A new approach to medical device manufacturing – TechToday

Andy Selvy, senior systems designer at industrial heater manufacturer Watlow, explains why medical device manufacturing requires a new approach and where heating technology makes sense.

In light of COVID-19, healthcare organizations have been moving patients to home care settings when possible to reduce the strain on existing healthcare facilities. This has been a double-edged sword for medical device manufacturers as demand for certain home medical devices has surged, but it has also led to increased scrutiny and more stringent safety regulations.

Medical device manufacturing is a rapidly growing market. The UK is home to more than 3,000 device manufacturers and is the third largest medical device market in Europe and the sixth largest in the world.

Each component used to create a medical device must be built with patient safety, reliability, and efficiency in mind. Less known is the role heating technology plays in some of the most used medical devices.

From anesthesia delivery systems and respiratory therapy devices to blood and intravenous (IV) fluid heaters and transfusion equipment, heating serves a critical function in many medical devices. Without a heater, moisture cannot be added to breathing equipment, instruments cannot be sterilized, and fluids cannot be injected into the body to help stabilize body temperature after surgery.

thermal system safety

The IEC 60601-1-11 standard for medical electrical equipment requires manufacturers of home medical equipment to identify product safety hazards associated with use of the equipment in an uncontrolled environment by untrained users.

Although it is sometimes possible to meet safety standards using existing technologies, this increases both the bulk and cost of the medical device. Device manufacturers naturally want to make devices smaller, cheaper, and easier to use. This may conflict with safety compliance measures. This is where innovation in thermal solutions, including heaters, sensors, temperature controllers, power controllers and supporting software, can make a difference.

Many medical devices require heaters to warm gases or liquids, which requires significant amounts of power that increases the potential for leakage currents and thus the risk of electric shock. This is an example of how more stringent standards exist for home care medical devices and how evolving heating technologies can better meet them.

Unlike medical devices in a clinical setting, home medical devices cannot be designed with the assumption that there are skilled workers on site who can use tested outlets and equipment according to established procedures. As a result, safety precautions must be built into the device design itself.

One way to improve patient safety is to incorporate an isolation transformer to step down the voltage going into the device, such as the “bricks” used to step down the voltage in smartphone chargers. However, isolation transformers are notoriously large, bulky, and expensive, which runs counter to the miniaturization goals of home medical devices.

Safety vs. miniaturization

Ensuring safety without bulky and expensive technology begins with designing devices within a systems approach.

For example, it is not sufficient to create a heater that operates at 95 microamps leakage so that it can be integrated into a device that must operate at less than 100 microamps. These types of heaters meet the given specifications but account for the majority of heaters. Appropriate heater design of the overall thermal system within the available leakage budget must take these difficult system-level requirements into account.

Take a systems approach

New generation thermal solutions are being used to ensure safety and economy of space, especially in home hemodialysis and breathing units.

When choosing an industrial heating equipment manufacturer to support your medical device project, it is important to consider the company’s portfolio of industrial thermal solutions.

For example, in hemodialysis machines, the blood must be kept at body temperature to prevent thermal shock. Higher temperatures are also required to disinfect the machine itself.

Today’s home medical devices must comply with high safety standards while maintaining a compact, user-friendly and lightweight design. Achieving this requires strengthening devices using thermal components and implementing a systems approach to component design that makes them smaller, lighter, and more thermally efficient to improve patient usability and comfort.