The final development milestone
With Camgenium’s innovative development methods, once the prototype is complete, it can be quickly transitioned to production systems.
The production prototype and any final clinical trial are the last key milestones before a product can be submitted for examination and certification prior to deployment.
With Camgenium, the production prototype is simply the last version of the prototypes, often with little change from the previous versions, as all development work is standards compliant. By comparison, if earlier prototypes have not been built to standards, the production prototype must often be completely new development project to ensure that all the steps required for regulatory compliance have been done. This adds significant time, risk and cost to a project. In fact, it is often a false economy to attempt to salvage earlier development work; better just to take forward the learning.
We collate the product technical file throughout the requirements capture, design and development processes. This is partly because we work to standards using our QMS and because the Camgenium platform automatically documents development processes. So the technical file will be largely finished with the completion of the production prototype. And if aspects of the product have already been trialled using prototypes, then a successful outcome can generally be guaranteed for the final clinical trial and the product validation process.
The technical file will include the test cases that we have developed to verify that the product meets the requirements. These include both manual and automated for regression testing, say after an upgrade to accommodate an Android or iOS update.
For connected physical medical devices and for SaMD devices, transitioning from development to deployment grade hosting in readiness for final clinical trial can be a complex process. Likewise at this stage, product fulfilment mechanisms must be put in place that were not needed for earlier prototypes.
Camgenium provides a wide range of hosting services and service level agreements (SLAs) globally to ensure that the requirements of each jurisdiction in which you want to deploy are met. Transitioning to full production grade hosting in the required locations is simply a contractual matter; we take care of all the technical and governance issues. Without Camgenium it is likely you will require new hosting systems, with new suppliers and supplier arrangements and you will need to hire a dedicated team to support them.
The Camgenium platform includes sophisticated user management systems and is integrated to Stripe for cash handling and invoice creation. These functions are often required and may have been overlooked before this stage.
The Soft Silicon connectivity technology includes mechanisms for adding devices to networks and for provisioning with Wi-Fi credentials. It also has sophisticated over-the-air upgrade capabilities so that future maintenance requirements can be met. Again, this functionality may not have been considered until this point in the development.
Camgenium also has extensive experience of submitting apps to the Apple App Store and Google Play Store together with the documentation they demand before making an app available on their stores. This information can, particularly in the case of Apple, be extensive.
Once the production prototype has been completed with its technical file it can be validated prior to submission to notified body for examination and certification as a medical device or IVD.
