One of Springboard’s longest-running device development projects involves the construction of a novel infusion pump technology from the ground up. As a result, we are in a unique position to offer significant expertise of the current industry landscape of stationary and ambulatory infusion pumps including any new technologies in the pipeline. We can assess whether your new or upgraded technology can disrupt what is generally regarded as an established sector with a few key players.
Springboard has carried out multiple Human Factors studies regarding the usage of infusion pumps. We can design the right study for your product while keeping any findings confidential. All our projects follow a human-centred approach to ensure products are safe, effective, and intuitive to use. It is also extremely important to ensure that the viewpoint of payers (i.e. healthcare agencies or hospitals) is taken into account when making design decisions, as they will make the final decision on whether to adopt new technologies.
As a medical device, infusion pumps must navigate regulatory frameworks such as the EU MDR & US FDA Title 21 CFR. We deliver all projects within our ISO 13485-accredited Quality Management System and can ensure that regulatory compliance is observed from the beginning of development, avoiding the need for any problematic ‘catch-up’ later. We have experience applying risk analysis techniques such as Failure Modes and Effects Analysis (FMEA) at an early stage and evolving it alongside a product design.
Please get in touch if you would like to leverage our strong engineering and scientific skills to push your infusion pump project in the right direction.