Medical device manufacturers can overcome challenges of EU regulations
Four years of political negotiations are expected to reach a conclusion in the coming months as the European Council finalises its position on reforming legislation surrounding medical devices. For the NHS and other medical institutions, the impact is likely to be significant due to the introduction of second-level checks. This extra layer of quality control will extend the time it takes for potentially life-saving devices to reach patients.
According to Martyn Gill, Managing Director for EMEA at InfinityQS International, it has never been more critical for medical device manufacturers to have an effective quality system to adhere to these new standards. In line with the Council's proposals, software, physical instruments, apparatuses, appliances, and implants would all qualify as medical devices and fall subject to new safety and performance requirements. Gill suggests that these universal standards, more stringent than many of the current standards in place with individual EU countries, will force many manufacturers to adapt to higher standard of quality control.
“The most important feature of the new legislation for manufacturers is the introduction of the new expert group (the Medical Device Coordination Group), which will have the power to review and comment on medical devices before they are put on the market. Every component of a device will be checked, requiring increased visibility across the entire enterprise and supply chain.”
Gill continued: “Medical device manufacturers will have to register themselves, and the devices they place on the EU market, in a central database and fit their products with a unique device identifier to ensure traceability. This new, post-market surveillance system holds manufacturers responsible for ensuring the quality, performance, and safety of all of their devices. Beyond this approval process, the new regulations create complications for medical organisations’ preferred supplier agreements. In the event that suppliers are unable to reach the level of quality/consistency that the new body demands, medical organisations will be forced to cancel these preferential arrangements and look elsewhere for their components.
“Fortunately, the new regulations would go into effect three years after the entry into force, so manufacturers have time to prepare. The best approach is to implement a more effective quality management system, which can, among other things, track exactly where errors occur so they can be resolved quickly. In addition, the new standardised regulations will require quality across the supply chain to be monitored. By using a centralised quality control system, medical device manufacturers can attain full visibility across all production facilities and into supplier operations. This prevents situations in which errors in one plant cause an entire line of devices to be subject to review.”
Gill concluded: “Though the adoption of the new standards will likely be arduous, medical device manufacturers can address and overcome the challenges that arise with the right technology and processes. End-to-end visibility of the product lifecycle will be the key to confidently complying with the new requirements.”
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Ultium Cells LLC/Li-Cycle: Sustainable Battery Manufacturing
Ultium Cells LLC - a joint venture between General Motors and LG Energy Solutions - has announced its latest collaboration with Li-Cycle. Joining forces the two have set ambitions to expand recycling in North America, recycling up to 100% of the scrap materials in battery cell manufacturing
What is Ultium Cells LLC?
Announcing their partnership in December 2019, General Motors (GM) and LG Energy Solutions established Ultium Cells LLC with a mission to “ensure excellence of Battery Cell Manufacturing through implementation of best practices from each company to contribute [to the] expansion of a Zero Emission propulsion on a global scale.”
Who is Li-Cycle?
Founded in 2016, Li-Cycle leverages innovative solutions to address emerging and urgent challenges around the world.
As the use of Lithium-ion rechargeable batteries in automotive, industrial energy storage, and consumer electronic applications rises, Li-Cycle believes that “the world needs improved technology and supply chain innovations to better recycle these batteries, while also meeting the rapidly growing demand for critical and scarce battery-grade materials.”
Why are Ultium Cells LLC and Li-Cycle join forces?
By joining forces to expand the recycling of scrap materials in battery cell manufacturing in North America, the new recycling process will allow Ultium Cells LLC to recycle cobalt, nickel, lithium, graphite, copper, manganese and aluminum.
“95% of these materials can be used in the production of new batteries or for adjacent industries,” says GM, who explains that the new hydrometallurgical process emits 30% less greenhouse gases (GHGs) than traditional processes, minimising the environmental impact. Use of this process will begin later in the year (2021).
"Our combined efforts with Ultium Cells will be instrumental in redirecting battery manufacturing scrap from landfills and returning a substantial amount of valuable battery-grade materials back into the battery supply chain. This partnership is a critical step forward in advancing our proven lithium-ion resource recovery technology as a more sustainable alternative to mining, " said Ajay Kochhar, President, CEO and co-founder of Li-Cycle.
"GM's zero-waste initiative aims to divert more than 90% of its manufacturing waste from landfills and incineration globally by 2025. Now, we're going to work closely with Ultium Cells and Li-Cycle to help the industry get even better use out of the materials,” added Ken Morris, Vice President of Electric and Autonomous Vehicles, GM.
Since 2013, GM has recycled or reused 100% of the battery packs it has received from customers, with most current GM EVs repaired with refurbished packs.
"We strive to make more with less waste and energy expended. This is a crucial step in improving the sustainability of our components and manufacturing processes,” concluded Thomas Gallagher, Chief Operating Officer, Ultium Cells LLC.