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Medical Device Concept Development: Idea Generation or Concept Creation
The conceptual design stage of a new medical device will require a collaborative effort of brainstorming and the refinement of free-flowing ideas to arrive at a final medical device that not only functions as required but is manufacturable. At CUBE Medical Innovations, we assist inventors in the first stages of medical device concept development by refining your product concept and building a production strategy with our team of engineers, designers, and project managers.
There are many ideation methods that can be used to effectively translate an innovative idea into a medical device concept that results in cost-effective product realization.
A critical examination of your proposed solution to a medical need, along with identifying a solid design intent that will fulfill those objectives, is important during this phase.
CUBE Medical Innovations can assist with providing the information that will ensure your medical device concept has the right balance of features versus manufacturing costs. Our team of engineers and design specialist can develop various conceptual ideations of your medical device for consideration as a final product. But medical device concept development is more than collaborative brainstorming sessions.
During this process we apply many proven techniques to arrive at successful product realization:
- Guard against deviations that may produce unwanted outcomes
- Explore areas of excess cost and manufacturing inefficiencies
- Apply clinical analysis to determine any concerns for the patient
- Examine any potential device malfunctions
A new medical device's main goal is to address a significant need or problem with a cost-effective solution.
In the past, medical device concept development has been a slow and often painful process. At CUBE Medical Innovations, we partner with our clients in a way that contributes to your success - applying effective ideation methods that produce real results in less time. Through our medical device engineering resources, supply chain logistics, and knowledge of state-of-the-art manufacturing processes, your new medical device idea becomes a reality and on the market with a strategic plan for successful product realization.
While your new medical device concept is approaching the early stages of design development, there are other factors that will determine success. These include securing intellectual property protections and establishing which class the new product will fall into. The right classification will then determine which regulatory requirements the medical device will need to meet for FDA approval. Therefore, the early stages of product realization will also focus on the safety and effectiveness of the medical device.
Medical device concept development includes consideration of the medical product's final manufacturing, in order to conform to Good Manufacturing Practices (GMP). This is the time to at least consider the device materials, end-user training, supplemental equipment, and sterile production requirements. Detailed documentation of these factors and all other procedures will be required to establish GMP adherence during the manufacturing process.
CUBE Medical Innovations is positioned to make sure your idea is viable, marketable, and profitable. Making the transition from concept development to research and discovery will require a multidisciplinary team for design prototyping and early-stage proof-of-concept testing. At CUBE, we are your product realization team offering a unique group of expertise for every stage of product planning and development.