Expert Witness
Alan Donald, MS, MBA, RAC, FRAPS
FDA Regulatory & Multidisciplinary Expert Witness
For more than four decades, I have worked at the intersection of FDA regulation, product development, engineering performance, and clinical science. My experience includes medical devices, pharmaceuticals, biologics, diagnostics, combination products, and software-based technologies. I have served as an expert witness, consultant, educator, and regulatory strategist, providing attorneys with a single source of expertise across regulatory, technical, and scientific issues.
Expert Witness Services
Alan Donald has been retained in over 25 matters involving FDA-regulated medical products since 1998 in both federal and state courts.
He provides independent, objective expert analysis and testimony with particular strength in technical product evaluation, failure analysis, root cause investigations, and assessment of regulatory compliance and warnings.
Services Offered
- Case evaluations and merit assessments
- Detailed expert reports
- Deposition testimony
- Trial testimony
- Consultation on regulatory strategy, discovery, and cross-examination preparation
Representative Expert Engagements
With more than 45 years of hands-on experience in medical devices and FDA-regulated products, Alan Donald serves as a single integrated expert combining deep regulatory knowledge, quality systems expertise, and technical failure analysis. He has been retained in over 25 matters, providing clear, Daubert-ready opinions that help attorneys build stronger cases.
Core Approach to Every Engagement
When evaluating a potential medical device case, Alan Donald applies a consistent framework focused on three fundamental questions:
01
What did the manufacturer know, and when did they know it?
02
Did the company meet its FDA regulatory and post-market obligations?
03
What technical and root cause factors contributed to the failure or adverse outcome?
This structured failure analysis approach consistently delivers actionable insights for both plaintiff and defense matters.
Selected Representative Matters
(anonymized)
Surgical Stapler Malfunction (Colorectal Anastomosis)
Detailed technical failure analysis of incomplete staple formation, 510(k) limitations, MAUDE patterns, and FDA recall actions.
TAVR Delivery System Failure
Balloon non-inflation and retrieval complications with Edwards Sapien 3 Ultra, including PMA history, Class I recall, and root cause review.
IVC Filter Strut Fracture & Embolization
Failure analysis of material fatigue, migration risks, and post-market surveillance obligations.
Breast Implant Warranty & QMS Failures
Expert opinions on excessive warranty claims, CAPA deficiencies, management responsibility, and 21 CFR Part 820 violations.
Baxter / Heyer-Schulte Breast Implant Litigation
Managed FDA/QMS regulatory and technical support across more than 50 plaintiff cases over three years.
Vioxx & Avandia Cardiovascular Risk Litigation
Multi-year plaintiff-side engagements involving post-market safety data, labeling decisions, and manufacturer knowledge analysis.
Cervical Plate Hardware Failure
Evaluated multiple 510(k) clearances, design controls, labeling, and warning adequacy.
Ambulatory Pain Management Pump
Opinions on 510(k) compliance, labeling claims, advertising, and off-label use allegations.
Additional experience includes combination products, Software as a Medical Device (SaMD/AI), regenerative medicine, molecular diagnostics, hemostatic technologies, and manufacturing/quality system failures.
Supports both plaintiff and defense counsel.
Products from major manufacturers including Pfizer, Merck, Johnson & Johnson, Boston Scientific, Baxter, Zimmer, and others are frequently involved.
Ready for Case Evaluation
Full CV, detailed case history, and testimony record available upon request for qualified engagements.
Contact Alan Donald directly at (619) 208-5624 or adonald@matrixmedcorp.com to discuss your matter.