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Register for any of the following workshops (separate registration) to gain even more expertise in health-care human factors/ergonomics.

FDA Pre-Symposium Workshops, Sunday, March 25, 2018

8:00 a.m.–12:00 p.m.
Validation of Combination Drug Products: An FDA Workshop
Presenters: Irene Z. Chan, PharmD, BCPS, CDR, U.S. Public Health Service, Deputy Director, Division of Medication Error Prevention and Analysis, FDA/CDER/OSE/
OMEPRM/DMEPA and Nicole Garrison, PharmD, BCPS, Safety Evaluator, Division of Medication Error Prevention and Analysis, FDA/CDER/OSE/OMEPRM/DMEPA

1:30–5:30 p.m.

Improving the Safety and Effectiveness of Medical Devices Through Human Factors Considerations: An Interactive Workshop 
Presenters:  Hanniebey Wiyor, PhD, LT, U.S. Public Health Service, Human Factors Reviewer, Human Factors Pre-market Evaluation Team, FDA/CDRH/DAGRID/HFPMET;

Xin Feng, PhD, Human Factors Reviewer, Human Factors Pre-market Evaluation Team,

FDA/CDRH/DAGRID/HFPMET; and Rita Lin, MS, Human Factors Reviewer, Human Factors Pre-market Evaluation Team, FDA/CDRH/DAGRID/HFPMET

Post-Symposium Workshops, Wednesday, March 28, 2018

Workshops 1, 3, and 4 take place at 1:30–5:30 p.m. Workshop 2 takes place at 1:00–6:00 p.m.
Workshop 1: How to Design Effective Safety Information for Medical Devices
Presenter: Eric F. Shaver, Human Factors MD
Location: Marriott Copley Place, Boston, MA
Workshop 2: Innovation, Not Just Evaluation: Leveraging Human Factors Tools to Inspire Innovation
Presenters: Karen Unterman & Serge Roux, Cambridge Consultants
Location: Cambridge Consultants, Boston, MA (transportation provided)
Workshop 3: You’re Not Done Yet – Conducting a Residual Risk Analysis After a Summative Usability Test
Presenters: Michael Wiklund, Erin Davis, & Andrea Dwyer, UL-Wiklund
Location: Marriott Copley Place, Boston, MA
Workshop 4: A Human Factors Approach to Root Cause Analysis
Presenters: Brittany Anderson-Montoya, Carolinas HealthCare System; Ken Catchpole, Medical University South Carolina; & T. Robert Turner, Anne Arundel Medical Center
Location: Marriott Copley Place, Boston, MA

Workshop 1: How to Design Effective Safety Information for Medical Devices 
Presenter: Eric F. Shaver, Human Factors MD
Wednesday, March 28, 2018, 1:30-5:30 p.m., Marriott Copley Place
Professionals: $350 by February 9; $400 after; Students: $200
It is incumbent on companies to design and develop high quality medical device labeling that meets the needs of users. This necessity stems from several sources. First, regulatory authorities have continued to expand the requirements for companies to demonstrate that users can safely and effectively employ labeling when operating medical and drug-delivery devices. Second, new market entrants are bringing cutting-edge techniques about designing effective labeling from other industries to medical and drug-delivery devices. Finally, users are expecting device labeling to meet or exceed what they experience with their consumer products.
One important, but often overlooked, aspect of device labeling is safety information (i.e., warnings, precautions, and contraindications). Though most companies readily acknowledge the importance of identifying and clearly communicating the potential hazards associated with their devices, they are often perplexed about the best methods for achieving it. Unfortunately, finding reliable and concise resources about how safety information should be designed and developed can be difficult to find.
This workshop will provide attendees with the necessary information to confidently apply the current science and best practices to design and develop adequate safety information. They will have the opportunity to participate in the development of a “system of safety information” for a fictional medical product. Shaver will share safety information lessons learned from working with clients in numerous industries, including pharmaceutical and medical device companies. This workshop is applicable to a variety of stakeholders, including human factors specialists, instructional designers, biomedical engineers, product managers, and medical device consultants.
Eric F. Shaver, PhD, is director of Human Factors at Human Factors MD, a consulting company that helps pharmaceutical and medical device companies create safe, effective, usable, and innovative products. Eric has conducted research and provided consultation to clients about safety information for more than 15 years. He has assisted clients in a variety of industries with the design and evaluation of safety information, litigation support and expert witness testimony, and training development and presentations on safety and human factors-related topics.

Workshop 2: Innovation, Not Just Evaluation: Leveraging Human Factors Tools to Inspire Innovation
Presenters: Karen Unterman & Serge Roux, Cambridge Consultants
Wednesday, March 28, 2018, 1:30-5:30 p.m., Cambridge Consultants (transportation from Marriott Copley Place provided)
Professionals: $350 by February 9; $400 after; Students: $200
Human factors in health care is traditionally focused on the evaluation of medical devices and their ability to support safe and effective use (as outlined by FDA guidance and ISO standards).

