Medical Design Briefs

www.medicaldesignbriefs.
com March 2017
Welcome to
Revolutionizing Spinal Fusion Surgery
your Digital Edition of

The Miniaturization of Medical Connectors
MES: Accessing the Right Data at the Right Time
2016 Product of the Year Winners
Medical Design Briefs

March 2017
SPECIAL SECTION:
Technology Leaders in
Tubing/Extrusion
From the Publishers of
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SteriPro.. The Expert Series
CREATING THE MOST EFFICIENT SUPPLY CHAIN

EO STERILIZATION
Dr. Reisbacher began his career at Sterigenics
in 2010 at the Wiesbaden EO facility, managing MEMBERS AAMI
ASTME61
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work. In his current role as SteriPro consultant
since 2014, he is leading ethylene oxide sterilization RADIATION TECHNOLOGY
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plants as technical expert and holding training sessions 6 Languages
on EO Sterilization for Customers and Notified Bodies. Globally SKILLED
Niki Fidopiastis has served the field of Medical Device and DOSIMETRY
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Joined Sterigenics International in 1998 as the primary consultant
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INFLUENTIAL
perience and practice in both in sterilization processing and laboratory
LEADERS
testing. Prior to joining Sterigenics, Ms. Fidopiastis served nine years 190 years
with North American Science Associates (NAMSA) where she held vari- combined
ous laboratory supervisory positions. EXPERIENCE
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Free Info at http://info.hotims.com/65849-901

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www.medicaldesignbriefs.com March 2017
R
Mi
Accessin the Right Data at the Right Time
MES: Accessing
redefining the limits

of extrusion technology...
SPECIAL SECTION:
medical extrusions
Tubing/Extrusion
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redefining the
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www.medicaldesignbriefs.com March 2017
MES: Accessing the Right Data at the Right Time
SPECIAL SECTION:
Tubing/Extrusion

Intro Cov ToC + A

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March 2017
Published by Tech Briefs Media Group, an SAE International Company
COLUMN 53 Advertisers Index
6 From the Editor 54 Global Innovations
FEATURES SPECIAL SUPPLEMENT

8 Fixating on Innovation: A Revolution in Spinal Fusion Surgery
Technology Leaders in Tubing/Extrusion
16 Connector Technology: Miniaturization in Medical Devices
28 Computational Fluid Dynamics in Extrusion Tooling
22 MES as a Single Source of Truth: Achieving Regulatory
30 Getting the Most from Your Extrusion Tooling
Compliance at Sparton
49 Improving Outcomes: 3D Printed Models for Simulating
Surgery ON THE COVER
When a person suffers from degenerative disc
TECH BRIEFS disease, spine trauma, or cancer of the spine,
43 Soft Robot Offers New Treatment Option for Heart Failure the result is decreased stability that can produce
pain during normal activities. If conservative treat-
44 Blood-Repellent Materials: A New Approach to Medical
ments are unsuccessful, the only alternative is to
Implants address the pain through fusion, which prevents
45 Researchers Use Natures Weaving Formula to Engineer movement in the unstable portion of the spine,
Advanced Functional Materials thus reducing the pain. A new type of fusion
46 Sound Waves Create Whirlpools to Round Up Tiny Signs of device offers a less-invasive alternative to tradi-
tional pedicle screws and other spinous process
Disease
plates that are placed in open procedures. Spinal
47 Wearable Watches to Monitor Your Blood Pressure Simplicitys Minuteman G3 is an innovative prepackaged sterile fixation sys-
tem that has made the procedure simpler, faster, and accessible to a greater
patient population. To learn more about this revolutionary device, read the
DEPARTMENTS article on page 8.
40 R&D Roundup (Credit: Bal Seal Engineering)
51 New Products & Services

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From the Editor
And the Winners Are... The Stratasys J750, an addition to the chip capacitors specifically designed to
In December, we asked Medical Design Objet Connex multicolor, multi-material meet performance specifications for
Briefs readers to cast their ballot to series of 3D printers, allows customers to implantable medical devices. Delivering
choose from our 12 Products of the choose from more than 360,000 differ- extremely tight capacitive tolerances,
Month the technology they felt was the ent color shades plus multiple material exceptionally repeatable performance,
most significant new introduction to the properties ranging from rigid to flexible and low ESR and high Q
design engineering community in 2016. and opaque to transparent. Prototypes at high frequencies,
The selected products reflect advances can include a vast array of colors, mate- including VHF, UHF, and
that enable new innovations in medical rials, and properties in the same part, RF bands, AVXs new
technology. Here are the winners of the speeding production of realistic models, Accu-P MP Series capac-
2016 Medical Design Briefs Readers prototypes, and parts for virtually any itors also exhibit high sta-
Choice Products of the Year. application need as well as delivering bility with respect to temperature, time,
3D printing versatility to produce tool- frequency, and voltage variation.
J750 3D Printer ing, molds, jigs, fixtures, and more. The capacitors are subjected to acceler-
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duces an industry first with its new 3D ly experience product prototypes within quality inspections for capacitance, as well
printer, the J750. This solution enables hours of developing an initial concept as proof voltage, IR and breakdown volt-
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Fixating on Innovation:
A Revolution in Spinal Fusion Surgery
W hen a person suffers from degen-

erative disc disease, spine trauma,
or cancer of the spine, the result is
plate received FDA 510(k) clearance in
January 2015 and the first procedure in
the United States was performed the fol-
decreased stability that can produce lowing April. A similar device, known as
pain often severe during normal the Minuteman G1, has been available
activities. Surgeons will first attempt con- in Europe since 2011. To date, over 500
servative measures such as cortisone procedures have been performed in
injections and physical therapy to Europe with the Minuteman G1
strengthen the muscles of the lower device. In 2016, the company intro-
back, but if these conservative treat- duced a hydroxyapatite-coated version
ments are unsuccessful, the only alterna- of its fixation device. The FDA-cleared
tive is to address the pain through sur- coating, also known as a bone mineral,
gery. This procedure, known as a fusion occurs naturally in bones and teeth, and
and fixation, prevents movement in the promotes osto-integration.
unstable portion of the spine, thus The Minuteman device consists of a
reducing the pain. core threaded post with graft window,
A standard fixation device consists of expanding plates that open on the far
plates and rods that are attached to the side of the spinous processes, a fixed
vertebrae with wire, pedicle screws, and plate for the near side of the spinous
hooks. Bone graft material is often processes, and a locking hex nut to
used to promote fusion for long-term secure the device in place. An inserter is
stability and relief from pain. used to surgically implant the device by
Unfortunately, these fixation devices expanding the wings and to tighten it to
often require the use of bulky instru- the inferior and superior spinous
mentation, which surgeons may find process using a simple instrument
awkward and difficult to use. design. The components of the system,
Interspinous process (ISP) fusion has particularly the Bal Spring canted coil
been shown to be a safe and effective spring, are critical to the devices unique
alternative to traditional methods of pos- design. This article examines the inner
terior spinal fixation (i.e., pedicle workings of the Minuteman and how the
screws). A high degree of biomechanical innovative design of the device has
stability and reliable fusion rates are advanced the treatment of complex
achieved with preservation of adjacent spinal disorders.
level structures when using ISP fusion
implants. Because ISP fusion devices do Minimally Invasive Procedure
not violate adjacent facet joints, they can Much like traditional spinal fixation
potentially decrease the likelihood of devices, the Minuteman device is intend-
adjacent segment degeneration, ed for fixation to the spinous processes
changes in the motion segments above to provide supplemental fixation for
and below the surgery site. degenerative disc disease, spondylolis-
A new type of ISP fusion device offers thesis, spine trauma, or spinal tumors. It
a less-invasive alternative to traditional can also be used as an adjunct to lumbar
pedicle screws and other spinous interbody fusions [e.g., anterior (ALIF),
process plates that are placed in open direct lateral (DLIF)], thus reducing the
procedures. Spinal Simplicitys approach-related trauma to normal
Minuteman G3 innovative prepack- healthy tissue. The Minuteman reduces
aged sterile fixation system has made the approach-related morbidity, decreases
procedure simpler, faster, and accessible OR time, minimizes blood loss, and pro-
to a greater patient population (see vides for quicker patient recovery and
Figure 1). The spinous process fusion return to normal activities.
8 www.medicaldesignbriefs.com Medical Design Briefs, March 2017

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Fixating on Innovation
Fig. 1 Spinal Simplicitys Minuteman G3

innovative prepackaged sterile fixation system.
Unlike other ISP devices, the surgical

technique is easily reproducible. The Fig. 2 The devices fixed plate, which mates with the locking hex nut, consists of two sets of spike
Minuteman device can be implanted grips that attach to the spinous processes to provide stabilization of the spinal segments.
under minimal fluoroscopy using a
direct lateral or posterior unilateral and other ISP devices, the Minutemans threads. The core threaded post is
approach. Direct lateral surgeons can lateral minimally invasive approach unique to the Minuteman device. It
now insert a supplemental posterior fix- means patients experience less soft tis- allows for the device to distract the spin-
ation device with the patient remaining sue disruption and less blood loss than ous processes in a controlled manner to
in the lateral decubitus position (lying during open spinal surgery as well as less help prevent spinous process fractures.
on one side) in 1015 minutes. The postoperative pain. The procedure occa- The core threaded post also provides
same access port used for the anterior sionally has been performed under local indirect decompression of the posterior
interbody is used during the direct later- anesthesia (with IV sedation in an outpa- column of the spine, which leads to
al approach to gain access to the inter- tient setting), providing a treatment widening of the foraminal diameter of
spinous space. Also unlike all other option for patients who should avoid the vertebral openings that house the
devices, the Minuteman does not general anesthesia due to their age or spinal nerve roots. This reduces the soft
require dissection, stripping, and because of comorbidities such as coro- tissue compression by stretching the lig-
retracting of the paraspinal muscles, or nary artery disease and aortic stenosis. amentum flavum, posterior annulus,
removal of the superspinous ligament. These patients, who are high-risk candi- and facet capsule. The threaded post
Following the dilation of the surgical dates for traditional spinal procedures, also has the largest graft window of all
access site (using an incision that is were offered relief from pain through a ISP devices available to the market. This
smaller than the diameter of a golf ball), minimally invasive approach that window size is on par with TLIF inter-
the surgeon uses Spinal Simplicitys doesnt require going under. body cages, and promotes the ingrowth
patented sizing instrument to lightly of bone by means of the graft material
decorticate the fusion site in a con- The Nuts and Bolts that is delivered to the spinous process
trolled manner and to determine the The devices fixed plate, which mates in this window. The Minuteman G3 has
appropriate implant size. To accommo- with the locking hex nut, consists of two hydroxyapatite coating on both the core
date various patient anatomy, the fixa- sets of spike grips that attach to the spin- and the extension plates to promote the
tion device is provided in five different ous processes to provide stabilization of ingrowth of bone to the implant.
sizes. Regardless of the implant size, all the spinal segments (see Figure 2). Each Auto-lock technology provides
use the same size plunger, which helps spike grip set contains three spikes. The secure, reversible, zero-step locking
ensure a consistent experience for the extension plate has two spike grips that fixation of plate halves, regardless of
surgeon from one surgery to the next. attach to the spinous processes, the plate positon on the spinous processes.
The lateral minimally invasive bony projections that extend from the The auto-lock allows the surgeon to
approach to the spine is posterior to the back of each vertebrae. Each spike grip tighten the Minuteman in variations
level of the facet joints, in what is also on the extension plate also contains depending on the anatomy and
considered a safer zone. This reduces three spikes. The extension plate is quality of bone without backing out
the potential of damaging the neural stowed during insertion and deployed or loosening the device. The vibration-
and vascular structures, avoiding the for final fixation. resistant auto-lock is reversible and
risks associated with misplaced pedicle The Minutemans core post sits on the can be repositioned during the sur-
screws. Compared with pedicle screws flat surface of the device, not the gery to provide optimal positioning.

