News: Rochester Electronics
Extending product lifecycles for long-term medical device support
Breathing life into end-of-life medical device designs
B
iomedical 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.
6 July/August 2022
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.
Components in Electronics
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 per cent 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 per cent authorised 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 per cent authorised 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.
For more information visit:
www.rocelec.com
www.cieonline.co.uk
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60 |
Page 61 |
Page 62 |
Page 63 |
Page 64 |
Page 65 |
Page 66 |
Page 67 |
Page 68 |
Page 69 |
Page 70 |
Page 71 |
Page 72 |
Page 73 |
Page 74 |
Page 75 |
Page 76 |
Page 77 |
Page 78 |
Page 79 |
Page 80 |
Page 81 |
Page 82
