Oxygen Mask

Design Assumptions:

This disposable device is intended for single-patient use in general respiratory procedures, administered by clinical staff, for a duration of up to 30 days.

The device comprises extruded plastic tubing and an injection-molded mask assembled with necessary connectors.

It is important to note that the device is not sterile.

Development Costs:

The developer is projected to incur approximately $500k in non-recurring engineering (NRE) costs, inclusive of limited production tooling for verification samples. Of this total, no less than 22% is earmarked for a proof-of-concept phase to assess feasibility before embarking on design for manufacturability.

Compliance Requirements:

The device falls under regulation number 868.5580, which governs low-risk Class I devices. Specifically, it aligns with product code BYG within this regulatory framework.

Anticipated regulatory compliance support costs are expected to be approximately $21k. Depending on the technological variance of the developer's concept, additional regulatory support or even a pre-submission filing with the FDA may be necessary for confirmation of exemption. In the event of exemption confirmation, no filing fees apply for registering a Class I device. However, a registration fee of approximately $7k is applicable if the device is developed with a new manufacturer.

Testing Requirements:

FDA-recommended consensus standards for testing include:

ISO 18562-1:2017, ISO 18562-2:2017, ISO 18562-3:2017, and ISO 18562-4:2017, which respectively cover biocompatibility evaluation and testing within a risk management process, emissions of particulate matter, emissions of volatile organic compounds, and leachables in condensate from breathing gas pathways in healthcare applications.

Additional mechanical testing, such as dead space analysis and connector compatibility, may be mandated based on device indications.

To demonstrate compliance with FDA-recognized standards, the developer should allocate up to $400k for testing expenses. It is crucial to note that failure to conduct these tests will result in assuming all product risk.

Manufacturing Considerations:

While extrusion and injection molding technologies are readily available, the mask segment of the market is dominated by manufacturers with large production capacities. This poses a challenge in maintaining competitive costs without substantial tooling investments.

For this device category, expenditure exceeding $200k is expected for high-capacity tooling for masks and tubing. Depending on the desired cost-effectiveness and production volumes, automation may be necessary, especially for volumes exceeding 500k parts annually. However, automation entails significant expenses, necessitating a thorough ROI assessment.