Cover story
Breathing life into obsolete medical device designs
Semiconductor obsolescence presents a serious challenge to the support of Biomedical products with long in-service lives and committed maintenance periods. In this article Ken Greenwood, Technical Sales Manager, Rochester Electronics discusses how companies can mitigate this risk and ensure certified and original long-term availability.
N
ow more than ever, the demand for high-quality, precision components continues to skyrocket. We at Rochester are always working to provide you with the deliverables you need, in the time frame you need, no matter what your requirements are. Biomedical devices are categorised in terms of
risk to the patient. Class I devices with low/moderate risk to health; Class II intermediate risk equipment such as Ultra/CT scanners; & Class III/IV devices critical to sustaining life such as dialysis equipment and pacemakers.
As the risk to patients rises, so do the certification costs (IEC60101-1, ISO13485, FDA-21CRF-Part807, and others). Original designs need to be maintained “as-is” for as long as possible. Semiconductor obsolescence presents a serious challenge to the support of Biomedical products with long in-service lives and committed maintenance periods.
It is not uncommon for large medical systems to have a concept-to- EOL lifecycle of 20 years, including in-service support. By contrast, semiconductor lifecycles continue to shorten especially those of the key Processor/FPGA/Memory components. It is inevitable that a supply gap of some kind will need to be bridged.
What can a customer do to mitigate the risk long-term?
Component obsolescence, which is foreseen, might be undesirable, but it is generally manageable, at a cost. Typically, Customers commit to a last-time-buy of finished components and the safe long-term storage of the semiconductors - often through a third party because the storage and handling of IC’s requires special conditions. Whilst this solution ties up cash in long-term component and storage costs, at least precious design and qualification resources are spared. Where future demand exactly matches last-time-buy supply, this is a perfectly adequate solution. However, as the current market conditions demonstrate - “Circumstances” can change – both in terms of DEMAND & SUPPLY. Whilst demand quickly outstripped most supply routes, authorised
after-market suppliers such as Rochester Electronics were able to offer risk-free stock.
Approving alternative IC sources, or a full product re-design was out of the question given the re-qualification timescales. This is especially true where component obsolescence also impacts software performance.
In an effort to bridge the supply chain gap, Ventilator manufacturers looked to breathe life into discontinued systems to fulfil this critical need. By using previously approved IC’s such as older die iterations, or by completely resurrecting older system designs, Ventilator production was able to continue. Authorised After-Market Suppliers such as Rochester Electronics are the trusted repository for all discontinued semiconductors after end- of-life. Fully within the Authorised bubble and stored under AS6496 conditions, Rochester’s stock provided an immediate risk-free source of supply.
As an Authorised After-Market Manufacturer, Rochester was also able to re-start production of several key components using its expansive store of wafer and die. When a component is discontinued, Rochester often receives all remaining tested wafer and die (KGD), the assembly processes, and crucially the original test IP. This means that previously discontinued components are still available newly manufactured, and
06 June 2021
www.electronicsworld.co.uk
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