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Device Type: Anesthesiology - Therapeutic
Device Type: Anesthesiology - Monitoring
FDA Description:
An apnea monitor is a complete system intended to alarm primarily upon the cessation of breathing timed from the last detected breath. The apnea monitor also includes indirect methods of apnea detection, such as monitoring of heart rate and other physiological parameters linked to the presence or absence of adequate respiration.
Design Assumptions:
The device is reusable (up to five years) and intended for facility or home use. It may be sold with a single patient use disposable, like a mask (with or without a head strap). Note mask data is not part of this report.
The device can contain injection molded parts in various sizes or configurations. In addition to top and bottom housing, the monitor will comprise other plastic parts such as a clear screen cover and potentially an internal battery holder. Hardware (i.e., screws) will likely be used for assembly, as opposed to bonding, allowing for maintenance and repair accessibility.
Internally, the device will contain at least one electronic control board with a touch user interface or custom molded buttons. We can also assume it will require various sensors to measure O2, CO2, and flow. The small size of these components typically adds cost for technological precision and handling time during assembly.
Finally, the monitor will need a power source (battery, wall outlet, or both). The power configuration may affect its regulatory classification depending on the country of sale.
Being made up of multiple interacting parts plus electronic controls with firmware or software, the developer should expect to spend over $450k on non-recurring engineering (NRE) costs, with no less than 15% allocated to a proof-of-concept for feasibility evaluation before starting design for manufacturability.
The device is not exempt from design controls and will require design traceability documentation to be compliant with regulations. The developer should expect this work to add 10-20% to the program's non-recurring engineering costs.
Regulation Assumptions:
The apnea monitor is a moderate-risk Class II device categorized under regulation number 868.2377, which covers at least one product code. Code FLS, for example, is assigned to an apnea monitor intended for facility use. 19 market-approved 510(k) devices are associated with this classification code.
The developer could expect to spend between $65k-$92k in regulatory compliance support, which may include pre-submission preparation. FDA fees for a small business entity may range between $8k-$35k for adult-indicated devices, depending on the regulatory pathway — 510(k) submission or De Novo request.
Devices assigned to product code FLS are NOT eligible for third-party review. The 510(k) Third Party Review Program provides medical device manufacturers with a voluntary alternative review process in which accredited third parties can review eligible low-to-moderate risk medical devices.
Risk assessments for this device should include an in-depth look at material cracking, leak, and temperature performance.
Testing Assumptions:
There are two FDA-recognized consensus standards recommended for testing: 1-159 ISO 18778 Second edition 2022-06, Respiratory equipment - Particular requirements for basic safety and essential performance of infant cardiorespiratory monitors and 3-129 ANSI AAMI EC53:2013/(R)2020, ECG trunk cables and patient leadwires. Connection tests may also be applicable depending on the type of assembly.
The developer should prepare to spend well over $100k on testing for this device to prove substantial equivalence to an existing 510(k) and more if they intend to prove uniquely different technological advancements, which require a De Novo filing.
Ease of Manufacturing:
The device does not employ any area of manufacturing technology that is not well established. However, it represents a complex set of functionalities working seamlessly to provide a specific outcome. The manufacturing assembly process will have to be well-detailed and traceable.
Ballpark Study includes visual and interactive data:
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.
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.
