Rather than trying to design and test every element at once, we suggest breaking down the process into isolated stages with their own focus, goals, and resource requirements. Staged prototyping is a proven, efficient path to success.
Below is a brief overview of the different stages of the prototyping process. The Kapstone team will manage each phase during the product development process, but it’s helpful to understand them at the outset in order to set and manage your team’s expectations.
Kapstone can provide prototyping services with any of these stages as part of our development services. Learn more about Kapstone’s approach to early medical device design & engineering.
Appearance modeling is the first stage of medical device prototyping. In this phase, the team will develop drawings, rendered images, or physical (usually non-functional) mockups of the device. These pieces can be used to gauge investor interest, inform preliminary patent research, or answer key questions about usability and product positioning.
Next up is proof of concept. In this stage, the device should begin to take shape in terms of function, but not necessarily final appearance. This prototype will allow for testing feasibility, investigating risks, evaluating material selection, and assessing initial performance of critical aspects.
An Alpha prototype, sometimes done as a proof of concept, is constructed of materials and components that may or may not be the same as the final product. The project team is learning critical aspects of the design or manufacturing process, and at this point is making prototypes with methods quicker than a beta prototype to allow for rapid iterations if needed.
A Beta prototype should resemble as close as possible the commercial product and should be “production-equivalent”. This is a more intensive process that can take months or longer to complete. It may not have been built at the production commercial volume but every process and step should be the same. Beta prototyping allows for verification and validation testing to ensure that the device performs its intended function. This testing will support a regulatory submission.
Kapstone is well-versed in all stages of testing, from initial prototyping through to complex V&V. Learn more about our approach.
After V&V testing is successfully completed, design transfer occurs for pilot manufacturing. Any units produced in this stage can be used for a soft launch (aka limited market release), pending FDA clearance.
Regulatory submissions are one of the most complex parts of the medical device development process. Kapstone is able to assist with any and all preparation, documentation, and filing to streamline the process for your team. Learn more about how we can help.