This workshop is intended to demonstrate how many of the skills and techniques human factors/ergonomics professionals employ for evaluation are powerful tools in the front end to support the generation of novel medical products that provide significant benefits to users.

Through presentation, discussion, case study examples, and interactive creative sessions, the presenters will

  • Briefly discuss how human factors is applied to medical device design, including current medical development processes’ integration of HF/E, HF tools used for evaluation, and the mindset applied as an HF/E assessor.

  • Introduce the front-end structure used to identify unmet needs and opportunities and to create novel product ideas and concepts, and the mindset change associated with creative work (yes and, no buts, etc.).

  • Show how the various HF/E tools the presenters use (contextual inquiry, task analysis, worst-case use scenarios, simulated use environments, intended user characterization, root cause analysis) can be transformed to be applied to generative research and creativity.

  • Conduct a mini-creative workshop in which participants can use these tools and see them in action. Stimulus from the workshop will be provided from ethnographic research Cambridge Consultants has conducted using the transformed tools and techniques.

  • Provide one to two case studies or examples showing the value of utilizing these approaches early in development to inform and shape the solution being created.

Workshop attendees will leave with a transformed set of tools and processes they can apply to the front end of innovation: generating novel medical products that provide significant benefit to users. The workshop will be of interest to professionals in medical device, pharma, and health-care companies; designers and engineers; human factors researchers and academics; practitioners and consultants in human factors; and health-care providers such as physicians, nurses, and pharmacists.

Karen Unterman leads the Human Factors Engineering group in Cambridge Consultants' Medical Technology Division. Karen is a project manager, workshop facilitator and user-centered design lead. She has experience performing human factors activities throughout the development of drug delivery, diagnostic and surgical devices – from early stage opportunity discovery through to product validation and submission support. Her expertise is in designing & conducting user research, facilitating strategic & creative discussions to generate new product and service ideas, and developing and validating safe and effective user-focused solutions in the Healthcare and Wellness sectors.

Serge Roux is an Associate Director in the Medical Technology division in Cambridge Consultants. His background in both mechanical engineering and industrial design gives him a valuable double culture for multi-disciplinary projects. He has over 15 years experience working in innovation management, from creativity facilitation, product down-selection and road mapping, to innovative concept design and eco-design in the most various environments, including automobile interiors, medical, surgical and consumer devices, as well as military-grade HMI design. Serge has been the industrial designer, lead innovation manager and facilitator for more than 30 MedTech front-end projects in the last 8 years, involving key stakeholders and opinion leaders in strategic decision-making, concept generation and down-selection activities. 

Workshop 3: You’re Not Done Yet – Conducting a Residual Risk Analysis After a Summative Usability Test
Presenters: Michael Wiklund & Erin Davis, UL-Wiklund
Wednesday, March 28, 2018, 1:30-5:30 p.m., Marriott Copley Place
Professionals: $350 by February 9; $400 after; Students: $200
Those who routinely conduct or observe summative usability tests are well aware that a “perfect” test – one that is free of use errors, close calls, and difficulties – is rare. Inevitably, a handful of use-related events occur, which can induce varying levels of concern depending on the seriousness of the events and a manufacturer’s readiness to perform the requisite residual risk analysis.
Analyzing residual use-related risks is an essential part of the product development process because it is the means by which a manufacturer determines if the level of risk remaining is acceptable or unacceptable. Accordingly, the analysis is the tipping point between concluding the device can be used safely and effectively (and, therefore, is ready for launch), or determining further redesign is needed to address unmitigated risks.
Many companies face varying degrees of uncertainty about how to analyze use-related events that occur during a summative usability test. The high-stakes nature of this analysis only intensifies their concerns and, accordingly, their desire to understand how to perform a “good” analysis. The presenters began to address this need in their 2017 workshop on root cause analysis. This workshop addresses the next step in the process: residual risk analysis. Attendance at the 2017 the root cause analysis workshop is not a prerequisite for this workshop.
The presenters will cover practical considerations for performing high-integrity residual risk analysis. The discussion will include strategies for

  • gathering evidence to facilitate residual risk assessment,

  • performing a thorough analysis, and

  • writing clear and compelling residual risk commentaries.

The presenters will also lead participants through several examples and facilitate a discussion about residual risk challenges faced by participants on their own product development efforts. Although the workshop will address the analysis through a summative test lens, the method and learnings can be applied to analyzing residual risk in other contexts (e.g., adverse event reporting).
The workshop will be of interested to medical device, pharma, or health care companies; designers and engineers; regulatory consultants; human factors consultants and practitioners; and health care providers (physicians, nurses, etc.).

