At a glance:

Client: SteadyMed Therapeutics

Product: Patch Pump Wearable Injector Drug Delivery Device

Sector: Medical Device, App Enabled Device, and Electronics

Services: Validation Process and Regulatory Compliance

Summary:

Challenge: SteadyMed Therapeutics had developed a revolutionary wearable, disposal infusion system that delivers medication to treat pulmonary arterial hypertension. This system utilizes an electronic pump to accurately deliver an exact dosage of medication over an extended period of time. SteadyMed had completed prototypes but as part of the required FDA testing for this type of device, they needed to move into series of small production runs to validate the accuracy and repeatability of the design (DVT). SteadyMed consisted of an amazing group of development engineers but they lacked the manufacturing skill set to manage the DVT phase, so they engaged RDS to lead them through the process.

Approach: As this product required FDA testing, which involves some of the most stringent testing and documentation requirements, RDS worked with their engineering team to develop testing requirements and documentation for recording the results. Electronic and plastic suppliers were contracted to perform small production runs. increasing in size for the span of a year This required multiple on-site visits to assure testing was being performed per our stated requirements as well as documenting all the results.

Outcome: At the end of the process, the Patch Pump was ready to move into the next phase of FDA testing. Shortly after we achieved this milestone, SteadyMed was acquired by United Therapeutics.