Eric Shaver

Human Factors Professional

The 2016 HFES Health Care Symposium was a Success!

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San Diego SkylineEarlier this month, the Human Factors and Ergonomics Society (@HFES) held the 2016 International Symposium on Human Factors and Ergonomics in Health Care: Shaping the Future at the Hilton San Diego Bayfront Hotel.

It was attended by nearly 400 human factors practitioners, industry representatives, researchers, and students.  One of the many reasons it’s a worthwhile experience is the opportunity to meet and hear from the human factors staff at the FDA.  Plus, it’s always nice to see old friends, along with meeting new people that are passionate about positively impacting the health care community.

The event started on Wednesday afternoon with the pre-symposium workshop Improving the Safety and Effectiveness of Medical Devices Through Human Factors Considerations: An Interactive Workshop with the FDA’s CDRH Human Factors Premarket Evaluation Team.  The workshop was chaired by Anthony D. Andre, with insightful commentary provided by the three panelists: Shannon Hoste, Hanniebey Wiyor, and Xin Feng.

The symposium kicked off Wednesday evening with the opening network reception, followed by talks, panels, and poster sessions on Thursday through Saturday.  A few of the more interesting panels and talks I attended included:

Dear FDA

Tim Reeves, Human Factors MD, Inc. (Chair); Anthony D. Andre, Interface Analysis Associates/San Jose State U.; Eric Bergman, Fresenius; Adam Shames, Core HF; Shannon Clark, UserWise, Inc.

Meet the New CDRH Human Factors Premarket Evaluation Team

Michael Wiklund, UL-Wiklund (Chair); Shannon Hoste, Hanniebey Wiyor, and Xin Feng, FDA CDRH Human Factors Team

CDER Perspective on the Role of Human Factors in Combination Product Design and Development

Anthony D. Andre, Interface Analysis Associates/San Jose State U. (Chair); Irene Chan and Kellie Taylor, Division of Medication Error Prevention and Analysis at FDA/CDER/OSE/OMEPRM/DMEPA

How Many Lives Could We Save by Spending $1 Billion More on HFE?

Michael Wiklund, UL-Wiklund; Sean Hägen, BlackHägen Design; Shannon Hoste, FDA/CDRH; Stephen Wilcox, Design Science; Lawrence Wolpert, MedStar Health − National Center for Human Factors in Healthcare

From Devices to Platforms: Implications of the Internet of Things for Health Care

Hugh Dubberly, Dubberly Design Office; Stephen Wilcox, Design Science

Overall, it was an informative and worthwhile event.  I look forward to attending – and potentially presenting at – the 2017 International Symposium, which will be held in New Orleans on March 5–8.

HFES 2016 Health Care Symposium is April 13th – 16th

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HFES Health Care Symposium 1

On April 13th-16th, the Human Factors and Ergonomics Society (@HFES) will hold the 2016 International Symposium on Human Factors and Ergonomics in Health Care: Shaping the Future (#2016HCS) at the Hilton San Diego Bayfront Hotel.

The symposium will include lectures, panels, and posters in four program tracks:

  • Clinical and Consumer Health Care IT
  • Health Care Environments
  • Medical and Drug-Delivery Devices
  • Patient Safety Research and Initiatives

Check out the preliminary program and make sure to register for the event before it sells out.  Hope to see you in San Diego!

FDA Publishes Human Factors Draft Guidance for Combination Products

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Combination Products Draft GuidanceOn February 3rd, the Food and Drug Administration (FDA) published the Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development draft guidance.

As noted in the Introduction and Scope:

This guidance describes Agency recommendations regarding HF information in a combination product investigational or marketing application and clarifies the different types of HF studies; the recommended timing and sequencing of HF studies; and how HF studies are part of the process to maximize the likelihood that the combination product user interface is safe and effective for use by the intended users, uses, and environments. In addition, the guidance describes how HF studies relate to other clinical studies. The guidance also provides process considerations for HF information in investigational or marketing applications to promote development and timely review of safe and effective combination products. (p. 2)

The comment period for the draft guidance is open until May 3rd.  For those interested in submitting electronic or written comments, visit this link for details.

FDA Publishes Human Factors Guidance

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Applying Human Factors and Usability Engineering to Medical Devices

On Wednesday, the Food and Drug Administration (FDA) published the long awaited Applying Human Factors and Usability Engineering to Medical Devices guidance document.

As noted in the Scope:

This guidance recommends that manufacturers follow human factors or usability engineering processes during the development of new medical devices, focusing specifically on the user interface, where the user interface includes all points of interaction between the product and the user(s) including elements such as displays, controls, packaging, product labels, instructions for use, etc. While following these processes can be beneficial for optimizing user interfaces in other respects (e.g., maximizing ease of use, efficiency, and user satisfaction), FDA is primarily concerned that devices are safe and effective for the intended users, uses, and use environments. The goal is to ensure that the device user interface has been designed such that use errors that occur during use of the device that could cause harm or degrade medical treatment are either eliminated or reduced to the extent possible. (pp. 1-2)

A more in-depth review will be posted in the coming weeks.

Human Factors Guidance Listed in FDA 2016 Priorities

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The FDA has released the CDRH Fiscal Year 2016 (FY 2016) Proposed Guidance Development and Focused Retrospective Review of Final Guidance.

In it they included Applying Human Factors & Usability Engineering to Optimize Medical Device Design on their “A-list” (…a list of prioritized device guidance documents that the Agency intends to publish within 12 months of the date this list is published…).

It should be noted that the draft guidance was also on the A-list for FY 2015.  I’ll be interested to see if the final guidance is published this year and whether it is substantially different or not from the draft guidance.

2015 MedBuild Symposium is September 17th

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MedBuild sign- final

Tomorrow, The CORE will host the inaugural 2015 MedBuild Symposium at the Riverside Hotel in Boise, Idaho.

The event will bring together professionals interested in medical technology innovation, specifically as it pertains to investment, intellectual property, and regulations.  Also, representatives from several local companies – including Human Factors MD – will highlight their product and service offerings.

Visit here to register for the event.