While many consumer devices have lifecycles of 18 months, medical device developers often must deal with lifecycles in excess of a decade.
Imagine this nightmare scenario: you have placed a purchase order for your electronic medical device from your contract manufacturer (CM), and you get a phone call from that company's customer service representative who explains: "Several parts for your device are no longer available, so we will not be able to fill your last order placed with us. What would you like us to do?"
For many medical device developers, this is no hypothetical situation, but a very real occurrence in which few good options exist. Most people, when faced with this situation, likely faced with a stock-out condition for your product.
Because electronic components obsolescence is an unfortunate reality of our business, Enercon has developed a multifaceted approach to respond to this eventuality.
A Recipe for Obsolescence
Many electronic components have life cycles that are shorter than the life cycle of the end product itself. This is especially true for medical devices. While most consumer electronics have lifecycles of 18 months, 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 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 on 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.
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 re-certification with the FDA, and a revisit to the existing 510(k) submission or 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 (from groups such as EMI or 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.
The Risks of Purchasing Obsolete Parts from Brokers
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.
A Multi-Faceted Strategy
For new product developments, Enercon has adopted the strategy of identifying 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, 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 proactively run databases monthly using an automated process. 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.
- Redesign with more contemporary components.
If redesign is necessary, we recommend including design-for-manufacturability (DFM) activities and other cost improvement activities to help justify revalidation expenses
With careful planning and coordination, this product life cycle challenge can be successfully managed. By automating many of the processes to identify EOL, potential problems can be identified leaving enough time to identify the best course of action.
Larry Bell is vice president of sales and marketing at Enercon Technologies (Portland, ME).