Human Centered Strategies

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Validation Studies
Standards & Guidances
AAMI HFE Course

AAMI Human Factors Course Focused on Process Perspective

Regulatory Implications of FDA's Emphasis on Pre-Market Clearances Given Center Stage

The AAMI Human Factors course, is a three day workshop-style format focused on the major aspects of integrating Human Factors methods, analysis and testing, into device manufacturer's product development process. With the growing emphasis FDA has placed on pre-market submission reviews, several modules in the course include valuable discussion on the "do's and don'ts" in preparing material going to the agency. The course is built around a knowledge of the Quality System Regulation Design Controls process, linking Human Factors activities to this required process by manufacturer's, although a thorough knowledge of Design Controls is not required for course participants. A summary of the course modules is presented below.

1: Introduction

Overview of course modules and orientation to Human Factors in Design Controls.

2: FDA Perspective

How Human Factors is positioned in the current device review process at the FDA's Office of Device Evaluiation and focus of evaluations on use error risk in the device user interface design.

3: Preliminary Analyses

Foundations of analysis for understanding user requirements and risks in the interaction with medical devices including User Profiles, Use Environment Analysis, and Use Scenarios.Review of methods such as contextual inquiry and focus groups. Introduction to Task Analysis methods including models of human information processing which provide detailed understanding of user requirements at a low level. Also covered are analysis methods leading to initial identification of use errors, user interface and labeling design requirements, and testable criteria for evaluation of user interfaces in formative and summative testing. This module provides the manufacturer with a sample format for the collection and documentation of the user requirements into a single table useful for device submissions.

4. Formative Evaluations

Review of techniques for evaluating user interface designs during Design Input, Output, and Verification stages including cognitive walkthroughs, heuristic evaluations, standards reviews, etc.

5: Validation Testing

Review of the required format and data collection for user interface design validation testing acceptable to the FDA and IEC 62366. The FDA pre-market approval requirements will be the focus of this module.

6. Human Factors/Usability Report

Outline and discussion of the pre-market approval format for presenting all human factors work essential to proving safety and effacacy of user interactions with devices. The FDA expectations will be presented which is also applicable to international human factors and usability requirements.

7. Case Study I: Combination Products

This module will provide a real life story of employing human factors in the development of a combination product drug injection device. Emphasis is on the planning of the human factors effort throughout the development cycle including examples of various test and evaluations that were conducted and resulted in pre-market approval.

8: Human Factors Standards Review

The current landscape of Human Factors standards are reviewed with a focus on how they are intended to be used in the development process. HE-75, the newly published design standard, will be reviewed from an organization and content perspective, and a practical guide to how it can be used in the daily design team activity.

9: Case Study II: Infusion Pump

Case study of the development of a new infusion pump using human factors throughout the process.

10: Validation Test Exercise

A group exercise ("final exam") involving the creation of an FDA-approved plan for a Simulated Use Summative Validation Study. The panel of experts (course faculty) will critique designs from the class involving various types of medical devices.