Who We Are
The name of this organization is the Statistical Interest Group for Medical Devices and Diagnostics (SIGMEDD) of the American Statistical Association, herein after referred to as SIGMEDD.
The objective of SIGMEDD 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 are eligible to be members in SIGMEDD.
Officers for Year 2013
SIGMEDD's elected officers organize events, initiatives, communications, and focus the energies of SIGMEDD's members toward advancing our common causes. Meet the SIGMEDD officers below.
Officers-Elect will succeed the current Officers in 2014.
"For the last 11 years I have been working as a consulting statistician in the medical device and pharmaceutical industry. I have worked for many medical device companies, small and large, in designing innovative, flexible designs that have helped create a new standard of designs in the industry. We continue to create innovative and efficient designs, raising the scientific bar and raising the profile of statistics within the device industry.
In my role as Chair I would like to focus on three concepts. The first is to raise the profile of statistics within the medical device industry. The second is to push for innovative, scientifically strong, and flexible designs and analyses in medical device applications. Third, is to help build a strong community of statisticians with a focus in the medical device industry.
The role of statisticians in the medical field in general is typically minor. I think we need to be at the table when big decisions are made. Statisticians need to be drivers of designs and decisions. This problem is even worse within the medical device community. Given the industry environment with many small companies, there are many companies that don’t have professional statisticians. Many statisticians in the industry play minor roles of data management and routine analyses. There is a great opportunity and need for statisticians in the medical device industry. The industry is unique, providing many opportunities for innovation and leadership and many of these differences highlight important statistical concepts. There is an enormous need and opportunity for statisticians to lead.
In order for statisticians to be leaders in this industry it demands we lead by example. We must be innovators, we must help create good solutions, while maintaining high scientific standards—we must perform.
In order to become leaders and innovators in the medical device industry we need to provide a strong group of statisticians. The SIGMEDD group can provide a great structure to share ideas, create innovation as an industry, and provide opportunities to raise the profile of the statistics profession within the device industry."
"I have extensive experience to offer to SIGMEDD as Chair-Elect. 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 DIA’s 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. SIGMEDD can play a major role in this endeavor and as chair-Elect, I will work with the current chair and active membership to further our efforts to:
1) Make SIGMEDD 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 SIGMEDD;
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."
"As the Deputy Division Director for Premarket and Operations in the Division of Biostatistics (DBS) of FDA’s Center for Devices and Radiological Health (CDRH), I oversee the pre-market statistical reviews of therapeutic, aesthetic and diagnostic device submissions. I understand not only the critical issues in the application of statistics to medical device and diagnostic clinical studies, but also the issues of mutual interest among industry, academia, and government statisticians.
I will continue to work closely with statisticians from industry, academia and the FDA and enhance the collaboration. For example, as the FDA Co-Chair of FDA/Industry Statistics Workshop 2013, I would strive to increase the visibility of SIGMEDD and the involvement of statisticians from the medical devices and diagnostics. Within the FDA, I would drive to increase the transparency and predictability of regulatory pre-market statistical reviews, and promote the application of novel statistical methods and the appropriate use of statistics."
"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-Elect of SIGMEDD, 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 SIGMEDD. This involves not only organizing potential topics from SIGMEDD members, but also actively communicating with conference organizers to lobby for numbers and times of available sessions dedicated to SIGMEDD topics. The second goal is to attract additional interest in SIGMEDD topics by persons who are not already SIGMEDD members. This is a combination of reaching out to potential new members of SIGMEDD 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-SIGMEDD 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 another’s 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 SIGMEDD 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."
"I have been working on medical device and diagnostic studies for over 15 years. I am a strong supporter in recognizing the differences between medical device and pharmaceutical studies and in developing appropriate and efficient statistical methods in the evaluation of devices and diagnostic methods. I have developed and maintained the SIGMEDD website since 2008 in order to help foster and facilitate communication among statisticians and other professional groups. "
Correspondence Secretary (2013-2014)
"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 SIGMEDD meetings and post the minutes timely. I will also actively report SIGMEDD 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. "
Officers for MDD if SIGMEDD becomes a section
Section Representative (2013-2014)
"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 MEDD 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 MEDD Section, and if requested by the SIGMEDD Chair, I will attend meetings of the Council of Sections as the Observer for SIGMEDD, and to promote the formation of the MEDD Section. Having a MEDD 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 will 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 SIGMEDD 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 SIGMEDD section (if approved) as it is a close match to my professional and research interests and thus would like to serve as the treasurer of SIGMEDD. If I am elected treasurer, 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."