“We are building a team of hard-working, collaborative, innovative employees at Miach,” said Martha Shadan, president and CEO. “Mike and Rita are results-driven individuals with substantial experience in their respective areas.”
O’Hara brings extensive expertise in compliance, product quality, quality systems and customer satisfaction, having served in quality assurance roles at TransMedics, ABIOMED, Medtronic plc, and Baxter. While at TransMedics he led premarket approval (PMA) submissions for two products and oversaw U.S. Food and Drug Administration (FDA) manufacturing inspections. At Miach, O’Hara is responsible for developing, implementing and managing the company’s quality function and quality management systems, including overseeing manufacturing and ensuring compliance within applicable regulations and standards.
Paparazzo is an experienced clinical trials research and clinical operations professional with a background in orthopedics. Through her roles at Boston Biomedical Associates and Inverness Medical/Biosite Inc., she managed multiple clinical trials, including an investigational device exemption trial from its inception through to the product’s PMA. At Miach, Paparazzo is responsible for the strategic and tactical execution of the company’s clinical trials for the BEAR implant.
Every year, approximately 200,000 anterior cruciate ligament (ACL) injuries occur in the United States. Without treatment, the ACL does not heal, resulting in ACL reconstruction surgery being one of the most common orthopedic procedures in the United States. Miach Orthopaedics’ new Bridge-Enhanced ACL Repair (BEAR) technology is a proprietary bio-engineered bridging scaffold used to facilitate healing of the torn ACL. It is hoped this new technology will restore more normal anatomy and function of the knee, and thus enable a higher percentage of patients to get back to activities they enjoy. The BEAR implant is an investigational device and is only available in FDA-approved clinical trials.
Miach Orthopaedics, located in Westborough, Mass., has developed the Bridge-Enhanced ACL Repair (BEAR) technology as a viable alternative to conventional ACL reconstruction for patients who have sustained an ACL injury. The BEAR technology was pioneered by Martha Murray, M.D., at the Boston Children’s Hospital Department of Orthopaedic Surgery with initial research funding provided by the NFL Players Association, Boston Children’s Hospital and the National Institutes of Health.