The quality and reliability of electronic equipment is vital for every industry, but it is especially critical in the medical industry where human life and safety depend on equipment operating as intended. This formidable responsibility not only impacts the device manufacturer, but the suppliers of every enabling component.
Current medical market trends driving collaboration between medical device and connector manufacturers include increased demand for safety and regulatory compliance, lower-cost disposable solutions, higher-resolution imaging capabilities, and enhanced durability.
Device manufacturers rely heavily on their connector manufacturer partners to deliver solutions that will effectively drive their most innovative product designs while also meeting size, cost, performance and compliance demands. Connector suppliers often draw upon their experience in other areas of the diverse medical device industry, as well as in other connector-critical market sectors — including the aviation, aerospace and automotive industries — to overcome challenges and enable the next-generation of medical devices.
Improved safety and regulatory compliance
The integration of additional features and functional capabilities means these devices are more susceptible to the effects of electrostatic discharge (ESD). Although static shocks are a widespread phenomenon, they can be hazardous in medical environments — causing software to freeze, reboot or malfunction, damaging delicate circuity, or even shocking patients and operators. As a result, the International Electrotechnical Commission (IEC) nearly doubled its ESD performance requirements in the fourth edition of the IEC 60601-1-2:2014 standard, which was published in 2014 and required global device compliance by Dec. 31, 2018. The minimum voltage that a panel-mounted receptacle must withstand is now 15 kV, measured from the receptacle housing to the internal electrical contacts, which represents a dramatic increase from the 8 kV minimum mandated by the previous edition of the standard.
To address new project developments with challenging connectivity demands, plastic REDEL SP series connectors are recommended. They offer advanced features including eight additional high-density electrical contacts in the same small form factor and a tested ESD resistance of 25 kV, which not only meets the new IEC standard, but also provides medical device designers plenty of room for future-proofing designs. For current applications that require backward compatibility, the popular REDEL 1P series plastic achieved an ESD rating of 13 kV, which is well over the incumbent standard, but still slightly short of the new one. LEMO USA’s engineering team quickly identified an elegant solution: by simply adding a thicker dress nut to their connectors, customers can meet the demands of the new standard without a costly redesign.
Lower-cost disposable solutions
Coupled with the longstanding desire for lower-cost medical solutions is an increasing trend toward disposable devices. Medical manufacturers are constantly imbuing their products with new and better capabilities to keep pace with market demands and remain competitive in a densely populated marketplace. Consequently, the significant cost constraints levied against disposable components present a real engineering challenge, especially since these devices still require advanced performance capabilities even though they will only be used for one procedure and then discarded. For example, the demand for higher-resolution imaging and mapping capabilities requires higher-density electrical contacts, but imaging equipment is one of the many medical device segments increasingly employing disposable devices. So, connector manufacturers must come up with creative solutions for minimizing cost while simultaneously enhancing capabilities.
Minimizing cost is an even greater concern in disposable medical applications than in reusable devices that can be readily sterilized many times. From the connector manufacturers’ point of view, the properties that cannot be compromised — like operating performance and reliability — must remain unchanged, while all those that can — like longevity — must be analyzed for potential cost-saving opportunities. Strategies include using high-quality but lower-cost materials that might be less mechanically or chemically robust than those employed in connectors designed to withstand thousands of steam cycles and mitigating the use of high-cost materials such as reducing gold-plating thickness.