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Audio conference highlights

Increasingly, FDA is requiring that clinical evaluations take into account human factors and their effects on device design. It is becoming more important to address how these affect the safety, performance and reliability of medical device use to ensure appropriate device design. Evaluating the human interface in the user environment produces critical data for pre-market applications to FDA. However, medical device trials intending to collect these unique data must be carefully designed to bring the most valuable data to light.

In this audio conference the speaker looks at various human factors which must be taken into consideration when designing a medical device clinical trial, and uses a series of real-life examples to illustrate how best to incorporate them into the design process. In addition, all attendees will receive a copy of Pleiad's Human Factors Considerations checklist.

This audio conference covers:

• What are human factors?
• How can they be incorporated into the clinical trial design process?
• Best practices for human factors evaluations
• Case study: Integrated Device Management System - HCP and patient usability
• Case study: Home hemodialysis - interfacing HCP with home caregiver and patient use
• Case study: Home-based treatment of Hepatitis patients
• Case study: Evaluation of a new IVD device for point-of-care use

About the speaker:

Annette Valles-Sukkar is the Senior Manager of Clinical Operations at Pleiad Inc, a full-service medical device CRO. She has more than 13 years of experience in the pharmaceutical, medical device and in-vitro diagnostics industries. She holds degrees in Medical Laboratory Science and in Health Policy from Northeastern University in Boston. Her career in research started with trials of novel in-vitro diagnostic devices for clinical laboratory and hospital use, eventually moving on to pharmaceuticals and medical devices, at times working with the R&D team in testing of prototype designs as they relate to the intended user. She has designed and conducted numerous device trials, and has focused her efforts on the incorporation of human factors analysis and testing into these investigations, thus helping to ensure the safety, reliability and performance of a medical device regardless of the user.

Who should attend?

• Clinical Managers
• Clinical Research Coordinators
• Clinical Research Associates
• Regulatory Managers for IVDs & other diagnostics
• Medical Device Marketing Managers
• Medical Device R&D Associates
• Project Managers – Product Development

*Please note: Each registration covers one line connected to the audio conference. Attendees dialing from separate locations are required to have separate registrations.