is being presented by Helen Colquhoun, CEO, of Pleiad Inc and airs on Tuesday, June 1st, 2010. For more details or to register, please visit our site at www.fxconferences.com
The FDA recently (20 April 2010) issued a news release about formulating guidance about the challenges of using complex medical devices in the home. There are many devices and diagnostics that are or could be used by patients in their own homes: in-vitro diagnostics with complex software algorithms and connections to computer databases and websites; haemodialysis machines; ventilators; artificial hearts; intravenous infusion pumps; and various types of wound-care devices. Home-based use of complex devices to treat liver disease, depression, and heart disease are in development. In fact, any complex device that delivers therapy over a prolonged period of time needs to accommodate home-use because payers will not pay for and patients will not attend prolonged hospital or clinic-based treatment regimens. There is good evidence from patients with renal failure on dialysis that more frequent, short-duration treatment sessions improve clinical outcomes and that may be true of many therapies delivered by complex devices.
In order to obtain labelling that allows use of a complex device or a diagnostic in the home, clinical data need to be obtained that demonstrate that patients of different ages, with different education and professional backgrounds, and different physical abilities (the so-called human factors), can all use the device or diagnostic successfully in the intended setting (the home). Setting up and managing clinical trials in patients' homes is very challenging but not impossible. In this audio conference, Dr. Helen Colquhoun describes these challenges and how best to meet them, using liberal examples.
