DESIGN
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Due to the high costs and long lead time of product development and regulatory approval, profitability in the medical device industry depends on a manufacturer's ability to design and develop products that have a long lifespan in the marketplace. However, population demographics and the rapid pace of technological change drive demand among both medical professionals and their patients. Therefore, products with a long life expectancy are only desirable as long as they continue to assist medical professionals in providing superior patient care.
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(click to enlarge) This Compact PC/104-Plus single-board computer is designed for medical devices that require substantial processing power.
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Electronic patient diagnostic and monitoring devices are complex systems that consist of a variety of discrete components. To design effectively for a long product life expectancy, medical OEMs need to be sure that the components they are designing (or embedding) into their systems continue to be available for the predicted market life of the device, which can be 5–10 years after market approval.
Medical equipment manufacturers need vendors that understand that product longevity and process consistency go hand in hand. Responsive technical support is one of the most important services an embedded-component vendor can provide. These elements are essential to extending the life cycle of a medical device.
Mitigating Obsolescence
When designing electronic medical equipment, OEMs must plan a strategy that mitigates problems caused by the obsolescence of critical components. This is especially true when designing and specifying the embedded single-board computers (SBCs) that are at the heart of many critical diagnostic and monitoring systems. Such systems are often designed with two separate internal computers to provide redundancy and to ensure that equipment is up and running.
Because SBCs are designed as industrial-grade products, they must be guaranteed to have long-term availability. However, with some electronic components, the rapid pace of technological change, coupled with the industry's long product development and regulatory approval cycles, guaranteeing reliability can be problematic. A manufacturer may choose to make a component obsolete. This is especially true if a part is no longer useful for the market life of an electronic device.
Unfortunately, such obsolescence cannot be avoided. For a product to recoup development costs and command long-term profitability, manufacturers must choose an SBC supplier that practices effective component obsolescence planning. Proper obsolescence planning is a highly specialized skill that requires not only an intimate knowledge of the market, but also close working relationships with component manufacturers. SBC manufacturers that have developed the infrastructure and processes designed to address component obsolescence may be able to extend a board's lifespan.
OEMs can partner with SBC manufacturers in this obsolescence planning. Although no one can predict the point in time at which the market will no longer demand a particular device, OEMs can provide the SBC manufacturer with a target market life. This strategy is the basis for an ongoing partnership between the OEM and the SBC manufacturer to plan for component availability during this time span. If later forecasting indicates that market demand would surpass this target life, an OEM can inform the SBC manufacturer so that more-rigorous obsolescence planning can be done.
Embedded Computer Selection
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(click to enlarge) PC/104 modules such as this VCM-DAS-3 can add I/O functionality to single-board embedded computing medical applications.
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Industrial-grade embedded computers come in various sizes and are based on a variety of architectures and manufacturer chipsets. Products based on the x86 architecture have a long history of reliable performance that consistently reinforces their staying power in the marketplace. Of the products using the x86 architecture, there are a variety of form factors and approved standards. These boards include EBX, EPIC, PC/104 and PC/104-Plus, COM modules, Micro TCA, and others (see the sidebar, "Single-Board Computer Options").
OEMs that design products that require high levels of processing in a reduced footprint typically look to the x86 architecture because of its computing capabilities, longevity in the market, wide industry acceptance, and solid backing from major industry players such as Intel, AMD, and VIA. These low-profile, high-powered, industrial-grade embedded form factors continue to be supported. Medical OEMs are increasingly demanding more-robust, smaller, faster-processing, and lower-powered SBCs. However, x86 platforms can still be used in many medical device applications.
If a device has size constraints, an OEM might select one of the smaller form factors. For example, one of the PC/104 modules might suffice. If advanced features and performance outweigh size concerns, an OEM may prefer the EBX or EPIC form factors. EBX has more than three times the available board space as PC/104, while EPIC offers more than twice as much. This extra real estate is critical when implementing CPU designs using the latest-technology processors and chipsets, graphics, and sound capability. The additional space also enable the use of multiple I/O ports and connectors.
Suppliers working within the field of electronic medical equipment design and manufacture have a unique set of challenges and hurdles. Indeed, depending upon the type of product being designed, three to five years may be needed during the product development process for required foreign and domestic regulatory filings and approvals. Governmental agencies must ensure that regulations, guidelines, and CGMPs are met. In addition, they need to determine whether the benefits and risks will remain constant over the life cycle of the product.
Because of the involved regulatory process, time to market is often extended. Consequently, manufacturers often take a long time to recover development and regulatory costs. Therefore, medical devices need to have long-term viability in the marketplace. This need for long-term viability makes it increasingly important to have considered long-term support and life cycle management well ahead of time. Such planning should take place during the design phase.
Choosing an SBC Supplier
The ever-increasing density and functionality of today's commercial board-level products can compound the issue of product obsolescence. The number of parts that can become unavailable increases with the number of features, functions, and components that are designed into an SBC. OEMs that maintain a close working relationship with their SBC vendors can be alerted of any changes early and can work with them to secure components to meet estimated future demands. In addition, OEMs can work with their SBC vendors to develop a component obsolescence plan to help mitigate the risk.
The OEM and the SBC manufacturer should undergo long-term planning and migration paths, which will help equipment developers plan for the device's future. In addition, responsible OEMs will qualify SBC manufacturers on whether they have multiple component suppliers. SBC manufacturers that make a point of having multivendor component suppliers in the life cycle management process are more likely to be able to reliably supply the embedded computer for the length of time required.
It is also important for an OEM to examine the fit between its company processes and philosophy and its supplier's business model. Criteria such as financial stability, manufacturing process control, understanding of regulatory hurdles, manufacturing capacity to meet demand, product quality and reliability, and reputation for on-time delivery and quality of service and support are all important factors that should be considered in the selection of a SBC supplier. Selecting appropriate products requires the selection of appropriate vendors that will honor their commitments and agree to adapt, customize, and upgrade their products to meet the needs of the OEM.
In some cases, an off-the-shelf product may not meet OEM requirements for performance or ruggedization. In such cases, the OEM will want to select an SBC vendor with experience and expertise in customizing their off-the-shelf products.
Typical customizations include application of a conformal coating for protection from humidity, installation of custom I/O connectors, custom BIOS development, and battery removal, among others. Such a customized product can provide substantial cost savings to the OEM versus a fully custom product. If, however, a fully custom product is needed, many SBC manufacturers are also experienced in designing products specifically for an OEM's particular application.
Conclusion
To deploy off-the-shelf products in a medical application that expects an extended life cycle, the areas that should be considered by a medical OEM include proper selection of products, long-term product availability guarantees, early component obsolescence planning, product quality and reliability, and overall fit and comfort with the SBC supplier's processes and business practices. With the right choice of SBC technologies and the use of vendors that offer open standards and have the support of multiple vendors, a medical equipment designer can realize low cost of ownership, good performance, extended deployment, and maximum profitability in its medical device.
