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Formative Methodologies
Formative Methodologies
- Conduct early-stage concept evaluations with prototypes and wireframes.
- Perform simulated-use formative usability studies with representative users.
- Execute heuristic analyses, expert reviews, and cognitive walkthroughs.
- Evaluate instructions for use (IFU), quick reference guides (QRGs), and labeling.
- Facilitate comparative use studies for design iteration and benchmarking.
- Provide rapid feedback loops for agile design refinement.
End-to-end Validation Testing Support
End-to-end Validation Testing Support
- Develop comprehensive validation test protocols.
- Recruit and manage participants representing all intended user groups globally.
- Moderate realistic simulated-use testing in appropriate environments.
- Perform thorough data collection, analysis, and interpretation.
- Prepare detailed Human Factors Validation Reports for submission.
- Ensure studies meet FDA, EU MDR, and other relevant regulatory body expectations.
Early Design Evaluation of Female Catheter
Situation
A client needed informed design inputs for the next generation of an external female catheter device for critical care and home users.
Successes
- Interviewed RNs nationwide, with extensive experience to understand points of pain in workflow.
- Invited 6 RNs to simulate placement of the device on a gynecological training assistant that represented the BMI of interest with 4 different prototypes to assess fit and function.
- Concept Evaluation - Evaluated the fit, placement, security and removal, of two novel external female catheter in-hospital designs on 8 “patient” participants that represented the BMI of interest.
- In-Home Longitudinal Study - Iteratively evaluated the fit, placement, security and removal, of multiple novel external female catheter in-home designs on 10 “patient” participants.
Services by Veranex
- Human Factors
- Research & Strategy
- Design and Engineering
3-Phase Formative for an At Home Wearable Device
Situation
The Veranex’s human factors team supported a project to re-imagine a left ventricular assist device (LVAD) for late-stage heart failure patients.
Successes
- The project team executed field research with LVAD patients, co-creation sessions for design concepts, and refined user needs for a wearable innovative LVAD design.
- Human factors team executed a formative study with the refined wearable design in 3 sessions:
- Initial interview for education of participant, overview of research and explanation of home tasks.
- At home exploration of participant with at home tasks over 48 hours with written feedback and video diaries.
- Closing interview 48 hours after initial interview around device size, fit, ranking the tasks and UI interactions on the simulated display.
Services by Veranex
- Research & Strategy
- Human - Centered Design
- Human Factors
Refinement of user needs for drug delivery device
Situation
A pharmaceutical client needed Veranex to conduct research for a drug delivery device platform to identify business needs, improve patient engagement, assess value, and ensure safety and usability without adding burden.
Successes
- Conducted multiple interviews with 11 healthcare professionals, 31 patients, and 10 business stakeholders across the US and Europe to gather insights on existing platforms.
- Identified key pain points and validated features for a connected autoinjectors through workshops and visual stimuli, fostering internal support for development.
- Demonstrated strong evidence of unmet user needs, leading to funded design and development, followed by three usability studies to optimize UI/UX and reduce risks.
Services by Veranex
- Research & strategy
- Human Factors
- UX /UI
Research and Strategy
Our teams specializes in uncovering crucial user needs & defining market opportunities early in the development lifecycle. With a robust strategic plan informed by real-world insights, your product is ensured to be purpose-built and address unmet needs.
Product Design
Our project design teams are constructed for your success. Our Industrial Design and Engineering teams collaborate directly with Human Factors experts, ensuring that ease of use and safety are prioritized from the earliest design inputs.
Regulatory Services
Ensure successful regulatory submission by integrating Human Factors and Regulatory expertise early in your strategic planning. Our collaborative teams work in lockstep to efficiently meet all necessary requirements, preparing a robust submission designed for confident approval.
Engineering and Development
Our specialized engineering services, integrated with rigorous quality assurance, are designed to finalize every design detail. Through iterative prototyping and comprehensive usability testing, we ensure that user needs are fully met, and that ease of use and safety are paramount in the final design.
