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Analytical Research
Task and Use-Related Risk Analysis
A valuable approach to identifying potential difficulties in using a system is to meticulously describe each step required to operate it. These steps often involve sub-steps. For example, consider the process of driving to work: you must first get into your car, which involves unlocking the door using your keys. To access your keys, you reach into your pocket and angle your hand in a specific way. If any of these actions fail, you won’t be able to get to work. Even seemingly straightforward tasks, such as using a new product, entail a complex hierarchy of actions. Each step can introduce challenges due to various reasons. By carefully analyzing the cognitive, perceptual, and physical actions necessary for each step, we can create a task analysis.
Additionally, considering the risks associated with potential problems or potential use errors at each sub-step allows us to predict where critical issues may arise. This breakdown can also help us verify that problems are designed out of a product and that the associated risks are mitigated as low as possible. The use-related risk analysis maps the identified use-related hazards associated with product use to the risk control mitigations and assists in the determination of which mitigations need validation to support safety and efficacy. A task analysis is critical for optimizing the usability of medical devices, and a use-related risk analysis supports the entire human factors process from development through post-market surveillance.
Comparative Analysis
Core can support comparative analyses of combination products to help sponsors determine whether human factors validation study results need to be submitted for FDA review as part of the marketing application or whether they only need to be maintained in the usability engineering file as part of design controls.
Core also offers regulatory support to companies developing generic ANDAs, aiming to make them comparable to existing Reference Listed Drugs (RLDs) already on the market. In some cases, conducting human factors studies for the ANDA device may not be necessary, as previous research in human factors can be leveraged to demonstrate comparability between the devices. To assess this comparability, the FDA requests a comparative analysis of the RLD and the ANDA.
During the early phases of product design, our human factors consulting team can perform a risk-based analysis of the drug-device interfaces for both the ANDA and the RLD. This analysis helps inform the design process, helping to ensure that the ANDA user interface aligns with the RLD and can be considered substitutable. Alternatively, we can conduct the comparative analysis after the device has been fully designed, presenting the findings to FDA for review.
FDA GUIDANCE DOCUMENT - Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA: Draft Guidance for Industry - JANUARY 2017
Expert Human Factors Consulting
Our human factors consultants have experience with products and systems ranging from wearable user interfaces to print-based instructions for use (IFU) and software as a medical device (SaMD). When it comes to user interactions with products and systems, we understand that no one has seen it all, but our extensive experience allows us to offer valuable insights. Our expert review process draws on what has worked and what has not, enabling us to guide a product’s development into the future. Whether clients are designing medical devices, combination products, or any other product, we’re here to help ensure that users are safe and have a great experience, all while meeting regulatory requirements and usability standards.
Understanding the expectations of Authorities Having Jurisdiction, commonly known as regulatory agencies, is crucial for a human factors and usability engineering program. Designing a human factors validation study that meets these expectations is essential. Compliance with the FDA human factors guidance and international usability standards, including IEC 62366-1 and HE75, is not just a requirement but a pathway to success. Our medical human factors consulting team has extensive experience guiding both large and small companies through the regulatory process for medical devices and combination products in the U.S. and E.U. markets. Our rich history of working on hundreds of products allows us to offer strategic advice based on the latest international standards for medical devices (including apps), pharmaceuticals, and combination products. Guidelines and standards are important to follow, but our stock in trade is staying on the leading edge of current regulatory and industry practices by being authors on the standards, helping clients read between the guidelines, and executing a successful strategy.
User Analysis and Use Specification Development
User analysis and usability testing work together to provide insights into how a product will perform in the real world. User analysis involves considering use cases to understand how a user may interact with a product and their goals when doing so. The Use Specification adds understanding of the use environments in which the product will be used (e.g., dark, wet, noisy). It also examines the intended users—whether they are experts, novices, or different age groups. User Analysis and Use Specification creation are critical to the appropriate application of human factors in healthcare.
The Use Specification ensures participants represent intended users based on the user attributes that may impact the use of the product. The product is then tested in a study environment that closely simulates the intended use environment, as described in the Use Specification. By conducting the User analysis and developing the Use Specification, we can answer a crucial question: How do representative users actually interact with the product in a simulated-use environment?
Competitive Evaluation
When clients want to know how their system stacks up against the competition, we can offer an objective perspective by directly comparing the usability and desirability of different systems. These head-to-head results can help streamline development by identifying irrelevant features to downscale or pinpoint key areas for improvement. With this information, clients can confidently proceed to create and market a more appealing product.
Cognitive Walk-Through
It is helpful to thoroughly understand the experience of using a product for the very first time. Will users be able to perform a task as intended? Are there any likely stumbling blocks? We can help answer these questions using a cognitive walkthrough. A cognitive walkthrough is a reliable medical device usability method for determining a user’s potential actions and thoughts when using the product. It details the specific sequence of action steps a user should perform to complete the tasks, uncovers the difficulties a user may encounter, and reveals the feedback provided by the system. Before investing a considerable amount of time and money in developing a functioning product, a cognitive walkthrough can be performed early in the design process method using initial mock-ups. Walkthroughs can also be repeated as the product development continues.
Expert Heuristic Analysis
Decades of expertise supporting product development have led to the creation of usability heuristics, which serve as guiding principles for designing user-friendly products. Our team of experts excels at identifying the most relevant set of heuristics for a given product and then applying them to evaluate and improve the design of a product. This is a fast, inexpensive way to determine major design issues before performing costly studies. We use a mix of standard and proprietary techniques to produce this precision snapshot summarizing issues likely to result in critical use errors or significant usability problems.
