Hb Meter- Haemoglobin measurement product - medical devices

I am looking for someone to develop a Hb Meter that will provide accurate and reliable measurements of haemoglobin levels for professional, medical diagnostic use. The Hb Meter needs to be capable of delivering near 95% to 99% accurate results, so exacting standards of design and performance must be adhered to in order to meet this requirement. I have detailed specifications regarding the design and functionality of the Hb Meter that need to be incorporated into the final product. Therefore, knowledge in the technical aspects of medical device development is essential. The successful candidate will need to demonstrate experience of designing and engineering similar devices; along with the relevant qualifications and certifications. The right person for this project must be able to provide timely progress reports as well as a thorough final review of the Hb Meter before delivery.

Proof-of-concept (POC) for a cuvette-based Hb meter that you can consider as a starting point. require expertise in medical device design, biosensing technologies, and regulatory considerations.

System Design:

Determine the desired features and specifications for your Hb meter, such as accuracy, measurement range, portability, and user interface.
Select the appropriate cuvette format (size, material) for sample handling.
Identify the key components required, including a light source, photodetector, signal processing unit, and display module.

Sample Preparation:

Develop a method for sample preparation that can be easily performed by the user.
Consider finger prick whole blood nto the cuvette

Optical Measurement:

Choose an appropriate wavelength of light (typically in the visible spectrum) for Hb measurement.
Implement a light source and photodetector setup aligned with the cuvette.
Optimize the optical path to ensure consistent and reliable measurements.
Capture the transmitted or reflected light intensity from the sample.
Calibration and Standardization:
Establish a calibration process using known Hb standards to correlate the optical measurements with Hb concentration.
Develop a calibration algorithm that converts the optical signals into Hb concentration readings.
Implement a mechanism for periodic calibration to maintain accuracy over time.

Data Processing and Display:

Design a signal processing unit to convert raw optical data into Hb concentration values using the calibration algorithm.
Incorporate a display module to present the Hb measurement results to the user.
Consider additional features like memory storage, data export, or connectivity options, depending on the desired functionality.

Prototype Development and Testing:

Build a functional prototype based on the POC design.
Conduct thorough testing to validate accuracy, precision, and reliability of the measurements.
Iteratively refine the design based on test results and user feedback.

Regulatory Compliance:

Will be our responcibility.