How are you influencing diagnostic devices?
Lowell Thomas
Chief Technologist, Metrigraphics, LLC
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Minimally invasive, electronic medical devices have created
a need for new circuit manufacturing technology. Some devices must be small
enough to be inserted through vascular catheters for both diagnosis and
intervention. Designers of these devices need to severely compact and package
the flexible interconnection circuits to achieve the scale required. They have
found that traditional flexible circuit manufacturing is limited to materials,
equipment, and processes that are inadequate or incompatible for these needs.
My company has been at the forefront of developing micro-fabrication processes
that meet these miniaturization requirements. Cooperative communication with
engineers at the design stage has provided the knowledge exchange necessary for
effective solutions. Necessarily, the circuits must have a small footprint and
be extremely flexible, having very small, interconnected, multilayer
conductors. The conductors must have sufficient voltage capacity to operate
integrated circuits and sensors and, in some cases, sufficient current capacity
to drive intervention techniques. If this technology is to grow into scalable,
cost-effective manufacturing, a good understanding of constraints by both
designers and fabricators is essential. New materials and equipment development
will be necessary to implement this effort. Our current implementation is
continually changing to meet the demand for ever more complex circuits.
Mark Benson
Director of Software Strategy, Logic PD
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As the state of the art in diagnostic devices evolves within
the context of our flattening world economy, manufacturers are facing key
defining challenges that affect not only business performance, but also users
and patients—uncertain regulatory landscapes, increasingly demanding user
expectations, and tightening cost pressures. By doing over 100 unique product
design projects per year, Logic PD is uniquely positioned to take design
patterns from adjacent, faster-moving, higher-volume industry segments and
apply them on behalf of our lower-volume, highly-specialized, diagnostic device
manufacturing customers. An example of this was when Logic PD recently helped a
diagnostics device company redesign their flagship product by eliminating
expensive home-grown proprietary integrated circuits (ASICs, FPGAs) and
protocols with more conventional integrated circuits (microcontrollers) and
protocols (I2C, SPI) that have more widespread parts availability and better off-the-shelf
software support. By helping stagnating, vertically integrated companies like
this analyze and implement design patterns from adjacent industries, Logic PD
is influencing diagnostic device design by opening the eyes of the design
process to create more nimble, innovative, and disruptive diagnostic products
in an increasingly competitive climate.
Jim Dandeneau
CEO, Putnam Plastics
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Guide catheters are commonly used to access endovascular
sites for diagnosis and therapeutic intervention. These catheters are costly
and challenging to manufacture due to complex shaft requirements, which include
a lubricious inner layer, a braided stainless steel middle layer, and a
variable durometer outer layer. Product performance can vary due to poor
bonding between the layers and at the union of the outer layer segments, where
hinge points occur. Putnam Plastics developed Tri-Tie extrusion technology to
eliminate traditional manual assembly of multiple components with continuous
processing that creates a three-layer composite shaft with maximum adhesion
between the layers and more gradual transition of the varying durometer outer
layer. Tri-Tie extrusion technology provides four key benefits over
conventional manufacturing of guide catheters. First, integrated bonding
between layers ensures reliable shaft performance. Also, continuous variable
durometer outer layer eliminates kinking at bonded segment interfaces. Further,
elimination of discrete components and manual operations improves quality and
validation. Finally, continuous manufacturing offers substantial cost savings.
Dave Beckstoffer
Project Manager, Portescap
Diagnostic devices are constantly challenged to process
samples faster, yet be more compact. Motion control bears the responsibility
for accomplishing both of these targets. Due to the critical nature of the movements,
closed loop systems are used to ensure precise positioning. Different types of
motors can be used in sample preparation, but hybrid step motors enable direct
coupling to the load, allowing an increase in the sample preparation speed.
Using this type of high torque density motor allows
engineers to remove the typical gearbox used with other technologies, therefore
reducing the overall system costs. Precision can be
enhanced via microstepping, increasing the number of samples that can be
processed per tray. Coupled with this increased motor precision are high
resolution encoders that monitor the movements to provide confirmation.
Since space is at a premium, low profile encoders are used
to reduce the overall length of the motor package. The closed loop hybrid step
motor systems create a smaller overall footprint for the diagnostic machine,
yet increase the number of samples that can be processed.
Rob Kim
Strategic Marketing Director, Honeywell Sensing and Control
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The use of diagnostic equipment continues to grow and evolve
as new diagnostic tests are developed, use of point-of-care devices increases,
and overall demand for sophisticated healthcare increases globally. A wide
range of companies serve the diagnostics market, ranging from large,
multi-national companies to start-ups. While the types of products and
companies are diverse, one common thread is the need for sensors. Complex
diagnostic devices, like chemistry analyzers or flow cytometry systems, use a
myriad of sensors to manage reagent movement and sample handling, and maintain
consistent temperatures. Leading sensor suppliers are able to provide a
one-stop shop, including pressure, optical, temperature, position, and magnetic
sensors, as well as switches. In addition, leading sensor suppliers are able to
provide tremendous value to diagnostic equipment designers through application
and technical expertise, helping to improve both design and speed to market. Given
that there are thousands of sensor types and variations, diagnostic companies
would be wise to engage a leading sensor supplier early in the design cycle and
leverage their expertise.
Marten L. Smith
Staff Engineer, Medical Products Group, Microchip Technology Inc.
Microchip is enabling medical device designers with
controller chips that provide more performance in smaller packages. This
technology has already been applied in the emerging category of
“point-of-injury” diagnostic medical devices. These are portable devices that
can be used for quickly diagnosing injuries, such as an athlete’s head trauma
at the venues where they occur. “Point-of-injury” devices can also be used in
developing countries, where quick access to hospitals may be difficult.
One example is the portable head scanner developed by a
Microchip customer. It allows an injured athlete’s head to be scanned right on
the field, enabling treatment decisions to quickly be made. In a developing
country, this scanner can be used to determine whether patients’ head injuries
are critical enough to risk transporting them over rough and difficult terrain.
The transformation of this type of scanner from a
hospital-based piece of equipment to a portable, field device was made possible
by Microchip’s dsPIC Digital Signal Controllers. The aforementioned scanner
design used the dsPIC DSC’s combination of powerful digital signal processing
capability and flexible MCU functionality. These attributes are useful in any
diagnostic device where cost, power consumption, and size are critical.
Darrin Manke
Director and Program Manager, Farm
As a medical development consultancy, we focus on user
research to gain insights into ways to improve diagnostic devices. This
user-centric approach enables us to optimize system workflow, reduce tasks,
increase productivity, and enhance user experience. Conducting early and often
formative user testing enables us to zero in on the features and needs that are
the most critical to the user. Summative testing conducted later in development
phases validates that we have met those needs and ultimately leads to
improvements to the device.
