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Due to the wide variety in technology, complexity, and intended use, medical devices can present novel statistical design and analysis challenges.
Since many statisticains in the medical devices and diagnostics fields met last August, at JSM 2007 in Salt Lake City, there is now been established a Special Interest Group for us in the American Statistical Association; it is called the Statistical Interest Group in Medical Devices and Diagnostics (SIGMEDD).
What is a medical device?
A medical device is an item for treating or diagnosing a health condition whose intended use is not achieved primarily by chemical or biological action within the body (Section 201(h) of the Federal Food Drug & Cosmetic (FD&C) Act). Simply put, a medical device is any medical item that is not a drug or biological product. Medical devices represent a panoply of medical products. They range from relatively simple products such as tongue depressors, latex gloves, thermometers, and simple surgical instruments, to ophthalmic devices such as intraocular lenses and PRK lasers, radiological devices such as MRI machines CT scanners, and digital mammography systems, cardiovascular devices such as pacemakers, defibrillators, heart valves, coronary stents, and artificial hearts, monitoring devices such as glucometers and bone densitometers, diagnostic devices such as diagnostic test kits for human immunodeficiency virus (HIV), prostate-specific antigen (PSA), and human papillomavirus (HPV), dental and ear, nose, and throat devices such as hearing aids, and general, surgical, and restorative devices such as breast implants, artificial hips, spinal fixation devices, and artificial skin. At the forefront of technology are multiplex genetic tests for simultaneous detection of multiple mutations and microorganisms, genomic and proteomic tests to diagnosis of disease and to inform on disease prognosis, nanotechnological devices, microspheres for molecular treatment of cancer, robotics, and theranostics (diagnostic biomarkers for predicting response or adverse reaction to a pharmaceutical therapy).