Overview:
This organization is seeking a potential partner including contract development and manufacturer company (CDMO)/white label/brand owner/etc) with experience manufacturing and designing a nasal irrigation device that delivers a saline solution.
The desired device will consist of a squeezable bottle or container that allows the user to vary the pressure of the saline solution flush into the nasal cavity. It should feature an ergonomically designed nozzle that fits comfortably in the nostril creating a light seal.
Criteria:
- CDMO must have:
- cGMP systems for medical device manufacturing (preferably with Medical Device Manufacturing license
- Active site registration with regulatory agencies (US FDA)
- Manufacturing locations in the USA
- Produce or supply the saline powder packets with the device and offer refill packets
- Must be an off-the-shelf product with possibility to do minor customization
- Solution must have a differentiator from generic nasal irrigation bottles.
- CDMO will preferably:
- Have design capabilities and the ability to work with our client to develop new designs and differentiating features.
- Manufacturing capacity to produce at least 500k units annually and up to 1M+ units annually within required time frame.
- Distribute in the markets of interest: USA, Mexico, India, and Germany
- Existing device should have:
- FDA Medical Device registration
- Preferably EU CE mark
- Gravity flow bottles or those that pump the water electrically are not of primary interest.
Possible Solution Areas:
- CDMOs currently making these products
- Existing nasal irrigation device manufacturers willing to white label
Desired outcome of the solution:
Looking for partners to make the saline nasal irrigation device under our client’s brand in early to mid-2023.
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