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Integrating Human Factors Into Medical Device Design Control And Beyond Workshop

June 6, 2017 to June 7, 2017
Minneapolis, MN
Regulatory, Legal and Compliance, Sales and Marketing
Workshop

Overview

Maintaining effective design control procedures is a key element of the quality system regulation. This interactive workshop takes attendees step by step through all aspects of design control, emphasizing how it interacts with other quality system elements and other company functions.

Understanding the user, the environment, and the desired outcomes will, at the earliest phases of development, allow the process to integrate critical findings and expedite a safe end product to market that precisely meets user needs. This workshop will demonstrate how and when to build human factors into a development program with examples and group exercises.

Most medical device companies know they need to make their product as usable as possible, and they probably know they need to run some usability studies on it when it’s done. But many struggle with how to design their product with usability in mind from the ground up.

Can you answer the following questions?

  • How should Human Factors be incorporated outside of usability studies?
  • What tools should be used and when? How does Human Factors inform risk documentation?

This workshop addresses the steps necessary to develop a truly usable product – one that fulfills regulatory expectations around safety and efficacy, and that simplifies life for end users. Without a human factors process, companies find themselves trying to evaluate the product on its usability without having designed usability into it from the beginning.

This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Agenda

Click here to view and download the agenda.

Day 1 Topics Include:

  • Introduction to Human Factors Engineering (HFE)
  • Consequences of poor HFE and the regulatory imperative to apply HFE; driving toward improved patient safety and improved healthcare
  • The regulatory imperative to apply HFE
  • The Commercial Imperative to Apply HFE
  • Overview of the HFE Process, Scaling, and Key End-Products
  • HFE Costs and Benefits
  • Models for Human Factors Engineering Practice and the Value of HFE Procedures
  • Defining Potential Use Errors 
  • Use-Related Risk Analysis and Mitigation
  • Formative and Summative Usability Testing
  • Root Cause Analysis of User Interaction Problems
  • Determining Residual Risk
  • Writing an HFE Report and Completing HFE/Usability Engineering File
  • Keys to Human Factors Engineering Program Success

Additionally, on Day 2 of this workshop, we'll feature a hands-on interactive session that will cover the following:
Most medical device companies know they need to make their product as usable as possible, and they probably know they need to run some usability studies on it when it’s done. But many struggle with how to design their product with usability in mind from the ground up. How should Human Factors be incorporated outside of usability studies? What tools should be used and when? How does Human Factors inform risk documentation? This workshop addresses the steps necessary to develop a truly usable product – one that fulfills regulatory expectations around safety and efficacy, and that simplifies life for end users. Without a human factors process, companies find themselves trying to evaluate the product on its usability without having designed usability into it from the beginning.
 
In this session on Day 2, participants will learn to:

  • Identify the usability gaps in their HF process today
  • Address the steps prior to and between usability studies
  • Integrate Human Factors learnings into risk documentation
  • Learn specific Human Factors methods that infuse usability into the design
  • Understand the value of each method

Presentation slides will be sent after the conclusion of the workshop

Speakers

Speakers include: 

  • Erin Davis, Managing Human Factors Specialist, Human Factors Engineering, Life & Health, UL
  • Michael Wiklund, General Manager, Human Factors Engineering, Life & Health, UL
  • Elizabeth Roche, Director of Research & Strategy, Ximedica
  • Savannah Kyle, Human Factors Engineer, Ximedica

Event Logistics

Medical Alley
4150 Olson Memorial Highway, First Floor
Golden Valley, MN 55422

Additional Info

Registration Fees

AdvaMed Member Registration: $1595.00 

Medical Alley Member Registration: $1595.00

AdvaMed Accel Member Registration: $695.00

Non-Member Registration: $2,095.00 

Government and Non-Profit Registration: $695.00 

Cancellation and Refund Policy
All cancellations must be received via email to AdvaMedEvents@AdvaMed.org. Cancellations received 10 business days or more prior to the start of the program are eligible for a full refund. There will be no refunds for cancellations received less than 10 business days prior to the start of the program, including "no shows". 

We welcome substitutions in lieu of cancellations at any time. Please contact us at AdvaMedEvents@AdvaMed.org with the substitute's registration information. All cancellation refunds will be processed within 30 business days from date cancellation request is received.

Topics and speakers are subject to change without notice. AdvaMed reserves the right to cancel or reschedule any program, and the full registration fee will be refunded or applied to the rescheduled program in accordance with the registrant's preference. In the event of cancelled programs, AdvaMed assumes no responsibility for transportation, hotel, or other expenses incurred by registrants.