Who We Are
MEET OUR OFFICERS
The objective of the Section on Medical Devices and Diagnostics 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.
Elected officers organize events, initiatives, communications, and focus the energies of MDD's members toward advancing our common causes. Meet the MDD officers below.
"I have been working at Boston Scientific since 2004 primarily focusing on statistical methodology of medical device trials, acting as the liaison between the Data Monitoring Committee and the company for selected randomized control studies, and currently performing daily work in the pre-/post- approval studies to meet the patient needs in interventional cardiology unit in an expedited manner and in compliance with the statistical principle and regulatory requirement. I have been fortunate to be able to participate in various capacities in roles providing experience for the chair elect position that I am nominated for, ranging from presenting, co-chairing, or co-organizing several annual statistics workshops during the past 10 years, as in the annual AdvaMed/FDA statistics workshop in April, the annual Joint Statistical Meeting in August, and the annual FDA/Industry statistical workshop in September. I personally find that it is rewarding to network with our industry, academic, and FDA colleagues with the common goal to share the best practice dealing with the statistical challenges in medical devices, presenting case studies that are unique in the medical device industry, and promoting good statistical practice in reference to the regulatory guidance.
As chair elect, I will lead the effort to work with the section executive board to rally our section members to take more active role in the medical device and diagnostic section of the ASA, to showcase our best statistical practice in our daily work in major statistics conferences, and to provide a network venue for the section members to interact among ourselves. I will also working closely with board and section members in soliciting if there is an interest for a mentee/mentor matching program for statisticians who are new to the medical device and diagnostic industry and creating a network to promote ideas of collaborative statistical methodology research for any invited session presentation in advance of a major conference. With the newly formed section of the ASA with added resources, I will propose to do a survey to find out any expectation or new ideas from the section members and will work closely with the board members to find means to meet our needs. I will also work with the board to balance the mix of the conference sessions for the advanced statistical challenges for experienced statisticians versus the basic statistical challenges for new comers starting their career in any upcoming statistics workshops tailored to our session members, in this way, we will be able to attract a broad spectrum of the statisticians working in the medical device and diagnostic sector to join the section."
Program Chair and Chair Elect
"Dr. Gene A. Pennello is a Team Leader and Mathematical Statistician at the FDA Center for Devices and Radiological Health, Division of Biostatistics, Diagnostics Devices Branch. He has been with the Agency since 1998. Before joining FDA, Dr. Pennello 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), a Master’s degree in Statistics from the University of California at Davis, and two Bachelor of Science degrees also from Davis, in Statistics and in Computer Science and Mathematics. Dr. Pennello has experience in the FDA review of in vitro diagnostic tests, including those that measure biomarkers for prognostic or predictive claims. He also has experience in the review of diagnostic imaging devices. Some of his statistical interests include Bayesian analysis, multiple comparisons, and missing data.
Program Chair Elect
I have been a member of the FDA’s Medical Devices Advisory Committee for 10 years. I have been the lead statistician on numerous device trials and diagnostic studies and have been a member of several Data Monitoring Committees overseeing device trials. I have a Visiting Professor Appointment in Japan where I teach clinical trials (focused on devices) at the National Cerebral and Cardiovascular Center in Osaka. Recent work includes lead authorship on an upcoming manuscript describing the results of the first study conducted by a new clinical trial research network (the Antibiotic Resistance Leadership Group), entitled “Informing Antibiotic Treatment Decisions: Evaluating Rapid Molecular Diagnostics to Discriminate Susceptibility vs. Resistance in Escherichia coli and Klebsiella pneumonia infection”. I am familiar with the ASA processes having been the Chair of two ASA Sections and an ASA Committee, the President of the Boston Chapter, and the Executive Editor of an ASA journal.
My primary role will be to develop ideas for session topics and speakers at JSM and possibly other meetings /events. I plan to solicit ideas from a number of sources including the preceding program chair (Gene Penello) as well as other academic and industry colleagues. I will also talk with FDA personnel at the FDASA year-end event and solicit input from membership via email. My ideas for topics include: benefit:risk in devices and diagnostics, issues in companion diagnostics and personalized medicine, drug-device (possibly contributed in in tandem with the biopharmaceutical section), and lessons from meetings of the FDA Medical Devices Advisory Committee. As the ASA now has webinar capabilities, we will consider a webinar event during the course of the year”.
"I have been working in the medical device industry for 17 years, on both therapeutic and diagnostic devices. My experience also includes serving as the SIGMEDD Communications Secretary for 2 years (2012-2013) and as the webmaster of the SIGMEDD website for 6 years (2008-2013). Since the conception of this special interest group, I have volunteered to develop and maintain the digital faces of SIGMEDD, introducing our focus and activities to the world and providing a channel of communication for this organization.
