Q:How are supply partners to medical device OEMs aiding in ensuring patient safety with home healthcare devices?
PASE System Designer, Watlow
As a strategic supplier to
medical OEMs, it is vital that
Watlow remains knowledgeable
of changes in market needs and
regulations. This allows us to
design and develop products in a rapid fash-
ion that meet the unique requirements of the
medical equipment market.
As a recent example, Watlow’s applied
insight into UL 60601 (more specifically
IEC60601- 2-39 for peritoneal dialysis equipment) helped design a UL-compliant heating
element for creepage distance, clearance, and
dielectric requirements for a manufacturer of
home healthcare peritoneal dialysis equipment. These requirements could easily have
been overlooked and required expensive and
time-intensive redesign much later in the
process, thereby delaying release of next
generation equipment into the market.
Understanding the regulatory environment
for medical device OEMs is critical in the
support of safer product design.
This deep knowledge also enables the
development of new products targeted for
medical devices. In response to the third edition
of the UL 60601 standard (more specifically
EN60601-1-11 for home healthcare), Watlow
developed a double insulated, low leakage, flow-through heater that delivers the performance
needed for fluid warming. The low-current
leakage allows the OEM to optimize the rest of
the system’s leakage budget for potentially enhanced safety. Additionally, Watlow’s ULTRA-MIC advanced ceramic heater was designed
to meet these UL 60601-1 requirements in an
extremely small package. Supplying all the heat
required for a hypothermia blanket application
in just a 25 mm square footprint, the ULTRA-MIC heater passes the required 4,000 VAC
hipot test requirement, which eliminates the
need for isolation transformers in the system.
Both of these solutions share a common value
proposition of enabling fewer components,
yielding a lighter, more portable, more efficient,
and ultimately safer system. MDT
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Combo-D 2WK2 with
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Medical Segment Manager, Portescap
At Portescap, we supply motors and gearing that go into critical care home medical devices. To ensure patient safety, we use prevention, containment, and OEM feedback.
During product design, we use a stage-gate system that incorporates multiple failure
mode and effects analyses at different points in development to gauge the severity and impact of a
single point failure. We use analysis results to drive to failure root cause and determine preventative
corrective actions via design and poka-yoke in order to ensure our products have the highest level of
quality and reliability built into the design prior to entering production.
Once in production, we focus on our quality system and control processes to contain deviations that
may occur during manufacturing. At Portescap, we incorporate 100% inspections of critical mechanical dimensions and electrical performance requirements. We also utilize statistical based AQL product
inspections prior to shipment to capture any possible deviations.
Lastly, we use data driven return analysis and customer inputs to integrate kaizen (continuous
improvement) into our design, development, and quality systems. We frequently use statistical data and
customer feedback to drive next generation product development and individual product quality and
reliability improvements that make end devices safer. MDT
Understanding the regulatory environment for medical device
OEMs is critical in the support of safer product design.