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Medical Device Interconnects Must Address Harsh Environments

Wed, 07/20/2011 - 9:44am
Anthony Kalaijakis, Molex Incorporated, www.molex.com
Technology advances in electronic consumer devices and the telecommunications industry are converging at a rapid rate with medical device technology. For example, the medical industry now embraces membrane switches from the appliance industry and relies on cell phone interconnects within portable medical monitoring devices. In addition, super-precise surgical tools have been further improved by combining advanced fiber optic and interconnect design technologies.

Converged technologies like these have not only greatly enhanced the ability of healthcare professionals to provide direct patient care in clinics and hospital settings but have also helped monitor patient conditions remotely. In today’s interconnected world, it is not unusual for healthcare professionals in Boston to consult with other healthcare professional in Los Angeles or around the globe. Increasingly, mobile communications are being used to monitor and coach patients with chronic conditions like diabetes.

Healthcare reform has also stimulated integrated approaches for patient diagnostics and real-time patient monitoring. Today’s telecommunications systems provide the super highway for managing digital information as illustrated by Picture Archival and Communications Systems (PACS). PACS brings the power of networking to medical diagnostics by improving efficiency and reducing errors.

ec1106mc103Fig1But as medical device manufacturers further improve existing products and bring new products to market that take advantage of the latest technologies, engineers face conditions unique to the medical industry that make designing and manufacturing more challenging. This is particularly true in the current economic climate—where the pressure is on to deliver healthcare more cost-effectively. Whereas medical interconnects have traditionally been supported by specialty manufacturers, industry trends are increasingly leaning towards standards from other industries, such as consumer electronics and telecommunications.

When developing medical devices, manufacturers must consider durability and reliability to a greater degree compared to the consumer and telecommunications market. That’s because medical devices are expected to last for many years, and in cases where devices are invasive to the human body, they must perform consistently in relatively harsh environments. This is a real challenge because it relates to the use of industry-standard interconnects in the medical environment, where the form factor may be correct, but the materials and lifecycle may not match.

The need for “modified-off-the-shelf” (MOTS) interconnects is a compromise of taking existing technology like a micro HDMI connector used in home audio/visual devices and perhaps ruggedizing it with different plating or retention features for use in medical devices. MOTS is where there is significant value for both the device designers and the interconnect providers, whereas using prior art at an 80 percent level, for example, can replace the need for a custom interconnect. When considering MOTS, it is beneficial to work with the company’s application engineers to indentify the risks and benefits of a particular interconnect solution.

The caveat is that many healthcare devices are attached on or into patients. In these cases, many medical device designers also face the extra challenge of providing functionality within small spaces with biocompatibility. Micro engineering must conform to the need for devices such as pace makers and hearing aids to fit as comfortably as possible within the human body. Again, the form factor could be in the correct scale, but biocompatibility and handling ease become the principle drivers. Due to the unique needs of the medical device market, there will always be a level of customization that requires a detailed specification (SPEC). SPEC driven applications can benefit from previous designs from other industries with adjustments to the medical application requirements.

Thus, a key consideration for device manufactures is the choice of interconnects that make it possible to reliably transmit data, signals, images and power. The effectiveness of healthcare devices relies heavily on the underlying electronic interconnects with robust design and engineering that enable devices to perform as expected.

For medical devices, the interconnects must have secure contacts with high mating cycles, long lifetimes and durable materials to survive the rigors of everyday use in environments that can include a variety of fluids. Devices must also take into account possible accidental physical interference, such as hospital carts running over cables. In addition, interconnects must meet many other challenges and requirements — including tight signal integrity tolerances; a high number of mating and actuation cycles; and reduced losses due to resistance, stringent electromagnetic interference, radio frequency and crosstalk characteristics.

When choosing interconnects for medical devices, it helps to work with a manufacturer that has proven expertise in developing connectors that perform in harsh environments from other industries such as chemical, solar, manufacturing, pharmaceutical, military and telecom. These industries require some of the same rigorous attributes that the medical device industry requires, and manufacturers with experience in developing interconnects for such conditions typically offer a range of connector platings that ensure durability.

Key Medical Device Interconnect Attributes 
• Reliability to consistently provide precise results 
• Durability to last under harsh conditions (including sterilization) for many years 
• Miniaturization for portability and easy fit within small devices 
• Flexibility for folding/bending and routing 
• Integration with other medical devices and systems 
• Easy disconnection capability for cleaning or disposal 
• High speed copper and fiber-optic transmission for PACS

Working with medical device interconnects that feature all of these attributes is now more important than ever because of the critical nature of medical device performance. As electronics advance and merge, it is critical that the risks and benefits of interconnects be assessed with the device designer. Failure of a heart monitor, for example, carries much greater risk than failure of a smart phone or a router handling consumer phone calls.

And with the rising cost of healthcare significantly changing how patients receive treatment, and with in-home care becoming more common, the demand for smaller and portable medical equipment is likely to increase sharply in the coming years. Medical design firms will need to choose their interconnects wisely in order to meet this need effectively.

About the Author
Anthony J. Kalaijakis is Strategic Medical Marketing Manager for Molex Incorporated, a global leader in the design and manufacture of electronic, electrical and fiber optic interconnect systems. For more information, visit Molex at www.molex.com.
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