Formative & Summative Testing
Evaluating Usability, Reducing Risk, and Supporting FDA Submission
Formative and summative testing are key stages in Human Factors Engineering (HFE). We develop the proper testing so that your device is supported by sound data for regulatory submission.
Why It Matters
Medical devices must undergo usability testing that validates they can be used safely and effectively. Formative testing identifies any usability issues early, while summative testing is all inclusive testing that ensures all issues and requirements are addressed.
The FDA requires detailed human factors data to accompany medical device submissions. If formative and summative studies are not done properly, regulatory approval can become much longer and more time-consuming. These delays will significantly increase time and cost, and may result in non-approval. These studies must demonstrate that potential user errors have been identified and resolved through design improvements prior to submission.
Besides compliance with regulatory requirements, this testing protects your investment and identifies design flaws before any significant work and production commitments are made. Early detection of usability issues saves you money and verifies that your device will operate reliably in real-world clinical situations.
Our Approach
We design and run organized usability testing that simulates real-life, real-world clinical use scenarios and adheres to all FDA guidelines. Our services include every aspect of the process from testing protocol design and participant recruitment to logistics, facility coordination, and facilitation.
Compliance and testing from the design phase
Our testing methods follow IEC 62366-1 and FDA Human Factors guidance documents for regulatory compliance. We work closely with you and your team to ensure human factors concerns are considered from the start of the project. This early thinking minimizes the chances of last-minute design modification requirements that can often result in a delayed arrival to commercialization.
Clinical simulations and tests
Our team will conduct clinical simulations and tests with real healthcare practitioners including nurses, physicians and techs depending on the devices intended use. We look for usability mistakes and unintentional interaction errors that can cause mistakes in real world, high pressure clinical scenarios.
Risk management
Risk management is also something that we consider from the start of your project. We conduct thorough user-related risk analyses that assess potential threats along with their severity and likelihood. We then design mitigation plans to avoid those situations throughout the development process. Safety is our top priority and always addressed proactively working with our team of experts.
The Formative Assessment Includes:
Early-Stage Usability Testing - Research conducted early on in development to find and correct usability issues before these turn into costs.
Rapid Iterative Feedback Cycles - Fast turnaround testing that supports a quick development timeline.
Concept Evaluation and Risk Identification - Assessment-based tests for design concepts help find any potential use errors and safety concerns.
Design Refinement Recommendations - Performance recommendations to help improve design refinement and optimize features.
The Summative Assessment Includes:
Final-Stage Validation of User Interface - Extensive final design testing program with assessments for usability and safety requirements and weaknesses.
FDA-Compliant Study Protocol Development - Check study protocols that comply with submission regulation requirements.
Simulated Use Testing with Representative Users - Realistic test settings with actual healthcare professionals who represent your intended target user group.
Data Collection, Analysis, and Interpretation - Statistical analysis and clinical interpretation of results to support regulatory claims.
Compilation of Summative Evaluation Reports - Completed documentation packages ready for regulatory submission.
Our experience and testing protocols help us test complicated medical interfaces, such as single-use disposable products, as well as complex equipment with numerous user touch points. We have expertise and experience with all types of Class I, II and III medical devices.
For summative validation, we run testing on sample sizes that exceed FDA requirements, which are based upon your device class. Our test protocols include worst-case scenario testing, stress testing under time-stressed conditions, as well as use by less experienced healthcare professionals who might use your device in the clinical environment.
Regulatory Integration
Our testing is easily integrated into your overall regulatory strategy. Our regulatory team verifies our human factors data is designed for your chosen regulatory path, whether 510(k) clearance, De Novo classification, or PMA approval.
We have streamlined and solid documentation practices that meet FDA inspection standards and improve your Design History File (DHF). Our reports are written with extensive protocols, raw data, statistical analyses, and clinical interpretations that regulatory reviewers anticipate in a final submission.
Quality and Compliance
Our ISO 13485 certification guides every decision we make. Our team stays on top of the ever changing regulatory requirements ensuring you are always one step ahead. Our team ensures our testing methods are current and are aligned with the latest FDA expectations and global efforts.
What You Get
When we finish testing, we provide you with clean, documented usability results, tracking, and feedback that will support your Human Factor findings and prove that your product is safe and effective to use. You will receive regulatory-ready documentation to submit to the FDA.
Our deliverables will include risk management documentation, which describes use-related risks and how identified hazards were addressed, as well as statistical modeling that confirms your device falls within acceptable risk parameters and functions as well as or better than predicate devices.
Along with the formal reports, you also have access to our expert team to guide you through human factors throughout the development process. We provide regular guidance on design decisions, regulatory strategy, and risk management plans that build on the required testing protocols.
The final product is a medical device backed by solid human factors data that guarantees regulatory clearance, reduces the risk of liability, extra costs associated with potential user errors, and functions reliably in the hands of healthcare professionals. Formative and summative testing is an investment that pays dividends in expedited regulatory clearance, fewer post-market issues, and better market acceptance.
Contact HaA Product Development and let us help you bring your vision to life!