Rostrum Medical Innovations Inc | Medical device overlay labels that meet regulations

Customer overview

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. 

Complex requirements for medical device overlay labels

During the early design phases of the VQm Pulmonary Health Monitor™, Rostrum Medical Innovations Inc. was looking for a partner to produce front and rear facing graphic overlay labels. When CleanMark approached Rostrum Medical Innovations Inc. with an introduction call, they realized there was an opportunity for guidance and help with this portion of their project.

Overlay labels for a medical device like Rostrum Medical Innovations Inc.’s VQm Pulmonary Health Monitor™ require precision engineering. These overlay labels 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 medical devices to operate successfully. 

It was important to Rostrum Medical Innovations Inc. that CleanMark’s engineering didn’t impact the use of the medical device. The company also needed a quick turnaround on this project so that they could start empowering clinics with this new technology.

Fast sampling to validate function of overlay labels

Through collaborative meetings and rounds of blueprint analysis, CleanMark was able to identify the most suitable and efficient overlay label construction for Rostrum Medical Innovations Inc.’s VQm Pulmonary Health Monitor™. CleanMark sent multiple custom label samples for the Rostrum Medical Innovations Inc. team to inspect and validate. Samples were received within days, which accelerated the beta testing process for phase one 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 and marketing specialist, Rostrum Medical Innovations Inc.

Compliant overlay labels delivered in record time

CleanMark’s collaboration with Rostrum Medical Innovations Inc. resulted in successful overlay labels that functioned properly with the company’s new monitoring device. Most importantly, we were able to produce a product that met their expectations. By obtaining their final overlay labels in a timely manner, Rostrum Medical Innovations Inc. was able to move forward with getting approvals from the applicable regulatory bodies. With this approval, Rostrum Medical Innovations Inc. was able to expand their support to clinicians across Canada as the first step of commercialization before going global.