When 'off-the-shelf' components aren't enough.
No matter whether the claim is authentic or not, adding "custom-made" to a product's description immediately elevates its status. "Custom electronics" carry even more clout in our increasingly digital-centric society. Eyebrows rise at the mention of these words because a specialized electronic component isn't some off-the-shelf mass-produced item for a humdrum everyday application--it was designed and manufactured for the out-of-the-ordinary requirement a customer has in mind for their device.
The medtech industry is already so highly specified in its own right that customizing a component any further seems redundant, and appears far too niche to generate significant business--but according to those operating within the industry, the market is actually quite vibrant. Healthcare delivery's shift from the clinic to the bedside has both miniaturized and fostered a new set of power demands for medical devices. In addition, personal health monitoring devices (both clinical and consumer) are proliferating due to patients taking a more proactive role in their preventative health and chronic condition management. Due to these trends--among other factors--several electronic component manufacturers have expanded their services to process custom requests, and the market is promising enough for some manufacturers to become dedicated providers of customized electronic components.
"Custom components and systems are a part of everyday life as a supplier to life sciences," explained Sam Ruback, product manager for Parker Hannifin Corporation's Precision Fluidics Division, based in Hollis, N.H. "We regularly do value add pumps, valves, and systems for both air and liquid. These are desired for miniaturization, customized for application and device to meet space and size needs, and aimed at helping with total cost of ownership. Quite often, the value add is based around integration, creating one subsystem and/or sub-assembly that can perform multiple functions by bringing components together."
"Our entire business is built around custom components," commented Steve Heckman, R&D manager for Roanoke, Va.-based Plastics One Inc. "The challenge for us is to convince potential customers of the benefit of a custom, proprietary connector design created specifically for their application versus a COTS [commercial off-the-shelf] commodity design. Custom design both allows the customer to tailor the design to their application or device, and just as important, it gives them control over the accessories market. In some cases, it would also limit liability as an inferior accessory cannot be used with the device without violating IP."
"We see a lot of custom requests for cord sets and power cords, for various lengths, colors, and custom labeling/packaging," noted Danny D. Ford, Jr., Oskaloosa, Iowa-based Interpower Corporation's technical support specialist. "In particular, one area over the last few years is for spring (spiral or coil) cords. Cords are a fundamental component for providing power for medical equipment. Equipment manufacturers look for cords that best serve the needs of the equipment and the user, though I'm not sure why coil cords are specifically called out. Also, a fair number of custom power distribution units--power strips--are seen. Often, these are desired to fit into certain applications based on size restrictions for given applications and for specific number of outlet positions."
Ford also spoke to the effect of the FDA's implementation of the Unique Device Identification (UDI) system to track medical devices through their distribution and use. UDI is currently in mid-rollout, with the next key compliance date looming on Sept. 24. He noticed that as a result of the initiative, "From a component/cord set standpoint, higher demand is coming from custom cords with UDI labels or custom labeling, with medical rooms identified so the cord stays in the room."
Minneapolis, Minn.-based Omnetics Connector Corp.'s director of technology, Bob Stanton, recognized a particularly interesting trend within his section of the industry. "Micro and nano connectors are in high demand for their adaptability to personal use medical devices, such as pain management, dental, and cochlear systems," he noted. "Medical electronic sensors and miniaturized modules are also being used more often. Micro and nano connectors are frequently attached to micro-cable that is highly durable and flexible. They are often customized to fit the specific applications, with ultra-thin overmolding for light weight and low profile design."
The Effect of the Digital Health Revolution
As Stanton and many other electronics manufacturers have begun to realize, the drive to develop specialized components can be seen as mirroring healthcare delivery's increasingly "personalized" strategy. Consumers are taking a more active role in personal health monitoring, and many technologies that were once relegated to the clinic are now possible to use at the bedside. Medical equipment migrating from the hospital to the home naturally involves a different approach to design--electronic component manufacturers must keep an eye on factors such as size, portability, and power limitations. The resulting shift in design and manufacturing strategy is transforming the electronic component market into a more complex and specified industry than has been seen before. This provides manufacturers with unique opportunities to corner electronics markets that didn't even exist five years ago. But as with any emerging industry, those seeking to reap the benefits must tread cautiously and consider every consequence.
"Because of the digital health revolution, market size of the electronic components has increased exponentially, and hence, calls for cost reduction," illustrated Kuldeep Tyagi, deputy general manager of Hyderabad, India-based Cyient. "The size and weight matters a lot now compared to a decade ago, and mHealth [mobile health] platforms on the mobile devices have become common now. The opportunity is that it has created a new industry within electronics to cater to the fast changing demand in healthcare compared to traditional industries."
