Have you allocated enough time and resources to ensure your medical device manufacturing efforts are compliant with the new global Restriction of Hazardous Substances (RoHS) law?
The looming July 2014 deadline to comply with RoHS legislation will require medical device OEMs to remove a number of hazardous substances from the electronic components they use if they wish to ship and sell their products in Europe. This directive, which aims to reduce the environmental impact of electrical and electronic equipment, has already come into effect for manufacturers of consumer devices. Similar legislation appears to be on the way in North America.
With less than two years left to comply with the law, engineers and operations managers need to assess their organization’s RoHS readiness. More importantly, senior management needs to demonstrate their commitment and empower their teams to move the transition plan along and support the initiative with an appropriate budget.
In addition to senior executive commitment, a single dedicated owner responsible for the processes and infrastructure needed to ensure RoHS compliance is also essential. RoHS planning cannot take place in silos. Simply asking the supply chain team or operations team to take over the compliance program without a single point of contact is not advisable.
RoHS planning also needs to take into account the product development pipeline. Organizations need to develop a documented process to help not only assess the current compliance status of each medical device product, but also to ensure compliance to future products. This duty would probably fall to an organization’s dedicated RoHS owner, who needs to act as a subject matter expert who can monitor any future changes to RoHS legislation.
For example, device manufacturers will have to be aware of new additions or exemptions to the prohibited hazardous substances list.
For manufacturers that have just started, or plan to start, their RoHS compliance program, the good news is that it’s not too late to accomplish these key goals and meet the July 2014 deadline.
“For manufacturers that have just started, or plan to start, their RoHS compliance program, the good news is that it’s not too late to accomplish these key goals and meet the July 2014 deadline.”
But they may not be able to do this alone.
From our conversations with industry experts, we’ve found that many organizations that have decided to implement RoHS without a strategic partner have spent several years working on only the initial data collection stage.
Even if an organization is not inclined to outsource, the new challenges RoHS bring to the medical device industry require manufacturers to play catch-up. If a medical device maker wants to stay focused on innovating and building next-gen healthcare products, it is crucial they find a strategic partner that can quickly get them up to speed and help them develop a new process.
A strategic partner that has cross-industry expertise in implementing RoHS processes and infrastructure across a variety of OEMs can be invaluable to medical device manufacturers looking to build up their RoHS knowledge base. Many of the lessons learned from other industries, such as the consumer electronics sector, can in fact be applied to the medical device manufacturing.
Of course, the medical device industry has unique challenges and risks when compared to consumer electronics manufacturing. The inclusion of medical devices to RoHS was delayed because of the strict requirements for high levels of performance and safety in the healthcare industry. For instance, the lifecycle of a typical hospital-grade medical device might be 15 to 20 years compared to the one to three year lifecycle on a consumer smartphone.
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Factors such as reliability under extreme temperatures and constant mechanical stress mean products have to be extremely dependable. And the mere fact that a manufacturer is RoHS compliant does not mean the product will be reliable.
Without an experienced strategic partner, medical device makers risk changing their manufacturing practices so drastically to meet RoHS that their products might suffer the unintended consequences, such as battling with tin whiskers.
The industry is especially at risk today because many of the components used to make medical devices are now coming from the same pool of RoHS-ready components used by consumer electronics manufacturers. As those components have changed, the challenges associated with using them to assemble these crucial healthcare tools have changed along with them.
The impact of non-compliance may not only lead to a major financial loss, but may also open up a manufacturing organization to serious liability risks.
This is a risk that no medical device manufacturer can afford.
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.