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Developing the System

When designing the Minuteman,
Spinal Simplicity faced several chal-
lenges related to its size and strength.
The goal was to develop a fusion device
that could be percutaneously placed in
the interspinous space. The device
would then deploy folded arms that
would affix to the spinous processes on
either side of that placement. The
smallest Minuteman implant is 8 mm in
diameter, so mechanism space is limit-
ed. The challenge was to design a
mechanism and deployable arms that
were strong enough to provide rigid fix-
ation of the implant. The resulting
design consisted of two opposing wings
that deploy from a linearly traveling Fig. 3 The system consists of two opposing wings that deploy from a linearly traveling plunger inside
plunger inside the body of the implant the body of the implant.
(see Figure 3). This plunger is held in a
neutral position, not affecting the
wings until the surgeon deploys the
them (see Figure 4). In this second
state, the plunger holds the wings open,
while the implant is tightened into its
final position (see Figure 5).
In order for the device to be minimally
invasive and to perform as desired, it was
determined that the device must have
deployable wings (extension plates) as
well as some sort of an anti-backout fea-
ture, locking the implant in place to pre-
vent accidental dislocation. Eventually,
these criteria drove the design of the
plunger so that a single feature could
deploy both extension plates at the same
time. However, in order for this design to
work, it was essential that the plunger
lock in place in an initial (predeploy-
ment) position and in a final (postde-
ployment) position. In addition, it was
critical that the mechanism be easy to
assemble while providing outward pres- Fig. 4 This plunger is held in a neutral position, not affecting the wings until the surgeon deploys
sure on the ID of the device. the them.
The original design called for a linear
compression spring for each extension elastomer and the metallic properties. manner. For the Minuteman, the Bal
plate; however, the springs took up too Ultimately it was determined that the Spring technology enabled the plunger
much space and the design was not fea- design required a component that could to lock in place, while allowing precise
sible for manufacturing. Another design easily and consistently reproduce the control of the 34 lb force when deploy-
considered integration of a finger needed 34 lb force. ing the extension plates to lock and
cutout that pressed outward within the The Bal Spring, a tiny mechanical unlock the plunger within the implant
plunger, but machining into a tiny component designed and manufac- ID. The spring also prevented move-
plunger required expensive manufactur- tured by California-based Bal Seal ment of the plunger within the implant
ing and the force was not consistent or Engineering, was critical for providing ID. The Bal Spring met the small profile
reproducible. Preliminary designs used this functionality. As a locking fastener, design (OD of 4 mm or less) require-
an O-ring seated in a circumferential the spring offers game-changing tech- ments to fit within all implant sizes.
groove on the plunger that mated with a nology for ISP devices. It can lock any The Bal Spring is attached to the
set of grooves in the implant. This two pieces together during surgery plunger, which is assembled into the ID
design was rejected, however, because of using minimal force, eliminating the of the Minuteman device. When the
concerns about wear, debris generation, need for other surgical tooling, and implant is assembled during manufac-
and failure of the O-ring itself due to freeing up the surgeons hands to con- ture (prior to sterile packaging), the
wear caused by material mismatch of the duct the surgery in a more efficient plunger assembly is inserted into the ID

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THE EVOLUTION OF SPINAL FIXATION TECHNOLOGIES

Pedicle Screws. The use of pedicle screws began in the 1960s, and introduced in 2007, and more than 30,000 devices have been sold
these are still considered the gold standard for supplemental fixa- worldwide. The Aspen requires a posterior approach and often
tion. However, the procedure, which takes 13 hours, involves a large removal of the superspinous ligament at the implantation site.
incision and cutting of the muscles and ligaments around the spine. Minimally Invasive Fusion. The Spinal Simplicity Minuteman G1
Spacers. Introduced in Europe in 2004, the Medtronic X-STOP inter- was the first MIS ISP fusion device. It received a CE mark in
spinous process decompression system was the first spacer to market. It September 2011 and was indicated for stenosis and multilevel use
was designed to distract spinal segments in order to provide nerve in the international market. More than 500 have been implanted.
impingement relief. Its long-term results are poor due to micro-motion, The Minuteman G3 received FDA 510(k) clearance in January
which causes bone erosion and thus loss of distraction and return of pain. 2015, the hydroxyapatite-coated Minuteman G3 received FDA
Interspinous Fusion. The Zimmer BioMet Aspen spinous process 510(k) clearance August 2015, and both received Canadian
fixation system was the first ISP fusion device on the market. It was approval in October 2016.
of the implant until it engages a groove the surgeon can then start tightening was also important that the spring be
where the Bal Spring is housed. The the implant so that the spikes of the composed of a medically implantable
spring holds the plunger in place to extension plates engage with the superi- material that could withstand steriliza-
ensure that it does not move prior to or and inferior spinous process. tion and meet cleanability requirements.
implantation during surgical insertion The canted coil spring locks the device In this case, titanium was selected
of the device. Once the implant is in into place in two different cutout reliefs because the implant itself is also made of
position, the surgeon uses the compa- within the implant ID: the initial position titanium. This material provides superior
nys insertion instrument to advance the (prior to plunger descent to deploy the strength and is highly resistant to corro-
plunger forward. This inserter is extension plates) and then the second, sion and fatigue, all of which engender
designed to overcome the 34 lb force final position to ensure that the plunger surgeon confidence.
of the spring, allowing the plunger to stays in place after deployment. It was
advance within the ID of the device, essential that this be repeatable across all Conclusion
thus deploying the extension plates. implants and predictably impart the Spinal Simplicitys MinutemanG3 is a
Once the extension plates are deployed, same force from implant to implant. It prepackaged sterile fixation system that

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single plunger that could deploy both
extension plates at the same time and
lock into two different positions.
Integration of Bal Seal Engineerings Bal
Spring has ensured that the Minuteman
fixation system provides consistent, reli-
able, easy implementation. The Bal
Spring technology provides the necessary
force to lock the plunger in place and
prevents movement of the plunger with
the implant ID. The devices unique func-
tionality, including its core threaded post
and locking plunger, have revolutionized
spinal fusion surgery by reducing risk,
decreasing OR time, and minimizing
blood loss, but most of all, providing for
Fig. 5 In the second state, the plunger holds the wings open, while the implant is tightened into
faster patient recovery.
its final position. This article was written by Steve Twork,
Global Market Manager, Medical Devices, for
offers a less-invasive alternative to tradi- minimally invasive system is especially Bal Seal Engineering, Inc., Foothill Ranch,
tional pedicle screws and other spinous promising for patients who are high- CA, with additional technical contributions
process plates that are implanted using risk candidates for traditional spinal by Douglas Snell, Director of Engineering,
open procedures. Compared with pedi- procedures that require sedation. Quality & Regulatory Affairs, for Spinal
cle screws and other ISP devices, the Developing a fusion device that could Simplicity, LLC, Overland Park, KS. Twork
Minutemans lateral minimally invasive be percutaneously placed in the inter- can be reached at stwork@balseal.com.
approach means patients experience spinous space was a challenge. The device A video of the procedure is available
less soft tissue disruption and less blood needed to deploy folded arms that would at www.youtube.com/watch?v=1Z8_EM-
loss than during open spinal surgery as affix to the spinous processes on either EZjQ. For more information, visit http://
well as less postoperative pain. The side of that placement. And it needed a info.hotims.com/65849-160.
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The limpness and feel of a
cable that complements the
connector can assist in
assuring patients that they
are being served in a quality
environment.
Connector Technology:
Miniaturization in Medical Devices
C
onnectors are getting smaller and tems. Oftentimes, designers select a circuit mobility. Many additional factors
denser. The question is, how small standard connector to begin their cir- include awareness and compliance to
can connectors go? To answer this cuit testing, but eventually find they biological protection, minimal open
question, it is important to remember need a custom design variation. gaps and creep in connected mated
that the applications that use connectors pairs that can hoard contamination as
demand a number of performance and Determining Size Requirements well as a specific material selection to
reliability requirements, particularly in Connector size requirements are allow for sterilization.
medical devices. often based on a few key application fac- Electrical signal noise in operating
Application-specific connectors tors and performance constraints, rooms must also be shielded to allow
and reduced-size connectors in particu- including electrical current load, signal many electronic systems to run simulta-
lar have come on quickly during the integrity, environmental conditions, and neously without interference to each
last five years. This is now fueling the
rapid change in a combination of tech-
nological advances, starting with new
solid model design and performance
prediction software that help new
advances in circuit chip technology.
These changes have aided in driving
increased performance and improved
capabilities. These evolving circuit chips
demand much lower voltages and cur-
rent flow but run much faster and store
and process significantly more data,
while yielding a longer battery life. New
software too has enabled designers the
ability to model much smaller connec-
tor options that can be manufactured
from a simple CAD rendering to a reali-
ty. New shell sizes and shapes can quick-
ly be altered and cut out with CNC
machines within minutes. These
changes provide a faster prototype cycle
at a reasonable price to designers that
need to squeeze every last millimeter of Omnetics IP68 Nano-Circular series is housed in one of the smallest form factors available and
space out of their interconnection sys- remains sealed.

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Connector Technology
SWISSS CONTRA ACT
M
SWAIS
NSUSFCAOCNTRA
TURI
AICT
NG
G
FROOM
MASNTUOFCAK
CTURIING
G
TUBING
FRO
NO
IN MASIT
ST NOLCEKSSTUBING
STEEL
IN
N STAINLESS STEEL
A miniature cable that is ruggedized and overmolded with medical-grade silicone has a connector at
the end that mates to a disposable catheter.
other. Even the limpness and feel of a still function independent of adjacent
cable that complements the connector is circuits. Designs must include protec-
considered a characteristic that can tion against signal cross talk, as well as
assist in assuring patients that they are protection from electromagnetic emis-
being served in a quality environment. sions or reception of other signal noise
in and about the system. Some modern
Electrical Current Load shielding tricks are often built into the
Each connector contact must offer a connector.
low resistance interface with its mate New shield materials often combine
and carry enough electrical current to braided wire and aluminum foil that are
satisfy the circuit it is serving. wrapped around the length of the cable,
Fortunately, advances in chip technolo- inside the jacket material. Also, small
gy have reduced the current flow rate, ceramic filter discs can be included
which enables the shrinking of intercon- inside the connector housing that
medical devices necting elements as long as they stay selects which frequency signal can pass
medical
needles devices
and probes within a safe range for good perform- through the cable and which are bled
needles and probes ance (with some variations for power off to ground.
and signal surges). Current limits are
often set by the diameter of the wire in Environmental Conditions
the cabling itself, because wire length Ruggedized connector designs for
times resistance will set the performance performance in extreme environments
and thermal capabilities of the intercon- are often controlled by specifications
nection system. that ensure continuous signal flow dur-
Using a low-resistance wire option that ing high shock and vibration, as well as
handles enough electrical current to run performance during extreme tempera-
the equipment is often critical. So many ture cycles. Blood perfusion monitors,
machines are often running simultane- for example, sit near the patient during
ously, that high resistance can slow down operations to assure the surgeon that
the signal processing units or delay the there is no internal bleeding that cant
Unimed SA
triggering of emergency alarms. When be seen from the operating table.
Lausanne,
Unimed SASwitzerland connectors are designed with matched A miniature cable that is ruggedized
phone +41 21
Lausanne, 624 21 51
Switzerland impedance, it also provides significant and overmolded with medical-grade sili-
fax
phone +41 21 62453
+41 21 624 2132
51 clarity in displays in the room. cone has a connector at the end that
www.unimed.ch
fax +41 21 624 53 32 mates to a disposable catheter. The
e-mail: info@unimed.ch Signal Integrity catheter rests inside the brain and is
www.unimed.ch As connectors and circuit modules small and delicate. In this case, the main
e-mail: info@unimed.ch squeeze into tighter spaces, circuits must cable protects the small catheter from
Free Info at http://info.hotims.com/65849-784 www.medicaldesignbriefs.com Medical Design Briefs, March 2017

Intro Cov ToC + A

Intro Cov ToC + A

Connector Technology
YOU DESIGN
being accidently moved or pulled on Circuit design can also help by com-
during its use. Eventually the catheter is bining signal systems for fewer lead
removed and disposed of, while the con- counts. Some connectors are being
nector and cable assembly goes off to used within a medical instrument dur-
the rigors of sterilization and cleaning. ing the assembly of the device. These
In some portable applications, such as connectors are mated once or twice in
neonatal monitors, electrocardiogram their lifetime and the design may be
systems, and other skin-sensitive detec- focused on longer-term reliability for
tors, connectors often face some addi- shock and vibration of the unit.
tional challenges. Ingress protection (IP) Recently, the evolution of combining
ratings, such as waterproof sealing and two or three connectors into one has
resistance can be critical in portable taken center stage. Instrumentation
cable and equipment. Omnetics designers are finding they can reduce
Connector Corporations IP68 Nano- the number of cables to the machine by
Circular series is an example of how this asking for connectors to have both a
problem is solved in todays market. power supply section and a separate sig-
These connectors are housed in one of nal processing function within the same
the smallest form factors available and connector. This saves space, weight, and
remain sealed. in many cases cost. Instrument design-
Selecting the proper materials and ers are adding multiple contact types
processing can also produce connec- into a single connector with the option
tors that exceed specifications in IEC of using: 1, 3, 5, or 10 A contacts in one
60601 and prevent any electrical leak- shell. This option has as allowed OEMs
age or shorting to the patient being to run the power and signal lines in con-
treated. Elastomeric seal rings are junction with one another, saving
often built into connectors to ensure design time and reducing the number
that neither moisture nor dust pene- of backup cables needed in stock.
trate through the connector and enter
the circuitry. Smaller and smaller seals The Challenge and the Market
will be needed as connectors continue Todays miniature connectors pro-
to miniaturize. vide great performance, carrying
charging power and signal routing in
Circuit Mobility one element. This method of using a
Connecting an active chip directly single flat-strip or lead-frame intercon-
into portable equipment is an example nection has led the way for higher-
of the demands on todays drive speed digital signal processing. Careful
toward miniaturization. Applications use of shape and spacing has allowed
such as robotic hands and medical another level of high-density intercon-
probe tips, are early examples. nection. As circuit speed increases and
WE BUILD Percutaneous connectors are now

being used in neurological pain man-
agement devices, and miniature con-
size decreases, the use of unique low-
dielectric-strength insulator materials
also paves the way for smaller connec-
nectors are being used on cochlear tors. Board-to-board connectors that
Rapid Prototyping devices. Even smaller connectors are use pins or press connections consume
being applied to neurological monitor very little space and cause only minute
Custom OEM Manufacturing and control devices for remote func- aberrations in signal transfer.
tion control circuits. How small connectors will go is still to
Cleanroom Manufacturing Leading the charge for smaller con- be seen. Larger connectors are currently
nectors seems to be coming from brain being replaced by smaller and lighter
mapping and neurosensing devices micro-circular connectors that use a
Automation and Assembly being applied in Parkinsons research, as 0.050 in. pitch, and those very same
medical designers are faced with trying 0.050 in. pitch solutions are being
Supply Chain Management to squeeze more functionality into replaced by nano variations at 0.025 in.
portable electronics. It is here where size pitch, handling multiple high-speed sig-
reduction begins. Standard designs are nals as well.
reviewed for potential form, fit, and This article was written by Derek Hunt,
function and then tailored using solid Regional Sales Director for Omnetics Connector
model designs to meet both the size and Corp., with contributions from Bob Stanton,
the reliability requirements. Pin-and- Director of Technology for Omnetics. Hunt can
socket sizes can be reduced to minimum be reached at dhunt@omnetics.com. For more
sizes that meet these criteria and still information, visit http://info.hotims.com/
cadenceinc.com | 800.252.3371
squeeze into the space allowed. 65849-162.
Free Info at http://info.hotims.com/65849-786 www.medicaldesignbriefs.com Medical Design Briefs, March 2017

