Because of the growing emphasis on the Internet of Things (IoT), a large number of analysts see the healthcare market as one of the biggest opportunities for high-tech. As a specialist in the healthcare business, I certainly agree that the next major step for healthcare requires treating pathologies in the very early stages, what IoT technology will enable. Early treatments are usually easier, cheaper and maximize the chance for a complete cure. This is called P4 medicine — preventive, participatory, predictive, personalized. But this requires continuously measuring many parameters within our bodies. If we don’t want to live with our physician, we need to wear the necessary measurement equipment and this is where the new high-tech industry plays a role.
With more than seven billion potential customers, the high-tech industry quickly identified healthcare business as an opportunity to grow and to serve humankind. However, designing an electronic component to operate in a car or in the latest consumer electronic device is not the same as a component that directly interacts with the human body. Here are three recommendations that high-tech companies should consider before entering the medical device market.
- Consider the human environment from the earliest stage of the design process.
Because the device will be in regular or permanent contact with the human body, the body will absorb most of the RF energy emitted by the equipment. To avoid turning each wearable device into a small microwave oven that deteriorates our soft tissue, it is essential to model the interaction of the device in its human environment.
- Test the product with large cohort of “virtual” humans.
People are all different. It is risky to just consider the average body when testing because the size and thickness of different soft tissue layers vary within the population. In addition, the mass of muscle and fat as well as the electromagnetic material properties of tissues change with age. All these elements could dramatically influence the results of testing.
- Use engineering simulation results to gain regulatory authorities’ approval.
Today, regulatory authorities such as the FDA (U.S. Food and Drug Administration) recognize the value of engineering simulation to accelerate the approval process. Using the computer-based models of the recommendations above could save a lot of time and money during this approval process.
As most medical device companies are familiar with the cost-effective and safe approaches suggested in these recommendations, high-tech companies would be wise to partner with a medical device pioneer so that they can learn from each other and quickly deliver innovative solutions for our well-being.
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AirPROM (Airway Disease Predicting Outcomes through Patient Specific Computational Modeling) is a five year European project; it aims to produce computer and physical models of the whole airway system for people with asthma and chronic obstructive pulmonary disease. Using a model of a patient’s own airway system and simulating its functionality through software could help to improve diagnoses, treatments and outcomes for people suffering from these conditions.