How We Work
In conjunction with the ATEX product life cycle, we manage each project using a collaborative, program management approach. Each product, no matter how big or small, is assigned a cross functional team consisting of business development, product development, and engineers focusing on development, quality and manufacturing. We also add in materials and chemical engineers when needed. This dedicated team will be there to support our customers throughout the development cycle, with availability for scheduled meetings so that we can collaborate together. All of this leads to precise work, fast turn-around time for samples, and on-time delivery - with a focus on eliminating lost time and rework.
We have a demonstrated, long term success rate in providing the highest quality novel implantable component solutions for the medical device industry. We are a proven solutions provider with a wide range of capabilities. We are vertically integrated, with a robust product lifecycle management system, and team of dedicated staff to support you. We have expertise in a wide array of materials with process engineering capabilities, and capacity to do product development on production equipment. We mitigate risk throughout the development cycle, and will exceed your expectations for both quality and delivery.
Phase 0 (Project Kick-Off): We gather information from our customer and, together, we collaborate and initiate the project.
Phase 1: In this phase we generate initial feasibility samples while formalizing design inputs into preliminary product specifications.
In Phase 2, we start to integrate traceability while still allowing some flexibility.
Phase 3 is the start of design freeze. We integrate manufacturing controls, conduct qualification runs, complete validations, and finally a move towards production with completion of our Design History File.
Phase 4 is focused on documentation to ensure that all manufacturing expectations and business agreements are in place for long term production. Once this phase is complete, Product Development steps out and production planning, manufacturing, and customer service takes the reigns.
Phase 5 is production manufacturing.
Phase 6 and 7 are phase out and obsolescence.