Human Factors Professional
Last week I published IEC 62366-1:2015 – More Than A Checkbox on the Human Factors MD website.
The post provides a brief overview of the medical device usability standard, the importance of a Usability Engineering Process, and how it better aligns with the FDA Draft Guidance Applying Human Factors and Usability Engineering to Optimize Medical Device Design.
A big thanks to my colleagues Tim Reeves, PhD, CHFP and Christina Mendat, PhD for their input and insights.
I’ve been in stealth mode over the last few months, but can officially announce that I joined Human Factors MD as the Director of Human Factors in June.
Since 2001, Human Factors MD has assisted a global clientele of medical device and pharmaceutical companies to create safe, effective, usable, and innovative products. Our work spans the entire product development lifecycle utilizing an approach refined through decades of combined experience.
In my role as Director of Human Factors, I assist clients in a variety of activities, including:
If you’re a medical device or pharmaceutical company in need of human factors expertise, please contact us to see how our organization can provide a custom solution to support your specific needs.
Next week the Human Factors and Ergonomics Society (HFES) will hold the 2015 International Symposium on Human Factors and Ergonomics in Health Care: Improving the Outcomes (#HFESHealth2015) in Baltimore, Maryland.
The event, which is hosted by the John Hopkins Armstrong Institute for Patient Safety and Quality, will be held April 26th – 29th at the Baltimore Marriott Waterfront Hotel. More than 450 attendees will have the opportunity to attend 77 oral presentations, 9 discussion panels, and 117 posters (see full program here) in four tracks:
One of the discussion panels is titled Do Standard UCD Methods Work in Health Care? and will take place on Tuesday the 28th between 3:30 and 4:30 pm. The panel is chaired by Ross Teague, PhD, and will include Rollin J. (Terry) Fairbanks, MD, MS, Christina C. Mendat, PhD, and Eric F. Shaver, PhD as panelists (see bios below for additional details).
This interactive panel will address the question Do Standard User-Centered Design Methods Work in Health Care? from the perspectives of a health care software vendor, consultant, clinician/researcher, and medical device vendor. An additional bonus is that each of the panelists have extensive experience applying UCD methods in and outside of the health care domain.
We’re planning to include input from attendees in the form of Twitter questions and comments posed prior to and during the session using the #UCD4HC hashtag, along with questions from audience members. Also, it’s our hope that the discussion will continue in the networking session that will follow our panel.
It should be a great panel (and audience) discussion! We hope you’ll be able to join us. But, if not, please tweet your questions and thoughts using the #UCD4HC hashtag – or post a comment – and we’ll attempt to answer them during the session.
Panelists
Ross Teague, PhD
Dr. Teague is the manager of the User Experience organization at Allscripts where he leads a team of researchers and designers in the creation of products and services that improve patient and provider lives. He’s led the effort within Allscripts to create a User-Centered Design process that teams throughout the organization can follow to receive value whether they have expertise in UCD methods or not. Ross has been leading research and design efforts for medical devices and healthcare software for more than a decade. He’s also worked as a product design strategy consultant in the areas of consumer, industrial and commercial products.
Rollin J. (Terry) Fairbanks, MD, MS (@TerryFairbanks)
Dr. Fairbanks is the director of the National Center for Human Factors in Healthcare and of MedStar Health’s Simulation Training & Education Lab (SiTEL), Associate Professor of Emergency Medicine at Georgetown University, attending emergency physician at the MedStar Washington Hospital Center in Washington, DC, and Adjunct Associate Professor of Industrial Systems Engineering at the University at Buffalo. He is a human factors/safety engineer, board certified emergency physician, former private pilot, and former paramedic and EMS Medical Director. His work focuses on applying the science of safety to medical systems, based within MedStar Health, a 10-hospital $4.7B non-profit healthcare system in the Baltimore and Washington DC region.
Christina C. Mendat, PhD (@christinamendat)
Dr. Mendat is the Director of Human Factors at Human Factors MD. Her work is focused on leading clients successfully through the human factors regulatory process. Christina’s passion is helping clients who are new to human factors or have had unsuccessful human factors programs or submissions. She takes great pride in leveraging the science of human factors with a practical application. This year she is serving as co-chair of the Medical Device Track.
Eric F. Shaver, PhD (@ericshaver)
Dr. Shaver is a Human Factors Lead with FUJIFILM SonoSite. His work has emphasized achieving an optimal fit between people, technology, and work systems to facilitate their safety, performance, and satisfaction. His professional interests include health care innovation, leadership development, team performance, and applied decision making. He blogs at ericshaver.com and actively engages with others on Twitter @ericshaver.
The program for the 2015 Symposium on Human Factors and Ergonomics in Health Care: Improving the Outcomes is now available for download. The event will be held next week (April 26th – 29th) at the Baltimore Marriott Waterfront Hotel. It should be a great event!
On March 17th, the FDA announced the release of “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling’’ Guidance in the Federal Register. This was followed by a webinar on March 24th by Elaine Mayhall, PhD and Geetha Jayan, PhD.
The Introduction notes:
This guidance provides recommendations for the formulation and scientific validation of reprocessing instructions for reusable medical devices. This guidance document also provides recommendations for the content and review of premarket notification submissions [510(k)], premarket approval (PMA) applications, humanitarian device exemption (HDE) applications, de novo requests and investigational device exemption (IDE) applications, concerning the labeling instructions for reprocessing reusable medical devices. (p. 1)
Moreover, it continues that:
…the focus of this document is to provide guidance to medical device manufacturers in the complex activities involved in crafting and validating reprocessing instructions that ensure that the device can be used safely and for the purpose for which it is intended. (p. 1)
Among other things, the Guidance outlines human factors-specific activities that should be performed during development of reprocessing instructions. Specifically, it states medical device manufacturers should:
For the latter, the guidance provides five recommendations (Note: it’s actually six; the last recommendation is actually two distinct steps) that follow the later stages of a typical human factors design and development process. They include:
[Update: 9.1.15] For a more in-depth look at IEC 62366-1, check out IEC 62366-1:2015 – More Than A Checkbox at Human Factors MD.
Last month, the IEC (International Electrotechnical Commission) published IEC 62366-1, Medical devices – Part 1: Application of usability engineering to medical devices (purchase here or here). As noted in the Forward:
This first edition of IEC 62366-1, together with the first edition of IEC 62366-2, cancels and replaces the first edition of IEC 62366 published in 2007 and its Amendment 1 (2014). (p. 4)
IEC/TR 62366-2, Medical devices – Part 2: Guidance on the Application of Usability Engineering to Medical Devices, is still in draft form and should be published in 2016. The Forward further explains the difference between -1 and -2 by stating:
Part 1 has been updated to include contemporary concepts of USABILITY ENGINEERING, while also streamlining the process. It strengthens links to ISO 14971:2007 and the related methods of RISK MANAGEMENT as applied to SAFETY related aspects of medical device user interfaces. Part 2 contains tutorial information to assist manufactures in complying with Part 1, as well as offering more detailed descriptions of USABILITY ENGINEERING methods that can be applied more generally to MEDICAL DEVICES that go beyond safety-related aspects of MEDICAL DEVICE USER INTERFACES. (pp. 4-5)
I first learned about the standard being divided into two parts from a presentation (.pdf) Ed Israelski, PhD gave at the HFES 2012 Symposium on Human Factors and Ergonomics in Health Care: Bridging the Gap.
I’ll post a more in-depth review of the standard after I’ve had some time to fully digest it.