Phase 0 - Proposal Generation

We begin each project by meeting with you to listen to you and understand your needs.  We endeavor to gain a deep understanding of goals and challenges of the project at hand.  We want to understand your business goals for the project as well as any schedule, clinical, technical, regulatory or intellectual property challenges.  Once we've gained a solid understanding of your needs and goals, we will develop a detailed project proposal for you, broken into phases and milestones.  We'll define our deliverables for each phase along with timelines and budgets.

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Phase 1 - Concept Development and Project Planning

In this phase we will develop a series of concepts tailored to satisfy your product and project needs.  We will review these concepts with you and help you select a concept or concepts for further development.  We will also work with you to establish critical requirements for your product and develop a plan that defines milestones and budgeting.  For medical products, or products in other regulated industries, we will work with you to develop a path for regulatory approval.  We will help identify suppliers for your product and initiate early supplier involvement activities.

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Phase 2 - Prototype Design & Development

In Phase 2, we will take the selected concept or concepts from phase 1 and create detail designs for them.  We'll review these designs with you.  Once the design has your approval, we will fabricate, assemble and test the prototypes.  Depending on the complexity of the prototype, several iterations of design and prototyping may be required in this phase in order to meet your feature and performance requirements.

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Phase 3 - Product Design

Once a stable design has been achieved, we will work up detailed manufacturing drawings, ensuring that quality, performance and cost requirements are met.  We will work with your suppliers on all aspects of manufacturing process development proceed according to schedule.

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Phase 4 - Design Verification 

Once initial manufacturing samples become available, we'll conduct design verification testing to confirm that all product requirements have been met.

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Phase 5 - Design Validation

We will also use initial manufacturing samples to assist in design validation / usage testing to validate that the product requirements have been effectively translated into product that meets user needs.

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Phase 6 - Design Transfer

While we integrate many design transfer activities upstream in the development process, we will also conduct an explicit design transfer phase for products requiring FDA compliance.  In this phase we will work with the supply chain to ensure that the initial production process can be effectively scaled up to your full production needs.