Device Development
A VALUE ADDED SERVICE
You have an idea. It doesn’t matter if it is in your head, on the back of a napkin, or a fully flushed out design – Picocyl can partner with you to turn that idea into a game-changing device to resolve real world problems. Our deep bench of designers, engineers, scientists, manufacturing, quality and regulatory experts can provide the expertise to fulfill your vision of improving the lives of the patients that you serve.
Ideation and concept exploration
In this part of a program, creativity, a deep understanding of the technologies and the business needs are woven together to shape the vision of the end product. This is the fast and iterative phase of the program that yields multiple concept ideas, prototypes, tests that are validated with users to provide the best concepts and the preliminary technical requirements.
- Ideation
- Multiple concept creation
- Prototype creation
- User feedback
- Preliminary requirements definition
Concept development & Proof of Concept
In this phase, we perform a detailed technical dive to fully understand the feasibility from both an analytical modeling/simulation and experimental perspective, with working prototypes to demonstrate that the performance meets the desired objectives. Rapid iterations of simulation, prototyping and experimentation refine the original ideas into viable Proof of Concept devices that fully demonstrate the performance and feasibility with robust working models to conduct statistical analysis of performance.
- Detailed concept refinements
- Analytical modeling and simulation
- Fully functional low-volume prototype designs
- Experimentation and results
- Technical feasibility evaluations
- Manufacturability assessments
- Risk assessment
- Detailed requirements definition
Product Development
In this phase, we design, build, verify and validate devices under ISO 13485:2016 design control to yield robust, finished, packaged medical devices with comprehensive Design History Files and Technical Files suitable for regulatory submission.
- Full risk management per ISO 14971 and ISO/TR 24971
- Product detailed design
- Tolerance Analysis
- Device Verification and Validation
- Accelerated Aging and real time testing
- Biocompatibility and Cytotoxicity testing
- Packaging/labeling development and verification
- Sterilization validations
- Detailed Design for Manufacturing/Design for Assembly assessments
- Summative Human factors studies
- Design History File and Technical Files suitable for regulatory submission
Manufacturing Development
In this phase, we transfer the designs to full scale production.
- Supply chain
- Injection molding process/tooling development
- Assembly process/tooling development
- Automation process/tooling development
- Inspection process/tooling development
- Process validation and qualification