Design to Delivery: Transonic OEM Program
Proven Accuracy in Clinical & Experimental Flow Measurement.
Transonic® offers the following program for implementation of a Transonic custom flowmetering module into a
new product. This program allows the OEM customer to:
- Evaluate Transonic® apparatus in the OEM device to define specifications
- Define and implement a custom flowmetering module in a device at minimal cost and time
Proof-of-Concept Testing
The OEM purchases a standard Transonic flowmeter and sensor. This system is used to perform extensive quality
testing to define the attainable specifications of the flowmetering technology in the OEM device. After testing is completed, the flowmeter and sensor remain as the
measurement standard with the OEM. (See spec sheet of the standard Transonic Flowmeters and Flow Sensors.
Co-Engineering program
OEM signs a non-disclosure agreement with Transonic Systems Inc.
- Transonic & OEM mutually define project specifications based upon OEM’s tests and requirements.
- Transonic submits a “Development Agreement” to the OEM for a one time NRE charge for a “right-to-use”
Transonic technology in an OEM system. The Development Agreement defines the customized OEM flowmeter product and its development time line, and includes a quotation
for Transonic’s one-time NRE charges and product prototypes. includes design review, and any added development fees based upon pre-established specifications, and
includes training and troubleshooting to bring the project to a successful completion. Prototype board and sensor pricing are also indicated (initial protype run is 10
units) along with a timeline for project development.
- Transonic submits a draft “Supplier Agreement” that describes the terms and conditions under which customized
OEM flowmeter products will be delivered upon project completion.
- OEM signs and submits the Development Agreementand a purchase order (PO) to Transonic. (Transonic Systems
requires a 50% deposit for development fees.)
- Transonic designs and builds custom flowmetering prototype systems.
- A custom version of the standard flowmetering system (prototype board) can often be delivered within 12 weeks after receipt of order. The timeline of the project is subject to the complexity of development. “Off-the-shelf” OEM boards may be available with shorter lead times. The OEM can compare its performance with the measurement standard flowmeter.
- Meanwhile, the terms of the Suppier Agreement may be refined and the Agreement signed.
- OEM performs field trials.
- OEM processes government approvals with assistance from Transonic Systems
- Upon prototype approval, Transonic engineering releases product for ongoing manufacture.
- Transonic delivers flowmeter boards and sensors.
- In time, manufacturing of components by Transonic maybe replaced by manufacturing by the OEM under license.
Regulatory Approvals
Because the customized combination of the Transonic OEM Flowboard and Flow Sensor derived from standard Transonic
products, its Medical Device Approval, FDA clearance and Clinical Performance Validation may draw upon a broad record of published independent Transonic validation
studies, historical safety and effectiveness records and substantial equivalency data, Transonic regulatory staff will assist its OEM customers with obtaining regulatory
approvals.
Transonic® pledges that its OEM modules will match the superior quality criteria of its standard
flowmeters.
|
