Current Officers

 
Welcome to the Section on Medical Devices and Diagnostics
American Statistical Association 

The objective of the Section on Medical Devices and Diagnostics (MDD) is to serve Association members with special interests in the application and appropriate use of statistics to the design, development, evaluation, quality control and use of medical devices and diagnostic tests in humans and animals, where a simple definition of a medical device is any medical product that does not work solely by chemical or biological means.

Any members of the American Statistical Association who are interested in medical devices and diagnostics can join this section. MDD is also on Twitter!




Selected officers organize events, initiatives, communications, and focus the energies of MDD's members toward advancing our common causes. Meet the MDD officers below.

Chair (2024)


Laura Yee
Dr. Laura Yee

Laura Yee is a biostatistician at the National Cancer Institute (NCI) at the National Institutes of Health. Laura is currently Head of the Biostatistics and Data Management Section in the Center for Cancer Research at NCI. Prior to this role, at NCI’s Division of Cancer Treatment and Diagnosis, Laura worked primarily on precision medicine clinical trials to incorporate novel biomarkers into cancer therapy trials. Her background is in in vitro medical devices, having worked at FDA’s Center for Devices and Radiological Health. Laura has previously served as MDD Program Chair (2021), Correspondence Secretary (2017-2018), and as a reviewer for the Student Paper Committee (2017-2021).

MDD Section Program Chair (2024)

Previous Roles: Section Representative (2020-2022), Program Chair Elect (2023)

Joanne Lin
Joanne is a trained biostatistician with exposure to both therapeutic and diagnostic areas and covers drugs and medical devices in various medical areas. In addition to her 2024 section program chair role, she also served as a section representative from 2020 to 2022

Council of Sections Representative (2023- 2025)

Xiaofeng Wang, Cleveland Clinic 


Treasurer (2022-2023; 2024)

Elysia Garcia

Communications Secretary (2024-2026)

Hari Sankaran

Correspondence Secretary (2024-2025)

Cristiana Mayer

Chair Elect (2024)

Hope Knuckles

Hope Knuckles has been working for more than 29 years at Abbott, in the Core Diagnostics Division, with over 19 years of management experience.  She recently co-chaired the ASA Biopharm Regulatory-Industry Statistics Workshop in September 2022.  She has provided statistical support for in-vitro assay development for hepatitis, retrovirus, and parasite blood screening assays and submissions to CBER.  She has also managed submissions for in-vitro assays to CDRH in areas of Cardiac, Cancer, Thyroid/Metabolic, and Abused Drugs/Toxicology. Hope received her MS in Statistics from University of Louisiana at Lafayette, 1994, and her BS in Mathematics from Tennessee Technological University, 1992.

Program Chair Elect (2024)

Ken (Guangxing) Wang, FDA

Student Paper Competition Chair (2023)

Cui Gao

Program Chair (2022), Chair-Elect (2022) 
Tracy Bergemann


Past-Chair (2022)
Scott Evans


Program Chair-Elect (2022)
Bipasa Biswas


Chair: Martin Ho


Martin Ho, MS, is the Associate Director for Quantitative Innovations at the Office of Surveillance and Biometrics in the FDA Center for Devices and Radiological Health (CDRH). He leads the Quantitative Innovation Program (QuIP) which provides methodological leadership to incorporate novel quantitative methods into regulatory decision making. These methods include benefit-risk assessment methods, patient preference data, and clinical outcome assessments, such as patient-reported outcomes, performance outcomes, and other outcomes based on user-generated data from wearable devices. The QuIP works with review teams across CDRH to conduct reviews of submissions with innovative these methods, develops good review practices, and builds review capacity to meet the Center’s long term needs. The QuIP is also the technical lead of the patient-related regulatory science projects funded by CDRH. For example, Mr. Ho provided technical leadership for the methodological aspect of the FDA’s Patient Preferences Information Guidance released in 2016.

Externally, Mr. Ho has represented CDRH to participate in regulatory research activities under the Medical Device Innovation Consortium, e.g., the 2015 Patient-Centered Benefit-Risk Assessment Framework Report, a first of its kind publication funded by the FDA to provide an overview of existing methods to quantitatively measure patient preferences for regulatory considerations. Mr. Ho also represents CDRH as its voting member in the FDA Research Involved Human Subject Committee, which reviews IRB applications of all the clinical studies funded by the FDA.

Mr. Ho is the Past President of the FDA Statistical Association (2016) and the current Program-Chair of the American Statistical Association (ASA) Medical Device and Diagnostic Section. He co-organized the 2017 ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop, the largest annual meeting of medical product statisticians of its kind in North America.

Mr. Ho was a statistical reviewer, team leader, and acting branch chief reviewing medical device submissions of various therapeutic areas before the QuIP was created. Prior to joining the FDA in 2009, Mr. Ho was a senior statistician in various contract research organizations planning and conducting clinical studies for 10 years.


Chair-Elect: Zhen Zhang


Zhen Zhang is currently a Director of Global Clinical Affairs at Abbott. He has extensive experience in clinical research and applied statistics. Zhen played a pivotal role in the design and execution of multiple large-scale randomize trials. His main responsibility at Abbott is to oversee clinical activities of several medical devices.

Zhen has multiple publications in medical and statistical journals. He is the president-elect of the Section on Medical Devices and Diagnostics (SMDD) of the American Statistical Association (ASA). He is also a member of the steering committee of the statistics working group of AdvaMed.