Contextual Inquiry
When it comes to understanding how people interact with devices in their everyday lives—whether at work, home, or in public spaces—contextual inquiries play a crucial role. This field research method involves observing users in their actual use environment as they interact with a system, asking them about their experiences, and collecting real-time feedback. By doing so, we gain valuable insights into how the system operates within its environment and how users actually engage with it. Our decades of experience in the medical human factors consulting field have exposed us to numerous and diverse user groups and use environments.
Observational Research
Formative Usability Testing
Optimizing medical device usability is best achieved through empirical testing during the early stages of development. Proactive and continuous quality enhancement necessitates iterative formative testing, where small numbers of intended actual users interact with the product features and user interface elements available. Such iterative medical device usability testing not only refines the product but also preempts potential issues. Discovering a significant usability flaw post-launch can lead to costly recalls, making it the least favorable scenario. The second least favorable is identifying issues pre-market but after the development phase, where even minor modifications can incur substantial re-engineering expenses.
Early user engagement with product prototypes facilitates easier and more appropriate adjustments based on real usage patterns. There's no replacement for empirical evidence in design; real users invariably reveal unexpected insights. Early awareness is crucial, and a formative medical device usability study can be initiated simply, sometimes with just a sketch on paper. We offer specialized assistance in designing effective formative studies that align with a project’s needs. Moreover, we provide guidance on implementing design modifications informed by the outcomes of these studies.
Human Factors Validation/Summative Testing
Comprehensive human factors validation testing or summative testing transcends mere validation of user needs; it's the culmination of diligent efforts, evaluating the safety and efficacy of medical devices or combination products. The human factors experts at Core conduct human factors validation testing to satisfy the FDA requirement to demonstrate that a device can be used by the intended users without serious use errors or problems, for the intended uses, and under the expected use conditions. It involves representative users performing tasks with either a production model or a functional equivalent and provides supporting evidence of whether the product is market ready.
Summative medical device testing is the definitive phase where all elements are examined for safe and effective use and can support design controls. Ideally, this stage should present no surprises, indicating a thorough understanding of the product. A human factors validation study instills confidence that the product is not only usable but also safe by providing evidence of mitigations successfully minimizing risks. For guidance on how to prepare for Summative Testing, refer to our Formative Usability Testing services.
Labeling Comprehension Studies
Ensuring that a product's instructions for use (IFU) are comprehensible to the end-users is crucial. Considering that half of the U.S. population reads at or below an eighth-grade level, crafting understandable instructions goes beyond using short sentences and simple words. Whether it's a regulatory requirement or a proactive measure to gauge user interpretation, Core is equipped to design and conduct empirical tests with representative users. These tests will ascertain the clarity of each critical step in a product or device’s instructions, revealing the users' actual understanding and takeaway.
Gap Analysis
The experts at Core Human Factors can evaluate a product’s current design and documentation, and identify any missing components needed to meet FDA and International medical device usability standards. Our human factors consulting team can generate a complete road map to provide all human factors requirements needed for a successful submission.
Self-Selection Studies
A meticulously conducted self-selection study provides insights into how individuals determine the suitability of a product based on the information provided. It delves into the initial decision-making process: what drives people to consider a product? If product labeling includes warnings, are they clear and effective enough to deter unsuitable users? This issue is far from minor, as for over-the-counter products there is no one standing next to the potential user in the retail pharmacy aisle helping them make this choice. These studies serve a dual purpose: they safeguard against unintentional misuse by unsuitable users that can lead to medical errors, and they gauge marketability by assessing the proportion of potential users who opt to use the product.
International Usability Research
The Core medical human factors team has experts and usability labs located just outside of Philadelphia, Pennsylvania; Los Angeles, California; and Houston, Texas. We also have consultants based in Scotland and Israel. Our network extends around the world, and we conduct studies everywhere. This enables us to support research in a variety of languages and cultures.
Prototype Testing and Down-selection
Our human factors consulting team can customize testing to evaluate the relative performance and/or preference of alternative designs our clients are considering. Like formative usability testing, often valuable to pair with iterative formative usability studies, prototype testing provides invaluable insights and guidance in the early stages of development.
Post-Market Evaluation
Gathering intelligence on how a product is performing in the field provides insights to guide future development. We can customize methodologies for each client depending on specific objectives (e.g., to address known pain points, conduct general assessments of user groups, gather subjective insights, compare international to domestic markets, etc.). It is important to not just gather use issues, but to understand the root causes of those issues.
Ethnographic Research
We can test completed products or advanced product prototypes in the field where users would use, or are currently using, a product. Both end users and/or healthcare providers can be involved in the research.
Marketing Research and HF Testing Integrated
We can perform early market studies or post-launch evaluations. We also offer unique combinations of marketing-oriented research with usability studies or human factors heuristic or performance studies. A blend of our techniques can provide important cross-functional insights.
Research Specialization with Spanish-Speaking Populations
If clients need usability research conducted in Spanish with Spanish-speaking user populations or in Spanish-speaking countries, our team includes several highly trained researchers that are native Spanish speakers and bilingual in both Spanish and English. We also have experience providing live, real-time Spanish-to-English interpretation for English-speaking stakeholders. Whether research is to be conducted stateside or outside of the United States, we are the team clients can trust.
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