Which is the right fidelity level for your medical prototype? We identify 5 levels of fidelity and link them to concrete purpose.
Prototyping in Medical Device Development
In the product development process, prototyping is an essential step between the project drawing and the production release. The aim of a prototype is to test the design and analyze aspects which are assessable only in practice. As the word itself says, a prototype is a “primitive form” and, as a consequence, it could reveal problems. All the revealed problems will become improvement hints for engineers and a step towards the desired result.
Mock up is a simplified representation of the product, useful in the first steps to evaluate dimensions, usability, ergonomics and particularly recommended for device to hold in hand.
Aesthetic prototype gives you the final aesthetic and finishing, it is very valuable for exhibition at trade-fair.
Functional medical prototype is suggested for product tests (e.g. IP test), painting and finishing treatment aren’t made (enabling cost optimization).
Validation prototype boasts all the benefits of the two previous prototype types, usually it follows the end of engineering phase and enables the validation of the main features of the project.
Pre-production series is the reproduction of the device will be marketed, it has the similar aspect and functionalities of the final product. It is used for medical trials and for reducing the time to market.