The Flume Catheter Company Ltd
The Flume Catheter Company is dedicated to revolutionizing urinary catheter design to improve patient experience and safety. Their innovative FLUME® catheter aims to eliminate common issues such as infection, blockage, pain, and distress by introducing a new patented design that is guided by patient feedback and manufactured with world-class quality standards. The company is actively involved in clinical trials, regulatory approvals, and market expansion, with a focus on making a significant impact on patient care and healthcare costs.
Industries
Nr. of Employees
small (1-50)
The Flume Catheter Company Ltd
Products
Indwelling urinary catheter with enveloping retention balloon and inset drainage ports
An indwelling urinary catheter where the retention balloon envelops the catheter tip on inflation and the drainage ports are inset at the balloon base; designed for urethral and suprapubic use and compatible with standard insertion/removal technique.
Indwelling urinary catheter with enveloping retention balloon and inset drainage ports
An indwelling urinary catheter where the retention balloon envelops the catheter tip on inflation and the drainage ports are inset at the balloon base; designed for urethral and suprapubic use and compatible with standard insertion/removal technique.
Services
Contract manufacturing qualification and scale-up support
Transfer of device design to contract catheter manufacturers, qualification of production lines and support for scale-up to automated, high-volume manufacturing.
Device qualification, independent testing and regulatory support
Preparation and execution of independent testing, design validation and documentation in support of regulatory submissions and clinical trial readiness.
Clinical study partnership and real-world data collection
Design and oversight of clinical evaluations and real-world studies in partnership with academic research organizations to assess patient comfort, quality of life and complication rates.
Sample provision and clinician evaluation program
Distribution of clinician samples for hands-on evaluation and feedback to inform product iterations and clinician adoption.
Contract manufacturing qualification and scale-up support
Transfer of device design to contract catheter manufacturers, qualification of production lines and support for scale-up to automated, high-volume manufacturing.
Device qualification, independent testing and regulatory support
Preparation and execution of independent testing, design validation and documentation in support of regulatory submissions and clinical trial readiness.
Clinical study partnership and real-world data collection
Design and oversight of clinical evaluations and real-world studies in partnership with academic research organizations to assess patient comfort, quality of life and complication rates.
Sample provision and clinician evaluation program
Distribution of clinician samples for hands-on evaluation and feedback to inform product iterations and clinician adoption.
Expertise Areas
- Indwelling urinary catheter engineering and design
- Device materials and coatings for catheters
- Design for Manufacture (DFM) and manufacturing transfer
- Clinical study design and real-world evidence collection
Key Technologies
- Balloon catheter design (enveloping balloon geometry)
- Dual-lumen catheter architecture
- Luer-valve inflation systems
- Biocompatible balloon polymers