Impact
Delivering expert analytical lab services to rapidly resolve production failures in a medical device
When a medical device company began encountering issues related to its drip regulator product, which manages flow rates and stability, the company needed a trusted partner to identify the root cause on a rapid timeline to minimize impacts on product sales and delivery.
The challenge demanded specific expertise in polymeric material evaluation and state-of-the-art instrumentation.
Root Cause of High Failure Rates Identified within Ten Hours
The client sought out our team of scientists based on our past work and expertise in analytic chemistry and process-of-elimination charting.
Our team evaluated the client’s polymeric material using differential scanning calorimetry (DSC) and Fourier transform infrared spectroscopy (FTIR) with the high level of precision required to target the specific need. Ultimately, we identified the root cause of the failures to be a change in the base polymer used to mold the device.
By assembling a team of experienced chemists and lab technicians, we were able to deliver for the client on a rapid turnaround. In fact, our team began the diagnostic approach and evaluation on the initial call with the client. By the time the samples arrived early the next morning, we were ready to carry out the analysis and definitively solve the problem less than 10 hours after receipt of the sample.
Quick Resolution Minimizes Losses and Informs Enhancements to Quality Process
Armed with the knowledge of the root cause of the product failure the client was able to minimize lost production and re-work. Our client worked with the manufacturer to ensure the correct polymer was used and that the drip regulator functioned as designed and the device could be relied on for patient care, ensuring the proper medication was being administered on a consistent basis.
In addition, our work helped improve the client’s existing quality process. We advised the client on the addition of a quality step and a schedule of lot testing to help guard against recurrence of this issue.
In light of our ability to deliver rapid and accurate answers, as well as long-term quality improvements, this client has engaged the RTI team repeatedly to help ensure its medical devices meet the safety and efficacy needs of doctors and patients.
