Market Strategy

Target Demographic: people over the age of 65

Using the Paul Merage Business School, we evaluate:

• Total Available Market (TAM)
• Serviceable Available Market (SAM)
• Target Market (TM)

At $40 profit per CardiGram:

• TAM: 617 million people worldwide over the age of 65 → $24 billion dollars
• SAM: 46 million people in the US over the age of 65 → $18 billion dollars
• TM: 2 million people in California over the age of 65 → $88 million dollars

Moving forward, mass production of our device will reduce the cost per wearable and will yield a higher profit.

Regulatory Pathway

The CardiGram is a class II medical device due it being non-invasive wearable. Class II medical devices pose minimal risk to the patient. When filing for FDA approval, CardiBeats will file for a 510K, justified by existing predicate devices that share the same intent and technological characteristics of detecting biometric signals. Our design does not raise any question over the safety and effectiveness in regards to its similarity in intent and function as the predicate. Upon filing, the device will undergo validation and verification testing, as well as clinical trials, to ensure quality and ethics are met. The CardiGram will be commercially available in the U.S. following FDA approval.