Westborough, Massachusetts-based surgical implant company Miach Orthopaedics, Inc. has announced the addition of two members to its senior executive team.
Miach Orthopaedics Expands Executive Team
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Michael O’Hara, M.Eng. will join Miach as its vice president of quality assurance and Rita Paparazzo, MBA, will join as director of clinical operations. Both executives will work to oversee quality systems and clinical trials for Miach’s Bridge-Enhanced® ACL Repair (BEAR®) implant for anterior cruciate ligament (ACL) repair.
The BEAR implant is a proprietary bio-engineered bridging scaffold. Miach hopes that this new technology will restore more normal anatomy and function of the knee, enabling a higher percentage of patients to return to their normal activities. The BEAR implant is investigational and currently only available in FDA-approved clinical trials.
O’Hara comes from a background in compliance, product quality, quality systems, and customer satisfaction at companies including TransMedics, ABIOMED, Medtronic and Baxter. At TransMedics, O’Hara was responsible for leading premarket approval submissions for two products and overseeing U.S. Food and Drug Administration manufacturing inspections.
O’Hara told OTW, “I am extremely excited about joining the Miach team and very much look forward to help bring this game-changing technology to individuals that suffer ACL injuries.”
Paparazzo has experience in clinical trial research and clinical operations, with a focus on orthopedics. At Biomedical Associates and Inverness Medical/Biosite Inc., Paparazzo was responsible for the management of several clinical trials, including an investigational device exemption trial.
Paparazzo told OTW, “I’m excited to join the passionate team of individuals at Miach. I look forward to growing and expanding our expertise in improving treatment options for sport injuries.”
Martha Shadan, president and CEO of Miach said, “We are building a team of hard-working, collaborative, innovative employees at Miach. Mike and Rita are results-driven individuals with substantial experience in their respective areas.” Shadan is a recent addition the Miach’s executive team. Miach announced Shadan’s appointment as president and CEO in January 2019.
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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