Efficiency
Advance from concept to final design with confidence with robust concept execution for medical devices. Rapid prototyping services enable an efficient and cost-effective assessment of the most promising designs.
Customized Testing
Battelle researchers are experienced in innovating unique testing methodologies that are customized to yield a wide-range of actionable data. Our team designs, executes, and provides comprehensive reports to inform safe and effective design decisions that align with your business and meet regulatory requirements.
![customized-testing-1 alt = an hcd team member working on a model of a medical device](/images/default-source/human-centric-design/customized-testing-1.jpg?sfvrsn=b7b442db_0)
![customized-testing-2 alt = hcd team member brianne bragg](/images/default-source/human-centric-design/customized-testing-2.jpg?sfvrsn=197e02a0_0)
![formative-evaluation-1 alt = an hcd team member working on a medical device prototype](/images/default-source/human-centric-design/formative-evaluation-1.jpg?sfvrsn=a8488810_0)
![formative-evaluation-2 alt = a close up shot of an hcd team member holding a medical device](/images/default-source/human-centric-design/formative-evaluation-2.jpg?sfvrsn=b6519d08_0)
Formative Evaluation
Battelle’s formative evaluations are conducted throughout the medical device product development process ranging from assessments of early development to proof-of-concept and near commercial equivalent products and systems.
Battelle’s state-of-the-art formative evaluations are used to:
- Verify Use Specifications
- Gain User Feedback & Performance Requirements
- Identify Areas for Opportunity
- Inform Design Inputs
- Inform Down-Selection of Ideations
- Identify and Evaluate Potential Risk Mitigations
Heuristic Evaluations
Heuristic evaluations are usability reviews of existing or potential concept products/system in which a group of subject matter experts examine the user interface against recognized usability principles (heuristics) and medical device industry guidance.
![heuristic-evaluations-1 alt = close-up of a hcd team member testing a medical device](/images/default-source/human-centric-design/heuristic-evaluations-1.jpg?sfvrsn=46833b8_0)
![heuristic-evalutions-2 alt = 2d design of a medical device](/images/default-source/human-centric-design/heuristic-evalutions-2.jpg?sfvrsn=9dc9bf4a_1)
Testing and Evaluation Services
Comprehensive, thorough, successful. Battelle has a proven track record of helping clients prepare their human factors documentation for regulatory submission.
Contextual Inquiry
- Ergonomic measurement and engineering testing
- Focus group facilitation
- Expert reviews
- Co-creation
- Heuristic evaluation
Usability Testing
- Formative testing
- Summative testing
- Simulated environment testing
- Software usability testing
- Label comprehension testing
- Comparative use human factors studies
Support Services
- Risk management
- Specific population recruiting
- Domestic and international studies
- Internal Institutional Review Board (IRB) review
- Work conducted under ISO 13485 certified Quality Systems
![hcd-glass-background-dark alt= close up of a blue, black and white stain window](/images/default-source/human-centric-design/hcd-glass-background-dark.jpg?sfvrsn=62dbc73c_0)