When an innovator has identified a medical problem, taking an efficient approach to identify the viability of potential solutions is key. Our Phase 0 focuses on evaluating critical product elements early, with limited cost and effort.

Key Questions:

• What is the clinical need or problem to be solved?
• How will the product’s critical features address clinical need?
• What is the product’s regulatory pathway?
• Can the innovator’s intellectual property be protected?
• Is there a market for the product? Who are the competitors?

At the completion of Phase 0, an innovator will have data-based support for the value in launching a full development program for the product.

In our experience, careful planning streamlines the development process, lowering costs and providing greater market predictability.

Key Questions:

• What are the product requirements and key risks?
• What design tasks are needed?
• What are the considerations for manufacturing and testing the product?
• How long will the project take and at what cost?
• Who is the project team, and what external resources are needed?

At the completion of Phase 1, the project team will have a clear vision for the path to generating the product.

Iterations of design refinement and evaluation allow for product evolution from the prototype stage to manufacturable assembly.

Key Questions:

• What does the product look like, and how does it work?
• What materials are in the product and how is it manufactured?
• Have all product risks been addressed?

At the completion of Phase 2, the project team will have the specifications and initial supporting test data for a functional product.

Thorough engineering evaluations of the product demonstrate whether the output of design efforts have met all of the product requirements.

Key Questions:

• Has the product met acceptance criteria for each functional requirement?
• Is the product safe to use?

At the completion of Phase 3, a project team will have statistically significant evidence of the product’s functionality and safety.

Thorough system and user testing demonstrate whether the design has sufficiently addressed the customer’s clinical need.

Key Questions:

• Is the product effective at meeting the user’s needs?
• Can users reasonably perform the tasks required to operate the product?

At the completion of Phase 4, a project team will have documented evidence as to whether the product is usable and solves the stated clinical need.

In order to scale production to quantities needed for sale, manufacturing processes must be shown to repeatedly and reliably generate the commercialized product. For many medical products, regulatory approval must also be granted prior to market introduction.

Key Questions:

• Is the product effective at meeting the user’s needs?
• Are all critical manufacturing processes producing assemblies that meet design specifications?
• Is the manufacturer prepared for product traceability, distribution and marketing?
• Have regulatory entities approved the product?

At the completion of Phase 5, the product will be ready for routine production and sale.