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Suppliers often market their personalized medical devices with
the promise, but not the proof, that their products make surgeries
faster and easier, and improve patient outcomes. While the FDA’s
application process for most medical devices does not require clini-
cal data, hospital committees should ask medical device reps for
the information or seek the advice of a consultancy such as inSight
Advisory that can help review the literature.
Patient-reported outcomes are typically tracked before surgery
and several times postoperatively. But for most of these products,
longitudinal data on patients’ health condition and implant per-
formance don’t yet exist. Even when it does, all clinical evidence
is not created equal. Rather, it can be rated on a scale between
I (high-quality randomized trial) and V (expert opinion). The high-
er the level a clinical study is rated, typically the less reliable it is.
“It’s fair to say that to date there is minimal evidence for better
outcomes with most of these products,” Conger says. “We recom-
mend that hospitals not accept any evidence that’s above Level
III (well-designed, controlled trials without randomization). A
premium price shouldn’t be charged for a device without the out-
comes backing performance claims.”
PRIORITIZE PATIENT BENEFITS
Before catering to physician preferences, initiate a conversation
with them about the impact their choices will have on patient sat-
isfaction and clinical outcomes. “First, ask physicians how they’re
vetting the device,” Conger says. “Have they just read marketing
materials, or have they gone out to observe the product in an actual
surgery? Have they reviewed the data, literature and clinical trial
Value analysis committees should require proof that newer, more
expensive devices are cost-effective and better for patients.
“Some of the new personalized technology could lead to signifi-
cantly better outcomes,” says Chris Stewart, assistant vice president,
inSight Advisory–Medical Device Management. “However, hospitals
need to weigh whether the added expense actually benefits patients.
In some cases, companies are charging a premium for a customized
product that may not be adding any real value.”
THE FUTURE OF PERSONALIZED DEVICES
The introduction of personalized medical devices is a relatively
recent occurrence, and currently there is little evidence to suggest
they contribute to better clinical outcomes. Most of the products
now available for orthopedic, spine and cranial surgery can help
surgeons conduct better preoperative planning and potentially
shorten operating times. As data are collected on device longev-
ity and performance, physicians and hospitals will begin to know
where to place their bets.
In the meantime, personalized medical devices are being
developed for other surgeries, and 3D printing, smart biomateri-
als, intelligent diagnostics and biosensors will be impacting every
surgical specialty. •
For more information on how to evaluate emerging technologies,
look for a newly published executive summary on personalized medical
devices at www.healthtrustpg.com/trending-topics, or email hpgsvc@
healthtrustpg.com or email@example.com.
Continued from page 10
SOURCEBOOK PURCHASING POWER
InVivoLink, part of HealthTrust’s suite of inSight Advisory Solutions, is a resource
for tracking outcomes and costs across the care continuum. Its proprietary technol-
ogy collects data, linking patient outcomes to the cost and types of implants used
in orthopedic and spine procedures. Providers can thereby extend their view of
care episodes longitudinally and continuously improve conversations between
administrators and surgeons.
HealthTrust’s inSight Advisory–Medical Device Management team provides
new technology reviews and sourcing strategies for physician-preference items
that are cost-effective, as well as supported by clinical evidence, best practices
and guidelines for appropriate use.
The team draws on the expertise of more than 150 physician advisors across 25 medical
specialties. These advisors help evaluate cutting-edge technology by reviewing and grading
clinical studies, gathering data, and providing an unbiased analysis of product advantages and
disadvantages. The team shares insights with physicians and decision-makers at the hospital level,
enabling them to reduce unwarranted clinical variation while making the best-value technology
available in their operating rooms and physicians’ offices.
HealthTrust’s size and purchasing power ensure a better price for partners on personalized
medical devices that have value in shortening surgical procedures, helping physicians better
accommodate patient needs and potentially improving clinical outcomes.
How HealthTrust Can Help
12 The Source | Third Quarter 2017
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