"Consumer monitoring devices are spilling into the marketplace, [addressing needs] from blood oximetry to glucose monitors; podiatry machines fill the hallways next to blood pressure machines in drug stores," Stanton pointed out. But he also advised manufacturers not to be overly hasty in embracing the burgeoning market.
"Customization of electronic components for these kinds of devices is on the rise, but with a big impact on cost and price," he cautioned. "Customized electronics are often more expensive than using standard components. Companies must study their market and feel strongly about the business volume being high enough to return the expense."
Now that the rise of digital health has created a fairly flourishing market supporting custom component manufacturing, organizations are taking notice of the technological innovations made possible--and subsequently, the more attentive health monitoring and resultant treatments tailored to each patient's specific condition. These new strategies are expected to create both an opportunity and strain on manufacturers entrenched in the market.
"The digital health movement is having the effect of remote patient monitoring, which creates another power draw; power efficiency is even more critical here," explained Ruback. "Devices also have communication access to components, subcomponents, and systems--for functions such as status and condition monitoring."
While wary of the cost of the market shift, Stanton was enthusiastic about the abundance of possibilities the digital health trend brings. "The new low-voltage, high-speed digital chip technology supports the medical industry significantly," he said. "First, it allows microvolt signal detection and processing that was very difficult previously. Secondly, it dramatically increases the designer's ability to collect large amounts of digital data, compare that data to previous medical standards and/or previous conditions of a patient, and automatically decide on stimulation or alert signaling to medical staff. With digital coupling and Bluetooth methods, information can be constantly monitored on critical health conditions and transmitted to professional monitoring and care centers. Newer software and solid modeling systems allow medical designers the opportunity to customize both physical size and shape of sensing and interconnecting devices to fit within and serve the specific applications."
But not all electronic component manufacturers have been impacted by the revolution, especially those given a custom order without knowing which device the component will end up in. "We are not affected so much, in part because we often do not know much about the end-use of the component we might be designing," stated Heckman. "In addition, most consumer devices are part of the "race to the bottom" trend--low-cost is the most important attribute. Most products in this category will be built offshore."
A Customized Set of Challenges
A custom electronic component naturally requires a "custom" approach to its design and manufacture. As such, there are challenges specific to each organization across the spectrum of electronic components manufacturers, for which there are no "off-the-shelf" solutions.
"When customers request custom medical grade modules, these are the hardest to customize because of the number of components that could be included in a module, and for the fact that tooling always has to be made for new custom designs," said Ford. "Tooling is expensive and time consuming to do, and therefore dictates large minimum runs to warrant developing new tooling."
"Electric motors are our most challenging customization," noted Ruback. "This is mostly driven by the cost structure of a custom component versus standard part, and our loss of economies of scale. A similar impact can occur with control circuits."
So exactly how can medtech manufacturers address the engineering and manufacturing challenges required to develop a custom component?
"With today's software and modeling technology, we must first concede that customizing many parts of electronic products is much easier and faster than years previously," assured Stanton. "Computer chips, cable, and connectors are available in standard and commercial off-the-shelf formats. By choosing the closest design that is readily available, one can use fast-turn modeling to trim and change standard designs more quickly than beginning a program for full customization."
In the medtech world, "bigger is better" is not a strategy that many adhere to. In fact, the opposite is true for the ever-shrinking technology of the industry. However, it's not fair to say that the trend toward miniaturization is specific to medical devices; electronics in general seek to become less physically intrusive (quite ironic considering how pervasive some personal technologies have become). That said, shrinking medtech means proportionally shrinking components, which challenge manufacturers to consider every tiny detail in producing a custom option.
"For items like IEC inlets and modules, there are standards that affect the size of many components, and there can also be issues with finding components for filtering that are sufficiently small enough while still meeting desired ratings," remarked Ford. "For items like fuse holders, there are concerns with overcrowding of components around them. Fuse holders require sufficient space for ventilation to avoid heat rise issues, so it is very important not to place other heat creating components too close to them, which will affect performance, or to supply adequate ventilation and air flow to dissipate heat."
"One impact of miniaturization is the cost per component. The miniaturization can limit some of the internal space that could be needed to do a custom component," explained Ruback. "The good news is that we have bigger components as well; as we encounter challenges with our smallest components, we do have other components that sometimes sacrifice size for customization capabilities."
When strategizing the best approach to develop a component, Stanton addressed the importance of considering the fact that many devices using custom electronics will be on or in the body. "As we design more systems that can monitor neurological signals--from EEG to spinal detection points--we are trying to place signal acquisition probes and servers within or on the body near the signal origin," he explained. "Percutaneous interface materials, mounting and mating methods, and even physical reliability for high-use and motion areas are constantly challenging the tradeoffs of biocompatibility and ruggedness of interconnecting wiring."
