Stay up to date on Keystone Solution's latest news on product development and medical device manufacturing.

Product Development Phase 5: Design Validation


As we move into actual production of the new product that Keystone and our customer have worked to develop, there’s another level of of tests we need to carry out: validation of the design and manufacturing process.

We already verified the product design during extensive tests of prototypes in Phase 3. In essence, we tested the prototype we built to verify that it met all functional and appearance specifications. Those tests told us that the product when built to the design we came up with works as intended.

Tags: Product Development

Product Development Phase 4: Design Transfer


All the work that Keystone and the customer has done in the first three phases, from taking a product idea and refining it, through extensive design and then testing of prototypes, leads to this critical juncture. Transferring the design to the production process requires a comprehensive assessment of design documentation, a precise definition of production methods, and a careful selection of components.

Tags: Product Development

New Product Development Phase 2 - Design and Development


In Phase 1, we defined your product’s form, function, specs and user needs as key parts of project planning. We also defined the required development steps for the project.

When we move into Phase 2, Design and Development, you and the Keystone Product Development staff enter into what is typically the most comprehensive and involved phase of product development. This is when the product truly takes shape, virtually in CAD modeling and physically in a working prototype. Yet we don’t accomplish that in one leap. Phase 2 involves:

Tags: Design and Development

New Product Development Phase 1: Project Planning


You come to Keystone with an idea for a new product. We have the expertise to work with you to develop that product and bring it to the market place. It’s time for us to roll up our sleeves and get to work.

In the first two blogs of this series, we identified the five phases of product development practiced at Keystone, and what we expect you to bring to the table when you come to us with an idea for a new product.

Tags: new product development, project planning

What is required of an FDA Specifications Developer?


The term “specifications developer” is a legal term used by the U.S. Food and Drug Administration. To become one requires companies to meet certain minimum requirements and put in place specific quality systems and procedures. While this blog is not meant to be an exhaustive review of all requirements, it is intended to shed light on the subject and add some definition to the often used phase.

Tags: FDA Specifications Developer

New Product Development: What do you bring to the table?

What To Bring To Table For New Product Development

You have an idea. You believe it meets a vital need in the marketplace and you have a basic concept of what your product looks like and how it might function.

But you’re a start-up company, not an established business. Do you even want to be an entrepreneur? Who will you find to help? Are you ready to begin product development?

Tags: new product development

Keystone’s Five-Phase New Product Development Process

Product Development

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.

Tags: new product development