Facing skyrocketing costs, healthcare providers are turning to mobile technology to improve the efficiency and quality of care, particularly PDAs and smart phones. Yet the primary impediment in delivering this technology is the disparity between consumer product lifecycles and medical device lifecycles.
The CPUs, memory, communication chips, and LCDs in cell phones, media players, and so forth have a market lifetime measured in months. Their suppliers typically are eager to move past their current product and retool for the next generation within a season. However, the approval cycle alone for a medical device can take years. Bridging this gap is a significant exercise mandating changes to the supply chain.
Interestingly enough, the most challenging technologies to build into long-lifecycle medical devices are often the commodity specified technologies like USB, 802.11, TCP/IP, and, of course, the operating-system application programming interface (API). As difficult as these development efforts might be, they have little to do with the core sensor, diagnostic, and software technologies that give the device value.
Typically, the best approach for medical device design is to split the project. Let one team focus on the core, and then get a specialized supplier to design, build, and supply the commodity platform. Designing a cost-effective commodity platform and keeping it available in the market for a suitable period requires specific business processes not shared by commodity commercial off-the-shelf (COTS) suppliers.
FIVE STEPS TO SUCCESS
OEMs can take advantage of
five techniques to achieve a longer useful product lifetime in
the market.
First, companies can use radical fast-turn design methodologies, including adapting proven designs in lieu of ground-up development. The fastest design will incorporate medical industry requirements from the beginning. These can include regulations for bill of materials (BOM) control (CFR 510K regulations, ISO 13485), HIPPA-mandated security (FIPS140-2), and standards for wireless (LEAP, PEAP, CCX).
Second, designs should start with beta silicon and software so they can be completed for integration and federal Food and Drug Administration testing as soon as the silicon is released for sale, guaranteeing maximum lifetime in the market. Getting into beta programs requires investment in long-term supplier relationships.
Third, the full supply chain needs to adhere to the rules requiring update notification to controlled BOMs and software. There is no "COTS" loophole for embedded systems analogous to the rule that lets approved software migrate across generations of PCs.
Fourth, every supplier in the chain must buy into the expected lifetime of the product. It can be especially challenging to find LCD and wireless communications suppliers who are willing to supply a particular part for the product lifecycle of a typical medical device. Software in particular always is an issue. It's notable that Microsoft offers 10 years of guaranteed product availability and maintenance.
And fifth, lifetimes can be extended at the beginning by starting with proven designs and beta silicon and software. Yet it's usually necessary also to extend it some measure at the end via lifetime buys. Medical device OEMs should plan for end-of-life (EOL) stock holding as the product starts up. Distributors who know they are the sole source for an essential part can be quite merciless in their pricing if they're approached late in the cycle and asked to hold stock past EOL shipment.
WORKABLE LIFETIMES, SAVING LIVES
Mobile and
embedded technology will be driven by ever faster consumer
product lifecycles. There are good reasons why the regulations
surrounding medical device design don't allow faster approval.
This means that the project tradeoffs and design principles used
in this generation of medical devices must adjust to allow workable product lifetimes in the market.