Miach Orthopaedics has added two people to its senior executive team to oversee quality systems and clinical trials for the Bridge-Enhanced ACL Repair (BEAR) implant for anterior cruciate ligament (ACL) repair. Michael O’Hara joined as vice president of quality assurance and Rita Paparazzo, as senior director of clinical operations.
O’Hara brings extensive expertise in compliance, product quality, quality systems and customer satisfaction, having served in quality assurance roles at TransMedics, Abiomed, Medtronic and Baxter. While at TransMedics, he led premarket approval (PMA) submissions for two products and oversaw U.S. Food and Drug Administration 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 trial research and clinical operations professional with a background in orthopedics. Through her roles at Boston Biomedical Associates and Inverness Medical/Biosite, 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.
“We are building a team of hard-working, collaborative, innovative employees at Miach,” said Miach Orthopaedics president & CEO Martha Shadan in a news release. “Mike and Rita are results-driven individuals with substantial experience in their respective areas.”
In March, Westborough, Mass.-based Miach Orthopaedics said that a study of its BEAR implant revealed results similar to those achieved by traditional ACL repair surgeries two years post-procedure. The BEAR implant is an investigational device and is only available in FDA-approved clinical trials.
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