Paradyne Medical provides complete product life cycle management from initial product development through production, supply chain management and continuous product improvement.
If you’re looking for a complete packaged medical device or a device component, the experienced product development team at Paradyne Medical has the expertise to design a product that meets your most rigorous requirements. From prototypes to fully validated devices we can deliver.
The seasoned Development team at Paradyne Medical combines over 50 years of medical device design and development experience. Paradyne Medical is equipped with a full array of processing and testing equipment, we can quickly move the development process from design concept, through verification and into manufacturing. All along the way our team keeps in mind the final manufacturability of your product both from a cost stand point and quality. Whether you have your own design or want the assistance of our experienced development team, Paradyne Medical has the resources to support your goals.
We utilizes a phased work method to describe the Design, Process Development, Verification and Validation and Manufacturing Implementation activities associated with a medical device development program.
Each phase of the project has clearly identified activities to be undertaken, objectives to be met and deliverables to be produced. Our design and process development phases often occur concurrently and we deliver the following client benefits:
achieve faster time to market.
optimize process parameters
produce a medical device that meets both design and business objectives
assures compliance with ISO Design Control and FDA QSR requirements
Every project and every client's needs are unique. We customize this overall approach to assure clear communication throughout the development process and to ensure rapid yet accurate movement from concept design through manufacturing implementation.
six phases: design > development > manufacturing
In this first phase, we define the marketing requirements of a product. These may include user and regulatory requirements, the product’s intended use and business or legal requirements. Product concepts are then developed and evaluated against the criteria of meeting the marketing requirements.
proof of concept
The proof of concept phase demonstrates that critical design features of one or more of the selected design concepts perform as intended. Prototypes of critical design features will be fabricated to explore and address design challenges. Where a design concept relies on one or more critical manufacturing processes, these too will be proven. A further outcome of the Proof of Concept phase is to finalize the design requirements drafted in Phase 1.
Product Design and Process Development
In design and process development, we fully develop the design and manufacturing processes identified in the concept phases. Detailed engineering drawings are produced and all applicable analysis tools are applied to the design. Also in this phase, the risk analysis is applied to both the product and the process. At the end of this phase, the design requirements have been translated into a detailed specifications.
Design Verification and Validation
This phase verifies that the product design meets the product specification and validates that it meets the end user’s intended use. Typically, the design verification will include engineering testing of functional prototypes in a lab setting and the design validation will include simulated use or clinical testing to confirm that user requirements are met.
Process Installation and Optimization
This phase establishes a manufacturing process and the equipment capable of consistently producing a product that meets the required specifications. This may include procurement, installation and qualification of requirement and tooling as well as process flow layouts and optimization. All required manufacturing documentation is released by the end of this phase.
Process Validation and Manufacturing Transfer
In this final phase, we finalize the validation of the manufacturing process through completion of the Process Qualification (PQ). Upon release of the product for commercialization, and a demonstrated ability to consistently meet quality and cost standards in manufacturing, the process is fully transferred into an ongoing manufacturing environment.