Medical Device Statistician Expert Witness
Medical-device disputes increasingly turn on statistical questions: whether premarket data support a clearance or approval, whether real-world evidence was analyzed appropriately, and whether adverse-event signals were measured correctly. Lei Li, Ph.D., is a biostatistician who has worked both sides of these questions — as a former FDA/CDRH device reviewer and as a Principal Biostatistician at a cardiovascular device company.
- Former FDA/CDRH statistical reviewer
- PMA · De Novo · 510(k) · IDE
- Real-world evidence & propensity scores
- Plaintiff & defense
Device disputes Dr. Li addresses
Statistical issues that recur across medical-device litigation, product-liability matters, and regulatory disputes.
- Premarket statistical evidence supporting PMA, 510(k), De Novo, and IDE submissions, including the design and adequacy of pivotal studies.
- Real-world evidence (RWE) and propensity-score methodology used to compare devices or support regulatory decisions.
- Early-feasibility and cardiovascular studies, including study-design choices and the statistical methods applied to early data.
- Adverse-event and incidence analysis — how event rates were defined, estimated, and compared.
- Clearance-probability calculations and the statistical assumptions underlying them.
- Statistical adequacy of pivotal data: endpoints, sample size, missing data, and analysis methods.
How Dr. Li helps
Independent statistical analysis and clear written work product, scoped to the questions in dispute.
Methodology review
Independent evaluation of the statistical methods, assumptions, and endpoints used in premarket studies and submissions.
Independent re-analysis
Reproduction or re-analysis of study data to test whether reported results hold under appropriate methods in SAS, R, or Python.
RWE & propensity-score critique
Assessment of real-world-evidence designs and propensity-score matching, including confounding, balance, and comparability.
Rebuttal
Response to opposing statistical reports, identifying where methods, assumptions, or interpretations are open to question.
Reports & testimony
Expert reports and declarations, with availability for deposition and trial testimony. Plaintiff and defense.
Directly relevant experience
Device statistics from both the regulator's and the sponsor's perspective.
FDA / CDRH — Statistical Reviewer
As a Mathematical Statistician and Primary Statistical Reviewer in FDA's Center for Devices and Radiological Health (2020–2022), Dr. Li reviewed PMA, De Novo, 510(k), IDE, pre-submission, and real-world-evidence submissions, and applied propensity-score methodology in RWE matters. He authored statistical memoranda for therapeutic and diagnostic devices, spanning general surgical, orthopedic, and in vivo and in vitro diagnostic products.
Edwards Lifesciences — Principal Biostatistician
As Principal Biostatistician (2022–2023), Dr. Li supported cardiovascular early-feasibility studies, developed statistical analysis plans, and applied mixed-modeling and win-ratio methods. He co-led the publication "Left Atrial to Coronary Sinus Shunting for Treatment of Symptomatic Heart Failure" in JACC: Cardiovascular Interventions.
Dr. Li is a former FDA/CDRH statistician and is no longer affiliated with the FDA. This site is not affiliated with, endorsed by, or sponsored by the FDA or any government agency. Disclosed litigation roles to date have been consulting-expert engagements; he is available for testifying roles. Every engagement is subject to a conflicts-of-interest check.
Frequently asked questions
What kinds of medical-device matters can Dr. Li support?
Matters involving the statistical evidence behind premarket submissions (PMA, 510(k), De Novo, IDE), real-world-evidence and propensity-score analyses, adverse-event and incidence analysis, and the adequacy of pivotal study data. He works for both plaintiff and defense.
Does Dr. Li have a current relationship with the FDA?
No. Dr. Li is a former Mathematical Statistician with FDA's Center for Devices and Radiological Health and is no longer affiliated with the agency. His regulatory background informs his analysis, but this site is not affiliated with or endorsed by the FDA.
Can he review real-world-evidence and propensity-score analyses?
Yes. He applied propensity-score methodology to RWE submissions while at FDA/CDRH and can evaluate study design, confounding, covariate balance, and the comparability of matched groups.
Is Dr. Li available to provide testimony?
Yes. He welcomes testifying roles, including expert reports, declarations, deposition, and trial. Each potential engagement begins with a conflicts-of-interest check and a written agreement.
Discuss a medical-device matter
Tell Dr. Li about the device, the statistical questions in dispute, and your timeline. Initial consultations are confidential and subject to a conflicts-of-interest check.