Manufacturing Support
Situation
Inflammatix required a partner to industrialize their proof-of-concept system into a commercially viable diagnostic instrument, which included the design, development, and validation of manufacturing processes to support the production of units for a clinical study.
Successes
- The team successfully designed, developed, and validated the use of manufacturing fixtures that supported controlled in-process testing.
- Over 20 fully traceable instruments were built to support the needs of the projects clinical study that was critical for a successful regulatory submission.
- The manufacturing process, fixtures, and work instructions were strategically designed to support a seamless manufacturing transfer to a full production facility with minimal inefficiencies.
Services by Veranex
- Engineering and Development
- Prototyping and Shop
- Manufacturing Engineering
- Design Assurance Engineers
- Manufacturing Quality Engineers
- Testing Services
- Regulatory Consulting
Concept to Successful Launch
Situation
Improve ease of use by designing and developing a mechanical veinous thromboembolism device that leverages existing system accessories.
Successes
- 84% reduction in use errors from on-device and product labeling was demonstrated via a usability formative study with healthcare professionals.
- The Veranex team supported the handle, packaging, and labeling design and development along with sourcing the system accessories to combine into a final kit.
- Strategically optimized and compiling robust DHF for expedited 510(k) submission to be within 1 year from project kickoff.
Services by Veranex
- Early discovery
- Product design ideation
- Rapid prototyping and testing
- Human factors and usability testing
- Product design refinement
- Manufacturing
Accelerat Development with Iterative Prototype and Testing
Situation
A client's clinically effective and physician-preferred device was unprofitable due to high material costs and a tedious assembly process, necessitating a complete redesign for commercial viability.
Successes
- After defining critical parameters for clinical success and ease of use with the client and partner physicians, the team refined the concept for the redesigned device.
- The product design and prototype teams worked in close collaboration, rapidly iterating device variations with different silicone durometers and dimensions to gain stakeholder feedback based on tangible feel and maneuverability.
- In parallel with device refinement, the team developed and validated a physiologically accurate anatomical model, which was used to assess prototypes and conduct formal usability assessments.
Services by Veranex
- Research and Strategy
- Regulatory Consulting
- Design Engineering
- Testing and Prototyping
Quality Services
Our quality experts ensure you perform the most critical testing by starting with a robust risk assessment. We then confirm your test methods are rigorously validated in accordance with regulatory standards, creating a clear and defensible path to submission approval.
Preclinical Services
Leverage our preclinical facilities and anatomical expertise to guide your test method development and refine your device design. Testing in a simulated clinical setting provides authentic, data-driven feedback, ensuring your device is optimized for real-world performance long before pivotal studies.
Engineering and Development
Our integrated engineering and development teams are central to your project’s success. We combine decades of experience with creative, solution-oriented strategies to solve complex challenges, ensuring your project navigates technical hurdles efficiently and reaches submission readiness faster.
Human Factors
From early usability models for formative studies to fully functional prototypes for validation, our teams provide the critical tools needed to guide user-centric design. We ensure your device is not only effective but also intuitive and safe for patients and clinicians.
