What are Domain-Specific Heuristics?

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I. Introduction

Expedite the New Product and Medical Device Design Process with Domain-Specific Heuristics

This article will address bringing products to market in a regulated industry, specifically medical device development, and how to effectively bring medical device systems to market in the United States. For a manufacturer to be able to bring an FDA-compliant product to market, they must follow the guidelines released by the Administration in Applying Human Factors and Usability Engineering to Medical Devices on February 3, 2016. What are the steps to follow to get a product to market safely?

  • To get your product to market, you should ensure it’s safe and effective for use.
  • To ensure it’s safe and effective for use, you should validate the design is aligned to its intended users, uses, and use environments.
  • To validate the design, you should evaluate whether users can operate the device without encountering safety-critical use errors that can lead to serious or greater harm.
  • To evaluate safety-critical use errors, you should identify critical tasks as part of your risk management process.
  • To identify critical tasks, you should take one or more analytical approaches to uncover what the FDA refers to as “Reasonably foreseeable misuse.”

Traditionally, this is done through Expert Review (also called Heuristic Analyses), conducted early, often, and throughout the design process. But Expert Review has its drawbacks.

II. The Problem

Can Medical Device Product Development Be Streamlined While Adhering to Expert Review Principles?

Now, let’s look at some definitions (from the FDA guidance), shall we? In other words, why are we calling it an expert review and a heuristic analysis?

It’s not enough to perform an expert review using a set of generic design heuristics. Expert reviews should take care to select the set of heuristics specific to that manufacturer’s domain – Domain-Specific Heuristics.

The Domain-Specific Heuristics (DSH) Expert Review is a hybrid approach that evaluates user interface (UI) designs effectively, by explicitly bridging the gap between traditional methodology and the demand for tailored, industry-specific evaluation techniques.

III. The Details

Why Should a New Product Development Firm Think Beyond Safety and Regulations?

Heuristic Analyses, also known as Expert Reviews, when conducted by Human Factors Engineering experts, help product development teams identify usability strengths and opportunities for improvement at every stage of the design process, from ideation to market launch, and beyond. Although more extensive testing with real-world users is always needed to iterate and validate designs, experts can use domain-specific heuristics, tailored to industry and customers, to identify opportunities to improve usability before user testing.

Evaluating a user interface (UI) is often accompanied by complex and unique challenges. These challenges begin with the integration of business objectives, customer personas, and customer journeys as well as methods for analyzing user goals, tasks, and interactions with the UI. Moreover, there are multiple methods for evaluating user satisfaction, performance, and safety depending on the product, stage of development, and unique customer goals. Implementing the right combination of methods to optimize product-market fit while taking into consideration time and resources can be a daunting task. For example, there might be times during development when you are not yet ready for user testing, but an evaluation against traditional heuristics alone is not enough to evaluate a device’s UI.

So, as we navigate the ever-evolving landscape of technology and user interactions, we need an evaluation system that balances usability and resource efficiency. In human factors engineering (HFE), the challenge is clear: we require a method to evaluate UI that is more specific than Nielsen’s Heuristics but can be used when traditional user testing may not be appropriate or practicable.

IV. A Targeted Approach

Why is the DSH Expert Review for Medical Product Development Necessary?

What are Domain-Specific Heuristics?

Domain-specific heuristics (DSH) are modified or newly established “rules of thumb,” which give experts the ability to evaluate UIs and identify opportunities to improve usability.

As such, a DSH Expert Review, also known as a Domain-Specific Inspection Evaluation, is a highly effective method that offers a customizable approach to UI evaluation aligned with the complexity and scope of the device or application under examination.

Methods of Establishing Domain-Specific Heuristics

The development of DSH begins with adapting general heuristics, or guidelines, for specific domains. The researcher (i.e., HFE performing the DSH expert review) can start with an established list of heuristics, such as Nielsen’s ten, Schneiderman’s eight, or Pribeanu’s fourteen. Then, as deemed necessary, researchers can add to this list to create context-specific rules that enhance UI evaluation (AlRoobaea, Roobaea et al. 2013). UIs can include computer screens and software, buttons on a medical device, and any interface that involves human interaction to complete a task and achieve a desired outcome.

Researchers can refine and customize these heuristics based on the needs of the specific domain. These heuristics can be established through market research, consideration of the latest industry guidelines, and/or compiling a weighted aggregate based on the opinions of subject matter experts (SMEs) who have deep knowledge of the technology, product, and end users.

The dynamic nature of this approach means that domain-specific heuristics can be adapted to changes in the industry, advancements in technology, and evolving user preferences. This adaptability is a crucial advantage because it affords organizations the flexibility to update their evaluation criteria to maintain relevance.

DSH Expert Reviews streamline and expedite time to market for products in industries like MedTech, software development, and more. Simultaneously, conducting a DSH Expert Review, early and often, enables timely prioritization of people-centered design, which can make or break a product’s success.

Real-World Applications of DSH in Medical Device Product Development

Healthcare Software for Clinicians

UI evaluation is critical in healthcare, where clinicians use software to program patient devices. DSH considers clinicians’ unique workflow, the importance of data accuracy, and the need for rapid decision-making. Domain-specific heuristics can evaluate the UI in a way that specifically addresses the challenges and goals of clinicians by incorporating their input and expertise from the very beginning. For instance, when evaluating the heuristics of a digital interface used in operating rooms, in addition to the general heuristics, one might consider adding ergonomics to the list to account for the sterile context in which the interface will be used.

Software Interfaces for Patients

Developing software interfaces, such as mobile monitoring applications or health logs for patients, demands deep empathy for a diverse set of users. DSH can be applied to include heuristics such as accessibility and inclusivity to increase the likelihood that fundamental user characteristics such as language/regional barriers are addressed. This increases the likelihood that software interfaces are intuitive, support clinical decision-making, and enhance patient care.

V. Takeaways

Why You Should Leverage Domain-Specific Heuristics for Your Next UI Evaluation.

Domain-specific heuristics represent an underutilized approach to UI evaluation. When implemented in addition to the traditional heuristics, the DSH Expert Review can increase effectiveness across the iterative people-centered design process.

It is important to recognize that DSH is not a one-size-fits-all solution—and it shouldn’t be. Its value lies in its adaptability to various industries and devices, making it a practical and efficient option for enhancing UI design for countless hardware and software UI (i.e., human-machine interface) applications.

DSH is a foundational element in the toolkit of UI evaluation. The DSH approach can be used in various project phases, from discovery research to design validation. A DSH Expert Review can serve as a screening tool to identify challenges and opportunities for improvement before launching full-blown user studies, which come at a substantial cost. With expert guidance from HFE experts at Goddard Technologies, conducting a DSH Export Review can help manufacturers identify the best evaluation path for their specific domain to increase their products’ market success.

Need a New Product Development Firm on Your Team?
Go Goddard for your DSH Expert Reviews

Goddard Technologies is a leading provider of people-centered design and engineering for the medical device, robotics, and industrial automation industries. Our process puts people at the center of product design and development, and we are dedicated to creating products that are safe, effective, and easier to learn and use. We’ll help design highly effective and targeted evaluations specific to your industry, and we’ll guide your team through the development process so you can execute user testing on your own accord or with us by your side through to the finish line.

If you have any questions, require further information, or wish to explore how a DSH Expert Review can benefit your specific project, contact Goddard or request a free consultation.

We’re here to provide the expertise and guidance you need to enhance your UIs, improve usability, and, ultimately, increase the success of your products and systems in the market.

Ready to Go Goddard? Let’s Get Started.
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