Developing medical sensors compliant with global requirements

Many technology trends in the medical device market are global, including miniaturization, low power consumption and liquid media compatibility; however, materials compliance, product requirements, and cost issues can vary from country to country.

This translates into the need for sensor manufacturers to provide flexible and scalable product lines to meet global requirements. They also have to ensure quality of product and quality of supply. To meet the requirements of global medical device makers, sensor manufacturers need to consider four key issues - miniaturization, materials and regulatory compliance, supplier quality assurance, and service and support.

Miniaturization affects size, portability and weight

Medical device designers are faced with the challenge to develop smaller, lighter and more portable equipment to save real estate in patient rooms and to allow medical professionals to move equipment from room to room. Equipment that benefits from miniaturization includes infusion or insulin pumps as designs move from bulky to portable and ambulatory models.

By providing smaller size options, a sensor can be more easily integrated into space-constrained infusion pump designs, as an example. Small size and low power consumption helps improve a patient's quality of life by increasing the portability of the infusion pump.

There also is a trend by healthcare providers, particularly in the United States and the European Union, to transition patients from in-hospital care to home-care treatments. This also drives the need to miniaturize medical devices including respiratory and diagnostic equipment.

In some cases, miniaturization allows for some diagnostics to be built into networked medical devices to monitor a patient's care remotely. As a result, sensors that integrate multiple functions, such as temperature and humidity sensing, in a single package will be required. This will free up board space to reduce the size of the medical device or allow for higher functionality. Medical devices that can benefit from integration include respiratory therapy, including ventilators and sleep apnea machines.


Another way sensor manufacturers meet these needs is by developing sensor lines that offer a number of options for mechanical interfaces, mounting styles, packaging and I/O options. This allows medical device designers to select the right interface to help them reduce space, cut costs and eliminate the need for additional components. As an example, pressure sensors should offer multiple mounting options to accommodate placement in space-constrained applications, so the designer can position the sensor exactly where it needs to be for accurate and precise measurement. This is vital in applications such as dialysis treatment where accurate and precise measurement of the dialysate and venous pressure is critical to a patient's safety.

Particularly for portable applications, sensors should meet low voltage and low power requirements for longer battery life. They should also provide wake-up/sleep modes, so the device is not consuming any power until it's switched on again. Sleep mode can help extend battery life, reduce the size of the power supply, and thus the weight of the medical device.