Key Areas of Expertise
- Regulatory Submissions (510(k), IDE, PMA)
- Biocompatibility and Preclinical Testing
- Device Classification and FDA Regulatory Compliance
- Dental Implants and Orthodontic Devices
- Combination Product Development and Assessment
Professional Experience
Senior Consultant – Blackwell Device Consulting
Portland, OR | July 2012-Present
- Advises clients on regulatory strategy, device classification, and pre-market testing for various medical devices, including dental implants, wound dressings, and orthodontic aligners.
- Specializes in 510(k) and PMA submissions, with significant experience in combination products and dental devices, such as bone filling materials and 3D printing resins for dental applications.
- Manages device registration, listing, and importation issues, serves as a U.S. Agent, and consults on FDA Emergency Use Authorization (EUA) requirements, particularly for masks.
Senior Consultant – Biologics Consulting Group, Inc.
Catawba, NC | Oct 2007-July 2012
- Provided consulting on regulatory submissions for medical devices, particularly dental implants and wound dressings, focusing on engineering, preclinical, and biocompatibility testing.
- Guided clients through the regulatory submission process for complex device types, including patient-specific CAD/CAM abutments and bone-filling materials.
Biomedical Engineer, Dental Devices Branch – FDA/CDRH/ODE/DAGID
Rockville, MD | Mar 1994-Sept 2007
- Reviewed 510(k) and PMA submissions for dental devices, including complex implantable devices with clinical data and combination products like oral wound dressings.
- Served as a PMA team leader, coordinating with multidisciplinary reviewers for devices containing PDGF and rhBMP-2.
- Conducted 513(g) and request-for-designation reviews, collaborating with CDER and ODE clinicians on regulatory pathways for dental bone graft materials with therapeutic proteins.
Education
Master of Science in Biomedical Engineering
University of Alabama, Birmingham
Bachelor of Science in Biomedical Engineering
Tulane University
Certifications and Training
- Multiple FDA and ISO training courses in regulatory writing, biomaterials assessment, and clinical trial design.
- Continuing education in dental device engineering, including training from NIH, NIST, and other leading institutions on topics such as nanotechnology and tissue engineering.
Honors and Awards
- FDA Outstanding Service Award (2006) – Recognized for performance in CDRH Premarket Submission Quality Review.
- Award of Appreciation from ASTM (2001) – For contributions to ASTM Committee F4.
Professional Affiliations and Activities
- U.S. Expert to ISO TC 106 SC8 Working Group on Dental Implants
- Member of the University of Alabama Birmingham Department of Biomedical Engineering Advisory Group
- Chairperson of the CDRH Biocompatibility Assessment Group
Publications
- Published several peer-reviewed articles, including in Journal of Biomedical Materials Research on bone healing and Transactions of the Society for Biomaterials.