Breathing life into end-of-life medical device designs
Biomedical devices are categorized 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; and Class III/IV devices which are 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 end-of-life 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 you do to mitigate the risk long-term?
Component end-of-life, 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 ICs require special conditions. While 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 and SUPPLY.
As the COVID-19 pandemic took hold, there was a sudden and unpredicted DEMAND for Ventilators. Component stocks at the mainline distributors were quickly consumed, and when the semiconductor suppliers themselves were unable to increase capacity, a critical supply gap soon developed. While authorized after-market suppliers such as Rochester Electronics were immediately able to offer risk-free stock, demand quickly outstripped even this supply route.
Approving alternative IC sources, or a full product redesign was out of the question given the re-qualification timescales. This is especially true where component end-of-life also impacts software performance.
To bridge the supply chain gap, Ventilator manufacturers looked to breathe life into discontinued systems to fulfill this critical need. By using previously approved ICs such as older die iterations, or by completely resurrecting older system designs, Ventilator production was able to continue.
As a 100% Authorized distributor, Rochester Electronics are the trusted source for all discontinued semiconductors after end-of-life. Fully within the authorized bubble and stored under AS6496 conditions, Rochester’s stock provided an immediate risk-free source of supply.
As a licensed manufacturer, Rochester was also able to re-start production of several key components using our 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 100% in compliance with the original specifications. No additional qualification is required.
Rochester Electronics remains fully operational throughout the pandemic and were able to provide a long-term supply and manufacturing solution to one Ventilator Customer for their core 32-Bit MCU need (MC68040) more than 6 years after the formal Freescale discontinuation.
Similarly, supply issues over the last 12 months have undermined the normal delivery certainties. COVID-19 related manufacturing, shipping disruptions, and even unexpected natural disasters have led to supply chain uncertainty and lengthening lead times. Component discontinuation notices have risen by 15% over the same period, as 3rd party fab priorities have changed, and the industry refocuses its fab investments to address a lower powered battery dominated landscape.
It has never been so critical for companies in the medical sector to:
- Insist on the maximum number of cross-references from the design phase onwards.
- Plan component purchases further in advance.
- Consider carrying more inventory of critical semiconductors.
- Monitor critical lead-times and component lifecycles regularly.
- Understand supply risks and prepare dual/multi-sourcing strategies to cover all eventualities.
- Partner with a 100% authorized supplier to help manage and maintain consistent longevity of supply
Rochester Electronics' focus on providing a continuous source of semiconductors aligns strongly with the long lifecycle requirements of equipment manufacturers. Rochester provides 100% authorized stock of active and end-of-life (EOL) devices from over 70 leading semiconductor manufacturers. As a licensed semiconductor manufacturer, Rochester has manufactured over 20,000 device types. With over 12 billion die in stock, Rochester has the capability to manufacture over 70,000 device types. We provide an instant risk-free source for:
- Shortages and extended lead time parts.
- Ongoing supply to support the need for additional discontinued parts - including EOL packages, such as plastic DIP/QFN etc.
- Rochester manufactured RoHS equivalents to previously non-RoHs ICs.