HFE for medical device development

PHOTO © Toowongsa | ADOBE STOCK

Medical device development is a high-stakes game. Patient safety, compliance with complex regulations, and your company’s reputation are all on the line, but one factor often makes or breaks success: human factors engineering (HFE) also referred to as human factors, which is used to design human interfaces. HFE bridges the gap between technology and user interaction. It’s essential to ensure the device operates as intended by all users, avoiding potential risks and failures. It’s not like putting in a tickler file to fulfil a regulatory submission requirement. It’s a necessary component of your design approach, and here’s why.

HFE leverages interdisciplinary fields such as psychology, ergonomics, and systems engineering to enhance human-device interaction. By aligning device functionality with real-world usage scenarios, HFE ensures medical devices meet safety standards, improve user performance, and minimize the risk of errors.

What’s HFE and why does it matter?

HFE is defined as the application of scientific information to design equipment by considering the people, technology, and their environment. It’s about the ways users engage with your device and make it safe, effective, and easy to use. The aim is to reduce the margin of human and technical mistakes and to increase the efficiency and functionality of the patient’s safety and benefit of the devices in view. A well-executed HFE approach leads to intuitive and user-friendly devices, increasing patient confidence and device adoption.

Additionally, HFE focuses on mitigating cognitive load and error-prone scenarios during critical device usage, especially in high-stress medical environments.

The MDR of the European Union, the FDA, and other governing bodies are focusing on the usability of medical devices. Why? Since user-related errors are one of the primary causes of recalled products, several improved methods of risk management communication will be introduced in this paper. A medical device may be very good mechanically, but if it’s confusing, you’re setting yourself up for failure.

HFE proves the device to be developed not only follows all the regulatory requirements but also the best design possible to avoid the risk of misuse and misunderstanding. By designing with HFE principles, you enhance usability and safeguard your device from unnecessary errors and costly recalls.

Early integration of HFE

Time and cost efficiencies in medical device manufacturing must be achieved to keep global investors happy. You may think you can add in HFE later, but this is a much more expensive and longer way of doing things. Some issues discovered in any of these phases of design are significantly more costly to address than others, especially when identified during the later stages of a project. Studies indicate that correcting usability issues costs as much as 10x its initial cost when done later in the cycle.

Integration of HFE from the onset eliminates the occurrence of design modifications and additional time it will require. The need to get feedback and testing on usability early on reduces costs incurred when problems appear at a later stage and makes attaining market approval a smoother process. This proactive approach minimizes future design revisions and helps stay within budget and timelines, avoiding delays in approvals and market entry.

The role of HFE in reducing risk

A poorly designed device not only negatively impacts a business, it may also become dangerous to patients. Mistakes from improper device design aren’t just costly, they could be fatal. When you pay early attention to HFE you’re likely to avoid these errors. Other research has ascertained that more than half of all adverse effects associated with medical devices stem from design. These issues can be minimized significantly through the right HFE strategies, such as:

• Usability testing at each design and development phase; including heuristic evaluations, cognitive walkthroughs, and iterative testing with representative users to ensure a seamless design evolution.
• More specifically, one is always keen to ensure there’s clarity in design to avoid entailing a problem of confusion or misuse.
• Actual feedback from the users of the technology is an important source used to enhance usability and functionality.
• Assess the risks associated with the usability of the medical device.

The regulatory authorities are getting more demanding, but compliance is only the first step. What HFE can do for you goes far beyond the adequacy rule to a level above compliance. While usability testing and user-centered design make it more likely you meet your compliance goals, they also make it more likely your product works smoothly when in the hands of doctors and patients.

But compliance isn’t just doing the bare minimum to meet the rules set down, it’s about convincing customers that your device is useful and safe to use. Through proper HFE, you demonstrate you’ve considered users’ needs for a user-friendly and safer product.

Why starting with HFE is a no-brainer

Integrating HFE early fosters cross-functional collaboration, enhancing design efficiency and compliance readiness.

Here’s why HFE should be part of your strategy from day one:

• Cost efficiency: The later HFE is adopted, the more costs for redesigns, recertifications, and recall possibilities.
• User safety: Errors must be minimized by having a design that’s easily navigated, eliminating chances of a wrong selection to protect the patient and your brand.
• Faster adoption: Ease of use is important in driving adoption of devices. When a product performs as advertised, consumers – including healthcare providers and patients – will adopt it.
• Regulatory success: HFE directs you to several regulatory standards and often helps go beyond them to achieve necessary market authorization.
• Improved product differentiation: A device designed with HFE principles stands out in the market for its superior usability and safety, giving it a competitive edge compared to less user-friendly alternatives.

How to apply HFE to improve your design

• Understand your users: You can’t create a product without understanding the intended consumer of that product. Learn more about tasks healthcare workers, patients, or any other user may encounter. It’s crucial to perform user research at the beginning of this step so one can compete with pain points and create solutions meeting these requirements.
• Usability testing is key: This is the only effective way to learn how the users are using the device you’re developing or have developed. It’s not necessary to make these decisions when you’re already halfway down the development cycle. Early testing and iterating ensure you meet the needs of the users and prevent costly changes later. It’s recommended that usability testing should begin as early as the conceptual stage and be modified whenever necessary.
• Work collaboratively: A cross-functional team including designers, engineers, regulation specialists, and marketers must work collaboratively to develop one simplified device meeting the needs of the user and conforming to the set standards.
• Improve and iterate: HFE isn’t a one-time question-and-answer session. It’s a continuous process because after each round of testing the feedback must be incorporated when designing subsequent rounds. Implementing the proposed iteration process affordably results in a steady improvement of the device to make it safe to use, efficient, and reliable.

Implementing HFE

At Freyr Solutions, we revisit realizations made with HFE. Our experts collaborate with you from the outset to apply HFE principles to your design, so your device achieves the client’s safety objectives and the intended use.

Here’s how we help:

• Global expertise: With FDA, MDR, and many other standards successfully implemented, we know everything about your device’s usability requirements.
• Tailored solutions: Each device and user base are distinct. Depending on your situation, we adapt our HFE strategies to augment usability of your product.
• End-to-end support: Our services also include every process of your product life cycle starting from identifying the basic concept to post-reconstructive market surveillance. Our ongoing feedback loop guarantees that throughout the product life cycle your device is easy to use and compliant.

HFE isn’t something you do once a product is ready – it’s an integral part of your development process. It’s most effective to incorporate it in your project from the first day of development because incorporation from the initial stage cuts down on time and cost and provides a guarantee of the safety and usability of the device. When you design with HFE in mind you’re doing more than meeting regulations; you’re designing for consumers and establishing credibility and market viability.

About the author: Shilpa Gampa is a regulatory affairs strategist with expertise in FDA submissions and C-level executive consultation for developing go-to-market strategies. She is acting as the regional delivery head for America’s clients at Freyr in her primary role for global market submissions.

Freyr Solutions
https://www.freyrsolutions.com