2022.07.06.
In healthcare, insufficient attention to detail can mean the difference between life and death.
Having robust processes in place ensure no such details are missed, and our overall process is carved into 5 distinct phases in alignment with industry standards.
Phase 0. Concept Feasibility
• At this stage, we need to understand the customer’s product/project idea.
• As part of this, we must define clinical needs as well as understand the target market and intended users to also capture their needs.
• Once initial requirements are set, the design discovery phase starts, focusing on concept generation, prototype manufacturing, simulations and benchtop testing.
• The design discovery phase typically contains one or more concept iterations depending on the complexity of the idea.
• Typical deliverables at the end of this phase include a feasible product design, design specification and requirements specifications.
Phase 1. Design Development Planning
• In this phase, we refine the design based on test results and create project guidance documentation.
• The deliverables in this phase are the development plan and product and project documentations.
• Based on the phase review report, the project progresses to its developmental stages.
Phase 2. Development and Design Verification
• This phase focuses on ensuring that the final medical device design and development meets all the regulatory requirements outlined in ISO 13485 and FDA medical device design control regulations.
• It includes usability, manufacturability, testability analyses and selection of manufacturing methods and processes.
• To certify the product meets design, quality and regulatory requirements, several tests are completed.
• This phase ends with a frozen product design ready for validation.
Phase 3 – Design Validation and Transfer
• This phase focuses on transferring the product into manufacturing.
• It includes initial setup of supply chain, completion of planned validations and potentially clinical trials.
• The regulatory application documentation package is submitted to respective authorities, requesting their approval for the commercial release of the product.
• At the end of this phase, product development is completed.
Phase 4 & 5. Market launch and Post-Market Surveillance
• This phase prepares the product for market launch.
• The supply chain is scaled up for serial production and proper mechanisms are established to react to customer feedback as well as design changes incorporating new features.
• At the end of this phase, once regulatory approvals are received, the product is released to the clinical community.