Our new product development process has five phases which include: project planning, design and development, design verification, design transfer, and design validation. We specialize in partnering with clients who have a concept for a medical device, but need help in bringing their idea through design, development, and manufacture so it can and will successfully reach the market. In this post, we will go over the five phases that you can expect to go through when you partner with Keystone.
Phase one: Project Planning
Project planning involves defining the product’s form, function, specifications, user needs, as well as the required development steps.
Phase two: Design and Development
Phase two is oftentimes the most involved and comprehensive part of the new product development process. In this phase, we do in-depth design, computer modeling, materials selection, testing, analysis, risk analysis, and documentation efforts required for a successful product.
Phase three: Design Verification
During this phase we ensure that your medical device meets all necessary requirements and specifications. 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.).
Phase four: Design Transfer
In this phase, we will construct the Quality Plan along with all Manufacturing Assembly Procedures (MAPs). In phase four we design, build and qualify the manufacturing equipment and fixtures needed for the product. We also submit the last production quote and place purchase orders with chosen suppliers.
Phase five: Design Validation
The final phase validates that the device conforms to intended user needs and uses. During this phase there is testing of devices and products in simulated or actual use scenarios.
At Keystone Solutions Group in Kalamazoo, we have been in the medical device development business for almost twenty years. In that time, we have built a network of companies that help make our clients successful after we’re finished producing their final product. Contacts us today with any questions you may have while deciding what medical device contract manufacturer is right for you.