Medical Device User Feedback & Testing

Real-World Validation to Improve Safety, Usability, and Adoption

User feedback is important because it verifies key requirements and needs in a medical device. When we apply feedback to our designs, we create devices that are effective and work flawlessly in the clinical environment. Real-world user testing provides the necessary information to validate your design, improves the performance, and ensures that it meets both user expectations and FDA requirements.

Conducting intensive, early testing with clinicians, technicians, and patients gives critical feedback and insight into how your product performs and reacts in a real world setting. Our simulated use testing, usability studies, and iterative feedback loops reveals areas of confusion, potential hazards that create injury, and workflow disruptions. User feedback and testing helps our team identify issues before they turn into regulatory delays and increased costs.

Our team of professionals translates the gathered information from user feedback and insights into clear recommendations. This feedback makes devices safer, more reliable and easier to use. We gather feedback at key points throughout the device development process to improve performance and mitigate risk.

In addition, we use strict testing protocols that meet FDA Human Factors Engineering (HFE) requirements. Conducting these studies is necessary for regulatory submissions and ensures you're ready to go-to-market. Our device usability studies ensure we develop intuitive devices that users can use in real-world environments. Feedback gives us insights into how a medical device fits into existing clinical workflows and how it will be utilized by physicians, nurses and technicians, whom are critical to drive adoption.

Why It Matters

Problems need to be spotted early

Testing devices with real patients can find unknown points of friction that were not identified during the development stage. Conducting this testing reduces the risk of user errors and confirms that the product works and integrates well into clinical practice.

User insights

User insights also help to connect cross-functional teams with real world use. Real world feedback shows you how a device will perform in the clinical setting.

Regulatory compliance

In addition this feedback ensures the patient's safety is at the forefront of design. It ensures you meet regulatory requirements to ensure a smooth pathway to regulatory approval. The result is a device that performs well in high pressure clinical situations.

Our Approach

Feedback is critical through all stages of development

We evaluate medical devices throughout all development stages. We review multiple factors including task analysis and simulated use within the clinical environment.. During these stages, our team also develops required documentation to support your Human Factors Engineering (HFE) file.

Real-world use

Through consistent feedback we discover real-world use patterns, possible failure points, and user needs, starting from the early concept testing to late stage usability testing. We work closely with clinicians and technicians, and other stakeholders to replicate real-world workflows and capture detailed feedback on how the product is used and previously undiscovered points of friction.

Our team identifies multiple use scenarios, risk profiles, and user groups to properly evaluate your product's safety and effectiveness. We employ research psychologists to observe clinical use and better understand how the user feels utilizing the device. This step ensures that we capture any unspoken user feedback.

We also provide all required documentation that includes study protocols, task analyses, usability test plans, and final reports, which meet FDA and IEC 62366-1 standards. Thorough documentation both supports your regulatory submission and strengthens your overall risk management strategy.

Our feedback protocols integrate human factors and experience throughout the design, testing, and lifecycle stages. This means the product we design is compliant, usable and easily integrates into existing workflows.

Our User Feedback & Testing Services Include

Testing helps us to learn how users interact with the medical device. Gathering this feedback and adapting the designs as a result, ensures we deliver a safe, trusted and efficient product that users will want.

Our User Feedback & Testing Services are designed to identify potential usability issues early in the process. These medical device development services are designed around the FDA Human Factors Engineering (HFE) standards.

Our approach tests cognitive load, task performance, and user interaction at each key development stage. Real-world feedback creates products that work as expected in the clinical environment. The feedback we get reduces risk, improves outcomes and streamlines your medical device to prepare for regulatory review.

Our services include the following:

Cognitive Walkthroughs
Task Analysis
Use-Related Risk Analysis
Heuristic Evaluations
Formative Evaluations
Summative Evaluations
Iterative Design Testing
Use Specification
User Interface & Interaction Specification
Use Requirements Documentation
Voice of Customer (VoC) Interviews
User Profiles and User Groups
Clinical Procedure Mapping
Potential Use Error Analysis
KOL (Key Opinion Leader) Interviews and Feedback
HF/UE Reports for FDA Submissions
Compilation of Full HF File
Instructions for Use (IFU) – Creation, Evaluation, and Validation

What You Get

Our deliverables include key findings reports that include insights that would not be known without this type of testing and evaluation. You also receive clearly defined use specifications, detailed user profiles, task and risk analyses results, and usability testing results that give you information to guide your design and engineering decisions.

Every decision is made with both user needs and regulatory requirements in mind. The result is a final medical device that is safe and user friendly that meets FDA and IEC 62366-1 requirements.

We provide the Human Factors Engineering (HFE) documentation that is needed for FDA submission, including formative and summative testing and plans, protocols and data summaries. This documentation aids in regulatory approval and assures investors that the product is market ready. The information gathered also drives marketing strategy for commercial launch.

Data gathered in the development processes ensures your device wins at all levels, clinically, commercially, and with regulatory reviewers.

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