During the medical device design and development process, engineers will spend countless hours prototyping by creating specifications, designing CAD drawings, and manufacturing physical products. These prototypes and their iterations are essential to device development. Medical device development evolves with each prototype. With each prototype, the design of a medical device gets one step closer to the medical tool that eventually ends up in the hands of surgeons, patients, or healthcare providers.
Prototype development can be helpful to evaluate different requirements of the device at different stages of product development. These requirements include how the device should feel in the user’s hands, the conductivity of materials used, or the types of switches. Engineers may purposefully use different materials or parts to manufacture prototypes that may not be part of the final product. Sometimes the materials or parts used in prototypes will not represent or resemble the actual product.
The materials or parts in medical device prototype development may differ from the final product to help with cost savings, time reduction, or availability of finite resources. Prototypes will look very different based on the role they are playing in product development. Based on product development needs, there are different types of prototypes: proof of concept, alpha, beta, pilot, and final prototypes.
Proof of Concept
The proof of concept prototype is made from scraps. It is the most beginning stages of development and prototyping. This prototype is typically made out of household items, just to show that your concept can work. It is a good idea, but the concept is unreliable and does not function like the final prototype. For the High-End Proof of Concept Prototype: What does the medical device look like and what will it do?
Alpha prototypes refer to samples of the device that are non-functioning. They are designed to learn if the product dimensions are correct and to understand how the product will look and feel. These prototypes are typically 3-D printed. Because they are non-functioning, alpha prototypes are typically cheaper to manufacture and can be produced quickly. Outside of design, manufacturers often use alpha prototypes in trade shows and conferences to inform the public about ongoing products or development.
To test out the functions of a device, engineers will utilize beta prototypes. Beta prototypes are typically not clean, nicely branded devices. The purpose of a beta prototype is to evaluate manufacturing or test features. These prototypes help test if the device is functional and evaluate manufacturing. Sometimes beta prototypes may only be one feature in a large device. Beta prototypes are functional but are not for human use and are typically not used for verification and validation testing.
Once the device design has gone through a few iterations of beta prototyping, then engineers might begin pilot prototyping. Pilot prototypes are refined beta prototypes that resemble the final, finished medical device. Once the design is finalized, pilot prototypes will be used in verification and validation testing. Verification and validation testing data is part of the evidence that is sent to the FDA as proof of the device’s safety and efficacy. If manufacturing cannot be scaled, manufacturers may use pilot prototypes in soft launches.
DeviceLab Medical Device Prototyping
DeviceLab has the resources to guide your product development team through medical device prototype development and finalize your product’s design. Contact DeviceLab today to schedule a consultation and to learn more about our services.