During the medical device design and development process, engineers will spend countless hours prototyping medical devices 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.
Evaluating Medical Device Prototype Requirements: Materials, Conductivity, and Component Selection
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.
How Material Selection in Medical Device Prototyping Affects Cost, Timeline, and Availability
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 Prototypes in Medical Device Design & Validating Your Idea Before Development
The proof of concept prototype is made from scraps. It is the beginning stage of development and prototyping. This medical device 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 in Medical Device Design: Testing Dimensions, Form, and User Feel
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.
Beta Prototypes in Medical Device Design: Evaluating Device Function and Manufacturing Feasibility
To test out the functions of a device, engineers will utilize beta stage 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.
Pilot Prototypes in Medical Device Design: FDA Verification, Validation Testing, and Soft Launches
Once the medical 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.
Partner With DeviceLab for Medical Prototype Design Services in Tustin, CA
DeviceLab has the resources to guide your product development team through medical device prototype development and finalize your product’s design.
