Medical prototype and product development
4 October 2021
Tex Plastics Barnstaple has developed a successful track record for helping medical device manufacturers develop plastic housings for their prototype product casings.
Justin Davies Managing Director of Tex Plastics
Working with designers to develop a DFM product
DFM, or Design for Manufacture is where our technical team works with the medical device product design team, taking the 'proof of concept' prototypes to create a manufacturing plan. This looks at the projected numbers, cosmetic appearance, plus any specific manufacturing requirements (i.e. white room or clean room manufacture, specialist polymers, 3D printing options, etc.). Our job is to help develop a critical path for the Alpha and Beta prototype stages (typically incorporating 3D printed components) through to the pilot production stage.
Prototype development stages and managing expectations
It's important to understand the end goals at the outset to create the correct moulding solution. Because having a common understanding of the functional utility for each stage of prototype development is essential to managing the expectations of all stakeholders involved in a project. The design transfer to manufacturing and the implementation of the quality management system is all done for the pilot production. This ensures the costings of the medical device are as accurate as possible and the device manufacturer has a robust roll-out plan.
Usability testing and clinical trials
These units may be used for summative usability testing and clinical trials, and they are suitable for initial release to market. Refinements from user feedback and production process can still be made, in addition to incorporating any user requests and identify cost-saving measures in the assembly process.
Tex Plastics can then scale up production for cost efficiency
The objective when working on any medical prototype and product development project is to set clear expectations for the development team, management team, and investors – as this will keep everyone pulling in the same direction during product development. Having a critical path where the manufacturing process is being fully considered through the pilot programme stages, has proved a highly successful approach for Tex Plastics and their respective medical device clients.