Workshop 4: A Human Factors Approach to Root Cause Analysis 
Presenters: Brittany Anderson-Montoya, Carolinas HealthCare System; Ken Catchpole, Medical University South Carolina; & T. Robert Turner, Anne Arundel Medical Center
Wednesday, March 28, 2018, 1:30-5:30 p.m., Marriott Copley Place
Professionals: $350 by February 9; $400 after; Students: $200
Despite the call to action spurred by the 1999 IOM report To Err is Human, adverse events continue to be prevalent in health care. Although the culture is beginning to change, more work is needed to continue to shift the thinking from a blame approach to a systems approach after an adverse event. Root cause analysis (RCA) is an approach used in health care to investigate what happened and why. Critical to the success of an RCA is uncovering the contributing system factors that affected the individuals involved in experiencing an error. HF/E professionals can serve an integral role in the RCA process to help the team identify those system factors and subsequently helping to shift the culture away from a blame mentality.
This workshop will highlight how an HF/E professional and/or approach can aid the team during the RCA investigation, identification of contributing factors and root causes, and action planning phases of an RCA. Specifically, health-care and HF/E professionals will learn how to apply the Systems Engineering Initiative for Patient Safety 2.0 model (Holden, Carayon, Gurses, Hoonaker, Hundt, Ozok, & Rivera-Rodriguez, 2013) to the RCA process, identify RCA pitfalls including how bias among facilitators can affect the RCA. Cognitive interviewing techniques will be introduced and practiced, and action planning will be addressed. No prior experience is needed to attend.
The workshop is divided into three sections:

  1. A new RCA model – defining and changing toward a more HF/E-centric approach. Attendees will learn about the history of RCA and how human factors can be used as a model to change the culture of thinking from “blame” to a systems approach. Participants will also be exposed to how the Systems Engineering Initiative for Patient Safety 2.0 model can be applied to the RCA process (Holden et al., 2013).

  2. From RCA to improvement – working with other healthcare professionals to improve the system after an RCA. Participants will be introduced to the deeming process, pitfalls that can derail an RCA, cognitive interviewing techniques, and the tools used during an RCA. Participants will then learn different approaches to action planning and how to develop strong action plans. In addition, they will be exposed to methods to identify how to improve the system from a human factors approach. Participants will have the opportunity to practice putting together everything they have learned.

  3. Limitations of RCA – alternative or complimentary approaches to RCA. The presenters will explore the potential for other systems modeling approaches – including Systems-Theoretic Accident Modeling and Processes (STAMP) and Functional Resonance Analysis Method (FRAM) - and how they might be introduced into a health-care environment. Also briefly explored will be prospective approaches to systems safety diagnosis that can be understood through direct observation

This workshop will be of interest to health-care providers (physicians, nurses, etc.), human factors/ergonomics practitioners and consultants, HF/E researchers, hospital administrators, and medical device, pharma, and health-care company professionals.

Brittany L. Anderson-Montoya, PhD, is research manager for Carolinas Simulation Center and the human factors specialist for Carolinas HealthCare System. She received her PhD in human factors psychology from Old Dominion University in Norfolk, VA. Anderson-Montoya has more than10 years of human factors experience, with an emphasis in health care. Prior to her current role, she was the human factors specialist in the quality department at Carolinas HealthCare System. During her time in that department, she helped to redevelop the root cause analysis training program into a two-day course to incorporate systems thinking into each phase of the investigation. She has also helped to teach and facilitate the newly designed course for the metro and regional facilities of Carolinas HealthCare System. Some of Anderson-Montoya’s current research interests include shift handovers and developing education to improve handovers, and developing a surgeon coaching and education curriculum using simulation to advance surgeons’ technical and nontechnical skills in the operating room. Recently, she has been involved with research regarding implicit bias and how biases people are unaware of can impact patient care.
Ken Catchpole, PhD, is a human factors engineer who has spent the last 15 years studying and improving safety and performance in acute care. His research has been primarily conducted in the UK and US, exploring trauma, cardiac, orthopaedic, vascular, gastrointestinal, spinal, and urological surgery. His collaborations with clinicians to apply the lessons of human factors to accident causation and quality improvement has also included the Netherlands, Norway, Australia, New Zealand, Dubai, Qatar, and Brazil. Current projects include robotic surgery, trauma and transplant, and sterile processing. Through public speaking, the media, and over 70 peer-reviewed publications, Catchpole has engaged thousands of people in the improvement of health care from a human-centered perspective.

Robert Turner, PhD, is research director for Anne Arundel Medical Center’s (AAMC) Department of Surgery in Annapolis, Maryland. He has a decade of research experience in health-care human factors, most notably with Old Dominion University and the American College of Surgeons. His current research at AAMC involves 3-D motion tracking, oculometry, electromyography, and other approaches to characterizing and addressing unique biomechanical and cognitive challenges within minimally invasive surgery. Turner also serves as a usability consultant to surgical device manufacturers and government entities. His goal is to help reduce surgeon burnout and musculoskeletal complications arising from poorly designed technical interactions.