Intro Cov ToC + A

i-CLAMPS (I D C)
One-Way Series
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T-Series
s IDC (Insulation Displacement Connectors) s Easy to use s Quick and reliable connections s Tamper Proof
s Designed to withstand shock and vibration s Housing made from durable Polycarbonate s Tin plated High Performance
copper alloycontacts s For use with 10-22 AWG insulated wires s One Way Series for splicing several lines together s T Series for
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ITS WHATS ON THE INSIDE THAT COUNTS

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MES as a Single Source of Truth:
Achieving Regulatory Compliance at Sparton
A
couple of years ago, contract sion to implement FactoryLogix as a was a combination of Microsoft Access
manufacturer Sparton Corp- manufacturing execution system (MES) databases, Excel documents, and home-
oration faced increasing solution. It also looks at how using a big grown applications. Reliance on multi-
demand for high-quality, highly data analytics approach has allowed ple data systems and paper-based work
complex products that were delivered as Sparton to provide customers with a instructions limited shop floor visibility.
quickly as possible. The multisite con- most effective and efficient approach to This created costly rework and long
tract manufacturer serves highly regulat- regulatory compliance. turnaround times for customers. These
ed end markets, including the medical disparate data systems also made deep
device industry. With customer needs The Challenge: Disparate Sources of traceability difficult to achieve.
that range from advanced robotics and Data Limit Deep Traceability Sparton considered two separate
lasers to sophisticated medical devices, To ensure safety for the end user strategies to address these challenges:
product quality is of utmost importance the patient medical manufacturers A solution based on the traditional
to meet complex regulatory require- must deliver only the highest quality approach to traceability with com-
ments. To meet its increasing demand products. Regulatory requirements from pliance and traceability as the single
effectively while also meeting compli- FDA include Title 21 CFR Part 11, which end goal.
ance and traceability requirements, the states that manufacturers must establish A solution based on a single source of
company found itself monitoring numer- a system of controls, electronic docu- manufacturing truth, which would ulti-
ous data sets across multiple facilities. mentation, and audit trails. In the event mately result in multiple advantages,
To advance its world-class manufactur- of an audit or recall, full product and including compliance and traceability
ing operation, Sparton implemented process traceability must be available as by-products.
Aegis FactoryLogix MES across several through a device history record (DHR)
sites to establish a single source of or electronic device history record The Decision: MES Establishes a Single
truth for all manufacturing data. Today, (eDHR). Compliance with this regula- Source of Manufacturing Truth
access to a unified data set in real time tion requires collection and control of The traditional approach to traceability
allows operators to enforce quality con- thousands of data points. views changing regulations as a burden
trol and reduce risk. This article exam- In 2014, each Sparton facility had its and attempts to simply do as little as will
ines the reasons behind Spartons deci- own method for collecting data, which meet the requirement. While this strategy
is one means to an end goal of compli-
ance, it is shortsighted in that it does not
adapt to prepare manufacturers for future
changes in the regulatory landscape.
During their decision-making process,
Sparton management realized that all
existing challenges could be addressed
by implementing an MES. This smart fac-
tory approach would leverage data from
robots, conveyors, testers, inspectors,
sensors, and scanners to support com-
plete process improvement and would
result in full traceability as a by-product.
Alternative Options: ERP and

Homegrown Systems
As part of their formal request for pro-
posal process, Sparton considered multi-
ple solutions, including extending its exist-
ing enterprise resource planning (ERP)
system and expanding its homegrown
Sparton Engineering uses FactoryLogix to view electronic CAD files and confirm their readiness, solution. Designed to handle the financial
allowing for increased speed and efficiency in the new product introduction (NPI) process. planning aspect of Spartons business, the

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Intro Cov ToC + A

Achieving Regulatory Compliance
companys ERP system did not allow for

detailed CAD-to-BOM comparisons and
the capture of critical data from the shop
floor. The option to further develop its
own internal solution would further com-
pound the number of data sources and
would take many months of customization
to be fully functional.
Selecting an MES for Compliance,

Adaptability, and Data Integration
Sparton required one consolidated
software package that spanned all of its
needs, including a system capable of
enforcing the tightest quality-control
measures to ensure safety to the end
user and assist in compliance with specif-
ic regulations. The contract manufactur-
er needed to provide complete eDHRs
with subassemblies and e-signatures to
support FDA 21 CFR Part 11 for cus-
tomers in the life science industries. The
company also looked for a quality man- FactoryLogix is used to define the manufacturing process and easily add on-the-fly steps for defining
agement system that validated continu- operations for one or more serialized units.
ous improvement to support AS9100C
certification for their aerospace and
defense customers.
Traceability to track factory processes
and minimize the scope of any product
recalls was another main component in
MES vendor selection. After review,
Sparton found that FatoryLogix offered
the most comprehensive system for
tracking serialized product for medical
and defense customers. The software
would introduce a paperless or digital
factory system to manage the entire dig-
ital thread from importing design data,
through revision control and work
instructions and bill of materials to final
dispatch, along with control of revisions
and engineering changes.
We had multiple requirements to
facilitate FDA compliance and ITAR
compliance. When we made our selec-
tion, we needed accurate and real-time Paperless intelligent work instructions leverage part and design data to develop rich, interactive sup-
eDHRs to tell where the product was and port documentation that guides operators through sequential assembly steps.
who worked on it through any point in
the production process. Product geneal- cessing, and serialized processing for both Advanced Reporting to Fulfill
ogy and traceability was critical because printed circuit board assembly (PCBA) Traceability Requirements
we had to be able to prove all steps, sub- and box-build applications. Based on the diversity of its cus-
assemblies, and components that went Finally, the MES was chosen based on tomers, Sparton needed a single system
into the top-level part, says Ryan Wells, its data integration model and the soft- that could slice data sets in multiple
information systems manager at Sparton. wares capacity for bidirectional commu- ways depending on changing needs and
Given its diverse product portfolio, nication with machines. Aegis vast library regulations. This functionality would
Sparton also chose this MES based on the of xLink adapters would allow for an out- provide customers with the highest level
systems advanced adaptability including of-the-box connection into Spartons of manufacturing insight based on pre-
integration with new and legacy produc- multiple machines. The universal system cise data. In addition, the ability for
tion machines as well as other ERP and database found in the MES would trans- operators to configure and generate
product lifecycle management (PLM) sys- form the disparate data types into streams their own reports would ease the bur-
tems. It also included the ability to adjust of standards-based data that could then den on the IT department and speed up
to batch-mode processing, lot-mode probe harvested for detailed analysis. the reporting process.

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FactoryLogix makes all of these data stop the line when a defect threshold has verification, and two-factor authentica-
available via comprehensive trace been met. Material and tooling setup and tion. The software also supports ITAR
reports that extend far beyond the mate- certification a critical component for compliance by providing the highest level
rials content records. Reports that serve reverse traceability lookups is enforced. of security in the form of active directory
as eDHRs include the products genealo- The software is configured to stop users security support, where user rights and
gy, the route, the operators and from proceeding if they are not trained or roles within the system are mapped to the
machines and times the unit passed certified, and it verifies that only person- users in the corporate active directory.
through them, test results, parametric nel with the appropriate clearances or
data, quality data, rework and replaced training status are permitted to work on The Result: Risk Reduction with a
component history, machine data, specified orders, jobs, and lots. The MES Paperless Factory
recipes, packaging records, tooling supports FDA CFR Part 11 through elec- The paperless factory model in the
used, and even the personnel that tronic signatures and approvals, training MES provides a documentation system
approved the release of the production
order to the floor. With drag-and-drop
dashboards and mobile interfaces that
operate in real time, the MES allows staff
to build custom reports in a simple man-
ner, without any knowledge of SQL,
scripting, or IT.
Implementation and Deployment: A

Tiger Team Approach
To implement the MES as efficiently as
possible, Sparton created a tiger team
comprised of MES users from four differ-
ent facilities. This synergized MES group
created a standardized, cohesive system
that helped de-silo communications as
each sites deployment progressed. There
were some cultural barriers to change
resulting from different definitions of
what MES meant at each facility. Focusing
on one cohesive definition of MES and a
single data set helped speed adoption
and effective implementation.
The speed of deployment of Spartons
MES averaged four months across multi-
ple facilities. Integration included merg-
ing the MES with all existing systems
including material movement through its
ERP system, back-feeding of all shop floor
data back to other systems, and configur-
ing its shop floor dashboards to display a
combination of MES, ERP, and PLM data.
Were at the heart of
Training of operators took place
through Aegis FactoryLogix University,
medical device innovation
which offers users the flexibility to learn
the software through on-site or online For a device designer, theres nothing more pulse-quickening
courses. Some users attended instructor- than being part of a breakthrough. We know the feeling.
led training courses at Aegis headquar-
Our precision-engineered Bal Spring canted coil spring has helped
ters, while others attended remote online
shape some of the biggest advances in medical technology, from
training sessions from their own locations.
VAD to DBS, orthopedics and beyond. It connects, conducts, shields
The Result: Improvements in Quality against EMIeven energizes seals for longer service life.
Control through One Data Set What will it do for you?
Today, a consolidated data set across
Call or click today, and start designing for tomorrow.
facilities allows Sparton management to
lift lid off the factory to monitor critical
quality information and enables subse-
quent corrective action in real time. Early
defect detection is possible through trig-
gered alarms on the factory floor that will 800.366.1006 w w w. b a l s e a l . c o m

Intro Cov ToC + A

Achieving Regulatory Compliance
that is guaranteed to be under control at and diagnostics and repair accuracy. diagrams and 3D images. The consoli-
all times. Incorrect documents are pre- Access to digital DHRs provides docu- dated system allows for complete trace-
vented from presenting on the shop mentation of all processes, verifying that ability, extending back to the process
floor, helping minimize the risk of defec- training records are current, equipment planning and even to R&D and design
tive product leaving the factory and is qualified, the right materials are used, via CAD data. The ability to reference a
reducing the risks associated with non- and all data is recorded. single data set has improved communi-
compliance. Revision control is no longer cation between engineering, produc-
manual but fully automated and ensured The Result: Increased Visibility from a tion, and operations, allowing Spartons
throughout the factory. Interactive visuals Connected Digital Factory business to pivot quickly in response to
with guaranteed current and proper The fully integrated MES allows for customer changes. Just by scanning a
parts list and CAD information increases real-time collaboration and data shar- unit, the correct revision assembly
assembly quality, inspection reliability, ing, including computer-aided design instructions, videos, CAD image, BOM
information, and all associated work
practice instructions and supporting
documents can be made immediately
available at every point along the route.
The MES tracks the entire production
flow from start to finish, including mate-
rials used, tools, operator and machines
involved, to provide keys against which a
group of serialized units can be recalled.
The Business Benefits: Future Proofing

and Return on Investment from MES
As todays regulatory requirements
evolve and customer demands for
greater traceability follow suit, Sparton
has an easily configurable system in
place to quickly respond to these
changes. Implementing the right MES
solution has allowed the manufacturer
to future-proof its processes because
the scope of the MES can easily adapt
to changing requirements without cus-
tom engineering.
The single cohesive set of data now
provided through the MES uncovers
hidden correlations across multiple
plants, enabling continuous manufac-
turing process adjustments. Since
implementing a consolidated data set,
some of the measurable improvements
seen at Spartons facilities include the
following:
A return on the companys software
investment was realized in just four
months.
5 percent reduction in defective parts
per million.
A drop of 30 percent in the average
assembly rework time.
Deep traceability available all the way
down to individual reference designators.
Across six sites, Sparton displays more
than 25 custom dashboards and reports
with an average development time of
one hour.
As Sparton continues to take on new
customers, it plans to expand the MES to
its facility in Ho Chi Minh City, Vietnam.
The company has also recently imple-
mented FactoryLogix R3s Logistics mod-
26 Free Info at http://info.hotims.com/65849-790 Medical Design Briefs, March 2017

Intro Cov ToC + A

Sparton operators use the entirely configurable graphical user interface
(GUI) for flexible display of work instructions while capturing material and
subassembly data.
A Sparton operator uses FactoryLogix on a touch screen monitor to select

operations and capture data quickly and efficiently.
ule at several sites, further optimizing resource scheduling and

incoming quality control, and introducing a mobile app that
increases operator mobility throughout the factory floor and
stock room.
Conclusion
Beyond the pressure that all manufacturers face to remain
profitable in the market, Sparton faced simultaneous
demand from customers and regulatory authorities to pro-
duce the highest quality products. Using a holistic big data
analytics approach to integrate disparate data sources across
multiple facilities allowed Sparton to enhance quality con-
trol while achieving end-to-end traceability as a by-product.
Access to the right data, at the right time now allows the
company to make well-informed and proactive business deci-
sions. Implementing Aegis FactoryLogix MES to harvest,
analyze, and store factory-critical information has resulted in
quantifiable improvements in enterprise-wide visibility and
has reduced risk.
This article was written by Alexis Zanger, Marketing Manager,
North America, for Aegis Software, Horsham, PA. She can be reached
at azanger@aiscorp.com. For more information, visit
http://info.hotims.com/65849-161.

