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Case Study
Situation
A client required a partner to not only design and develop an improved mechanical venous thromboembolism device that leveraged existing system accessories but also to establish and execute manufacturing for a successful commercial launch.
Successes
- Integrated project teams prioritized design for manufacturability and supply chain optimization, supporting development and controlled builds which were key to achieving 510(k) submission within 1 year from project kickoff.
- Leveraging this optimized design and strong supplier relationships, Veranex then utilized its internal manufacturing capabilities, including its Class 8 cleanroom, to successfully produce over 1000 commercial units to meet critical product launch needs.
- This rapid and efficient transition from prioritized design and regulatory submission support to full-scale manufacturing, ensured the client's quality device was ready for a successful commercial launch.
Services by Veranex
- Early discovery
- Product design ideation
- Rapid prototyping and testing
- Human factors and usability testing
- Product design refinement
- Manufacturing
- Regulatory
Pre-Mature Infant Humidification Device
Situation
The client needed Veranex to support pilot and initial commercial manufacturing of a pre-mature infant humidification device while they established a new manufacturing facility for long term production.
Successes
- 80 pilot units produced and distributed domestic and internationally
- Managed supply chain and commercial manufacturing for 1000+ units annually
- 4 years of interim commercial production support to a successful manufacturing transfer with seamless output.
Services by Veranex
- Manufacturing solutions
- Product Development
- Design Quality & Quality Assurance
- Supply Chain Management
- Project Management
Benchtop Immunofluorescence
Situation
A start-up needed their benchtop immunofluorescence device to be first to market to gain market share.
Successes
- Veranex composed a strategy to meet demanding timeline goals by enacting a short validation phase to move to manufacturing launch sooner, allowing the start-up to realize over $50M in revenue and over $20M
- Purpose built manufactured devices that are fully traceable with ISO13485 controls were released to market for 4 years.
- Veranex has supported over 75 changes that have been implemented in 14 releases from continuous DFM on manufactured product by responding to field issues via rolling up and releasing design changes.
Services by Veranex
- Manufacturing
- Design Quality & Quality Assurance
- Supply Chain Management and Procurement
- Design and Engineering
Engineering and Development
Manufacturing success starts long before production. See how our integrated Product Development expertise builds manufacturability into your device from concept, saving you time and cost down the line.
Preclinical Services
Need controlled builds to support your preclinical studies? Our manufacturing capabilities seamlessly integrate with our Preclinical Services to provide the precise units and documentation required to accelerate your research.
Testing and Prototyping
Rapid iteration is key in early development. Our Labs and Prototyping capabilities work hand-in-hand with manufacturing to provide quick, high-quality prototypes and testing, accelerating your design validation before scaling production.
Clinical Investigations
Your clinical trials require reliable, compliant units. Partnering our manufacturing team with Clinical Services ensures you receive the controlled builds and streamlined support necessary to keep your clinical investigations on track.
