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5min
Device Type: Anesthesiology - Therapeutic
FDA Description:
An oxygen mask is a device placed over a patient's nose, mouth, or tracheostomy to administer oxygen or aerosols.
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 leachable 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 $250k for testing expenses. It is crucial to note that failure to conduct these tests may result in unforeseen product failures.
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.
Custom Reports include detailed visual and interactive tools:
Feasibility Score: The Feasibility Score, or Zewski Score, is a number between 1-100 that identifies how difficult of a program your project is to initiate and maintain a plan and budget for relative to other projects on the scale. The higher the risk of the project, the lower the score. Average Class II projects fall between 40 and 60. Projects above 75 are generally straightforward. Those below 25 are complex and extremely high risk.
Compliance Score: Similar to the Feasibility Score, the Compliance Score runs between 1 and 100. However, this score only looks at the difficulty of the FDA approval process. Its values focus more on patient risk and testing challenges than business feasibility. Your Compliance Score may differ depending on the overall project details. For example, a project with a small market but little risk will have a lower Feasibility Score than Compliance Score.
Indications Assessment: Detailed breakdown of the typical indications for product code BZE and the impact on risk, cost, and time related to the development and delivery of this project.
Milestone Data: Breaking the project into approximately 50 activities over 5 phases helps identify the most critical items that will impact time and cost on a macro level. Depending on the project's complexity, fewer or more items may be involved.
Manufacturing Study: Expert assessment of the technology needed to bring your product idea to fruition. Through research and experience, we will lay out a likely path from your product's production methods and the fields of expertise needed to make it happen.
Financial Assessment: Includes cost scenarios based on the manufacturing process and location, with the necessary quality level for each aspect of your project. It will also look at low- and high-volume scenarios plus any needed labor and automation to assess possible cost efficiencies.
