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Medical Device Valuation:- A Reliability-Based Method

Medical device based startup valuation based on accuracy sensitivity specificity and robustness

Signal Capturing Devices

Just as we are continuously sensing visual, audio, smell, taste, touch, sensors(like IoT sensors are sensing such signals). Certain parameters are extracted from these signals.

Example:- A heart rate sensor captures either electrical signal or optical signal from the body, from which a HEART RATE parameter is calculated.

If the heart rate calculated from a new heart rate sensor, matches that with an existing sensor, then the device is called ACCURATE.

Biomedical Signal Processing : Biomedical Signal Processing

Acceptance of a Biomedical Signal Capturing Device

Accuracy is just the tip of the iceberg. Does the device remain accurate even when the source is abnormal? The sensing is performed essentially to detect such anomalies.

Example:-
Based on Anomaly detection, true & false positives, and true & false negative are obtained, from which the following is evaluated:-

If a new device has more than 70% ACCURACY, SENSITIVITY, SPECIFICITY, PRECISION, and RECALL, Then the device is ACCEPTABLE. If they are above 95% Then the device is Gold Standard.

Range and Resolution

The normal heart rate range is between 60-100 for adults, and for adult patients may be below 60 or above 100. So, the (minimum, maximum, and median) range of the parameter in which your acceptable device can operate is called the RANGE.

Every real data is continuous, and sensors samples the data at a certain frequency called the sampling frequency. The more samples are captured, the more processing overhead increases, and the cost goes higher. This factor of Cost of a gold standard device to that of a new device is called COST_FACTOR.

Based on various applications, (eg:- MI, surgical, patient monitoring, fitness, etc), the range is selected. A trade-off is made.

The ratio of Median of the range of the gold standard device, for a specific area of application, is called RESOLUTION.

Robustness

The sensors not only have sensitivity to the abnormality of the source, but also an environmental anomaly. For example, human temperature varies between 36’C – 40’C. Most heart rate sensors start malfunctioning in the cold temperature(due to low blood pH and constricted vessels). There are standard environmental conditions in which different devices are tested.

The fraction of sensitivity of your device in such physical condition, vs normal sensitivity is called ROBUSTNESS.

Peer Review:-

All these findings are to be documented through a standard test process and must be published in a peer-reviewed journal, where reviewers are the experts in the field, and their comment is your validation(not the publication).

VALUE =((ACCEPTABILITY+RESOLUTION+ROBUSTNESS)/3)/COST_FACTOR

VALUATION=(Annual Sales of Compared Device)x VALUE/(Number of Years of Business of the Compared device)

Final Note

You can simply put your metrics in journals and publish your valuation with use cases in a peer-reviewed business journal. Let reviewers value you for free, and you get the review report as a stamp of authenticity.


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Excell porn-based MBA valuation is nothing but a scam, whether one is some GHI banker or ABC Accountant. Most startups are science and tech-driven. The current valuation system has no affinity to either. Most have never published any peer-reviewed works of their valuation, and have never valued any early company in a public place for later scrutiny. Thus, there is neither any credibility attached to the methods, nor any challenge, nor contradiction.

Valuation is a science. And any science is quirk if it is not peer-reviewed. Anything that is not valuable, can’t be marketed, in anyways. If you are patient enough to diligently test your product, then people come to you for marketing rights. Because it means you care for your end-users and your future stakeholders. If you care for them, you will also care for money is a simple fact that every investor understands.

Business is not tricks. It is just discipline to create value in people’s life at more ease. The price of paper doesn’t prove your value. It is proven by the intention, which is proven by the process, which is proven by discipline, which is proven by data, and is validated by multiple different sources, and through thorough critic and review.

Passionate, Accountable Student for Life

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LEGAL DISCLAIMER All of the material on this site is intended as educational information only in regards to alternative, and personalized healthcare options available to healthcare consumers. The advice on this site is intended solely for informational and educational purposes and is NOT intended to replace your doctor. Please consult a medical professional if you have questions about your health.