Along with our initial human fitment Study Team, including Dr. Phyllis D. Marx (Principal Investigator), Dr. William E. Gannon, Jr. (Medical Monitor), and our CRO Teams at Stiris Research and Radiant Research, ViaTechMD has just completed a series of very successful patient fitment, comfort and organ interaction trials.
ViaTechMD has contracted and is in collaboration with Emergo’s senior-level experts in regulatory pathway and market entry strategy, risk management, device classification and registration, quality management system compliance, and clinical evaluation reports. Emergo, a UL company, has become a leading consultancy organization with more than 2,800 medical device and IVD clients worldwide. The company maintains offices in 25+ countries.
ViaTechMD has contracted Freudenberg Medical, to provide polymer engineering, manufacturing, assembly, packaging, testing and quality control services to our venture. With 11 locations worldwide, Freudenberg Medical is part of the Freudenberg Group. Founded over 165 years ago, the company develops innovative products and services for more than 30 market segments worldwide, and serves 43 of the 50 largest medical device companies in the world.
In collaboration with Baylor College of Medicine, Christus Santa Rosa Health System and Children’s Hospital of San Antonio, ViaTechMD is undertaking a second human fitment study under IRB approval FDA guidelines. This comes ahead of our second FDA Pre-submission Filing, which will include a sophisticated clinical trial proposal being designed in collaboration with regulatory experts from DuVal & Associates and JD LYMON Group, which promises to bring our groundbreaking, device-based treatment to a growing and tragically underserved patient population suffering from Preterm Labor.
Our IDE clinical trial being designed in collaboration with regulatory experts from DuVal & Associates and JD LYMON Group will be undertaken at Children’s Hospital of San Antonio’s state-of-the-art facilities, and will be overseen by the ETP Principle Investigator, Andrea D. Shields, MD, Vice-Chair, Department of Obstetrics and Gynecology, Children’s Hospital of San Antonio; Member, Medical Executive Council, Children’s Hospital of San Antonio; January 2017; and, Director of Research, Education and International Development, Department of Obstetrics & Gynecology, Baylor College of Medicine, San Antonio, TX. The ETP will also include collaboration with Dr. Brook Thomson, director of the OB Hospitalist program, and Dr. Peter Nielsen, OB-in-chief for the Children’s Hospital of San Antonio.
In June of 2018, ViaTechMD engaged DuVal & Associates to assist in FDA negotiations and development of a risk and mitigation analysis and clinical trial design as requested by the FDA. DuVal & Associates was formed in 2004 with a mission to focus on serving companies with unique needs that are regulated by the FDA, leveraging the firm’s exceptional industry experience, practicality, and responsiveness. The firm brings pragmatism and unapologetic advocacy. Its President and CEO, Mark DuVal, spent 17 years in-house between 3M Pharmaceuticals, 3M Medical Devices, and Medtronic. As a general counsel, he used to hire regulatory and compliance counsel from the big law firms in Washington, D.C. and felt they were often impractical, too expensive and less responsive to the exigencies of business, and did not deliver the results he needed. He often felt short-changed by these firms. They were afraid to advocate hard for clients because they are always fearful of not remaining friendly with the Agency. In contrast, DuVal & Associates believes a lawyer can advocate aggressively, yet diplomatically and with respect, and obtain better results for clients while maintaining the firm’s and the client’s positive relationship with the FDA. DuVal & Associates has been doing that for years, and understands that a firm should serve with distinction as a strategic partner and trusted advisor with real world insight gained from industry experience.