As the Communications Secretary, I will continue to deliver timely and relevant information to, from, and for all statisticians interested in medical devices and diagnostics."
I’m currently a statistician at the Center for Devices and Radiological Health of FDA. I have more than six years of experiences on different aspects of clinical trials, including statistical review work, as well as guidance writing and research development. I have the privilege to contribute to the statistical community in different roles including serving as a journal referee for statistical journals, publishing research work in peer-reviewed journals, presenting, organizing and chairing different sessions at statistical conferences and workshops, including JSM, FDA/AdvaMed workshops, FDA/Industry workshop, etc. I served as CDRH Center Representative to the FDASA (FDA Statistical Association) and the Treasurer for FDASA and am on the FDA/Industry Workshop steering committee. I have a Ph. D. on statistics from Carnegie Mellon University.
As the Correspondence Secretary, I will take minutes at MDD meetings and help prepare the logistics of committee meetings. I will work with the Communications Secretary to update the MDD website when appropriate. I will also coordinate the MDD newsletter compilation with the editor and other efforts (such as media coverage of MDD activities and member news) to raise awareness of MDD.
"Since 2001, I have worked in the medical device industry, at Boston Scientific, as a Senior Biostatistics Manager on the design, analysis, and interpretation of clinical trials, for the regulatory approval and commercialization of medical devices in endoscopy, urology, and gynecology. Prior to that, I worked on clinical trials in the diagnostics industry, to develop tissue classification algorithms for diagnostic devices. I have been an ASA member since 2005. Prior to that, I was a long-time member of both the Statistical Society of Australia, including some time as chair of the Biostatistics section, and the International Biometric Society. Since 2006 I have co-organized, chaired, and presented papers on statistical design & analysis at both the annual AdvaMed/FDA Statistics Workshop and the SIGMEDD contributed-topics sessions of JSM. Each year at JSM, I have attended the organizational business meeting of SIGMEDD.
As the MDD Section Representative, I will promote to the ASA Council of Sections the application and appropriate use of statistical designs and analyses in medical devices and diagnostics, to raise the profile of statistics in decision-making within these industries. Prior to SIGMEDD becoming the MDD Section, I attended meetings of the Council of Sections as the Observer for SIGMEDD, and to promote the formation of the MDD Section. Having a MDD Section will further raise the profile of statistics in devices and diagnostics among ASA members, and Section activities will highlight that these industries provide many opportunities for statistical innovation and leadership. Section activities include sponsoring our own sessions on devices and diagnostics at JSM, as well as at smaller meetings such as the annual FDA/Industry Statistics Workshop, to raise our visibility to others considering different career paths and to grow our Section membership. As Section Representative, I will liaise with the ASA Council of Sections to achieve these aims, and I will represent members not just from industry but also from academia and FDA in this capacity, many of whom I have worked closely with in co-organizing both MDD sessions for JSM and sessions for the AdvaMed/FDA Statistics Workshop."
"I have more than 20 years of statistical consulting experience in both industry and academic settings in a wide variety of subject areas, but have recently focused my work in biotechnology, including medical device and diagnostics. My current clients include a number of medical device and diagnostics clients, for whom I provide statistical advice and data analysis, including writing statistical analysis plans and clinical study reports. My previous experience includes 14 years in academia, teaching biostatistics and serving as the lead statistician on several NIH and NSF grants. As a tenured associate professor of statistics at San Diego State University, I co-founded and co-directed the university’s statistical consulting center. At Victoria University in Wellington, New Zealand, I directed the university’s statistical consulting centre, providing advice and data analysis for university researchers and the Ministry of Health. At Exponent Inc., I provided statistical consulting services to industry and legal clients. Additionally, I have served as an expert witness in civil cases involving construction defects, medical devices, intellectual property, antitrust and employee compensation. My research is primarily focused in biostatistics, developing statistical methodology to address biological and medical problems.
I have been active in my local ASA chapter (in San Diego), serving as Vice President for Academic Affairs, Vice President of Professional Affairs, and President. I am very interested in being active in the new MDD section as it is a close match to my professional and research interests and thus would like to serve as the treasurer of MDD. I will do my best to provide timely and excellent service to the section, including maintaining the books, providing an annual report, filing annual reports to the ASA. Additionally, I hope to help the section thrive in its first few years by helping to organize talks, conferences, and other activities that will meet the members’ professional needs."