Rostrum Medical Innovations Inc. manufactures the VQm Pulmonary Health Monitor™, a non-invasive cardiopulmonary monitoring device. It provides clinicians insights into the effects of changes in lung health to help optimize ventilator settings based on patient specific needs. This is important for ensuring mechanically ventilated patients, specifically patients with ARDS, Shock or COVID-19 get the care they need. During the early design phases of this device, Rostrum was looking for a partner to produce front and rear facing graphic overlay system labels. When CleanMark approached Rostrum with an introduction call, they realized there was an opportunity for guidance and help with this portion of their project.
The Challenge & Requirements
Functional overlays for a device like Rostrum’s Health Monitor require precision engineering. Labels and overlays for medical devices must be compliant with different regulatory bodies which require special approval of materials and adhesives. Precise dimensions for sampling ports and sensors must be executed with care. Design formatting, screen printing layout for symbols, color matching and die-cutting techniques for features like ‘see through’ windows all must work in harmony in order for monitoring devices to operate successfully. It was important to Rosturm that CleanMark’s engineering didn’t impact the use of the device. Rostrum needed a quick turnaround on this project so that they could start empowering clinics with this new technology.
The Process & Solution
Through collaborative meetings and rounds of blueprint analysis, CleanMark was able to identify the most suitable and efficient overlay construction for Rostrum’s Health Monitor. CleanMark sent multiple samples for the Rostrum team to inspect and validate. Samples were received within days, which accelerated the beta testing process for phase 1 of this new design.
"The CleanMark team was very helpful and diligent throughout the whole process, from selecting materials to production. We needed a label manufacturer to help us produce labels for our pre-production systems, and we are very happy with the outcome of our project."
Kelsey Ramadhan, Sales & Marketing Specialist, Rostrum Medical
CleanMark’s collaboration with Rostrum resulted in a successful overlay that functioned properly with their new monitoring device. Most importantly, we were able to produce a product that met their expectations. By obtaining their final system overlays in a timely manner, Rostrum Medical was able to move forward with getting approvals from the applicable regulatory bodies. With this approval, Rostrum was able expand their support to clinicians across Canada as the first step of commercialization before going global.