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 in-home use because payers will not pay for and patients will not comply with prolonged hospital or clinic-based treatment regimens.

In order to obtain labelling that allows use of a complex device or a diagnostic by the patients themselves, the medical device first needs to be designed in a way that minimizes potential use errors. This involves usability testing, which takes into account different characteristics of the patients who will use the device such as age, education, professional background, and different physical abilities (the so-called human factors). If clinical data are required for approval, these are usually obtained by testing the device in the intended setting such as patients using the devices at home. Setting up and managing clinical trials to accommodate these requirements can be challenging.

This audio conference presentation discusses the process of designing and testing medical devices intended for use in the home, and provides case studies and insight on how best to obtain the requisite clinical data in a home setting.

This audio conference covers:

• A description of human factors and usability testing
• The challenges facing companies setting up trials to gather clinical data in "real life" settings such as patients using devices themselves at home
• How to address those challenges successfully
• Various examples of home-based studies to illustrate the points made

About the speaker:

Dr. Helen Colquhoun is CEO of Pleiad Inc, a full-service medical device and diagnostics CRO. Pleiad has run several home-based studies (and one "street-based" study) over the years and has developed an expertise in human factors assessment.
Dr. Colquhoun has worked in the medical device and pharmaceutical industries for more than 20 years. She is a physician with a depth of experience in vigilance, pharmacovigilance, regulatory affairs, clinical study design and management, and product development planning. Her expertise covers North America and Europe. She is based in Cambridge, Massachusetts

Who should attend?

• Clinical Trial Managers
• Project Managers
• Monitors
• Outsourcing
• Senior Managers