Since we manufacture on site, we’re thinking beyond prototypes from the start, looking for ways to ensure successful, sustainable, repeatable, and dependable manufacturing solutions.
When you’re finished with the medical device prototyping stage, RBC Medical Innovations is ready to manufacture with capable staff, reliable suppliers and well-equipped facilities.
Medical Device Design & Development Services
Medical device prototyping determines if and how the project continues into manufacturing. Which one of these four would best suit this stage of your project?
- Proof-of-Concept Prototype. This medical device prototype is used to analyze the technical and business risks of the envisioned solution. It is intended to prove through testing with a predefined, working prototype that the risks can be managed and the challenge overcome.
- Form/Concept Prototype. This medical device prototype lets you see and “feel” how the device will look and function once it’s completed. This prototype cost-effectively facilitates feedback from all stakeholders regarding the shape, size, color, and gross function of the final product, before you invest in detailed design, implementation, and testing.
- Form, Fit, and Function Prototype. This fully-functional, working medical device prototype is created and tested for manufacturability, electro-magnetic compatibility (EMC), and full functionality once the design is finalized. This prototype is usually suitable for early clinical testing as well.
- Pre-Production Prototype. This medical device prototype is for formal verification and validation. In addition, it is used for manufacturing to eliminate potential issues with the fabrication processes.
Many think of the devices made during the first manufacturing run as “prototypes” as well. If no issues are found during the process validation, these “prototypes” become your first units for sale. If issues are found, the development and medical device manufacturing teams use these results as an opportunity to adjust for effective and efficient full production runs of your product.
RBC Medical Innovations has made thousands of medical device prototypes in its 24-year history. Almost all of these Class I, Class II, and Class III medical devices presented electronics and software challenges that we enjoyed solving. It’s one of the most satisfying aspects of our business, and we look forward to doing the same for you.
A special note to early stage medical device companies!
RBC Medical Innovations offers feasibility support for early-stage firms who may be new to medical device prototyping and manufacturing. We can guide you through the assessment of potential intellectual property, regulatory, budgeting, marketing, and manufacturing issues and provide a proven infrastructure for you and your investment partners. Simply contact us for help.
510(K), PMA, AND CE MARK SUBMISSIONS
Depending on your needs, RBC Medical Innovations can produce all or part of the design documentation required for a FDA 510(k) submission, pre-market approval, or a CE Mark technical file.