The engineering team at Proven Process has a wealth of experience in early stage medical device development. The company's 20-plus years of experience as a Class II and III medical device developer and contract manufacturer confirms our ability to expertly perform tasks critical to early stage medical device development including:
Customer needs, user needs, and human factors are all design demands that need to be planned for. For this effort Proven Process will collaborate with our Clients to define the technical, business and regulatory requirements that need to be fulfilled in order to build a product. Clear, concise analysis will be conducted to demonstrate that suitable technologies and processes exist which meet the demands of the customer and user needs. Risks will be identified and a program developed to mitigate those issues.
Proof of Concept Analysis
At its core, Proof of Concept (POC) Analysis provides Proven Process the ability to verify the feasibility of one or a set of technologies or processes. Oftentimes facilitated through prototyping, POC Analysis also allows the Proven Process and customer teams to quickly understand a device's capabilities and potential limitations. Lessons learned at this early phase will allow product development to proceed using solutions that mitigate risks, allowing for successful medical device designs.
Proven Process provides rapid prototyping. In its most basic application, rapid prototyping allows the design team to confirm the shape and feel of a medical device quickly and at an economical price point. Basic ergonomics can be readily discussed and quickly adjusted. Rapid prototyping, because of its relative immediacy, can also serve to inform and enhance conversations across multidisciplinary teams, sometimes in separate locations. We are also adept at creating fully functional prototypes quickly, which can then be assessed through a full suite of testing, including tests at clinical sites. Count on Proven Process for rapid prototyping of simple and highly complex medical devices or sub-components.