Human Factors Regulatory & Strategy (HURAS) Capabilities
The Kymanox HURAS team provides turnkey comprehensive Human Factors (HF) solutions and strategies from product conception through post-market and life cycle management.
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Comprehensive Human Factors Solutions
Kymanox provides comprehensive Human Factors (HF) solutions and strategies to ensure products are safe and effective for the intended users, uses, and use environments.
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Customized Human Factors Strategies
We plan and execute for “Right First Time” submissions, clear regulatory communication & documentation, integration into design controls and your QMS, post-market signal detection, and life cycle management.
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FDA Regulatory Support
Kymanox staff have extensive experience at the FDA, so we can provide guidance and support to conform to current industry practices, standards, and FDA regulations.
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Integrated Approach
Our team leverages the extensive expertise within Kymanox to deliver an integrated approach for your product development strategies and programs including Quality, Regulatory, Engineering, and Validation.
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Kymanox Human Factors Regulatory & Strategy (HURAS) Resources
Meet our Human Factors Regulatory & Strategy Experts
QuynhNhu Nguyen, MS
DIRECTOR, HUMAN FACTORS
Helpful Links
Here are some of our favorite resources on this topic
Markets That Benefit from Our Human Factors Regulatory & Strategy Solutions
Combination Products
Our experts understand the interaction between devices and drug products. Our experience includes injectables, nasal, respiratory, and more.
Biologics & Cell and Gene Therapy Services
We understand why “the product is the process” and how to implement solutions to your unique challenges.
The Kymanox Human Factors Regulatory & Strategy Difference
Our clients tell us traditional integrators simply do not fully understand the complexities of working in a highly regulated environment. The Kymanox team lives in regulatory environments every day so you’ll get practical solutions.
Unmatched Expertise
Our team features former regulatory leadership from the FDA Center for Devices and Radiological Health (CDRH) and Center for Drug Evaluation and Research (CDER) / Division of Medication Error Prevention and Analysis (DMEPA) with over 900 medical reviews and evaluations of medical devices and combination products submissions.
Flexibility & Agility
At Kymanox, we make it easy for clients to get the solutions they need, when they need it. Clients tell us our flexibility is one of the key reasons they keep coming back.
“Right First Time” Execution
Our branded methodology, Ideal Knowledge TransferTM, combines technical project management, fundamental engineering practices, quality and regulatory expertise, and business acumen.
Frequently Asked Human Factors Regulatory & Strategy Questions (FAQs)
What is human factors? What is usability? Why do I care?
Within ANSI/AMI HE 75:2009, human factors is defined as “the application of knowledge about human capabilities (physical, sensory, emotional, and intellectual) and limitations to the design and development of tools, devices, systems, environments, and organizations”
Within ISO/IEC 62366:2007, usability is defined as “Characteristic of the USER INTERFACE that establishes EFFECTIVENESS, EFFICIENCY, ease of USER learning and USER satisfaction.”
Usability has a broader lens than human factors as it includes ease of use and user satisfaction. Regulatory bodies focus on the application of human factors and usability during product development to generate data and evidence to support the conclusion that the product user interface can be used safely and effectively by the intended users, for its intended uses, and use environments. The term user interface refers to all points of interactions between the product and the user and may include the device and its associated elements such as displays, controls, along with the product’s packaging, product labels, instructions for use, etc.
What is the role of human factors in the development of medical devices and combination products?
Human factors is pervasive and plays an integral role in product design, development, total product life cycle management for both medical devices and combination products. Human factors feeds in design verification and validation, supports an optimized user interface in clinical trials, continually manages use-related risks portfolio, answers the question of whether we have designed the product right for the intended users by generating evidenced-based data to demonstrate safe and effective use, and serves as key consideration to post production changes.
What is my chance of passing HF validation?
It depends. Human factors is a process where the preliminary analysis and formative testing would be utilized to uncover use errors and use-related risks, then by the time the user interface is tested in validation, the results should not be surprising. When the HFE process is not carried out during product development, and the only testing done is validation, the possibility of the validation results supporting the safe and effective use of the user interface can be slim.
What is a use-related risk analysis (URRA) and why is a URRA needed for medical devices and combination products?
The URRA is a tool that is helpful for the FDA’s review as part of other human factors information/packages. According to the FDA’s draft guidances titled “Contents of a Complete Submission for Threshold Analyses and Human Factors Submissions to Drug and Biologic Applications”, and “Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development”, a URRA is a comprehensive and systematic evaluation of all the steps involved in using the proposed product (e.g., based on a task analysis), the errors that intended product users might commit or the tasks they might fail to perform, taking into consideration known problems with similar products.
The potential negative clinical consequences of use errors and task failures including the severity of the resulting harm. It also includes user task description and categorization (e.g., critical), the mitigation strategies employed to reduce identified risks or eliminate hazards and the proposed methods used to validate these mitigation strategies. It is also expected that manufacturers include an analysis of known-use problems with similar approved products when applicable.
The URRA is a living document that should be used to inform product development, iterate the product user interface during development in order to eliminate or minimize use errors that could cause harm or compromise medical care. As a result, the URRA is the foundation for FDA’s review of human factors study designs, testing and evaluation for medical devices and combination products.
How does CDER define critical tasks for CDER-led combination products? How is the definition different from CDRH’s definition?
The Center for Drug Evaluation and Research (CDER) defines critical tasks for drug/biologic-led combination products as: “user tasks that, if performed incorrectly or not performed at all, would or could cause harm to the patient or user, where harm is defined to include compromised medical care.”
Center for Devices and Radiological Health (CDRH) defines critical tasks for standalone devices or device-led combination products as: “a user task which, if performed incorrectly or not performed at all, would or could cause serious harm to the patient or user, where harm is defined to include compromised medical care.”
For combination products, we need to take into considerations medication errors when we combine a device with a drug or a device with a biologic in addition to immediate physical harm resulting from use. We need to account for use errors that can result in underdose, missed dose, or overdose, which are categorized as critical tasks, regardless of levels of severity of harm. For example, consider an underdose for an autoinjector that is indicated for patients to self-administer to treat rheumatoid arthritis. Given that rheumatoid arthritis is a chronic condition, one instance of underdose may not lead to physical harm immediately; however, over time patients do not get the therapy they need to treat their condition, which leads to compromised medical care.
My product is a prefilled syringe (PFS) intended to be used by healthcare professionals (HCPs) in a healthcare setting. Do I need to conduct a HF validation study?
Because the proposed product is a combination product, the device constituent should comply with the Quality System regulation, 21 CFR Part 820. In particular, Section 30 Design Controls, includes requirements relevant to human factors as described above. However, from a submission review perspective, it may be possible to engage with the FDA prior to your formal submission to discuss your plans with regards to HF and to ensure alignment on next steps with regards to human factors data needs.
The pre-submission can include your HF plans along with your URRA. In addition, your plan can include an evaluation tool known as comparative analysis. This is a tool that can be used to compare your proposed product to similar marketed products through labeling, task, and physical product examination. The FDA’s draft guidance titled “Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA” provides a detailed outline of the comparative analysis and how to go about putting one together. Note that while the guidance explicitly states this is for ANDA or generic products, this tool can be used generally for new products that have similar marketed products. Lastly, your plan should include a justification to FDA for concurrence that you do not need to submit the results of the HF validation study to support the FDA’s review of your marketing application. It is important to ensure that the FDA aligns with your HF plans in the pre-submission space.
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