5th Human Factors & User Experience for Medical Device Design  

1-2 May 2019   |  San Diego, California

 For registration details and multiple attendee discounts, please contact:

Melini Hadjitheori 
melinih@marcusevanscy.com 

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 by attending?

THE SPEAKERS

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LOCATION

SAN DIEGO, CALIFORNIA

ABOUT THE INTERVIEW

You will be presenting on “Leveraging Usability Testing Earlier in the Product Development Process to Ensure Successful Approval,” what are some key takeaways the attendees can expect from your session? 

My session will cover 4 main areas:
1. Understanding the importance of testing early and often.
2.  Types of formative evaluations that reduce budget and save time.
3.  How to leverage usability testing with end users, what do we do with the data, how will it drive design decisions, and when do we know we have tested it enough.
4.  How iterative design and test can reduce risk during 510k submission of HF Validation tests.
All of these items require important consideration.  Planning for a submission can be time consuming and should be very methodical and systematic.  I work in Infusion Pumps – they are very complex and require many safety mitigations that need to be proven effective.  The last thing a manufacturer should do is wait until validation to test the effectiveness.  Ideally you have done enough testing during design and development that validation becomes more of a formality than something that could end your project, delay your submission or exceed your budget expectations due to a repeat test being required.

What strategies can be leveraged to ensure validations are passed?

It is imperative that the manufacturer ensure that all critical tasks are evaluated and/or tested prior to an HF Validation test.  Consider segmenting a User Interface Design Validation and Human Factors Validation Tests.  Because HF Validations are much more rigorous you can reduce test time be testing user needs unrelated to critical tasks in a UI Design Validation test.  For lower risk mitigations it is possible to evaluate them with subject matter experts and Human Factors Engineers to ensure the design follows industry standards and basic usability heuristics.  While testing with end users is always the best way to evaluate the success and usability of your product there are times when this latter strategy is a good option. 

How can conducting early formative testing benefit the overall product development cycle? 

Testing early and often can provide significant design direction, decrease development time and result in a much more usable and safe product.  The minute you have something to show users, show them.  Gather feedback, update the design and continue to iterate until your users glide through product use with ease.

Why is it important to embrace usability testing in the beginning rather than at the end? 

Many teams will come to me at the end of the project.  They look at usability testing as a one and done checklist item.  Their product is designed, that have not gathered any feedback from end users and they are ready to submit.  Several issues arise because of this.
1.       The design may be completely wrong.
2.       Going back to the drawing board becomes a real possibility because the usability of the product fails.
3.       The amount of money that teams spend on doing usability testing too late can actually double. (design time, development costs and testing)
4.       The Design History File does not reflect a robust usability engineering process.
5.       Submission, and therefore launch, can be delayed significantly. 

In your experience, what are the best strategies to guarantee a device will address users’ needs properly? 
                1. Early Contextual Inquiry at the very beginning of your project and potentially into the design phase.
                2.  Post Market Surveillance – if you have a similar predicate product get out there an understand the pain points.
                3.  Researching Known Use Errors and reviewing your complaint database.
                4.  Administer the System Usability Scale to users that either use your predicate or your competitors similar product.
This type of User Research can be critical to identifying what your users really need, what workarounds are they implementing with similar products that don’t meet their needs and how can your product fix those pain points.

You have participated in this particular event before in the past. What key drivers motivated you to attend this conference yet again? 

This is one of my favorite conferences because it is focused on HF and Medical Devices completely.  There are many events that include medical and HF but they may not hone in on the issues like the speakers at this conference do.

Ahead of the 5th Human Factors & User Experience for Medical Device Design, we spoke with  Tressa J. Daniels, Senior Manager User Experience Design and Human Factors Engineering at Becton Dickinson about leveraging Usability Testing Earlier in the Product Development Process to Ensure Successful Approval.

TRESSA DANIELS'S PRESENTATION TOPIC

Tressa J. Daniels,  will be presenting during the second day, 2nd of May at 2:15 pm. 
  
Presentation topic:Leveraging Usability Testing Earlier in the Product Development Process to Ensure Successful Approval

•Embracing usability testing in the beginning rather than at the end to identify issues and make improvements

•Conducting early formative testing to save time, money and effort in the product development cycle

•Incorporating human factors early for advantages in design instead of making changes last minute to pass validations

•Analyzing study results to reveal whether a device has effectively addressed user’s needs