomes, reduce healthcare costs, and increase profitability. Over the last 13 years, Dr. Mulvihill built a central Pennsylvania company that develops, manufactures and sells medical devices. By establishing an internal “start-up ecosystem,” her team has the infrastructure to incubate creative ideas and quickly test. Those ideas that demonstrate market potential are developed to commercial exits. Knowing that FDA cGMP is key to technology valuation, AMI’s process is ISO 13485:2016 certified. To endure the long timelines of medical device regulatory approvals and sales, AMI differentiates from others by using diverse financing model (e.g., SBIRs, sales revenue, Ben Franklin, debt, personal funds and Angel investment). Implementing a stringent hiring process has led to 20 dedicated and engaged team members that apply their skills to multiple projects resulting in 23 issued patents and over 40 pending patent applications, and three products generating early revenue. With the greater visibility, medtech start-ups are coming to AMI for development assistance and/or IP out-licensing (e.g., startups from Houston, TX and Asheville, NC). AMI’s capital-efficient location in central Pennsylvania places AMI within driving distance of several top research and clinical facilities, making it possible to forge strong industry relationships. Within Pennsylvania, AMI is partnering with clinicians and researchers at Children’s Hospital of Philadelphia (CHOP), Penn State (PSU)-University Park, PSU-Hershey, PSU Children’s Hospital and University of Pittsburgh. In 2018, AMI was awarded a Vizient Nationwide Innovation contract for the TubeClear system. The innovation contract is highly regarded as few products achieve this recognition. In 2019, the TubeClear system was awarded a Breakthrough Technology contract with Premier, Inc. The TubeClear system has gained early adoption from several large hospitals across the United States (e.g., Carilion Roanoke Memorial Hospital, Ohio State, Harborview and UC Davis). TubeClear’s market uniqueness attracted the attention of five US regional distributors signing with AMI, thus expanding TubeClear’s nationwide sales force and doubling commercial revenue in 2018 and again in 2019. Due to her experience growing a start-up, Maureen L. Mulvihill was appointed to the AdvaMed Accel BOD to represent small emerging medical device companies in 2017. In 2020, she was elected to the Full AdvaMed BOD alongside larger medical device manufactures, including some Fortune 500 CEOs.