Intro Cov ToC + A

TECHNOLOGY LEADERS Tubing/Extrusion
Computational Fluid Dynamics

in Extrusion Tooling
A
pplying fluid dynamic princi-
ples to extrusion tooling design
benefits any medical device
company involved with continu-
ous extrusion. Benefits include improved
product tolerances, reduced waste, and
stable, predictable performance.
It is well known that different poly-
mers have unique properties making
them desirable for certain applications.
As an example, some products may
require a stiff, tough cover with high
electrical insulating properties, while
others might need to be soft and flexi-
ble for medical applications. It is
important to recognize that the flow
characteristics of different polymers
and polymer blends are unique and
can be measured.
Polymers are non-Newtonian fluids Computational fluid dynamics allows everyone involved in the design process to visualize polymer flows
throughout the tooling from the breaker plate to the exit of the die. Here is a triple layer co-extrusion crosshead
the viscosity changes as the force applied die example that simulates velocity of all three layers throughout the co-extrusion die and adapters. Designers
to the material changes. To measure and use this output from the software to make sure flow is optimized throughout the tooling before any metal is cut.
compare how different polymers behave
when they flow, a device called a channel is large and higher when the and the results of the calculations. As a
rheometer is used, and shear viscosity channel becomes small. Therefore, the simplified example, perhaps in the ini-
data is obtained. As polymers are shear viscosity data are important: they tial design the calculated pressure is
exposed to higher shearing forces, their help to understand how the polymer too high. The flow channel size is
viscosity tends to be lower, and at a shear changes as the force it is exposed to increased to lower the pressure, and
stress that is too high can damage some changes. Of course, it is possible to the calculation is rerun. Once the cal-
polymers. Melt fracture is a common break down the steps in the flow path culated pressure is within the desired
example of this. Shear viscosity data can and understand what is happening range, the distribution can be adjusted
be used to compare how materials flow along the way, but this becomes tedious. to ensure that the final product is uni-
relative to each other, and the tests can The modeling techniques available form. If multiple sizes of products and
be run at different temperatures to show today make this easier to manage. line speeds are to be run using the
how heat can affect the flow. To begin any tooling evaluation or same head, CFD indicates how this will
Many blends of polymers are extrud- design, it is important to first understand affect the process, and the tool can be
ed, including some mixed with color a few basics about the process, including adjusted accordingly.
additives, some that are reground or use the type of application, the rheology of CFD can be used to identify problems
recycled materials, some that contain the materials being extruded, the size in existing tooling and to optimize new
cross-linking additives, and blends of dif- range of the product, flow rates, toler- designs. It helps to visualize the flow of
ferent materials along with fillers. These ances required, and requirements the material through the tooling to see
blends affect the flow characteristics and unique to the specific application. Once areas that may be stagnant or places
should be considered as well. Ideally, the first phase of the tool design is com- where the shear that the polymer is
whatever is going to be extruded should plete the computational fluid dynamics exposed to is too high.
be measured. (CFD) work can begin. It is common to In some applications, a tool must pro-
In practice, as a polymer is pushed design the tooling using solid modeling duce a narrow range of products consis-
through the extruder, adapters, and software, allowing everyone involved in tently. A good tool design allows the
tooling, the flow channel geometry the design process the ability to visualize process to run without the pressure
changes, but the flow rate should what the components of the tool will being too high, while minimizing the
remain constant. The shear forces the look like, and how they all fit together. volume of polymer within the tool. The
polymer is exposed to vary during the The CFD steps are iterative begin- polymer is exposed to less shear, and less
process. The forces are lower when the ning with the initial design of the tool energy is required to run the process. A

Intro Cov ToC + A

be used to design tooling that can
increase the processing window.
To get the best insight into an extru-
sion process, it is essential to understand
what the flow path looks like from the
extruder through to the die exit. In
many cases problems start because of
low flow or stagnant areas caused by
transitions from one area to another,
and these are not always intuitive.
Using CFD provides more information
about the extrusion process. It is possible
to predict what happens if a different
resin is used, or help explain why chang-
ing from one lot of the same polymer to
another lot affects the way a process
reacts. Gaining this additional insight
leads to a better overall understanding of
Computational fluid dynamics allows everyone involved in the design process to visualize that there is even what is happening within the extrusion
velocity at the exit of the die. This slide shows a cross-sectional snapshot in the distribution section of a triple
layer co-extrusion crosshead die. Tooling designers use this information to make sure the velocity for all three process and ultimately help processors
layers is even at the end of the die. reduce cost and increase quality.
This article was written by: John Ulcej,
good tool design requires less operator ucts and polymers through the same Director of Technology for B&H Tool
intervention as well. Other customers extrusion line. CFD can help determine Company, San Marcos, CA. For more informa-
might want to run a wide variety of prod- where limitations might occur, or it can tion, visit http://info.hotims.com/65849-168.
WHERE ON THE CUTTING EDGE

MEETS ON THE MEND.
Medical Connectors
We believe the best way to help patients get better is to always be at our best. So we continually
innovate, test, and improve our medical connectors. From luer and blood pressure connectors
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connections for all of your medical applications. Thats better for you and better for patients.
For more information, visit cpcworldwide.com/medical.

2017 Colder Products Company

Intro Cov ToC + A

Getting the Most from Your Extrusion Tooling
B
y using state-of-the-art produc-
tion equipment and processes,
machining tolerances are held
extremely close on todays multi-
lumen and multi-layer medical tubing. It
is important to note that any misalign-
ment of the tools may be exaggerated in
the final product output.
Clean parts, especially with sealing
and locating surfaces, are key to product
performance and successful end prod-
ucts. These surfaces receive the most
care and attention during manufactur-
ing and are the control surfaces that
ensure uniformity throughout the tub-
ing. Remember, precision-machined
alignments are affected by even a speck
of dirt measuring only a few thousandths
of an inch. A human hair is about 0.003
in. (0.08 mm), and because there are
many such surfaces in a quality tool, Double and triple-layer extrusion heads by nature have more sealing and centering surfaces.
cleanliness is critical.
Checking the tools for any deformities Use a vise with soft jaws, such as copper. nance time. Overhead costs add up, and
is also important. Burrs, scratches, and Use special equipment, such as tip losing money is the result. Some start up
scrapes are usually a result of careless removal tools, etc. Standard tools quickly and make scrap, whereas others
handling or storage of equipment. include wrenches, soft-faced hammers, start up and run a product oversized to
Double- and triple-layer extrusion heads etc. hold minimum tolerance. They waste
pose an even greater challenge for main- Maintain a supply of soft, clean rags. 1020 percent of the material, which can
tenance. The number of sealing and Use cleaning solutions in spray bottle. run from 50 to 90 percent of the prod-
centering surfaces multiplies and can Use spare parts as suggested by your uct cost.
magnify the results of dirty tools. tooling supplier, properly organized The tooling supplier goes to great
During changeovers, the head may be and stored. lengths so that tips and dies are
disassembled in order to change com- Keep handy the equipments machined to a determined specification,
pounds and tips and dies. Foreign mat- repair/maintenance manual. ensuring perfect concentricity and
ter is usually introduced at this point Have a small surface plate to provide a alignment. The material is then distrib-
and residual materials must be thor- true flat surface. uted in the proper location as part of the
oughly removed. Physical tool damage Use a set of appropriate gauge and tip finished product.
often occurs during this phase due to pins for initial tool location adjustment.
mishandling and poor storage tech- Make sure all proper lifting aids are Understanding Maintenance Procedures
niques. These are highly precise parts, available, including overhead hoists, It is important to get organized before
but can also be heavy and bulky to hydraulic lifts, etc. In most situations, you even start. Here are some examples:
remove by hand. the head and tooling will still be at ele- Example 1 In this example, with an
Use of a dedicated work cart exclusive- vated temperatures; therefore, lined improperly centered tool, a calculated
ly reserved and equipped for extruder gloves are needed when handling. out-of-tolerance area of 0.059 in2. (38
head maintenance is recommended. Today, tubing manufacturers com- mm2) was derived. When the two sur-
This cart along with a supply of spare pete with companies worldwide. To be a face areas were compared, the calculat-
components and hardware is easily justi- successful and profitable company, ed material waste was 11.8 percent of
fied, especially when examining the quality and efficiency are essential. This the finished product.
potential cost savings that result from is especially true in extrusion, where Example 2 Alternatively, if the per-
well-maintained tools. material costs are usually much higher centage wall can be increased from 80
The following should be considered: than labor costs. to 95 percent, a savings of about 12
Maintain a clean, organized work Like a racing car stuck in the pit, percent of total cost can result. Savings
area with soft and clean renewable many extruders sit idle because of poor will vary depending on the designs, of
work surfaces. or damaged tooling and excess mainte- course.

Intro Cov ToC + A

Get help for heavy parts and awkward
situations. Surfaces and edges are hard
and therefore somewhat brittle, so
dropping a part or striking parts togeth-
er can result in damage. Store tools
properly in a dry, clean area a dedi-
cated spot for each tool is best. These
areas should have soft surfaces, and
each instrument should be covered
after cleaning. Also, tools should be seg-
regated so that they do not come into
contact with each other. And tools and
all instruments should be cleaned thor-
oughly before storage.
For disassembly of tools, it is imper-
ative to use purpose-built tooling to
facilitate disassembly. These should be
available from the supplier. If they are
not, consult with a reputable tooling
house for replacements. The cost of Courtesy EnvisionTEC
these tools is easily offset by potential
damages, frequently caused by use of
improper equipment such as hammers
and drifts.
Follow the guidelines outlined in the Find groundbreaking medical 3D printing solutions
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Visit rapid3Devent.com/mmi to learn more.
MAY 8-11, 2017 | EXHIBITS MAY 9-11

Machining tolerances are held extremely close on
todays multi-lumen and multi-layer medical tubing. David L. Lawrence Convention Center | Pittsburgh, PA

Intro Cov ToC + A

care and maintenance. Here are some Removing Excess Material for Optimum harder to remove. Clean the body feed
useful tips: Machining Efficiency port using compressed air and brass pli-
Clean equipment while it is still hot Clean parts are critical to extrusion ers to simultaneously cool and remove
because the residue is easier to tooling performance and quality manu- the excess residue from the feed ports.
remove. It helps to remove and clean facturing. This is especially true for the This procedure is followed by brushing
one piece of tooling at a time. sealing and locating surfaces that control with a round brass brush that polishes
When cleaning a dual-compound uniformity of the production process. For the surface. The flow area of the 2 in.
crosshead (plastic and rubber), clean general maintenance of the tools, before (51 mm) flange adapter should be
the plastic tooling first and the rubber storage or tooling changeover, a thor- cleaned by carefully using a brass brush.
second. ough cleaning and removal of the excess Examine all surfaces for any irregulari-
Never use steel tools such as scrapers material ensures the precision machining ties such as burrs and scratches since
or screwdrivers because these can alignments required to produce end these must be repaired before the head is
scratch and mar the tooling. products to the precise tolerances. reassembled. Most manufacturers recom-
Do not use open flames because this Equipment should be cleaned while it mend using a hand polishing stone to
generates excessive heat, especially in is still hot, because residual polymer and remove the offending burr. Follow ston-
thin sections, which can affect hard- rubber will be easier to remove. Be sure ing with a light application of 600-grit
ness, concentricity, and tolerances of to follow all material safety data sheet emery cloth if necessary, but avoid round-
components. recommendations when heating the ing edges that are intended to be sharp.
Recommended cleaning tools and tooling. Thermal gloves are used to pro- Flat sealing surfaces can also be
materials include: tect the hands from the heated tooling cleaned using a stone, followed by a
Brass pliers to grip material and aid in surfaces. A brass scraper, as well as a 600-grit emery cloth. Place the cloth
pulling. brass or copper wool cleaning cloth, are on a clean, flat surface, preferably a
Brass scrapers in different widths for recommended because they are soft surface plate, then apply friction in a
cleaning flat exposed surfaces. enough not to scratch the surface. circular hand motion until the area is
Brass bristle tube brushes that are clean and even. The parts in question
available in diameters from 1/16 to 1 Make Tool Cleaning Easier should all be hardened steel alloys and
in. in 1/16 in. increments (ideal for The quickest way to remove the die is will not be adversely affected using
cleaning holes and recesses). to employ the pressure of the extruder these methods. Inconel, monel, and
Brass rods different diameter rods to push it out. Clean the body by using Hastalloy are typically not heat-treat-
are good for pushing material out of an air compressor and brass pliers so ed, requiring special care and han-
flow holes. that the material cools down. This dling to avoid any damage.
Copper gauze for cleaning and polish- method increases the melt strength,
ing exposed round or conical surfaces. making it into one lump instead of an Dont Overlook Repairs
Copper knives for removing residue elastic, gummy-like substance that is Tooling maintenance helps ensure a
from recesses and other hard-to-reach quality extruded product one that
areas. Also, polishing compound meets dimensional specifications and
restores polished surfaces. maintains the specified minimum tol-
Compressed air, which is more effec- erance and is economically produced.
tive for releasing plastic, but also aids Dirty, neglected, and improperly
in rubber removal. Be careful not to adjusted tools contribute to excessive
force debris into recesses with com- compound applications, which in turn
pressed air. complicate maintenance of minimum
Cleaning solutions may be useful, so thickness tolerance. Excess material
remember to use fresh, clean rags results in unnecessary costs, and these
(used rags often have metal chips directly affect the profitability of your
embedded in them, which may scratch company and the relationships with
polished surfaces). your customers.
Cleaning oven for plastic only.
Follow manufacturers recommenda- The Important Final Step
tions. If no temperatures are specified, Reassembly
do not exceed 850 F(454 C). Dont Working from a dedicated tool cart,
quench tooling to cool. This can affect follow the manufacturers instructions for
tooling hardness, concentricity, and reassembly. Give each component a final
tolerances. wipe down with a clean rag before
Purging compounds several are installing. Even the smallest amount of
offered to purge the extruder Extrusion tools require a disassembly/reassembly grit, dirt, and residual material must
cart as shown here. This allows precise realignment
screw/barrel of residual polymer and and prevents costly collisions that damage the die always be removed. Use mechanical or
rubber compounds. sections and product integrity. manual assistance for heavy and awkward

Intro Cov ToC + A

May 16-18, 2017
Eastern States Exposition
West Springeld, MA
FIND SOLUTIONS
It is important to form a concentric cone as quickly
and accurately as possible in the primary section of
the die when the extrudate first emerges from the
FOR YOUR
die's distribution capillaries.
components to avoid unnecessary
MANUFACTURING
mishaps. Reapply anti-seize compound to
all fasteners if required.
CHALLENGES
Tighten fasteners to manufacturers
recommended specifications as well as in
the recommended sequence. This fasten-
ing sequence should be specified in the
manual and is generally in a star pattern.
Tighten gradually until the proper
torque is achieved to prevent distortion
of the tooling. EASTEC is focused on the manufacturing
One of a die manufacturers main ideas, processes and products that make an
goals is to form a concentric cone as
quickly and accurately as possible in the impact in the Northeast region. Be proactive
primary section of the die when the and research the latest manufacturing
extrudate first emerges from the dies
distribution capillaries. A properly advancements at EASTEC 2017. Find
designed and manufactured die has even technologies to resolve production problems
distribution close to the extrudate
entrance point, but this effort is negated and reduce build time, ultimately leading to
once the die is adjusted, shifting the bottom-line improvements to your business.
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This article was written by Glen
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Engineering Co., West Warwick, RI. For more
information, visit http://info.hotims.com/
65849-167.