Zhen holds a bachelor’s degree in Statistics from Nankai University, Tianjin, China, and a doctorate degree in Biostatistics from the University of California, Davis in Davis, California, US.

Treasurer: Chava Zibman



Council of Sections Rep: Joanne Lin


Chair for Student Paper Competition: Bin Wang

Dr. Bin Wang is a mathematical statistician in the Division of Clinical Evidence and Analysis (II) at the FDA Center of Devices and Radiological Health. He received his PhD in Statistics from Case Western Reserve University in 2003. Before joining FDA in 2019, Dr. Wang had been serving the Department of Mathematics and Statistics at the University of South Alabama. Dr. Wang has extensive experience in data analysis and statistical consulting. His research interests focus on selection bias, measurement errors and gene expression data analysis.

Correspondence Secretary: Hongfei Guo

Hongfei Guo is currently a Sr. Manager at Abbott Global Biometrics. Hongfei leads a statistics team that provides statistical support to the design, execution, data analysis, interpretation, and reporting of medical device clinical trials. Hongfei holds a PhD degree in Biostatistics from the Johns Hopkins University. Hongfei worked as an Assistant Professor at the University of Minnesota Division of Biostatistics prior to joining Abbott. He was an officer of ASA Twin Cities Chapter and serves as a reviewer for multiple journals.

Communication Secretary: Zhihao Yao

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Zhihao “Howard” Yao is a mathematical statistician in the Division of Biostatistics at the FDA Center of Devices and Radiological Health. He has extensive experience in data analysis and software development. He provides both quantitative and qualitative analysis to large volume of data with applications of multiple types of mainstream data tools, including R, SAS, Python, JavaScript, SQL server and etc. He received his master degree from University of Rochester.

Section Representative: Greg Maislin



Greg Maislin is Principal Biostatistician of Biomedical Statistical Consulting, a CRO focusing on clinical trials of medical devices for regulatory review.  He is also Adjunct Professor of Statistics in Medicine at the Perlman School of Medicine of the University of Pennsylvania where he leads the Biostatistics Core for the Division of Sleep Medicine.  Professor Maislin has authored or co-authored over 200 medical research publications. An ASA member since 1983, he served on every nominating committee for SIGMEDD before the Special Interest Group became the MDD Section and was subsequently elected as MDD Section Representative to the ASA Council of Sections.

Past Program Chair: Tyson Rogers


Tyson Rogers is a biostatistician at NAMSA where he serves as a Senior Product Development Strategist, helping clients develop their clinical program strategy and optimally design the clinical studies needed for approval and adoption of medical devices.

He has been designing and analyzing data from clinical trials since 2004. He has authored dozens of clinical research publications across a range of therapeutic areas including heart failure, atrial fibrillation, nephrology, and urology. His primary statistical interest is clinical trial design with a focus on strategic use of interim analyses, adaptive designs, and Bayesian methods.

Prior to joining NAMSA in 2014, Tyson worked for Medtronic's Cardiac Rhythm and Heart Failure business and for the University of Minnesota's Department of Medicine. Tyson has a Bachelor's degree in Biomedical Engineering from Arizona State University and a Master's degree in Biostatistics from the University of California Los Angeles (UCLA). 

 

Past Chair: Ted Lystig


Past Program Chair: Norberto Pantoja-Galicia

Norberto Pantoja-Galicia is a mathematical statistician in the Division of Biostatistics at the FDA Center of Devices and Radiological Health. He joined FDA after completing a post-doctoral research fellowship at Harvard University School of Public Health, Department of Biostatistics. He obtained his PhD in Statistics from the University of Waterloo, Canada, where he also worked as an instructor in statistics and completed a research fellowship in Statistics Canada. His interests include design, analyses, guidance writing and reporting of clinical studies to evaluate medical diagnostic devices in areas such as diagnostic imaging, infectious diseases, molecular genetics, medical countermeasures, as well as ROC curve methodology, complex survey data and benefit-risk analyses for diagnostics. Dr. Pantoja-Galicia has been a regular FDA presenter at Advisory Panel Meetings and is a member of the Editorial Board of Statistical Communications in Infectious Diseases (SCID). He received the 2015 American Statistical Association Medical Devices and Diagnostics Section Best Contributed Paper Award at JSM. Dr. Pantoja-Galicia has served as the 2017 program chair of the ASA MDD section.


Lead of (FDA/AdvaMed) Day 0 Conference Planning: Gene Pennello

Gene is a Team Leader in Diagnostics Statistics Branch 2 of the Division of Biostatistics at the FDA Center for Devices and Radiological Health.  He is also a past chair of the ASA Section on Medical Devices and Diagnostics. Before joining FDA, was a postdoctoral training fellow at the National Cancer Institute, Division of Cancer Epidemiology and Genetics.  He has a Ph.D. in Statistics from Oregon State University (1993), and a Master’s degree in Statistics from the University of California at Davis.  His official area of expertise at FDA is application of statistics to the design and analysis of studies concerning diagnostic devices, with particular emphasis on drug-diagnostic co-development and the evaluation of imaging systems.  For the ASA, Gene has served as chair and program chair for the Section on Medical Devices and Diagnostics. In 2016, Gene was selected as a Fellow of the American Statistical Association (ASA).  His statistical interests include Bayesian analysis, multiple comparisons, missing data, measurement error, and benefit-risk evaluation.