Press Release: November 2005

Contact: Steve Ebben
248-551-2667
steve.ebben@beaumontservices.com

Beaumont Technology Usability Center Completes Successful Project For Handylab

The Beaumont Technology Usability Center announced today that it completed human factors consulting for the new HandyLab® Analyzer developed by HandyLab, Inc., an emergent healthcare diagnostics company. By working closely with the HandyLab team, the Usability Center reduced the potential of use errors and contributed to a safer, effective and more usable product.

HandyLab has developed a small, low-cost nucleic acid analysis system for clinical diagnostic markets. This system, which is based on proprietary microfludic technology, is capable of integrating and automating multiple laboratory processes in a single disposable cartridge, making it a rapid, cost-effective alternative to traditional laboratory testing. Designed to automate all the steps of nucleic acid testing, including complex sample preparation, minimally skilled personnel can perform tests and analysis on raw specimens in approximately 40 minutes.

To maximize the utility of the system, HandyLab desired an external human factors evaluation with clinical staff. HandyLab’s goals were to maximize the functionality of the user interface while decreasing potential use errors that could arise for laboratory personnel. The scope of services provided for the HandyLab analyzer review included:

1. Critiquing the graphical user interface and supplemental reference material
2. Process enhancements to the analyzer setup and testing operation
3. A risk assessment of potential inconsistencies in the design of the equipment

HandyLab, Inc. was pleased with the assessment made by the Usability Center's clinical staff, and consequently initiated several changes to their initial design based on the review. “The direct feedback with clinical users was a real benefit to us,” said Martha Rumford, Director of Quality Assurance & Regulatory Affairs at HandyLab. “One advantage of our system will be the “ease of use” compared to current nucleic acid test instruments. BTUC helped us meet the challenge of recognizing the difference between what seems easy to what really is useable in a medical setting. As a result, our Graphical User Interface was improved by using appropriate color and clear terminology, and the instruction sheets were also improved.”

Rani Gebara, a Human Factors Engineer with the Beaumont Technology Usability Center, was the project leader for the HandyLab analyzer review. “By integrating usability testing early in the developmental phase of medical devices, the Usability Center is able to contribute to the advancement of patient safety through an improved user interface for the Handylab analyzer. The Center provides this type of clinical expertise to medical manufacturers with objective feedback on the functionality and usability of medical devices at different stages of their product development.

The Beaumont Technology Usability Center is a multidisciplinary team of health care experts affiliated with Beaumont Hospitals. Beaumont is comprised of two hospitals - including a 1,061-bed tertiary care, teaching, research and referral center in Royal Oak and a 254-bed acute care community teaching hospital in Troy. Beaumont also includes six community-based medical centers, rehabilitation, primary and specialty care clinics, four nursing centers, home care and hospice.

The Technology Usability Center’s mission is to advance excellence in healthcare by improving medical technology and its use. The Technology Usability Center works with manufacturer design teams seeking product evaluations on usability testing, risk assessment/operations improvement, clinical trial protocols and prototype development services.