Clients

There are many hurdles to be crossed before a new medical device can be approved. Some of these are statistical - for example design and analysis of experiments and clinical trials, writing statistical sections of PMA and 510k submissions, and providing a technical statistical interface to the FDA.

Not all medical work - even with device companies - has a product approval as the objective. Statistical methods that have been used in the non-regulatory area include design and analysis of experiments, reliability, statistical modeling and recursive partitioning.

A broad array of statistical methods has been useful here. These include quality improvement, environmetrics, modeling, categorical, multivariate and regression analysis, queuing theory, system simulation and geostatistics/spatial statistics.