6th Human Factors & User Experience for Medical Device Design  

18-19 September 2019  | Minneapolis, USA

Darin S. Oppenheimer

Executive Director, GRACS Device & Digital Health

"Streamlining Device Development to Enhance Medical Device Innovation."

Jeremy Schwark, Ph.D.

Staff Human Factors Engineer

"Leveraging Human Factors Earlier in the Product Development Process to Ensure Successful Approval"

" Creating Better Alignment and Collaboration between Teams to Promote a Successful Product Development Process"

User Experience and Human Factors Engineer
Becton Dickinson 

Brittany Williams

 For registration details and multiple attendee discounts, please contact:

Melini Hadjitheori 

Tina Rees, Ph.D.

Associate Director- Human Factors
Ferring Pharmaceuticals

"Exploring Rigorous Recruitment Methods to Improve Human Factors."

We brought together key industry leaders  from medical device and life science firms that have devoted their time and energy into human factors and user experience for Medical Device design. 

Interested? Do you feel you will benefit?


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 You will be presenting on “Organizing Implementation of Human Factors in Design Control for Effective Development of Medical Devices,” what are some key takeaways the attendees can expect from your session? 

Attendees  can expect to walk away with an understanding of the cadence of deliverables to meet Design Control Phase Requirements, the role of HF in user needs/design input identification, the relationship between HF and risk management, and methods for applying summative testing for both design validation and risk management needs, among other topics. 

How can combining human factors studies and V&V activities be achieved? 

For verification activities, HF studies may be involved in verifying product handling and performance against human capabilities. In other words “Did we build the device right?” Can users see indicators, activate controls, hear alarms, etc…
At a high level, structure summative evaluation protocols in a thoughtful manner to meet the needs of design validation followed by specific usability validation tasks required for risk management. HF should be observing for effectiveness of risk controls and mitigations during all exercises. 

What strategies can be leveraged to strengthen risk management activities? 

Putting together a core team with strong cross-functional relationships and collaboration between R&D, Systems, Design Quality & RM, and Human Factors is paramount. Being involved in team building activities and understanding each other’s point of view will help facilitate conversation and discovery of risk.
Work with your team to develop a robust Task Analysis to feed iterative Use Error and Use Condition Analysis Meetings.  Then, define a feedback loop of information between Use Error and Use Condition Analyses, design inputs, and hazard analysis. Finally, identify critical safety tasks requiring validation early in product development to feed iterative formative research 

Why is it important to integrate human factors in user needs/design inputs identification? 

Often unmet needs within a well-developed procedural space are those that cannot be well articulated and require more intensive means of research & analysis than surveys and interviews can provide.  Human Factors should have the expertise to guide a project team through that in-depth work and help them maintain a research plan.
When it comes to translation, the HF group should help the team to maintain focus on needs of the user and outlining requirements of the design, not the design solutions themselves at the early stages.
Human Factors should also apply foresight of required validation activities and question the team “How will we validate this need?” and/or “Does this require a clinician to validate?” 

In your experience, why is it beneficial to include both formative and summative in design control phase reviews? 

This helps to maintain clarity with larger cross-functional project team in terms of Product risk and any associated Project Risk. 

What key drivers motivated you to attend this conference? What do you hope to gain? 

I hope to continue to expand my understanding of the human factors and usability work space as well as meet and discuss these topics with other human factors professionals. 

Ahead of the 6th Human Factors & User Experience for Medical Device Design, we spoke with Drew Seils, Principal Human Factors Design Engineer at Medtronic about the  Design Control Phase Requirements.


Drew Seils will be presenting during the first day, 18th of September at  1:30pm.
Presentation topic: Organizing Implementation of Human Factors in Design Control for Effective Development of Medical Devices

• Integrating human factors in user needs/design inputs identification for greater product success
• Strengthening risk management activities associated with human factors to reduce risk
• Combining HF studies with V&V activities to promote effective development of medical devices
• Highlighting both formative and summative inclusion in design control phase reviews to gain more insight
• Organizing usability file deliverables at various phases of design control