Donna Wheeler, Ph.D.
Product Development
Dr. Wheeler has over 20 years of experience in musculoskeletal education, research, product development, and project management. In recent years she has focused on design, implementation, and management of preclinical safety and efficacy studies involving orthopaedic medical devices and combination products. She contributes to these projects in her areas of expertise including imaging modalities (CT and MRI), biomechanics, histopathology/biocompatibility, histomorphometry, data management, statistical analyses, reporting, and regulatory submission. She has conducted or managed more than 100 GLP and non-GLP preclinical evaulations in areas of sports medicine (ligament/tendon & cartilage), spine (modeling, kyphoplasty/vertebroplasty, fusion efficacy, implant design, & intervertebral disc), oncology (custom limb spare design, allograft science, & adjuvant treatment efficacy), trauma (fracture healing, implant evaluation & design, orthobiological supplementation), osteoporosis (dietary influence, model development, treatment efficacy, & orthopaedic consequences), osteomyelitis (antibiotic delivery & influence on osteointegration), total joint arthroplasty (implant design, osteointegration, & interface/bone strain), and osseous and osteocondral defects (grafting & tissue engineering). Her background in engineering, material science, biology and physiology provide expertise for assessment of emerging orthobiologic and tissue engineering products. Dr. Wheeler partners with client companies in the areas of: - Preclinical safety and efficacy studies
- Study Design
- Study Placement
- Study Monitoring
- Histopathology services and histomorphometry analysis
- Radiographic interpretation and analysis
- Study data review, statistical analysis, and reporting
- Support for regulatory submissions
- Project management
- Technology assessment and due diligence
- Literature reviews
- Educational workshops and lectures
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