Intro Cov ToC + A

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&&5).',+5,("3+5-,.(+$3!&5

Intro Cov ToC + A

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Intro Cov ToC + A

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Medical Design Briefs, March 2017 www.medicaldesignbriefs.com 37

Intro Cov ToC + A

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Intro Cov ToC + A

Spinal Stimulator Improves Finger Control Wearable Sensor Improves Perception for Visually
Scientists from UCLA, Los Impaired
Angeles, CA, have tested a spinal A wearable assistive device from the VTT Technical Research
stimulator that will help individuals Centre of Finland (Espoo, Finland) enables users to sense
who have suffered a spinal cord their environment and move around more safely. The clinically
injury, and a resulting loss of move- tested device, worn like a heart-rate monitor, functions on the
ment and strength. The electrical basis of a VTT radar system.
stimulation increased one patient's An experimental device By relying on radio waves, the signal passes through cloth-
finger control and grip strength up being tested at UCLA ing. The radar uses vibration and voice feedback to convey
to 300 percent, according to the helped Brian Gomez regain information to the user. The technology detects most obstacles
movement and strength in
researchers. his hand after a traumatic in the wearer's surroundings,
In June 2016, 28-year-old Brian injury. (Credit: UCLA Health) although difficulties remain,
Gomez became one of the first peo- according to the developers, in
ple to undergo surgery for the experimental device. Five years sensing objects such as thin
earlier, Gomez had suffered a traumatic injury a broken branches and bushes.
neck due to a dirt-bike accident. The radar has been clinically
VTT Technical Research
The UCLA scientists inserted the 32-electrode stimulator Centre of Finlands wearable tested in trials approved by the
below the site of Gomezs spinal cord injury, near the C5 ver- assistive device. (Credit: VTT) National Supervisory Authority for
tebra in the middle of his neck. The injury area is most com- Welfare and Health. The test group
monly associated with quadriplegia. included 25 visually impaired people, of whom 14 were blind,
Additionally, doctors implanted a battery pack and processor 7 partially sighted, and 4 deaf-blind.
within the lower back. The palm-sized device is paired with a The VTT trial showed that 92 percent of wearers felt that the
remote control that patients and doctors use to regulate the device helped them to perceive their surroundings; 80 percent
frequency and intensity of the stimulation. felt that their trust in their ability to move around independ-
For more information, visit www.medicaldesignbriefs.com/ ently had increased; and 32 percent would immediately start
component/content/article/1104-mdb/features/26296. using the test device in its current form.
For more information, visit www.medicaldesignbriefs.com/
'Painless' Patch Delivers Insulin When Needed component/content/article/1104-mdb/features/26298.
Treatment for certain diabetes
cases involves constant monitoring Novel System Puts 'Spin' on Wound Healing
of blood-glucose levels and daily Chitosan, a substance extracted
insulin shots. Researchers from the from crustacean shells, has antibac-
University of North Carolina, terial and wound-healing proper-
Chapel Hill, NC; North Carolina ties. Although fiber derived from
State University, Raleigh, NC; and chitosan is considered valuable for
the Changchun Institute of Applied functional clothing, the material is
Tiny, painless microneedles Chemistry, Changchun, P.R. China expensive and fragile. In addition,
on a patch deliver insulin in sought a simpler, shot-free way to the material easily generates static
response to rising glucose
levels. (Credit: American manage diabetes. Zhen Gu and her electricity during the spinning Chitosan (shown) has anti-
bacterial and wound-healing
Chemical Society) team created a painless smart process, causing the fibers to tear properties. (Credit: The Hong
patch that monitors blood glucose and cling around the roller. Kong Polytechnic University)
and releases insulin when levels climb. A novel system from The Hong
Individuals with Type 1 or advanced Type 2 diabetes regular- Kong Polytechnic University, Hung Hom, Hong Kong, spins
ly prick their fingers to measure blood-sugar levels, and some the chitosan fibers into yarn. The material can then be woven
patients must inject themselves with insulin when needed. The or knitted into fabric.
scientists developed a skin patch covered in painless micro- The Hong Kong team developed conductive spinning
needles. Each tiny needle contains tiny insulin-carrying pouch- rollers to remove the static electricity generated on the fibers.
es. The pouches are engineered to break apart rapidly and By addressing the breaking and clinging of yarns, waste and
release the insulin in response to rising glucose levels. production costs are reduced.
Diabetic mice wearing the patch maintained consistent Test results showed that a greater number of chitosan within
concentrations of insulin in their blood. After a shot of glu- the yarns led to a higher ability to suppress microbial growth.
cose, blood sugar levels spiked initially, and then fell to nor- To improve the healing of wounds, the chitosan material can
mal levels within two hours. be applied to wound dressings and bandages.
For more information, visit www.medicaldesignbriefs.com/ For more information, visit www.medicaldesignbriefs.com/
component/content/article/1104-mdb/features/26297. component/content/article/1104-mdb/features/26299.

Intro Cov ToC + A

New Sensors Detect Single Protein Molecules
Chemical engineers from the Massachusetts Institute of
Technology, Cambridge, MA, have developed arrays of carbon
nanotube sensors that spot single protein molecules as they are
secreted from cells, or even an individual cell.
Scientists can use the sensors to track viral infection, monitor
cells manufacturing of useful proteins, and reveal food contami-
nation.
We hope to use sensor arrays like this to look for the
needle in a haystack, says Michael Strano, the Carbon P.
Dubbs Professor of Chemical Engineering at MIT. These
arrays represent the most sensitive molecular sensing plat-
forms that we have available
to us technologically.
Stranos lab has previously
developed sensors that
detect many types of mole-
cules, all based on modifica-
tions of carbon nanotubes.
With the new MIT arrays, the MITs arrays of carbon nanotube
researchers used chains of sensors. (Credit: MIT)
DNA called aptamers to coat
the carbon nanotubes. The molecules bind with a specific
signaling proteins and change the nanotubes fluorescence
in a measurable way.
In the pharmaceutical industry, the sensors could addition-
ally be used to test cells engineered to help treat disease.
For more information, visit www.medicaldesignbriefs.com/
component/content/article/1104-mdb/features/26300.
Bone-Repair Technology Advances Toward Clinical Trial

Orthopedic device company OrthoMend Research,
Philadelphia, PA, acquired the rights from Temple University,
Extend The Life of Tools and
Philadelphia, PA, to commercialize an innovative bone-repairing Wear Surfaces Up to 1000%.
material. The nanodiamond-studded orthopedic fixation screws,
developed by Bioengineering Chair Peter Lelkes, dissolve in
bones over time and promote bone healing.
Lelkes, director of Temples Institute for Regenerative
Medicine and Engineering and also a professor of mechanical
engineering and of surgery,
says the materials stronger
screws and suture-like design
improve upon a current
biodegradable material used
in orthopedic repairs.
The orthopedic pins or
Bioengineering Chair and Laura H.
screws will be the first items Improve and renew Micro-Electronic Tools, Surgical Instruments and Micro-
Carnell Professor Peter Lelkes tested and manufactured. The Laboratory Instruments with the Hunter Carbitron 300. This simple easy-to-
(shown) is working on technology to development group then use process applies tungsten-carbide to tools and wear surfaces extending
create a cutting-edge material for the life up to 1000%.
use in orthopedic surgery (Credit:
plans to make plates and
Ryan Brandenberg) other bone-repair technolo- The Carbitron 300 system, consisting of an adjustable power supply and
gies, including hollow screws vibrating hand-tool is a heavy-duty unit incorporating the features of units
made of the same material that will deliver medications direct- selling for 5 10 times its low price.
ly into damaged bones to improve healing. Used for Tissue Forceps, Needle Holders, Micro Needle Holders, Micro Pliers etc.
With our technology, we can secure a bone and allow it to
heal while the polymer screws dissolve and are eliminated Hunter Products Inc.
within six to nine months, says OrthoMend Research CEO
Joseph P. Connell. 908-526-8440
For more information, visit www.medicaldesignbriefs.com/ www.hunterproducts.com
component/content/article/1104-mdb/features/26301. E-mail: sales@hunterproducts.com

Intro Cov ToC + A

Upcoming...
Webinars
Using UVC LEDs to Reduce the Spread of
Healthcare Acquired Infections (HAIs)
Tuesday, March 14, 2017 at 2:00 pm U.S. EST (HAIs)
It is more critical than ever for healthcare OEMs to adopt technologies that will help reduce healthcare associated infections. Integrating
UVC LED technology can be a key differentiator for OEMs as they look for new methods to address the growing HAI problem.
This Webinar looks at how R&D departments and product engineers can satisfy specific target log reductions by understanding dosage
as it relates to exposure time and UVC intensity.
Presenter:
Mark Pizzuto Rajul Randive This 30-minute Webinar includes:
Director of Global Product Director of Applications Live Q&A session
Management Disinfection, Engineering,
Crystal IS Application Demo
Crystal IS
Access to archived event on demand
Please visit www.techbriefs.com/webinar415
Designing Medical Devices That Are

Disinfectant Ready
Tuesday, March 21, 2017 at 2:00 pm EDT
Frequent exposure to aggressive disinfectants are damaging medical device housings and hardware made with commonly used materi-
als. Device failures not only impact quality of patient care but also increase overall operational costs. In this webinar, Eastman experts
unveil a new 4-step testing protocol that identifies weak points earlier in the development process, allowing for easier adjustments to
devices prior to going to market.
Presenter:
Yubiao Liu, Ph.D. Cynthia Lewis Ellen Turner
Medical Application Market Insight and Strategy Market Development
Development Representative Manager, Manager,
and Medical Technology Eastman Chemical Company Medical Device,
Platform Leader, Eastman Chemical Company
Eastman Chemical Company
This 60-minute Webinar includes: Live Q&A session Application Demo Access to archived event on demand
Available On Demand!
Benefits of Silicone Elastomers for
Healthcare Applications
When the human body requires support or artificial replacements to function properly or to boost the healing process, it is essential
that the materials employed meet the highest quality requirements.
This Webinar outlines the benefits of silicone elastomers for healthcare applications. A selection of various silicones are presented,
including a spotlight on recent innovations.
Speakers:
Scott Richardson Gregory Dull This 30-minute Webinar includes:
Technical Manager, Sr. Marketing Manager, Live Q&A session
Healthcare, Medical Devices, Application Demo
Wacker Chemical Corp. Wacker Chemical Corp.

