Orchid Design Process
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Phase 1: Concept and Definition
All successful projects begin with a strong understanding of User Needs and Business Requirements. We want to understand the problems that the product will solve, how users will interface with the product and how the product will fit into the competitive landscape. We assess risks through Hazard Analyses processes to ensure the project is initiated with a solid understanding of potential risks that will need mitigating. We will document all these requirements and use this as a basis for Concept Development. Orchid Design's diverse team of engineers and technicians brings a wealth of experience that spans clinical, design, mechanical, manufacturing, regulatory and beyond. This unique set of skills and perspectives drives creative ideas on how best to solve the problem at hand. Through a series of individual and team brainstorming and hands-on prototyping sessions, we develop novel yet practical design concepts. Hand sketches, 3-D CAD models and rapid prototypes are all used to rapidly develop the very best and simplest solutions. Our teams have immediate and unlimited access to our prototype shop to evaluate and evolve concepts. We know that the best products start with strong concepts; this is when IP is born, and we excel in delivering unique and practical solutions.
Phase 2: Feasibility
Orchid Design's Feasibility phase is focused on evaluating the feasibility of selected concepts and identifying and mitigating technical and business risks. We drive to achieve a “Design Stable” state by fully defining the design inputs, evaluating risks, and identifying and testing critical design features. A stable design can be achieved when all major product and project risks have been considered including manufacturing hurdles and regulatory strategies. Product design is stable if major changes are unlikely, a complete system bill of materials (BOM) exists and a verification test plan is approved. Stable designs should not require further prototyping or evaluation before design verification and validation testing... We have proven time and time again that this critical, yet streamlined process works.
Phase 3: Product Design
At Orchid Design, we understand that the "devil is in the details." The product design phase is where our team of experts brings its experience with more than 800 projects in the past 12 years. We Initiate the Device Master Record (DMR) by fully defining the design outputs through detailed drawings, models, and specifications. Specifications in the DMR need to fully incorporate manufacturing feedback and include inputs to quality plans.
Phase 4: Verification and Validation
In this Phase 4 we confirm that the product meets its specifications, user needs and that risks are mitigated to the lowest possible level. Orchid Design performs design verification testing and analyses to make sure the product meets the defined requirements including functionality, strength, wear and fatigue. Then, we perform design validation testing with users to make sure our product works as intended by using it in a simulated condition such as a cadaver lab. At its conclusion, the product will have survived a vigorous process to prepare it for use in a clinical.
Phase 5: Launch
Orchid Design brings a wealth of manufacturing experience to the table for every project. This detailed and in-depth knowledge helps our manufacturing and quality engineers transition your device to a manufacturing environment. We work with the supply chain early and throughout the entire transition to production to make sure design intent is maintained.