Human factors and medical devices continue to be a focus of the FDA for new product testing and approval. Often considered intuitive and inherent to product design, more emphasis is being placed on the human–device interaction during testing. Formal testing and demonstration of safe use is now a critical element of product testing and review. This critical element will potentially change testing requirements for many companies. Additionally, this change could cause delays in device clearance and approval if testing is not properly conducted.
According to the FDA’s “Applying Human Factors and Usability Engineering to Medical Devices,” human factors engineering is the application of knowledge regarding the behavior, abilities, limitations, and other characteristics of medical device users and how that affects the design of medical devices. In the development of medical devices, considerations in three major components of the device and user system determine if there is a use error or if it will serve its correct use: the users, the device use environments, and the user interfaces. In order to ensure a medical device is operating as intended, companies must monitor the following: device components, product setup, user interfaces, documentation and user workflow. If a device functions as intended but is prone to user error in operation, or has inherent design flaws that are not optimal for specific use cases, this could put patients at risk.
IMPORTANCE OF HUMAN FACTORS IN PRODUCT DEVELOPMENT
Optimization of product design to ensure the developed device successfully completes its purpose is crucial. In medical device development this is critical for product adoption and product sales. In order to reach product adoption, the product must successfully complete its intended purpose and fit into expected workflows. Although many products built around great advances in technology, they are not always easy to work with. These products have increased features and capabilities, yet may not gain traction simply because users did not like them.
WHY IMPLEMENT HUMAN FACTORS TESTING
Human factors are a critical part of product design and product testing. Benefits of application of these principles include:
HOW TO IMPLEMENT HUMAN FACTORS TESTING
Live and simulated testing are fundamental steps in the design and development process. With that being said, the purpose of these tests is to anticipate, observe and remedy foreseeable risks. As a result, this process is becoming an integral element of a company’s risk management program. Formal processes like Failure Mode Effects Analysis (FMEA) and Fault Tree Analyses (FTA) are now being regularly implemented to assess these risks.
HOW CAN HUMAN FACTORS AFFECT MY CUSTOM CONNECTOR OR CABLE ASSEMBLY?
Human factors risks associated with the critical tasks surrounding cable and connectors include:
Global Interconnect, Inc. (GII) has engineering expertise in the design, development and quality testing of wiring, cables and connectors. Our full regulatory capacity and Chief Medical Officer allow us to assist in optimal design and regulatory strategy surrounding these critical device components. In addition, GII vertically integrates with product manufacturing to ensure quality workmanship to design specifications. With this expertise and feedback throughout the full product life cycle, GII can anticipate issues and design around them for optimal component design and manufacture. Global Interconnect can assist in product design to optimize product features and specifications. A product optimally designed for use with inherent safety should result in increased product safety, market adoption, and sales.
Steven S. Brooks, MD MBA FACC
Chief Medical Officer
 Applying Human Factors and Usability Engineering to Medical Devices, Guidance for Industry and Food and Drug Administration Staff. FDA Publication February 3, 2016.