Regulatory & Industry Strategist, Pilgrim Software Inc.
In 2014, we will see the next evolution of the most effective
utilization of resources across the medical device industry, based
on “smart” information that will touch almost every healthcare
stakeholder, where key data will have a tighter linkage from design through
patient safety monitoring.
The strategies discussed over the past decade are culminating tactically in
2014 to help shape this paradigm shift:
• The Unique Device Identifier (UDI) Rule will link a device to its manufactur-
er for ease of use by healthcare professionals, user facilities, and international
• Real-time monitoring of patient vital information will allow healthcare pro-
fessionals and even patients to be more proactive in their day-to-day care
• The Medical Device Single Audit Program (MDSAP) Pilot through which
key countries are moving toward an alignment of regulatory approaches and
oversight of quality management systems to divvy the work of international
regulators and minimize burden on industry
• Continued focus on supply chain quality
• Focused investigations driving to root cause that can be effectively mitigated
and then shared for new product design
Industry is focusing on defining leading indicators of quality measures, both
internal and external, to an organization to move beyond compliance, where
the patient is the winner and the use of “smart” information is...just the
Engineering Group Leader, Thermacore Inc.
Regardless of whether the 2.3% medical device tax is here to
stay or not in 2014, regulatory and competitive pressures are
forcing medical OEMs to consider new technologies to re-
duce costs. Active thermal management technologies, such as
forced convection, liquid cooling, or refrigeration systems, are
being reconsidered since they are potential failure points, requiring docu-
mented routine maintenance that often costs more than the device itself.
Alternatively, passive thermal management solutions, such as heat pipe
assemblies, vapor chambers, phase change materials (PCM), and Annealed
Pyrolytic Graphite, can improve the efficiency of heat sinks. Their rated
service life practically eliminates the possibility of failure, thus reducing
service cost, downtime, and the total cost of ownership.
Healthcare providers are also demanding versatile devices capable of
multiple functions, rather than maintaining an assortment of function-spe-
cific devices, to reduce capital equipment costs and floor space. These mul-
tipurpose devices require more electronics in less space, which results in
larger and more concentrated heat loads. Designers will need to consider
both active and passive solutions to keep temperatures at acceptable levels.
Finally, the new IEC 60601-1 third edition places strict temperature
limitations on medical equipment. Advanced thermal solutions will help
engineers meet these standards while reducing service costs. MDT