Who We Are
MEET OUR OFFICERS
The objective of the medical devices and diagnostics section (MDD) is to promote application and appropriate use of statistics to the design, development, evaluation, quality control and use of medical devices and diagnostic tests in humans. All 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 extensive experience to offer to MDD as Chair. I have been a statistician with the Center for Devices and Radiological Health at FDA for the past 22 years. The last 7 years I have served as a team leader for the General and Surgical Devices Branch reviewing study designs and analyses of clinical trials for a wide variety of devices including OB/GYN, gastroenterology, urology, diabetes, pulmonary, anesthesia and dental devices. In the past I have had the privilege of serving in a variety of capacities with several statistical organizations including: President of the FDA Statistical Association (2005), co-chair of the FDA/Industry Workshop (2006), Steering Committee for the FDA/Industry Workshop (2007-2011), Education Committee of the Society of Clinical Trials (2006-2008), Program Committee for DIAís Workshop on Multi-Regional Clinical Trials (2010), and Executive Committee, Program Committee and Regulatory Committees for the International Society of Biopharmaceutical Statistics (2008-2012). I have also organized many sessions and short courses for JSM, SCT, ISBS, and FDA/Industry Workshop on important topics including Bayesian Statistics, Adaptive Designs, Missing Data, and Multi-regional Clinical Trials. In addition, I have presented sessions on medical device clinical trial design, conduct, and analysis in both national and international meetings.
There are many challenges in the development of efficient and cost-effective study designs and sound statistical methodologies for therapeutic and diagnostic medical devices, especially in this quickly changing regulatory environment. In order for us to effectively meet these challenges, FDA and industry statisticians, as well as our academic statistical colleagues, will need to collaborate and develop the necessary innovative and flexible techniques in clinical trial design and analysis. MDD can play a major role in this endeavor and as chair, I will work with the current chair and active membership to further our efforts to:
1) Make MDD a welcoming, inclusive, and relevant community for therapeutic and diagnostic device statisticians;
2) Grow the organization and develop programs of mutual interest to both industry and FDA statisticians in an effort to address both the common and separate issues we face;
3) Set up relevant committees (e.g. communication, membership and by-laws, methodological development, etc.) to address the needs of this growing organization and to get more of the membership actively involved in MDD;
4) Explore mechanisms for FDA, industry and academic statisticians to work together to develop the innovative and efficient statistical techniques needed to further our goal of bringing medical devices to market in a timely and more cost-effective manner; and
5) Support the program committee in their task of bringing us relevant and useful statistical programming."
"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."
"I am the Lead Corporate Biostatistician for Medtronic. My duties include providing leadership and guidance in the use of robust statistical and research design methods, and serving as the company's primary statistical representative for key interactions with regulatory agencies and external subject matter experts. This means that I advocate both internally and externally for the development and implementation of best statistical practices for important issues in the medical device arena. In order to work effectively, I maintain close ties with academics, regulatory personnel, and persons with diverse roles within industry. These ties have been invaluable as I organized contributed and invited sessions at ENAR, JSM, FDA/MTLI Medical Device and IVD Statistics Workshop, and the ASA Biopharmaceutical Session FDA-Industry Statistics Workshop.
As Program Chair of MDD, I will focus on three related goals. The first goal is the most obvious: organize thematically related sessions and conferences/workshops that are of interest to members of MDD. This involves not only organizing potential topics from MDD members, but also actively communicating with conference organizers to lobby for numbers and times of available sessions dedicated to MDD topics. The second goal is to attract additional interest in MDD topics by persons who are not already MDD members. This is a combination of reaching out to potential new members of MDD through increased visibility of our sessions, and simply expanding the pool of persons that would find our topics interesting by facilitating the mix and selection of topics at these sections that would also have appeal to non-MDD individuals. Devices are different from drugs, but there are aspects of problems that can be intriguing to persons working in both spaces. The third and final goal is to leverage the existing process of reporting previously completed work at conferences in order to encourage future research on areas of interest to those of us in medical devices and diagnostics. It will be easier to make substantial progress if we not only report on the past, but collectively plan out work for the future. Ways to do this include strategically combining presenters in sessions that are likely to benefit from exposure to one anotherís work, or pre-allocating slots at conferences for certain topics and asking well ahead of time for subsequent submissions of papers on the pre-specified topic. Working together, we can continue to develop MDD into an organization that is both a vibrant, valuable resource for its members, and is seen as a strong ally in developing and promoting best practices by the broader statistical community."
Program 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 Masterís 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.
"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 staff statistician at Abbott Vascular. During my time at Abbott, I had the opportunity to work on all aspects of the development of cardiovascular stents, from R&D, preclinical animal studies, stability studies, and PK/PD studies to multiple clinical trials (IDE and PMA submissions), as well as post-marketing surveillance studies. I have been an active participant of SIGMEDD activities, including JSM SIGMEDD sessions and FDA/MLTI Statistics Workshops. My recent research includes variable selection, covariate-adjusted analysis, subgroup analysis, and multiplicity issues.
As the Correspondence Secretary, I will take minutes at MDD meetings and post the minutes timely. I will also actively report MDD related activities to publications such as Amstat News. In addition, I plan to post at least one interview of statistician(s) that have made outstanding contributions to the medical device industry to publications such as Amstat News. "
"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 universityís statistical consulting center. At Victoria University in Wellington, New Zealand, I directed the universityís 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 membersí professional needs."