Kindly takes us through your journey of your most famous invented device GlideScope.
The product and market development was a multi-prong innovative process to, first and foremost address and resolve the specialist’s inability to view the patient’s airway in difficult conditions (Grade IV). All to facilitate inserting safely and correctly an endotracheal tube (ET) within a very limited time. So, the strategy in the first step was to analyse and develop a solution to assist the specialist in placing the ET in very difficult situations. The second step was to engineer and integrate the power control, digital camera, viewing screen into the device and to simplify the total operations so that the specialist would be able to focus on the insertion of the ET into the patient’s airway. The third important step was to create a business case to justify time and resources by expanding the into cases where the viewing of the airway was improved but not as challenging (e.g. Grades 3,2 and 1). This allowed for wider requirements for such a device in all intubation conditions. To add to the business case, trademarking the intended use (gliding of ET and scoping / viewing). the GlideScope name was borne and trademarked.
Which products are in development for Rostrum Medical?
After the sale of Saturn Biomedical and the GlideScope to Verathon, we embarked on the strategy to develop a product that would give the specialist insight of the intubated patient’s internal ventilation-perfusion (V/Qm®) conditions. Rostrum Medical was formed with a Long-term goal to develop and commercialize unique solutions for patient care; the V/Qm® Pulmonary Health Monitor. The four parameters provided by the VQm PHM™ developed and designed to provide clinicians with a full picture of the relationship between the heart and lungs, something that is currently not available to clinicians at the bed-side, non-invasively. The parameters include Shunt fraction (Qs/Qt), Dead space, Pulmonary blood flow (PBF) and Functional Residual Capacity (FRC).
After the approval of VQm PHM, which other countries approvals are planned?
The US, followed by France, Austria, Canada, Japan and China.
Over the year, manufacturer lobbying FDA approval to cover the loopholes of the device for what they claim to do. How do you see this problem?
The FDA process is comprehensive and covers de Novo and 510k based on different parameters. Again, product applications and categories vary.