Cover Story
Cybersecurity for Medical Products
This posterior lateral interbody fusion
device uses Structural Encoding to
enable detection of unauthorized
duplication. Tantalum marker pins
embedded within the device are en-
coded with unique information during
manufacturing that is only detectable
via X-ray imaging. The encoded data
combined with product physical
characteristics allows for part authen-
tication and fraud detection. (Credit:
Watershed Idea Foundry)
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They look like normal parts, but under
X-ray algorithms appear relating to the
device to information such as the man-
ufacturer, part number, lot number, part
authentication and more.”
Kieser adds that traceability of ortho-
pedic implants has been an issue. “Parts
are typically tracked only until it goes
into the patient. History is reliant on
electronic data and paper trail. With our
technology, the patient can walk into any
medical facility, get X-rayed and have all
the device data about their implant even
if all their records are unavailable or lost.”
A Never Ending Challenge
New guidelines and documents coming
from the FDA are telling all sides that
they need to implement cybersecurity.
But they are very deliberate not to be
prescriptive. In the most recent guid-
ance sent out December 2016, the FDA
introduced the concept of an information
analysis center called IT- ISAC.
Engineered Solutions
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(3.2” x 1.9” x .90”)
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“They are trying to get manufacturers
and hospitals/medical providers to join
together and to agree that whenever
anyone finds a security issue, they will
distribute it so everybody can learn from
it. I joined it,” Domas says. “The FDA
also held out a carrot to joiners by telling
them that if they did this, the FDA will
reduce the regulatory reporting require-
ments.” Domas explained that the time
and labor savings the streamlined report-
ing process enables would be a strong
incentive for manufacturers to share this
critical information with other communi-
ty members.
“Security is more important than ever
and it is only going to get more important
because hackers are always working on
ways to crack new security,” Kennelly
adds. “It will be a challenge to stay ahead
of them. Microchip wants to make that
security as easy as possible to implement
so medical designers and device developers
can stick to doing what they know best.”
1032
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(5.5” x 3.5” x 2.7”)
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MDTmag.com
Made in
the USA
 All the sources we interviewed Nick Cordaro Watershed Idea Foundry
concurred with Kennelly’s observation, CEO, Watershed Idea Foundry 401 E. Sonterra Blvd. #375
that security is an ever-moving target, Brian Kaieser San Antonio, TX 78258
and given enough time, anything can V.C. Backer, Fountainhead Investment 1.210.510.4207
be hacked. Whether it’s human error Partners no email/online message only
such as a computer operator opening up
malware, or a new exploit cooked up in
the wilds of Kazakhstan, it’s impossible
to be certain that any device or system is
100 percent un-hackable. The good news
is that it’s becoming possible to make
many types of attacks difficult enough to
foil most cyber criminals and make them
uninviting targets to the rest. MDT

1
US Bureau of Justice Statistics
https://www.bjs.gov/index.cfm?ty=t-
p&tid=41

Contributors to this feature:

Stephanie Domas
Lead Security Engineer
Battelle DeviceSecure® Services
Battelle
505 King Ave.
Columbus, Ohio 43201
1.800.201.2011
email online form only

Alan Grau
President and Founder of Icon Labs
alan.grau@iconlabs.com
Icon Labs
3636 Westown Parkway, Suite 203
West Des Moines, Iowa 50266
1.888.235.3443 (toll free)
1.515.226.3443 (local and int’l)
info@iconlabs.com

Xavier Bignalet
IoT Marketing Manager, Microchip
Steve Kennelly
Sr. Product Manager, Medical Products,
Microchip
Jeannette Wilson
Product Manager, Computer Products
Group, Microchip
Microchip Technology Inc.
2355 West Chandler Blvd.
Chandler, Arizona, USA 85224-6199
1.480.792.7200
(no email contact – online only)

Medical Design Technology® July/August 2017 / 11

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