Stringent regulatory approvals for airway management devices is one of the major factors restraining the growth of this market. These medical devices are used for lifesaving procedures and hence subjected to rigorous clinical testing and evaluation before being approved for patient use. The approval process involves pre-clinical testing on animal models to check for device functionality and biocompatibility. Only after successful animal studies, limited human clinical trials are permitted which takes around 1-2 years to collect adequate safety and efficacy data. During this time, companies cannot commercialize or market the devices. The clinical trial process requires enrolment of large number of patients across multiple hospitals which poses significant logistical and financial challenges for manufacturers.
Market Opportunity – Emerging Opportunities in the Airway Management Device Industry
A growing and aging global population will increase demand for emergencies and procedures requiring airway management. New entrant devices promising improved outcomes over existing products may see strong uptake if clinical trials are successful. There is also room for innovation in single-use devices for cost-savings and in portable devices suitable for pre-hospital settings.
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