Keystone’s Five-Phase New Product Development Process

Keystone Solutions Group specializes in new product development for client companies who have a concept but need assistance to bring their idea through design and development so it can successfully reach the market.

West Michigan hosts one of the most robust clusters of medical device companies in the United States. Located as it is in the region’s heart in Kalamazoo, Keystone specializes in working with both start-up and larger medical companies and OEM’s. The Keystone Product Development arm of the company, however, also has a solid reputation of bringing products to reality in the automotive, aerospace and general industrial markets; but it all centers on new product development.

In any project that Keystone takes on, we use a five-phase process to develop the product. Future blogs will go into details of each phase. For now, to help potential customers better understand what to expect when they bring a project to Keystone, let’s give you an overview of our product development process.

Phase 1: Project Planning

The key to project planning in Phase 1 is defining the product’s form, function, specifications, user needs, as well as the required development steps.

You come to us with an idea for a product to fill a need in the marketplace and a sales strategy. Together, we typically expand on your original idea to develop an initial concept, conduct formative studies and survey the voice of customer activities. Keystone reviews any previous scope of work, integrates that into the new design, and initiates the Design History File documentation. During Phase 1, we complete an initial Engineering Product Specification (EPS), Preliminary Hazards Analysis (PHA) and a Project Charter.

During this phase of the project, we review the existing design work together with the client to complete the EPS or design input document. We will develop a product verification plan (test plan) that ensures the final product meets the requirements laid out in the Functional Specification and review any existing intellectual property rights, regulatory requirements, and applicable standards, and construct the initial draft of the risk assessment document.

Phase 2: Design and Development

Once we reach Phase 2, the client and the Keystone Product Development staff are really rolling up our sleeves and getting to work. This is often the most comprehensive and involved phase of a product development project, for this is when we do in-depth design, computer modeling, materials selection, testing, analysis, risk analysis, and documentation efforts required for a successful product.

Our team will incorporate any changes made as a result of our findings and concept direction from Phase 1, and update the EPS document. Keystone will generate production CAD models and drawings, and often produce production representative prototypes.

Phase 3: Design Verification

The name of this phase is pretty self-explanatory. Keystone will verify that your device or product meets all of the requirements of the EPS. We write test protocols and complete all of the testing outlined in the verification plan from Phase 1. Keystone’s testing includes product verification, electrical compliance, software and hardware validations, as well as packaging and transit testing. We also include any applicable certifications by applicable compliance bodies (CE, UL, TÜV, etc.). Prior to entering Phase 3, Keystone will separately quote production representative packaging and applicable certification testing by the compliance bodies.

Phase 4: Design Transfer

Keystone will complete all final documentation requirements for the product manufacturing transfer. We will construct the Quality Plan along with all Manufacturing Assembly Procedures (MAPs). In this phase, Keystone designs, builds and qualifies the manufacturing equipment and fixtures needed for the product. We will submit final production quotes and place purchase orders with all suppliers.

Phase 5: Design Validation

The Design Validation phase ensures the device or product conforms to defined user needs and intended uses. This phase includes testing of production units under actual or simulated use conditions. Keystone completes this testing using initial production units or their equivalent.

Is Your Idea Ready for the Next Phase?

Maybe your idea is just a sketch on a napkin? Or perhaps it’s based on years of business experience and marketing data. Is it ready for Keystone Product Development? The first step is to call us at 269-343-4108, or send us an email using the form on the Contact Us page to learn more about our products and services.

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