By Matt Dharm, JumpGen Systems
It happened again: After screening multiple vendors, the computer hardware you've selected to use in your new medical device project is discontinued shortly thereafter. You're left thinking: There has to be a more efficient, long-term solution to getting the components you need.
Medical equipment manufacturers face unprecedented pressure in managing the supply-chain and fulfillment process. They must develop and commercialize innovative products faster at lower costs than ever before while remaining in compliance with increasingly stringent regulatory standards. On top of this, they need to make sure their devices are durable. It follows that having reliable partners in the supply chain is crucial to a medical program's success.
Complicating matters is the fact that obtaining the off-the-shelf hardware parts needed for your device can be difficult, as the vendors offering them may simply intend to limit or end support for the product.
Finding new computer hardware components can also be tough, as revalidation requirements are tedious. Nevertheless, it's become an acceptable difficulty of doing business. As in other industries, medical equipment manufacturers often outsource to fulfill both core and non-core functions within their product life cycle.
It's time to take a new tact: Contract with an outside vendor to custom design and manufacture your embedded computer hardware and I/O modules.
But what should you be looking for in such a vendor? Here are some tips to help you out:
1. Are they really offering better performance?
The purpose-built design approach allows improved performance over off-the shelf products. You only pay for features you need and can define the size, power limitations, and I/O--meeting all the requirements of today, while providing plug-in or enhancement options for the long term.
2. Make sure there's extended lifespan.
The selected engineering firm will manage the product life-cycle for an extended lifespan, designing in the ability to substitute like-components without affecting final product functionality. Minor revisions to accommodate changing components are easier to manage than validating an entirely new vendor or off-the-shelf part.
3. Be skeptical of claims.
Medical device manufactures frequently have to make decisions about unfamiliar hardware technologies. As they survey the marketplace for custom hardware development, program managers often rely on information from self-interested hardware vendors, or conventional wisdom. But keep this in mind....
4. Bigger is NOT better.
The notion that a large corporation would be able to custom-build a product more cheaply than a smaller company is completely off the mark. Big companies have bigger expenses and often more cumbersome procedures. As such, big companies typically require a large upfront commitment. However, not all embedded product manufacturers demand high-volume orders. A smaller, more eager firm has more flexibility to competitively price a customization job.
Another assumption is that bigger corporations offer more robust support. However, most of the time all you really get is a big headache when something fails; you have less leverage with a big company concerning a non-standard product.
5. Make sure there's a technology agnostic approach.
Look for a quality-conscious, technology agnostic company that houses expert hardware engineers with active relationships/experience with leading technology silicon vendors. They will possess healthy and latest knowledge regarding next-generation processors and technology components. While some vendors attempt to modify their existing designs to accommodate an aggressive delivery schedule, pick a company with a ground-up design approach and agile development. As projects progress, other needs may pop up (i.e. specialized testing and additional validation fixtures), and you want to be able to rely on their engineering expertise to fill in the gaps. Once a project is rolling, it is very difficult to validate another vendor without delaying the entire project.
6. Make sure there's access to the engineers.
Select a company that offers direct contact to their engineers from cradle to grave on your program, which is especially important if you put a high priority on design quality and schedule. Thoughtful technical design discussions evaluating the trade-offs of the latest technology available early on in the vendor evaluation will translates to a fast turn-around in prototype delivery.
|Refresh your medical device industry knowledge at MEDevice San Diego, September 10-11, 2014.|
7. Are manufacturing services part of the package?
Hardware development is a specialized field and only experienced people can handle it. This is the reason why you can find various companies offering custom hardware development--but only a few are able to provide manufacturing services as well.
As you go through your embedded hardware validation process, look for a company with both design and manufacturing capabilities, that has tried and true product lifecycle management procedures in place, employing strict production and quality practices.
Matt Dharm is chief technology of Carlsbad, CA-based JumpGen Systems, which uses the latest technologies to provide hardware platforms designed from the ground up. JumpGen touts its purpose-built design and manufacturing services as a route to best-in-class embedded hardware and single board computers.