The “For Such A Time As This—OrthoChallenge” is seeking the ten top ideas to present to the FDA to fast-track the innovations to patients.
Due to COVID-19, thousands of orthopedic patients have experienced a sudden cancellation of scheduled hip, knee, shoulder, extremity, and spine surgeries, as well as physical therapy sessions. These patients will be forced to endure their pain and limited mobility for an indefinite amount of time. Surgeons, physical therapists and engineers in the orthopedic community are challenging themselves and the public to rapidly deliver innovative products, services, and software that can bring relief.
NovApproach Spine’s CEO, Raymond Cloutier, is sponsoring the For Such A Time As This—OrthoChallenge to help expedite introduction of new product, software, and services that address the needs of orthopedic patients whose surgeries and therapies are delayed. The top 10 ideas will be presented to the Food & Drug Administration and other government leaders to help “fast track” these innovations to patients.
The new product, software, or service ideas will help orthopedic patients with their pain and limitations while they wait for surgery and reduce the COVID-19 risks unique to orthopedic patients.
Submissions may be submitted digitally at www.ForSuchaTimeAsThisOrtho.com during the month of April and the top 10 will be announced in May.
Co-sponsor, Joseph Zuckerman, M.D., chair, Department of Orthopedic Surgery, NYU Langone Health; past president, American Academy of Orthopedic Surgeons said, “There are so many patients with orthopedic problems who will have their surgery delayed for an unknown amount of time and will continue to suffer from the pain and disability of their underlying condition. This is an opportunity for us to develop measures to mitigate the symptoms until we are able to freely provide the care that our patients need.”
According to Dr. Zuckerman, his hospital typically performs 2,000 orthopedic procedures per month. He estimates more than 90 percent of these procedures are elective. With thousands of hospitals across the globe, the number of suffering patients is “extraordinary and profound”.
Co-sponsor, Dawn Lissy, CEO/founder of Empirical Technologies Corp., stated, “A hallmark of the orthopedic community is innovation through collaboration. This is an opportunity to demonstrate this once again for the patients we serve.”
Marilyn Moffat, PT, director of the DPT Program at New York University and past president of the American Physical Therapy Association said, “With the mandates to stay at home as much as possible, many individuals are having to delay their elective orthopedic surgical procedures. The need for guidance and encouragement to continue their exercise programs and physical activity that can be provided by a physical therapist becomes paramount. The ‘For Such A Time As This—OrthoChallenge’ gives hope that novel and effective ways of doing this can be brought to patients sooner.”
According to Cloutier, “Healthcare providers, particularly during the COVID-19 pandemic, are demonstrating this truth: ‘greater love has no one than this: to lay down one’s life for one’s friends‘. As the world faces this pandemic crisis, orthopedic surgeons, physical therapists and industry are stepping up to help meet the needs of orthopedic patients. Wholly new products, software and services are anticipated that may advance the ‘standard of care.’”
Unprecedented times call for unprecedented actions…’For such a time as this’.
Dawn Lissy is a biomedical engineer, entrepreneur, and innovator. Since 1998, the Empirical family of companies (Empirical Testing Corp., Empirical Consulting, LLC, and Empirical Machine, LLC) has operated under Lissy’s direction. Empirical offers the full range of regulatory and quality systems consulting, testing, small batch and prototype manufacturing, and validations services to bring a medical device to market. Empirical is very active within standards development organization ASTM International and has one of the widest scopes of test methods of any accredited independent lab in the United States. Because Lissy was a member of the U.S. Food and Drug Administration’s Entrepreneur-in-Residence program, she has first-hand, in-depth knowledge of the regulatory landscape. Lissy holds an inventor patent for the Stackable Cage System for corpectomy and vertebrectomy. Her M.S. in biomedical engineering is from The University of Akron, Ohio.