The ECG app on Apple Watch Series 4 marks the first direct-to-consumer product that enables customers to take an electrocardiogram right from their wrist, capturing heart rhythm in a moment when they experience symptoms like a rapid or skipped heart beat and helping to provide critical data to physicians. The irregular rhythm notification feature on Apple Watch can now also occasionally check heart rhythms in the background and send a notification if an irregular heart rhythm that appears to be atrial fibrillation (AFib) is identified. Apple worked with the Food and Drug Administration (FDA) for a number of years to receive De Novo classification for the ECG app and the irregular heart rhythm notification, making the features available over the counter.

a)Make a commercialized concept statement of the product discussed above, covering all the necessary requirements.

b)How much risk is involved in making and introducing this innovative product to the market? (Implement innovation risk matrix to support your answer)