Applying Human Factors in Medical Software Development

  • Michael Wiklund, General Manager of Human Factors Engineering (HFE) at UL–Wiklund and Jon Tilliss, UL–Wiklund’s Design Director
  • Tuesday, November 10, 2015 at 6:30pm
  • At Constant Contact, 1601 Trapelo Road, Waltham, MA

Michael_Wiklund headshot 2014      Jon_Tilliss

Abstract

Since its inception in 1982, the SIGCHI community seems to have been chiefly concerned with business-related and personal software applications, and more recently with myriad types of websites. Over the years, members have shared insights about making user interactions with software products more effective, efficient, and satisfying. Only occasionally has product safety been a concern, noting that the harms that could arise from usability problems and use errors have rarely fit the personal injury category. But, safety is the primary concern when it comes to designing today’s expanding array of healthcare-related software, such as electronic medical records used in hospitals and physician’s’ offices, smartphone applications that help users monitor and treat medical conditions, websites that track therapy compliance, and software embedded in capital equipment such as telemetry systems. In fact, regulators require that developers apply human factors engineering rigorously to patient safety-related software. The presenters, who have worked on such software products for many years, will summarize the regulators’ expectations pertaining to different software products and how best to meet them. For instance, they will discuss how to define user interface requirements and then proceed to validate that a software product meets them with sufficient rigor to satisfy the USFDA. They will also share their insights on the movement to ensure the safe use of electronic health records by applying many of the same techniques that have been used for years to ensure the safety of medical devices.

Slides

[pdf-embedder url=”http://www.bostonchi.org/wp-content/uploads/UL-Wiklund_CHI_Presentation_10Oct2015-copy.pdf”]

Bios

Michael Wiklund is General Manager of human factors engineering (HFE) at UL–Wiklund. The UL business unit delivers HFE consulting services to the medical device, scientific instrument, and laboratory equipment industries. He has over 30 years of experience in human factors engineering, much of which has focused on medical technology development. He is a certified human factors specialist and licensed professional engineer. He is author, co-author, and editor of several books on human factors, including a recent one titled Usability Testing of Medical Devices. He is one of the primary authors of today’s most pertinent AAMI and IEC standards and guidelines on human factors engineering. As Professor of the Practice at Tufts University, he teaches courses on human factors in medical technology and software user interface design.

Jon Tilliss serves as UL–Wiklund’s Design Director/USA. He has designed user interfaces and instructional materials for a wide variety of therapeutic and diagnostic devices, laboratory equipment, and consumer products. His usability research efforts have included observing complex medical products in actual use, interviewing prospective users regarding new device requirements, and leading both formative and summative usability test efforts to assess product safety and usability. He is co-author of Summative Usability Testing of Medical Devices (AAMI Horizons, 2010) and frequently guest lectures in courses on human factors and software user interface design at Tufts University.

Evening Schedule

6:30 – 7:00 Networking over pizza and beverages
7:00 – 8:30 Meeting
8:30 – 9:00 CHI Dessert and more networking!

Monthly Sponsors

Thank you to our generous sponsors. If you’re interested in sponsoring BostonCHI, please let us know.

Constant Contact is hosting us and providing pizza.

Vitamin T is sponsoring dessert.

Getting to the event

ConstantContact

Constant Contact
1601 Trapelo Road
Waltham, MA 02451