Intro Cov ToC + A

Soft Robot Offers New Treatment Option for Heart Failure
Sleeve attaches directly Heart failure affects 41 million people help with friction between the device
worldwide. Today, some of the options and the heart.
around the heart. to treat it are ventricular assist devices The Wyss and SEAS engineers worked
Harvard University Wyss (VADs), mechanical pumps that pump with surgeons at Boston Childrens
Institute, Boston, MA blood from the ventricles into the aorta, Hospital to develop the device and
and heart transplants. While VADs are determine the best ways to implant the
Harvard University and Boston improving, patients are still at high risk device and test it on animal models.
Childrens Hospital researchers have for blood clots and stroke. The cardiac field had turned away
developed a customizable soft robot that To create an entirely new device that from idea of developing heart compres-
fits around a heart and helps it beat, doesnt come into contact with blood, sion instead of blood-pumping VADs due
potentially opening new treatment Harvard researchers took inspiration to technological limitations, but now with
options for people suffering from heart from the heart itself. The thin silicone advancements in soft robotics its time to
failure. sleeve uses soft pneumatic actuators turn back, says Frank Pigula, MD, a car-
The soft robotic sleeve twists and com- placed around the heart to mimic the diothoracic surgeon and co-correspond-
presses in synch with a beating heart, ing author on the study, who was for-
augmenting cardiovascular functions merly clinical director of pediatric car-
weakened by heart failure. Unlike cur- diac surgery at Boston Childrens
rently available devices that assist Hospital and is now a Faculty Member
heart function, Harvards soft robotic at University of Louisville and division
sleeve does not directly contact blood. chief of pediatric cardiac surgery at
This reduces the risk of clotting and Norton Childrens Hospital. Most
eliminates the need for a patient to people with heart failure do still have
take potentially dangerous blood thin- some function left; one day the robot-
ning medications. The device may one ic sleeve may help their heart work
day be able to bridge a patient to well enough that their quality of life
transplant or to aid in cardiac rehabil- can be restored.
itation and recovery. More research needs to be done
This research demonstrates that before the sleeve can be implanted in
the growing field of soft robotics can humans but the research is an impor-
be applied to clinical needs and tant first step toward an implantable
potentially reduce the burden of soft robot that can augment organ
heart disease and improve the quali- function. Harvards Office of
ty of life for patients, says Ellen Technology Development has filed a
Roche, PhD, the studys first author patent application and is actively pursu-
and a former graduate student at the ing commercialization opportunities.
Wyss Institute of Biologically This research is really significant at
Inspired Engineering at Harvard the moment because more and more
University and the Harvard John A. people are surviving heart attacks and
Paulson School of Engineering and This image shows a soft robotic sleeve placed around the ending up with heart failure, says
Applied Sciences (SEAS). Roche is heart in a pig model of acute heart failure. The actuators Roche. Soft robotic devices are ideal-
embedded in the sleeve support heart function by mim-
currently a postdoctoral fellow at the icking the outer heart muscles that induce the heart to ly suited to interact with soft tissue
National University of Ireland. The beat. (Credit: Harvard SEAS) and give assistance that can help with
research, published in Science augmentation of function, and poten-
Translational Medicine, was a collabo- outer muscle layers of the mammalian tially even healing and recovery.
ration between the Wyss Institute, SEAS heart. The actuators twist and compress The research was co-authored by
and Boston Childrens Hospital. the sleeve in a similar motion to the Markus Horvath, Isaac Wamala, Ali
This work represents an exciting beating heart.The device is tethered to Alazmani, Sang-Eun Song, William
proof of concept result for this soft an external pump, which uses air to Whyte, Zurab Machaidze, Christopher
robot, demonstrating that it can safely power the soft actuators. Payne, James Weaver, Gregory Fishbein,
interact with soft tissue and lead to The sleeve can be customized for Joseph Kuebler, Nikolay V. Vasilyev, and
improvements in cardiac function. We each patient, says Roche. If a patient David J. Mooney. It was supported by a
envision many other future applica- has more weakness on the left side of Directors Challenge Cross-Platform grant
tions where such devices can delivery the heart, for example, the actuators from the Wyss Institute for Biologically
mechanotherapy both inside and out- can be tuned to give more assistance Inspired Engineering, a Translational
side of the body, says Conor Walsh, on that side. The pressure of the actua- Research Program grant from Boston
PhD, senior author of the paper. Walsh tors can also increase or decrease over Childrens Hospital, the Harvard School
is a Wyss Institute core faculty member time, as the patients condition evolves. of Engineering and Applied Sciences and
and the John L. Loeb associate profes- The sleeve is attached to the heart the Science Foundation Ireland.
sor of engineering and applied sciences using a combination of a suction For more information, visit https://
at SEAS. device, sutures and a gel interface to wyss.harvard.edu.

Intro Cov ToC + A

Blood-Repellent Materials:
A New Approach to Medical Implants
Materials could lower risk for surgical implants with lower risk of biocompatible materials. Starting with
of rejection of surgical rejection by the body. sheets of titanium, which are common-
implants. Its an outside-the-box innovation ly used for medical devices, their labs
achieved at the intersection of two disci- grew chemically altered surfaces that
Colorado State University, plines: biomedical engineering and act as perfect barriers between the tita-
Fort Collins, CO materials science. The work, recently nium and blood. Their teams conduct-
published in Advanced Healthcare ed experiments showing very low levels
Medical implants like stents, catheters Materials, is a collaboration between the of platelet adhesion, a biological
and tubing introduce risk for blood clot- labs of Arun Kota, assistant professor of process that leads to blood clotting
ting and infection a perpetual prob- mechanical engineering and biomedical and eventual rejection of a foreign
lem for many patients. engineering, and Ketul Popat, associate material.
Colorado State University engineers professor in the same departments.
offer a potential solution: A specially Kota, an expert in novel, superomni- Chemical Compatibility
grown, superhemophobic titanium phobic materials that repel virtually A material that is phobic (repellent)
surface thats extremely repellent to any liquid, joined forces with Popat, an to blood might seem counterintuitive,
blood. The material could form the basis innovator in tissue engineering and the researchers say, as often biomedical
scientists use materials that are philic
(with affinity) to blood to make them bio-
logically compatible. What we are doing
is the exact opposite, Kota says. We are
taking a material that blood hates to
come in contact with, in order to make it
compatible with blood. The key innova-
tion is that the surface is so repellent, that
blood is tricked into believing theres vir-
tually no foreign material there at all.
The undesirable interaction of blood
with foreign materials is an ongoing
Blood, plasma, and water droplets beading on a superomniphobic surface. CSU researchers have
created a superhemophobic titanium surface, repellent to blood, that has potential applications for problem in medical research, Popat says.
biocompatible medical devices. (Credit: Colorado State University) Over time, stents can form clots and
obstructions and can lead to heart attacks
or embolisms. Often patients need blood-
thinning medications for the rest of their
lives and the drugs arent foolproof.
The reason [that] blood clots is
because it finds cells in the blood to go to
and attach, Popat says. Normally, blood
flows in vessels. If we can design materi-
als where blood barely contacts the sur-
face, there is virtually no chance of clot-
ting, which is a coordinated set of events.
Here, were targeting the prevention of
the first set of events.
The researchers analyzed variations of
titanium surfaces, including different tex-
tures and chemistries, and they compared
the extent of platelet adhesion and activa-
tion. Fluorinated nanotubes offered the
best protection against clotting, and they
plan to conduct follow-up experiments.
Growing a surface and testing it in the
lab is only the beginning, the researchers
say. They want to continue examining
other clotting factors, and eventually, to
test real medical devices.
Fluorinated nanotubes provided the best superhemophobic surface in the researchers experiments. For more information, visit http://
(Credit: Colorado State University) source.colostate.edu.

Intro Cov ToC + A

Researchers Use Natures
Weaving Formula to
Engineer Advanced
Functional Materials
Biomedical engineers have woven a
smart fabric that mimics the
sophisticated and complex properties the
bone tissue periosteum.
University of New South Wales, Sydney, Australia
For the first time, biomedical engineers have woven a
smart fabric that mimics the sophisticated and complex
properties of one of natures ingenious materials, the bone tis-
sue periosteum.
Having achieved proof of concept, the UNSW researchers
are now ready to produce fabric prototypes for a range of
advanced functional materials that could transform the med-
ical, safety, and transport sectors. Patents for the innovation
are pending in Australia, the United States, and Europe.
Potential future medical applications include intelligent
compression bandages for deep-vein thrombosis that respond
to the wearers movement. The research is published in
Natures Scientific Reports.
Many animal and plant tissues exhibit smart and adap-
tive properties. One such material is the periosteum, a soft
tissue sleeve that envelops most bony surfaces in the body.
The complex arrangement of collagen, elastin, and other
structural proteins gives periosteum amazing resilience and
provides bones with added strength under high impact
loads.
Until now, a lack of scalable bottom-up approaches (build-
ing up from most basic elements) by researchers has stymied
their ability to use smart tissues to create advanced functional
materials.
UNSWs Paul Trainor Chair of Biomedical Engineering,
Professor Melissa Knothe Tate says her team had for the first time
mapped the complex tissue architectures of the periosteum, visu-
alized them in 3D on a computer, scaled up the key components,
and produced prototypes using weaving loom technology.
The result is a series of textile swatch prototypes that mimic Power Supplies and
periosteums smart stress-strain properties. We have also
demonstrated the feasibility of using this technique to test other Cords to 60601-1
fibers to produce a whole range of new textiles, Tate says. When power is critical to your equipment
To understand the functional capacity of the periosteum, as well as your patients, you can rely on
the team used an incredibly high fidelity imaging system to MEGA Electronics to deliver.
investigate and map its architecture. Power supplies and cords to UL60601-1 and
We then tested the feasibility of rendering periosteums international approvals. Power supplies meet
natural tissue weaves using computer-aided design software, Energy Level VI, 4th edition and 2x MOPP.
Tate says. Upon your next requirement, please keep
The computer modeling allowed the researchers to scale up MEGA in mind.
natures architectural patterns to weave periosteum-inspired,
MEGA Electronics Inc.
multidimensional fabrics using a state-of-the-art computer-
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controlled jacquard loom. The loom is known as the original New Brunswick, NJ 08901
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rial that mimics elastin and silk that mimics collagen, Tate says.

Intro Cov ToC + A

In a first test of the scaled-up tissue turing applications, the UNSW team is parts in the lab to replace and repair
weaving concept, a series of textile ultimately focused on the machines our failing joints that reflect the biology,
swatch prototypes were woven, using human potential. architecture, and mechanical properties
specific combinations of collagen and Our longer-term goal is to weave bio- of the periosteum, Ng says.
elastin in a twill pattern designed to mir- logical tissues essentially human body An NHMRC development grant
ror periosteums weave. Mechanical test- received in November 2016 will allow
ing of the swatches showed that they the team to take its research to the
exhibited similar properties found in next phase. The researchers will work
periosteums natural collagen and with the US-based Cleveland Clinic
elastin weave. and the University of Sydneys
First author and biomedical engineer- Professor Tony Weiss to use the smart
ing PhD candidate Joanna Ng says the technology to develop and commer-
technique had significant implications cialize prototype bone implants for
for the development of next-generation preclinical research within three
advanced materials and mechanically years.
functional textiles. For more information, visit http://
While the materials produced by the newsroom.unsw.edu.au.
jacquard loom have potential manufac-
Periosteum is a tissue fabric layer on the outside

of bone, as seen in the upper diagonal segment
of the tissue image volume. The natural weave of
elastin (green) and collagen (yellow) are evident
when viewed under the microscope. Elastin gives
periosteum its stretchy properties and collagen
imparts toughness. Muscle is organized into
fiber bundles, observed as round structures in
the lower diagonal segment of the tissue image
Professor Melissa Knothe Tate with her computer- volume. The volume is approximately 200 200
controlled jacquard loom. (Credit: UNSW/Paul m (width height) 25 m deep. Joanna Ng with the weaver's loom. (Credit:
Henderson Kelly) (Credit:UNSW/Melissa Knothe Tate) Leilah Schubert/UNSW Media)
Sound Waves Create Whirlpools to Round Up Tiny Signs

of Disease
New technique could form While there are many ways to accom- der to produce a whirlpool that can cap-
the basis of a small, plish this today, most are expensive, ture these disease-signaling nanoparti-
time-consuming, or too cumbersome to cles in its vortex. The system shows early
inexpensive point-of-care take to the field, and they might require promise for new diagnostic devices
device for early disease trained experts. Duke engineers are because it is compact, inexpensive, low-
diagnosis. moving to develop a new device that energy, and does not alter the properties
addresses these obstacles. of the corralled particles.
Duke University, Durham, NC In a new study, researchers paired a The results appear online in the jour-
Mechanical engineers at Duke Uni- small acoustic transducer to a glass cylin- nal American Chemical Society Nano.
versity have demonstrated a tiny whirlpool Diagnosis impacts about 70 percent
that can concentrate nanoparticles using of healthcare decisions, says Tony
nothing but sound. The innovation could Huang, professor of mechanical engi-
gather proteins and other biological struc- neering and materials science at Duke.
tures from blood, urine, or saliva samples If we can improve the quality of diag-
for future diagnostic devices. nostics while reducing its costs, then we
Early diagnosis is key to successfully can tremendously improve the entire
treating many diseases, but spotting healthcare system.
early indicators of a problem is often The new technology relies on calculat-
challenging. To pick out the first warning and manipulating the effects of the
ing signs, physicians usually must con- two forces associated with sound waves
centrate scarce proteins, antibodies, or acoustic radiation and acoustic
other biomarkers from small samples of The new acoustic whirlpool device with a penny streaming. If youve ever blown air
for scale. The acoustic transducer creates a
a patients body fluid to provide enough whirlpool in the long, thin, blue capillary tube across the top of a bottle to create a
of a signal for detection. that effectively concentrates nanoparticles. tone, then youre familiar with the latter.

