Mark Roby, Ph.D., an inventor on over 50 patents in the areas of polymers and adhesives, is the new Vice President of R&D at Boston, Massachusetts-based Hyalex Orthopaedics, Inc. According to the company, Dr. Roby “is an experienced medical device industry executive known for building high-performing teams and delivering results was most recently CEO of BI Medical.”
Mark Roby, Ph.D. New VP of R&D at Hyalex Orthopaedics

“Mark’s strategic acumen and proven track record of leadership delivering over 25 complex and innovative medical surgical products to market made him the ideal choice to lead our R&D organization,” said Mira Sahney, Hyalex President and CEO. “We are pleased to have Mark join our company as we work to bring our novel technology platform into the clinic and the marketplace.”
Dr. Roby held R&D leadership positions with Bard, Covidien, Salient Surgical (acquired by Medtronic) and US Surgical in addition to leadership roles including production, quality, clinical, marketing and sales.
“I’m excited for the opportunity to lead such an exceptional team of innovators and product developers through the next phase of growth for the company,” Roby said. “Implant systems we are developing based on the HYALEX synthetic cartilage technology have the potential to positively impact patient treatment outcomes and transform orthopaedics.”
Dr. Roby told OTW, “I will continue to build the product development team to execute toward our planned first-in-human clinical trial.”

Discussion
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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