Many electronic components have lifecycles that are shorter than the lifecycle of the end product itself. This is especially true for healthcare medical devices. For example, most consumer electronics have lifecycles of 18 months whereas many medical devices have a product life in excess of ten years.
Medical devices are typically not fitted with technology upgrades because of the high costs and/or long development times associated with the new product development cycle. There are often significant challenges to modify, upgrade and maintain their systems over the life of the device.
Many medical devices are "safety critical", and therefore require time-consuming and costly qualification and certification cycles, even for seemingly minor design changes. As a result, medical device OEMs are more focused on sustaining (manufacturing as well as servicing) their products for long periods of time (often 5-10 years or longer) rather than upgrading them.
Obsolescence issues occur when the “slow-to-change” medical device industry relies upon a supply chain that was originally and primarily developed to support a rapidly changing industry (such as consumer electronics). To compound the problem, the medical device industry typically has less control over their electronic part supply chain because they have relatively low production volumes compared to consumer electronics.
Medical Device Product Verification and Validation Requirements
To compound the component obsolescence problem, any change to a medical device design requires an evaluation related to product risk and performance. The change of a critical component would require notification and recertification with the FDA (and a re-visit to the existing 510k submission/PMA). Even a relatively straightforward change to replace something such as a touchscreen user interface would dictate new software, and therefore require third party testing (EMI, EMC), potential packaging changes, as well as subsequent verification and validation tests. In summary, the need to replace a critical component that goes obsolete can be extremely expensive from a resource and time perspective, as well as the cost ramifications of potentially gapping out supply of the product in the marketplace while a solution is secured.
With the obsolescence of a component, a suitable “drop-in” replacement may be possible. But much of the time, the mechanical packaging of that electronic component has changed, dictating a new printed circuit board layout, and therefore resubmission for EMI and EMC third party tests.
To avoid design changes, there is always the temptation to purchase obsolete components from part brokers. This brings with it the high potential for counterfeit parts to enter the supply chain. The components may look and appear to be the same, but the performance may be substandard or fail altogether in the field. At first, it could appear to be functioning properly, but in actuality may not be providing the validated performance of the original OEM component. If absolutely required, broker parts should be sampled for physical equivalence to validated components. This may not be necessary for consumer electronics, but medical devices are often safety critical, so additional verification testing (cost) must prove that the brokered parts come from the original OEM, and meet original parametric measurements. Medical device companies know well that a significant cost of doing business includes research of potential replacements, sampling, verification and validation.
For new product developments, we identify components that should be available for a long time. Using an integrated approach—combining available databases along with our internal processes, we identify the precursors to “End-Of-Life” (EOL) scenarios for components, such as a reduction in the number of sources, available inventory, and/or price increases. In addition, we avoid single source solutions where possible. If alternates exist, we work to validate these alternatives up front, and note the alternates on specifications.
For current production, we pro-actively run databases monthly utilizing an automated process. We have our program managers share any feedback to their customers at the earliest signs of obsolescence.
If we do identify EOL for components along the way, we develop a response strategy with the customer, which typically includes some or all of the following:
- Purchase additional inventory (life-time buy, last-time buy)
- Locate alternative components
- Prototype and validate alternatives
- Re-design with more contemporary components
If re-design is necessary, we make sure to include Design-For-Manufacturability activities and other cost improvement activities to help justify re-validation expenses
With careful planning and coordination with customers, we successfully manage this product lifecycle challenge. By automating many of the processes to identify EOL, we proactively work to identify potential problems with enough time to develop options. And with in-house engineering and product design expertise, we can provide customers with the best response solutions that fit their unique product requirements.
For more information, visit www.enercontechnologies.com.