Intro Cov ToC + A

Wearable Watches to
Monitor Your Blood
Pressure
New model measures blood pressure
without regularly cutting off circulation.
NIST, Gaithersburg, MD
What if there were a wearable fitness device that could mon-

itor your blood pressure continuously, 24 hours a day?
A sample of 500-nm particles in solution. In the top image, the acoustic Unfortunately, blood pressure measurements currently
whirlpool device is turned off. The bottom image shows that when the device
is turned on, the nanoparticles are concentrated to the point of becoming require the use of a cuff that temporarily stops blood flow. So,
visible as a dark line down the center of the chamber. a wearable blood pressure watch using todays technology
would squeeze the wrist every few minutes, making it impracti-
cable to use not to mention annoying.
A better method might gauge subtle pressure changes at
the surface of skin above one of the main wrist arteries
the radial artery without regularly cutting off circulation.
But before scientists can create this new technology, they
need to understand what the pressure inside a blood vessel
looks like on the surface of the skin. And to do that, they
must make a physical model that can be used to test wear-
able devices in a laboratory.
Nanoparticles tagged with fluorescent markers to make them easier to see NISTs Physical Measurement Laboratory (PML) is cur-
are concentrated in a column by a new acoustic whirlpool device. rently collaborating with Tufts Universitys School of
Medicine to develop just such a model, a blood pressure wrist
Acoustic streaming is the same phenomenon but in reverse,
where a vibrating body induces a fluid to flow.
Acoustic radiation is also easy to visualize just think of any
cartoon where a giant loudspeaker knocks somebody off of his
or her feet. While that scenario is unlikely to occur without
killing someone, sound is nothing more than a traveling pres-

sure wave, and it does push on whatever it encounters. Devices Internationally Recognized Consulting Company to the MEDICAL
have used this phenomenon to concentrate particles before, DEVICE/IVD/PHARMACEUTICAL INDUSTRIES
but it does not provide enough force on its own once particles
drop to the nanoscale. mdi Consultants Inc. has the expertise and can provide you
In the new device, a small, 5-V acoustic transducer creates a exceptional professional aid in the following areas:
standing sound wave aimed toward a long, thin glass vial.
FDA compliance Regulatory strategy development, clinical
Because the vial is perpendicular to the sound wave, and trial development/ management, cGMP compliance, ISO, CE
because Huangs team has precisely tuned the two to each Mark, On-site audits, validation (process, software and
other, the vibrations in the glass create a standing vortex along sterilization)
the vials axis. The whirlpool sucks in any particles suspended in 510(k)/PMA/ANDA/NDA/DMF/IDE Planning - Preparation
the test liquid such as those extracted from blood or urine and Submission, device listing and registration
samples while the acoustic radiation keeps them there. Customized Quality Systems for FDA QSR/cGMP/ISO
In the study, fluorescent markers help make suspended Compliance
nanoparticles more visible. But in an actual diagnostic device, Assist with your MDSAP audit planning
Huang says that wouldnt be necessary. FDA Troubleshooting, Response to 483 and Warning letters
My goal is to create a small diagnostic device about the size UDI & GUDID Compliance
of a cell phone that can autonomously separate biomarkers Official Correspondent and United States Agent for Foreign
from samples, says Huang. With this vortex technology, the Companies
biomarkers could then be concentrated enough to see with a FDAAWARE FDA database for all your FDA inspectional
insights
simple camera like the ones found in todays cellular phones.
Huang now plans to work on other components of such a
device and to collaborate with scientists at Duke Health to test Main Office:
the new vortex technology in disease diagnosis. 55 Northern Blvd., Great Neck, NY 11021
(Tel.) 516-482 9001 (Fax) 516-482-0186
This work was supported by the National Institutes of Health Email: info@mdiconsultants.com
(R01 HD086325) and the National Science Foundation (IDBR- Website: www.mdiconsultants.com
1455658).
For more information, visit https://today.duke.edu/research.

Intro Cov ToC + A

dously in terms of top of the silicone, what is it really see-
optimizing our tech- ing? says Zeeshan Ahmed, lead
nology for wear- researcher for the NIST PML team. Is it
able blood pressure just seeing the primary wave from a
devices. pulse of fluid going through? Is it seeing
The NIST-Tufts a lot of reflection waves, when the pri-
blood pressure phan- mary wave bounces off the metal plate?
tom consists of a slab How does the pressure change over the
of squishy silicone, time it takes for each pulse of water to
which stands in for pass through the artificial artery?
human tissue, sitting The sensors they are currently test-
on top of a metal ing are thin optical fibers called Bragg
plate, the stand-in gratings, designed to block a specific
for bone. A pliable frequency, or color, of light from pass-
tube runs through ing through them. When the pressure
the silicone to mimic changes inside the Bragg grating, so
A close-up of one end of the fake wrist. an artery, through does the color of light that is blocked.
which fluid flows via Researchers can use this change in
phantom essentially a fake arm a mechanical heart pump. The tube was color to identify the pressure that was
that mimics the mechanical properties made with a 3D printer by NIST collabo- applied to the fiber. The final phantom
of blood pulsing through an artery sur- rators at Walter Reed Medical Center. will likely incorporate about a half
rounded by human tissue. The materials were carefully selected dozen of these Bragg sensors, running
The phantom will give us very pre- to match the properties of skin, soft tis- through the silicone and over its top as
cise measurements say, for example, sues, bone, and artery walls, the well as inside and outside of the artifi-
what is actually the force on the blood researchers say. But unlike actual live cial artery.
vessel wall? And what is the force on human tissue, the phantom can easily Currently, the NIST team is conduct-
the soft tissue and the skin? says Tufts have sensors running through it, measuring preliminary tests to gauge the per-
University School of Medicine assistant ing the pressure changes that occur each formance of their sensors using a proto-
professor Mohan Thanikachalam, who time water is pumped through the tube. type without the mock artery. Instead of
is collaborating with NIST on this One of the things we want to under- pumping water through a tube, they
work. I think it will help us tremen- stand is, if a sensor is sitting up here on apply pressure to the silicone by crush-
ing it with weights. For example, to
mimic a blood pressure of 140/60, they
use masses of about 11.8 kg (approxi-
mately 24 lb).
So far, they have found that their
sensors can detect pressures from 170
mmHg, (about 22.5 kPa, or about 3
psi) down to 60 mmHg (about 8 kPa,
or a little more than 1 psi) with a reso-
lution of 2 mmHg (about 250 Pa, or
less than 0.04 psi). In terms of weight,
this means that they are measuring
masses of about 1 kg with a resolution
of just 20 g.
Also promising, Ahmed says, is that
the results are reproducible. Each time
the silicone is crushed, it springs back to
its original form, so that the results are
the same no matter how many times the
experiment is run.
The NIST team, which includes
Kevin Douglass, is currently preparing
to test the sensors ability to measure
pressures that change over time, using
a universal testing machine that they
call the crushinator. If all goes well,
the collaboration could potentially
have a working prototype sometime
This version of the fake wrist includes the artery, sitting in the center of the squishy silicone pad that this year.
acts like human skin and soft tissue. Thin fiber optic sensors are embedded in the silicone pad; their
extensions coil around the table at the top of the image. Note: To make it visible in this photograph, For more information, visit www.
the artery is illuminated by a red fiber optic cable that is not part of the actual experiment. nist.gov/news-events.

Intro Cov ToC + A

Improving Outcomes: 3D Printed Models for Simulating Surgery
he Department of Neurological Surgery at St. Louis
T University has partnered with the universitys School of
Engineering to begin quantifying how advanced manufactur-
ing practices such as 3D printing can enhance the training as
well as the surgical practice for neurosurgeons. The ongoing
study, which focuses on specifically saving a patient who is
experiencing a brain aneurysm, compares 3D printing against
traditional training methodologies such as cadavers (human,
animal), foam models, and other conventional practices.
The 3D printing study was spearheaded by Saleem
Abdulrauf, MD, professor and chairman of the Department
of Neurological Surgery and neurosurgeon-in-chief at the
St. Louis University Hospital. He is also president of The
Walter E. Dandy Neurosurgical Society, a premier forum for
neurosurgical surgeons that provides education and train-
ing to surgeons on cutting-edge practices that improve
patient outcomes. Dr. Abdulraufs mission is to improve
patient outcomes during the most complicated neurosurgi-
cal operations using all the innovative tools available to him.
I personally perform a lot of brain aneurysm surgeries. It is
a complex operation given the number of anatomical issues
that were dealing with under the microscope. I knew if there
was a way of simulating those complications before the opera-
tion using the same tools and under the same microscope,
wed have a higher positive impact on the procedure outcome
for the patient, he says.
Challenge
Brain aneurysms differ minutely from patient to patient.
During the operation, a surgeon is tasked with determining
how to reach the aneurysm with minimal effect on surround-
ing tissue. The surgeon must calculate, in real time, the opti-
mum angle to get into the area while factoring in the depth at
which the aneurysm occurs and the size of the clip needed to
close the aneurysm area.
Every aneurysm is different in size, contour, and location.
We have hundreds of clips sizes and types we can use, and
were typically making the decision on clip size during surgery.
If I can make that decision beforehand by practicing on a
model using the same tools and clips I plan to use in the final
operation, it really makes a difference during surgery,
explains Dr. Abdulrauf. Saleem Abdulrauf, MD, trains a surgeon using a 3D printed brain.
Developing a method to simulate an individual patients
specific brain aneurysm presented a few challenges. for doctors, a fast and a cost-effective production method is
Because the simulation would be most effective as a physical required. Ideally, each model would be created as a one-off
model on which the surgeon could practice the procedure, part unique to each patients particular brain abnormality.
the models therefore needed to be a 1:1 scale of the Therefore, conventional production, with high costs for single
patients brain. If the models could additionally mimic the tools that are dedicated to large volumes of identical parts,
look and feel of brain matter so that surgeons could use the would be unsustainable for the low-volume needs pertinent to
same equipment on the model as they would on the patient, a patient case-by-case creation.
it would be even more beneficial to surgeons.
Achieving simulation models with those parameters first Solution
requires an accurate high resolution map of the patients brain One of the fastest and most cost-effective production
translated into a 3D CAD model. Next, an extremely fast man- methods for one-of-a-kind parts is 3D printing, and so it was
ufacturing method is needed because patients would be suffer- quickly considered as a viable solution for creating the brain
ing from the aneurysm in real time. Lastly, for the models to models. From the selection of additive manufacturing tech-
truly demonstrate potential as a future business model viable nologies, PolyJet stood out as the most ideal 3D printing
Medical Design Briefs, March 2017 wwww.medicaldesignbriefs.com 49

Intro Cov ToC + A

The Stratasys team focused on ensuring the accuracy and detail of the
aneurysm area throughout the entire production process.
the feel of the spongey sulci and gyri in the brain. The ure-
thane material filled in around the anatomically correct
A 3D printed model simulates the procedure to assist in planning the PolyJet printed aneurysm. The mixture cured within the
surgery. TangoPlus and, with the aneurysm intact and in place
according to the patients exact brain map, resulted in a
process because it is capable of meeting the time, cost, and completed, multi-material piece ready for operation.
material challenges Dr. Abdulraufs team faced.
Additionally, PolyJet is one of the only 3D printing processes Results
capable of printing a range of durometers into a single part, These preliminary surgeries using a 3D printed model to
a significant boon to achieving the best feel for the skull of simulate the procedure prior to operation provided valuable
the model. feedback for Dr. Abdulrauf and his team. Having the 3D print-
To create the models for the preliminary patients, scans of ed model here has a very positive impact on the procedure
the patients brains were sent to the St. Louis University results, says Dr. Abdulrauf. The model has helped to identify
School of Engineering. The engineering students translated and overcome surgical challenges, like optimum access to the
the scans into high- resolution models that were exported as aneurysm or the depth and angle of the approach, before sur-
stereolithography (STL) files compatible with 3D printing. gery begins.
Although the university had its own PolyJet machine, to With these positive preliminary results, the next step is to
achieve the quality and materials diversification necessitated measure the success of 3D printed models through blind
by the project the team chose to outsource the models. They studies. Dr. Abdulrauf has proposed a two-arm study with
sent multiple CAD files of the brain, skull, and aneurysm to resident neurosurgeons. All of the residents will be asked to
Stratasys Direct Manufacturing, Poway, CA, for printing. perform a procedure on a cadaver. Half of the residents will
Together with Stratasys Direct, the engineering and medical receive a 3D printed model of the cadavers brain prior to
students noted the critical area of the aneurysm. The surgery while the other half will prepare for the surgery
Stratasys Direct team focused on maintaining flawless accura- without a 3D model. The two groups will then be compared
cy and detail on the aneurysm area throughout the entire blind. The assessors will not know which group received the
production process. 3D printed model. The success of one group over the other
Stratasys Direct was chosen as the 3D printing provider will be measured by the time undertaken during the
for the project for a few key reasons: its capacity, expertise, process, absence of errors, and the ability of the groups to
and dedicated anatomical department. The Stratasys Direct keep the circumference of the surgery as minimally invasive
anatomical department is one of the leading innovators in into healthy tissue as possible. From this study, Dr.
revolutionary manufacturing methods in the field of Abdulrauf hopes to quantify the use of 3D printed models
anatomical training models. Some of its key achievements in presurgical planning.
include providing 3D printing and urethane components A second study will involve measuring the outcomes of
for birthing simulators, as well as dental, heart, bone, and patients who receive the traditional gold standard of care
kidney models. Stratasys Direct collaborated with the univer- during surgery and patients who receive the gold standard
sity to build the scans of the brains, aneurysms, and skulls plus their neurosurgeons receive a 3D printed model of
using PolyJet and urethane casting. their brain to practice on prior to surgery. The recovery
The combined teams from Stratasys Direct and the univer- time of patients and overall patient comfort post-surgery
sity chose PolyJet Rigid VeroYellow for the skull and an over- will be carefully monitored in both groups. By studying actu-
molded TangoPlus material with a durometer of Shore 27A al patient outcomes, Dr. Abdulrauf hopes to gain measura-
for the brain. The TangoPlus brain was built as a multifunc- ble insight into the benefits of 3D printing for surgical pro-
tional piece. Initially, it served as the solid brain. Within the cedures.
CAD design, the aneurysm was 3D printed according to the The future of medicine is all based on measuring outcomes.
aneurysm pattern experienced by the actual patient. Finally, The most important thing is quantifying whats better for
the skull was built with the inner support material that patients and improving the lives of patients. To do that, we
hugged the grooves and depressions of the sulci and gyri must know the absolute best measures we can take using the
likeness of the patients brain. This support material served tools we have to improve their lives, explains Dr. Abdulrauf.
as the pattern for creating the inner brain matter. This article was provided by Stratasys Direct Manufacturing,
The interior of the TangoPlus brain was filled with a spe- Poway, CA. For more information, visit http://info.hotims.
cially formulated gelatinous colloid material that mimics com/65849-165.

