The first area of concern is supply-chain readiness.
Medical device manufacturers will not only need to understand their supply chain in a post-RoHS world, but also their ability to provide evidence of RoHS compliance for all of the components, parts, and materials they ship. This is a key lesson learned from the consumer electronics world and is an often overlooked issue for companies in their initial planning for RoHS compliance.
An oversight in this area can also lead to significant financial losses, due to product inventory seizures and fines.
A preview of this financial loss occurred while many consumer electronics manufacturers were ramping up their RoHS compliance efforts leading up to the 2006 deadline. The Netherlands, which had a regulation banning cadmium in place by 1999, seized millions of gaming consoles and accessory packs worth millions due to cadmium found in some of the cables.
These situations can be avoided by a comprehensive supply chain verification exercise that addresses all aspects of the product and its packaging, not just the electronic components. In medical products, serious attention needs to be paid to the enclosures, connectors, interconnects, accessories, and mechanical support devices.
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Component suppliers that are unique to the medical device field or to a related industry that has not yet been affected by RoHS will also need to be evaluated. These suppliers may not have the skills and the knowledge to demonstrate full RoHS compliancy. It is critical to understand how these suppliers separate compliant materials from non-compliant materials to ensure the correct inventory segregation and prevent these supplies from mixing.
Of course, this leads to another area of concern, which is, what happens after product material changes are made.
Consumer electronics manufacturers quickly learned that changing to lead-free component terminations —as well as interconnect solders—had a significant effect on the product’s reliability in the field. These material changes led to greater brittleness of the resultant interconnect and an overall more fragile product.
To overcome this technical challenge, consumer device manufacturers moved to implementation of modified solder formulations, ultimately resulting in improved reliability.
For many consumer electronics OEMs, RoHS compliance also signalled a shift in manufacturing culture. For the higher end consumer devices, the emphasis on brand protection in terms of product reliability and cost-to-performance ratio were always important throughout the transition to RoHS compliance.
It is important to begin the conversion process early to prevent stockpiles of non-compliant inventory, which would be deemed unusable after July 2014. Using a partner with global presence and expertise in RoHS compliance practices can help get the process started and ensure medical device manufacturers can perform the required testing and evaluations well before the RoHS deadline.
Simin Bagheri, M.A.Sc., P.Eng. is the customer engagement lead for the engineering services division at Celestica Healthtech. She will be presenting this topic and the RoHS implications for materials selection in depth at MD&M West 2013 Conference, Feb. 11 – 14 in Anaheim, CA.