One of the ASA’s special interest groups became a section at the beginning of this year. SIGMEDD, the Statistical Interest Group for Medical Devices and Diagnostics, has officially become the Medical Devices and Diagnostics Section (MDD) of the American Statistical Association.

The common term “medical devices” incorporates many categorically different products: heart valves, pacemakers, artificial joints, maggots, laboratory tests for diagnostic medicine, and software for medical decisionmaking, to name just a few. Assessment of performance for such a heterogeneous group requires a wide spectrum of trial designs, such as Bayesian and adaptive methodologies. Many trials differ from the classical drug trial setting (e.g., randomization and masking often are not feasible). In addition, diagnostic tests have a unique set of challenges, and they have gained increased prominence due to the burgeoning interest in personalized medicine.

SIGMEDD was born when a group of statisticians in this large, fast-growing, and important field realized many of the statistical methods required to evaluate medical devices and diagnostics have not been fully developed. With the leadership of Greg Campbell, director of the Division of Biostatistics in FDA’s Center for Devices and Radiological Health, SIGMEDD was officially founded in 2007 to bring these challenges to the attention of the entire statistics community.

As a special interest group, SIGMEDD had no ASA-recognized membership, dues, or many rights and privileges of sections. Despite this lack of formal status, it was highly involved in statistical forums, including JSM, the FDA-Industry Statistics Workshop, ENAR, and the FDA/AdvaMed meeting. It organized and presented numerous topic-contributed sessions in the areas of Bayesian statistics, adaptive designs, propensity scores, and other challenging issues in the conduct and analysis of medical device studies. Its members are at the forefront of developing and enhancing statistical design and analysis methodologies to address these challenges.

Members of MDD will carry on these traditions and continue to work closely with the ASA’s Biopharmaceutical Section in these endeavors. In addition, MDD’s new status within the ASA will allow it to serve members interested in the areas of medical devices and diagnostics better than ever.

MDD members are looking forward to making new friends within the ASA to better serve the needs of the medical devices and diagnostics sectors of the medical practices. Visit the ASA website to learn more. Also, consider joining MDD by checking the box for the Medical Devices and Diagnostics Section when renewing your ASA membership.