Intro Cov ToC + A

Mounting Arm Extensions
PRODUCT OF THE MONTH GCX, Petaluma, CA, offers 8 and 14-
in. extensions for its newest variable
High-Strength Alloy height medical mounting arms, the
Foster, Putnam, CT, has intro- VHMPTM and VHM-PLTM. The exten-
duced compounds for medical sions are die-cast, making them well suit-
device components that require ed for various applications. The arms
high strength, yet cannot use met- offer significant advances in cable man-
als or traditional reinforced plas- agement, precision movement, cleanabil-
tics. The Nanomed MAX com- ity, durability, and load capacity. The medical-grade arms, which can
pounds, based on an alloy of conceal up to eight cables internally, have a smooth, unibody alu-
meta-xylene diamine polyamide minum construction for easy cleaning and provide a wide range of
(MX nylon), are USP Class VI movement to accommodate various users in both sitting and standing
tested and suitable for reusable instruments or components that positions.
must withstand gamma, e-beam, and ethylene oxide steriliza- For Free Info Visit http://info.hotims.com/65849-175
tion. Nanomed MAX compounds incorporate nanoclay particles
into a high-strength nylon alloy. These platelet-shaped particles, SLS Production 3D Printer
less than a nanometer thick and up to 1000 times greater in sur- Methods 3D, Sudbury, MA, has introduced
face diameter, provide reinforcement at the molecular level. a selective laser sintering production 3D print-
This enhances strength and rigidity of the polymer without hin- er featuring fast speeds, high print resolution,
dering flow into thin sections. Nanomed MAX compounds and an extensive range of engineered compos-
include less than 10 percent by weight nanoparticles resulting in ite materials. Created for the manufacturing
15 percent more tensile strength than unmodified PEEK, for floor, the ProX SLS 500 is the newest genera-
approximately half the price. tion of SLS printers that redefines production
For Free Info Visit http://info.hotims.com/65849-169 capabilities with repeatable results. This print-
er is designed to produce exceptionally
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2017 Product of the Year
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high print resolution, and edge definition.
For Free Info Visit http://info.hotims.com/65849-178
Flexible Packaging Design Guide External Power Supplies

An online flexible packaging TDK, National City, CA, has intro-
design guide is now available duced medical- and ITE-certified exter-
from Technipaq, Crystal Lake, IL, nal power supplies. This DTM300-D
on its web site. The site guides series offers a choice of class I or class II
design efforts by leading users (no ground connection) inputs and
through a series of 15 design meets the stringent Level VI DOE stan-
questions, many strengthened dards for efficiency and off-load power.
with alternatives and material The convection-cooled DTM300-D is housed in a rugged, vent-free
suggestions. A simplified specification is generated. When requested enclosure, measuring 222 112 45 mm. AC is applied using the
by the user, the specification can be emailed, which is followed by a standard IEC 60320-C14 (3-prong) or 60320-C18 (2-prong) connector,
quote and hand samples. and DC is provided through a 10-pin Molex Mini-Fit connector. The
For Free Info Visit http://info.hotims.com/65849-172 adapters also feature overvoltage and overcurrent protection.
For Free Info Visit http://info.hotims.com/65849-177
DC-DC Converters
XP Power, Singapore, offers miniature Panel-Mount Pump
2-W rated DC-DC converters for use in Watson-Marlow Fluid Technology
medical device applications that require Group, Falmouth, UK, offers a range of
safety isolation between the input and panel-mount pumps. Designed for the
output. The IML02 and ISM02 converters surgical ablation market, the 400RXMD
provide 4000 VAC reinforced isolation DriveSure range is highly adaptable and
with 1 x MOPP at 300 VAC (250 VAC directly accepts market-standard analog
model IML02) working voltage and have control signals. The pumps deliver very
a very low 2 A patient leakage current. low flows with high backpressure up to 87
the converters are available in an SMD psi through catheters or needles in cool-
package (model ISM02) or a throughhole, industry standard SIP7 ing applications. A tube holder ensures that the tube stays in the right
package (model IML02). The IML02 measures 0.77 0.39 0.49 in., position when the safety guard is closed, providing rapid, trouble-free
and the ISM02 is 0.94 0.71 0.36 in. tube loading and minimizing the risk of human error.
For Free Info Visit http://info.hotims.com/65849-174 For Free Info Visit http://info.hotims.com/65849-179

Intro Cov ToC + A

Radiopaque Wire Optical Sensors
Custom-manufactured radiopaque clad wire Werth, Geissen, Germany, has
that improves the visibility of stents and wire released noncontact probing optical
under fluoroscopy as an effective alternative to sensors for high-precision 2D and 3D
marker bands is available from Anomet measurements of micro features. The
Products, Shrewsbury, MA. The wire can be sensors enable many measurement
manufactured with different degrees of visibility points to be captured quickly and easily.
by modifying the alloy composition and The sensors application-specific resolu-
cladding thickness. Available in sizes from 0.05 tion can be adjusted easily by selecting an appropriate magnification.
to 1.52 mm OD, the wire can incorporate gold, The 3D-Patch and NFP Nano Focus Probe can be used in conjunction
platinum-iridium, tantalum, tantalum-tungsten, with 3D CAD data to assess surface topography. If the area to be meas-
and similar alloys bonded to high strength wires such as 316LVM stainless ured is greater than the sensors field of vision, several measurement
steel, nitinol, and MP35N with 2 percent or more cladding thickness. point clouds can be arrayed and processed into a single overall surface.
Flexible Epoxies Optical Encoders

EpoxySet, Lincoln, RI, offers the EB- US Digital, Vancouver, WA, has added
109M series of flexible epoxies 400 and 500 cycles per revolution (CPR)
designed for sealing, laminating, and resolutions to its existing E4T line of
encapsulating optical, electronic, and miniature optical encoders. The new
semiconductor components. Most of E4Ts deliver position and velocity feed-
the epoxies are low viscosity, room tem- back, while fitting NEMA motors as small
perature curing compounds that can offer low stress environmental as size eight. The new resolutions repre-
protection. The series contains products with varying viscosities and sent up to a 38 percent increase in available CPR and support applications
hardnesses to fit specific design requirements. For example, the EB- requiring up to 2000 pulses per revolution. The encoders, which maintain
109M-11 has a four-hour working time with a viscosity of 200 cps. It the package form factor, electrical characteristics, and output signal robust-
offers excellent impact resistance as well as high bond strength with ness of the existing line, are available in both single-ended and differential
protection from moisture and chemicals. signal outputs for applications where noise immunity is critical.
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March 2017

Intro Cov ToC + A

ADVERTISERS INDEX
Advertiser Page Web Link
AVX....................................................41.......................................................www.avx.com
Publisher.................................................................... Joseph T. Pramberger
Bal Seal Engineering, Inc. .................... 25................................................. www.balseal.com Associate Publisher.................................................................... Helene Beck
(908) 300-2538
Cadence, Inc....................................... 20................................................... cadenceinc.com
Sales Director........................................................................Desiree Stygar
CPC Colder Products Company.......... 29, 38.................................. www.cpcworldwide.com (908) 300-2539
Editorial Director........................................................................ Linda L. Bell
COMSOL, Inc. .................................... 5, 52.......................... comsol.com/application-builder Editor & Director of Medical Content.......................................... Sherrie Trigg
Managing Editor, Tech Briefs TV................................................. Kendra Smith
Create The Future Design Contest........ COV III.....................www.createthefuturecontest.com Production Manager............................................................. Adam Santiago
Assistant Production Manager.................................................Kevin Coltrinari
DA/Pro Rubber Inc. ............................ 4............................................ www.daprorubber.com
Creative Director...................................................................... Lois Erlacher
Fluid Metering, Inc. ............................ 45............................................... www.fmipump.com Senior Designer................................................................... Ayinde Frederick
Marketing Director............................................................... Debora Rothwell
Fluortek.............................................. 1..........................................................Fluortek.com Marketing Communications Manager........................................... Monica Bond
Digital Marketing Coordinator................................................. Kaitlyn Sommer
Hunter Products, Inc. ..........................41......................................www.hunterproducts.com Audience Development/Circulation Director......................... Marilyn Samuelsen
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Chief Executive Officer.................................................. Domenic A. Mucchetti
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MedBio, Inc. ...................................... 52............................................. www.medbioinc.com Systems Administrator.............................................................. Vlad Gladoun
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MEDICAL DESIGN BRIEFS ADVERTISING ACCOUNT EXECUTIVES
NewAge Industries Inc. ......................52..... http://www.newageindustries.com/sample-mdb7 MA, NH, ME, VT, RI, Eastern Canada.............................................Ed Marecki
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Okay Industries....................................13.........................................................okayind.com (203) 938-2418
MI, IN, WI..............................................................................Chris Kennedy
PhotoMachining Inc. ............................ 52..................................... www.photomachining.com (847) 498-4520 ext. 3008
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Tech-Etch............................................ 11.............................................. www.tech-etch.com CO, UT, MT, WY, ID, NM............................................................. Tim Powers
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Teleflex Medical OEM.......................... 2, 3435...................... www.teleflexmedicaloem.com S. Calif., AZ, NV............................................................................ Tom Boris
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TRUMPF Inc. ...................................... 3, 52......................................... www.us.trumpf.com
Europe Central & Eastern.......................................................Joseph Heeg
Unimed S.A. ...................................... 18....................................................www.unimed.ch 49-621-841-5702
Sven Anacker
Zeus, Inc. .......................................... 7, 37.............................................www.zeusinc.com 49-202-27169-11
Europe Western...................................................................... Chris Shaw
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March 2017, Volume 7, Number 3.

Intro Cov ToC + A

GLOBALL I
INNOVATIONS
Device Combines Ultrasound and Photoacoustics to Improve Imaging

University of Twente
Enschede, The Netherlands
www.utwente.nl/mira/news
I
n collaboration with various compa-
nies, scientists at the University of
Twentes MIRA biomedical research
institute have recently developed a
prototype for a handheld device that
combines ultrasound technology with
photoacoustics.
Where ultrasound offers images of
structures, photoacoustics offers images
that contain more functional informa-
tion, such as where blood is located in
the body. By combining both technolo-
gies in one device, images are generated
that offer considerably more informa- The device integrates pulsating diode lasers in the ultrasound probe to produce better images than
tion. The combination of ultrasound either technology can do alone.
technology and photoacoustics was made
possible through the integration of pul- od of time, for the purposes of discov- heat, causing a small increase in pres-
sating diode lasers in the ultrasound ering how the illness is progressing sure. This increase in pressure then
probe. The result is a compact, handheld and learning more about the effects of moves through the body in the same
and relatively inexpensive system. medication. Fewer mice will be need- way a sound wave would. This sound
Doctoral candidate Pim van den ed with the use of this technology. wave on the skin can be measured.
Berg tested the technology for a variety Working with University College Photoacoustics technology is an exten-
of applications as part of his PhD London, van den Berg also tested the sion of ultrasound imaging. In ultra-
research. His research shows that the device for measuring the flow rate of sound imaging, the sound is transmit-
device can be used to see a clear differ- blood, which provides physicians with ted into the body, where it bounces off
ence between arthritic fingers and information about inflammation. The of various tissues in a variety of ways
healthy fingers and to detect fibrosis of test has been very successful, he says. and produces waves that can also be
the liver in laboratory animals. In the We would like to find out how fast the detected on the skin. Photoacoustics
future, fewer mice will probably be nec- blood flows, how many blood vessels does not measure echo, but rather it
essary in research into liver fibrosis. there are near the site of the inflam- measures the sound that is produced
mation, and the levels of oxygen and through the absorption of light. This
Potential Applications nutrients. This information will tell us means a much greater sensitivity to
The combination of ultrasound and more about the inflammation. substances that absorb light such as
photoacoustics in a compact device In the future, the device could also be blood is needed. The method is pri-
means that the applications of this tested for use in mapping other ailments, marily suitable for measuring waves in
technology include a simpler and more such as skin cancer, burns, or hardening relatively superficial parts of the body,
accurate diagnosis of the degree to of the arteries. In a new European proj- up to 15 mm under the skin.
which patients with rheumatoid arthri- ect with the same partners, we will be con- This research was conducted by the
tis are suffering from inflammation of ducting measurements to greater depths Department of Biomedical Photonic
the joints. to detect hardening of the carotid artery, Imaging at University of Twentes MIRA
Another potential application is says Prof. Wiendelt Steenbergen, van den Institute in collaboration with Ruchi
fibrosis of the liver. Fibrosis of the liver Bergs thesis supervisor. Bansal and Jai Prakash from the
means damage to liver tissue due, for Department of Biomaterials Science and
example, to Hepatitis A or B or alco- How It Works Technology (MIRA) and with Thore
hol. This combination device can help In photoacoustics, short laser pulses Bucking, Joanna Brunker, and Paul Beard
detect the disease in laboratory ani- are emitted into a patients body. from University College London. The study
mals. It would allow researchers to When the laser hits a blood vessel, for was partly funded by the European
track a single mouse for a longer peri- example, the light is converted into Commission (FP7/318067).

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Off-The-Shelf-Custom SM
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Its Not An Oxymoron.

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Cable type/color
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