Industry Consultant & Former FDA Biomedical Engineer

EDUCATION

M.S.        Biomedical Engineering, University of Alabama Birmingham (1992)

B.S.        Biomedical Engineering, Tulane University (1989)

EXPERIENCE

Industry Consultant

Portland, OR (July 2012 – Present)

Advise clients on many aspects of pre-market decision making such as testing, classification, regulatory path, and implications of device design changes.  Write or edit regulatory submissions of all types including 513g, RFD, pre-sub, IDE, 510k, and PMA. Has many years’ experience with decisions regarding combination products, particularly dental and wound products. Has extensive experience with dental implant 510ks and significant experience with bone filling materials, orthodontic aligners, and 3D printing resins for dental uses. Has experience with masks for both FDA and NIOSH processes and can help determine the best paths for your specific mask design. Is familiar with all the current EUA requirements for different mask types. Can help sort out device registration, listing and importation issues and will act as US Agent.

Consulting Firm

Catawba, NC (Oct. 2007 – July 2012)

• Advised companies on engineering, preclinical and biocompatibility testing
• Experienced with regulatory submissions for many types of devices and combination products
• Examples of device types include dental implants, dental implant abutments (including patient specific CAD/CAM abutments), dental impression materials, wound dressings, and bone filling materials

FDA/CDRH/ODE/DAGID, Dental Devices Branch, Biomedical Engineer 

Rockville, MD         (Mar. 1994 – Sept. 2007)

• Extensive experience in review of 510ks including some for implantable devices which contain clinical data and some for device /drug combinations (oral wound dressings).  
• Over thirteen years of experience reviewing IDEs including those which result in both PMAs and 510ks.  
• Nine years of experience as a PMA team leader for 5 companies’ products. This involves coordinating with reviewers from different areas, editing their reviews, and making everything into an overall review. Also involves writing the PMA summary which is released when the product is approved.
• Reviewed many requests for classification (513g) and requests for designation, and am familiar with these processes and how they involve interaction with the Program Operations Staff and the Office of Combination Products.
• Long term projects with combination products involved working with CDER, ODE clinicians, statisticians, and patient labeling staff to approve clinical trials for dental bone filling materials containing therapeutic proteins and then reviewing the PMA.
• Served as team leader for the first bone filling material PMA approved which contained PDGF and also for the first dental bone filling material PMA approved which contained rhBMP-2.
• Worked on the rhBMP-2 project for thirteen years and the PDGF project for six years.
• Served as senior engineer for the following product areas:

• Tissue engineered dental bone grafting materials
• Oral wound dressings
• Lubricants for dental hand pieces
• Endosseous dental implants, including their abutments and CAD/CAM systems used for designing them in the dental office
• Temporomandibular joint prostheses
• Oral and maxillofacial bone plates, screws and distractors

CONTINUING EDUCATION

HONORS & AWARDS

PARTICIPATION IN INTERNATIONAL AND NATIONAL STANDARDS ORGANIZATIONS

• U.S. Expert to ISO TC 106 SC8 Dental Implants Working Group On Mechanical Testing
• ADA/ANSI Subtag to ISO TC 106 SC8 Working Group Chairperson on Mechanical Testing of Dental Implants
• FDA Liaison to ISO TC 106 Dentistry SC8 Dental Implants
• FDA Liaison to ISO TC 106 Dentistry Working Group on Biocompatibility
• FDA Liaison to ADA/ANSI Subtag of ISO TC 106

OUTSIDE PROFESSIONAL ADVISORY AND CONSULTING ACTIVITIES

Member of University of Alabama Birmingham Department of Biomedical Engineering

Advisory Group

FDA SPECIAL ASSIGNMENTS AND ADVISORY ACTIVITIES

Chairperson of the CDRH Biocompatibility Assessment Group

DAGID Biocompatibility Focal Point

Mentoring of new DAGID biomedical engineers

PUBLICATIONS

Charlene M. Flahiff, Angela S. Blackwell, J. Marcus Hollis, and Dale S. Feldman. “Analysis of a biodegradable composite for bone healing,” Journal of Biomedical Materials Research, 32,419-424 (1996).

A.E. Steedley (maiden name), R.C. Anderson, M.W. Bidez, D.S.Feldman. “Finite Element Model of a Biodegradable Intrameduallary Rod,” Transactions of the Society for Biomaterials, 16, 51 (1990).

OTHER PUBLICATIONS

ISO/CD 22794 Dentistry – Implantable materials for bone reconstruction in oral and maxillofacial surgery – Contents of a technical file.

ISO 22803 Dentistry – Membrane materials for guided tissue regeneration in oral and maxillofacial surgery – Contents of a technical file. September 1, 2004.

Dental Devices; Reclassification of Root-Form Endosseous Dental Implants and Endosseous Implant Abutments. Final Rule. Federal Register 69, 92 May 12, 2004.

Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments. May 12, 2004.

ISO 14801 Dentistry – Fatigue testing for endosseous dental implants. May 13, 2003 and subsequent revisions.

Dental Products Devices; Reclassification of Endosseous Dental Implant Accessories. Final Rule. Federal Register 65, 196 October 10, 2000.

American National Standard/American Dental Association Standard No. 127 Fatigue Testing for Endosseous Dental Implants June 6, 2012.