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Dressing and Augment Implant System for Rotator Cuff Repair

Lin Chia-wei, Taichung Tzu Chi Hospital
Year 2018Year Period:2018-12-01 to

Overview

  • Currently rotator cuff repair (RCR) surgery is performed mainly under the double row approach. Costing a total of US$4,000, four suture anchors are needed in a single surgery—a complicated procedure that takes two hours or so. Indeed, it is inefficient and expensive.
  • The team has thus come up with a more efficient and economical RCR alternative.
  • In addition to shortening surgical time, the procedure renders bolstered biomechanical strength to attain a firm and secure stitching outcome, thereby mitigating the risk of tendon re-tear.

Development Process

Over the course of this project under the Applied Research Incubation Program, the team completed biomechanical strength testing; biocompatibility tests—cytoxicity test, intracutaneous irritation test, skin sensitivity test, acute systemic toxicity test, pyrogen test—for ISO 10993 compliance; functionality assays. Animal tests and preparations for a pre-submission to the FDA are now under way.

Milestones

2018
  • Admission to the MOST’s Nursery Program.
2017
  • Forms De Novo Orthopedics Corp.
2016
  • Supported by SPARK program.
  • Selected for the STB Program.
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Project Leader

Project ManagerJiaru Wu　 SpecializationBiomedical materials and biomolecular engineering, bio-membrane R&D, surface modification for medical devices, medical devices regulations and product launch applications: having been certified as a reserve seed consultant for medical devices regulations and for Creo Parametric/AutoCAD competence.
More Professional Partners
Contact me sabrinawang@biip-mdcc.org +886-3-658-8760#2031
Project Manager Jiaru Wu
Contact me sabrinawang@biip-mdcc.org +886-3-658-8760#2031
Specialization Biomedical materials and biomolecular engineering, bio-membrane R&D, surface modification for medical devices, medical devices regulations and product launch applications: having been certified as a reserve seed consultant for medical devices regulations and for Creo Parametric/AutoCAD competence.
Duty Guidance for teams focusing on biomedical materials; drawing on her academic and professional expertise and understanding of applicable regulations to help academic or research teams commercialize their technologies and bring their products to market
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