Previously we have discussed the important role of prototypes in the medical device industry. Prototypes can be used to explain a new type of device, to share with company stakeholders, or to test the use of the device. Prototypes can be further defined into four main categories. There are feasibility prototypes, low-fidelity user prototypes, high-fidelity user prototypes, and live-data prototypes. Each of these prototypes serves a different purpose and is important in bringing new devices to the market.
Feasibility Prototypes
Feasibility prototypes are often what engineers use while in the lab in the very early stages of development. In some organizations, feasibility prototypes are used in advanced engineering prior to committing to developing the device. These are very simple models, sometimes these prototypes are non-functioning. These prototypes may even be of components instead of the whole device. At this stage, engineers use feasibility prototypes to evaluate the technical performance and general risks of the device. These models are some of the first of the devices.
Low-Fidelity User Prototypes
Low-fidelity user prototypes for medical devices are early development devices that are non-functional. These devices will look and feel similar to the final device but are really designed to see how the device will fit into its workflow or environment. Doctor offices, surgeons, medical technicians use many medical products in a given procedure. So medical devices need to co-exist with other products. It is critical for a medical device’s adoption that it is able to integrate into its workspace. This includes evaluating how the device needs to be stored, compatibility with other products, and ease of use for the user. Low-fidelity user prototypes are a cost-effective way to evaluate this workflow integration for a medical device.
High-Fidelity User Prototypes
High-fidelity user prototypes are the closest to the real final device form. These prototypes are functional and typically manufactured using the same methods as the final device. These prototypes are useful to demonstrate how the device works and if it is compatible with other products. These prototypes may undergo some preliminary design testing. They will help inform what changes need to be made to a medical device before performing verification and validation testing. High-fidelity user prototypes may go through many iterations until the engineers feel that they have the final successful device.
Live-data Prototypes
Live-data prototypes are not for human use but are used to collect data. Live-data prototypes are devices that undergo verification and validation testing. The goal with these types of prototypes is to prove efficacy. These may differ from the final device because there might be multiple types of live-data prototypes or they may be manufactured in a lab rather than on a manufacturing line.
DeviceLab Manufacturing and Prototyping
DeviceLab is uniquely positioned to help manufacturers develop prototypes. No matter your use case or stage of development, DeviceLab is here to help you develop prototypes of your vision. DeviceLab has a team of experts and manufacturers facilities here to help bring your device to life. Contact DeviceLab today to set up a consultation.
