How are you influencing diagnostic devices?

Lowell Thomas
Chief Technologist, Metrigraphics, LLC

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

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

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

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.