Heckman added (presumably with somewhat of a chuckle), "Making smaller connectors is a challenge. As in many cases, the desired performance is reaching the limits of what materials are capable of achieving. However, overcoming such challenges is what engineering is all about."
Another challenge necessary to overcome in developing customized components for medical electronics is their interaction with a device's power architecture. In many cases, a complex device--such as a continuous glucose monitor with embedded analytics--will operate in multiple power modes and run software algorithms regularly.
"The challenge in power architecture for medical devices lies in how and what the device does," said Stanton. "When it is moving or assisting humans out in daily life, an easily charged battery pack system seems to solve most problems. Exoskeleton devices are using counter balanced elastomeric banding techniques to save power dependency to keep power demands low. Data processing and signal detection devices can be programmed for low percent duty-cycle monitoring on many types of devices, which significantly reduces the demand and greatly extends battery life from constant monitoring devices."
"Leakage current limitations are a key in medical electronics, for patient-connected devices," added Ford. "There are system limits that have to be met, and component considerations for items like transformers, filtered modules, and even wiring and cord sets/power cords are often vital to the system and need attention during the system design phase. Special low leakage devices, cables, and shorter lengths of wiring and cables are often important to design criteria."
"Common considerations in medical electronic devices include high efficiency, power on data line, and higher power-to-weight ratio," explained Tyagi. "Some of the other significant parameters to consider are power generation from an unconventional source (e.g., solar, Bio, etc.) and wireless power distribution. In developing power architectures for complex medical electronic devices, the main challenges are getting used to the lossy topologies and unavoidable use of passive components."
And let's not forget perhaps the most important factors in medical device (or most any device, for that matter) development--convenience and efficiency. "Portability is a significant power consideration, in making devices that are optimized for lithium batteries--that influences the voltage requirement," said Ruback. "Heat is also a consideration when designing to maximize efficiencies."
Looking to the Future
It doesn't look like the customized, personalized approach to either healthcare or electronic component manufacturing will disappear anytime soon. In fact, as the U.S. Food and Drug Administration (FDA) reviews and approves more consumer health technologies, there will be a corresponding greater need for customized components to support their specialized functions.
In his outlook on the future, Tyagi asserts, "the growth will be very high, and as the FDA continues to release guidelines for mobile apps and software, it will further fuel the demand to have small sensors and wireless capability. The USPTO [United States Patent and Trademark Office] has seen tremendous increase in patents to both the mobile healthcare and remote health industries so far, which use a lot of customized components."
As far as the types of technologies these custom components will end up inside, Stanton predicted that "Pain management, robotics or prosthetics, and neuromodulation appear to be the key high technology growth areas. Consumer products may follow, as cost controls and FDA approvals come along--though, a bit more slowly."
"Different custom made electronic components, like RFI filters, stepper and BLDC motor drives, and high-resolution image sensors, will be in high demand," anticipated Tyagi. "Devices such as MEMS [micro-electro mechanical sensors], nanotubes, and multicore microprocessor architectures are the future of medtech because of its trend toward miniaturization."
For better or for worse, in order to stay current, manufacturers must embrace the emerging market of customized electronic components in some capacity. It will certainly require a shift in manufacturing protocol--custom requests are less likely to be high-volume. There is a definite need for cost assessment as well, in order to account for the "customized" design engineering strategies, turnaround times, and regulatory concerns.
"Medtech is often spoken of as an industry focused on low cost equipment, but more often, we see high reliability and portability as the keys to equipment and devices in this industry," concluded Stanton. "Fast turn solid models for new designs of cable and connector systems can assist new designs and new electronic component systems. I would advise designers to look at current standards, and then adjust application-specific changes to those designs. This will keep costs and time to market down, and improve the whole development cycle of the system."
Many electronic component manufacturers have demonstrated the willingness to work with customers looking for something a little out of the ordinary that their project may require. In fact, the challenge the custom electronics business presents is one that some manufacturers are happy to take on.
"There are a wide range of customization value-add requests from customers with regard to difficulty or complexity," explained Ruback. "Some are quick turn around--like a custom connector or lead length--and others are much more involved, which impact the physics or electronics of the component. Call us; just because it's not on a data sheet doesn't mean we don't have it or can't do it."
Sam Brusco * Associate Editor
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|Title Annotation:||Custom Electronic Components|
|Publication:||Medical Product Outsourcing|
|Date:||Sep 1, 2016|
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