Company insight Keeping it hot
Thermal control is crucial across a range of medical devices – but from regulation to safety, integrating this technology isn’t easy. Medical Device Developments talks to Andy Selvy, the chief system designer at Watlow, to explore the scale of these challenges and consider how securing talented external support can help.
F
rom dialysis to oxygen therapy, many medical procedures would be impossible without efficient thermal control. But between safety concerns and the difficulty of integrating heat technology into complex power and software components, OEMs risk spending too much for too little gain. But by leveraging external expertise, manufacturers can ensure their thermal systems work seamlessly – as one global company is proving.
Few people are better suited to reflect on the importance of medical device thermal control than Andy Selvy. A two-decade veteran at Watlow, he’s now a chief system designer at the company, headquartered in St Louis, Missouri. And, as Selvy says, integrating sophisticated thermal control is crucial across a range of medical devices. Consider contrast media. “If it’s too hot, or too cold,” Selvy explains, “it could create unhealthy pressure as the fluid is injected,” he emphasises, adding that controlling temperature is similarly vital in ensuring patient comfort for treatments like dialysis and test accuracy in laboratory diagnostic equipment. Yet if Fortune Business Insights has found that the global thermal management system market size is expected to reach over $85bn by 2030, the practicalities of thermal control can be tricky. Regulation is one broad problem. In the US, to achieve FDA 510(k) clearance, or the CE mark in
Europe, obliges OEMs to ensure a machine’s safety. A particular issue, Selvy continues, concerns microamp leakage. Especially because medical devices are typically used on vulnerable patients – who may be unconscious or otherwise unalert – there’s a strict limit on the leakage permitted. The point, though, is that directives like IEC 60601-1 apply at the system level. If, therefore, a heating solution hypothetically leaks 80% of the microamps permitted, manufacturers may struggle to find power or mechanical components that don’t tip machines over the legal threshold.
A systems approach
ULTRAMIC advanced ceramic heaters enable device miniaturisation.
Of course, OEMs have a range of potential solutions to meet safety standards, running the gamut from double insulation to hard wired grounding. But each of these options comes with pros and cons – and choosing poorly can hamper flexibility or unnecessarily raise costs. That’s where Watlow comes in. Offering deep thermal solution expertise, this privately-held company isn’t afraid to guide customers to the best solution. To explain how powerful this approach is in practice, Selvy offers the example of an oxygen therapy machine. Initially, the OEM asked Watlow to develop a cartridge heater for them. “But to get the right power level and leakage current level,” Selvy says, “it would need to be very large” – inappropriate for the device footprint. As an alternative, Selvy and his team instead advocated for a compact ULTRAMIC heater. For one thing, Watlow stressed that the aluminium nitride ceramic design ensured it enjoyed “very high performance” from a thermal standpoint. Just as importantly, current leakage levels hovered at well under 20 microamps, making it easier to secure
Medical Device Developments /
www.nsmedicaldevices.com
Watlow’s small ceramic heaters ensure optimal temperature uniformity.
regulatory approval across the whole system.
The practical consequences of this holistic style – what Selvy calls a “system approach” – are clear. Leveraging Watlow’s deep expertise, the OEM ensured its product was both compact and safe, along the way shipping 100,000 units. And if this case study speaks to other advantages of Watlow’s model – notably around having the courage to prod customers towards the best technology – it also hints at the care the company takes elsewhere. Unlike some other players in this space, for instance, Selvy notes that Watlow is able to leverage its international spread to offer bespoke thermal solutions to different markets. As we spoke, he was liaising with teams as distant as Italy and India. From there, Watlow also offers what Selvy calls “cradle to grave” customer service, supporting audits and component obsolescence across a product’s lifecycle, all made easier by Watlow’s robust supply chains. Once you factor in the company’s reputation for financial stability – Watlow has thrived for over a century – and it makes sense that Selvy is so optimistic for his employer’s offering. As he puts it: “We believe we’re really the best in class.” Given everything Watlow has achieved already, it’s hard to disagree. ●
www.watlow.com 75
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