In accordance with FDA Design Control Guidance, MIS has formalized a phase-based approach for our customers to successfully design, develop, and manufacture a robust and reliable medical device. Whether you are starting with a brand-new concept that requires feasibility prototypes or have a fully developed product and need a reliable manufacturing partner, MIS is positioned to accommodate our customers’ needs wherever they may be in the product development process. Our Development Process consists of five phases with detailed design controls and deliverables in each phase. Each of the deliverables in each Phase can either be completed by MIS with customer approval or executed by the customer, allowing for a very flexible and responsive partnership on each project. Execution of this phase based approach ensures a complete design history file that meets applicable regulations, while ensuring flexibility to meet specific customer requirements and timelines.
The first phase of the design control process is Concept Development and Optimization. The purpose of this phase is to develop and evaluate initial designs, design inputs, project requirements, project budget and timeline, and any additional customer requirements. MIS will partner with the customer to develop a set of design inputs and initial functional requirements. If the customer already has these, MIS will aid in a review of the design inputs – user needs and intended uses – to develop the Product Specification or Customer Input Documents. The completion of this Phase is summarized as Concept Freeze.
Following the Concept Phase is the Feasibility Phase (Phase 2). The purpose of this phase is to continue to develop the product design, the associated manufacturing processes, and the required test methods. These actions and deliverables drive to establish target design requirements and ensure the design will meet the product specification requirements. MIS approaches this design and development process leveraging Design for Manufacturing (DFM) and vendor selection/ management to ensure the long-term customer needs and volumes will be met. Completion of this phase is summarized as Design Freeze following Pre-DV testing and Phase Reviews.
After completion of Phase 2, the project will move into the Design Verification (DV) Phase (Phase 3A). The purpose of this phase is to conduct design verification and validation testing to demonstrate that the design outputs meet the design inputs. Design outputs that are essential for the proper functioning and safety of the device are identified through review of the project risk documentation. MIS can handle all the protocols, builds, and testing management for Verification Testing, leveraging in house validated test methods to reduce costs for our customer. It is common for the customer to complete the Design Validation testing based on their preferred KOL relationships but MIS can support builds needed for this testing and reporting. Upon completion of DV activities, MIS will deliver a complete technical file and DHF that will support the customer’s regulatory submission. As an additional option, there is a second component to Phase 3 which is Phase 3B. This Phase serves as a good plateau point depending on specific customer and project needs. If First-In-Human (FIH) trials are required, all of the previous work can be leveraged to support these studies. This Phase is intended to deliver the minimum viable product for all phases of clinical trials. MIS is set up to support the appropriate lot release testing for product verification and ongoing human use builds to support trials for as long as needed.
The final phases of the Development Process are Process Validation and Commercialization. The purpose of Process Validation is to establish a manufacturing process that consistently meets all product requirements without ongoing verification testing. MIS works with our customers to develop and execute an Operational Qualification and Process Qualification plan to minimize or eliminate ongoing product verification testing based on each customer's needs. In parallel to Process Validation, MIS will initiate the Commercialization process through an initial pilot line ramp. Additional activities within this phase include elements such as additional onboarding and ramping of line resources, training, implementation of process specifications and process controls/ monitoring, and closure of design review action items. Upon successful completion of Commercialization, the product enters the Post-Market Surveillance process and MIS continues support of the production line with planned ramp strategies, aggressive OEE targets, and a robust VIP program to achieve short-and long-term cost targets.