IVD Technology Industry Buyers Guide
Electronic and mechanical components and software
Fundamental to the success of any IVD product is the selection of components from which it is created. Form, fit, and function are vital—and each of these factors must be considered during the process of selecting a system's components—however, let's not forget about the budget. System manufacturers are often driven secondarily by hospitals that are themselves constantly being pushed to reduce costs. Predictably, system manufacturers pass these cost pressures on to the component manufacturers. The listings in this section provide the instrument and system designer with a complete guide to the essential hardware and software items needed to design any IVD system.
Hot Topics
In the IVD marketplace today, there are three general categories of instrumented systems. At the top of the categories are the largest automated systems with full cap-piercing functionality and the capability of analyzing hundreds of samples per hour. Next in line are the small- and medium-sized laboratory systems of the benchtop variety. And finally there are the point-of-care (POC) devices designed to achieve the portability and ease of use necessary for near-patient testing.
Each of these categories of IVD systems employs a different kind of technology, depending on the type of assay being run. For instance, IVD instruments are commonly designed to accommodate the use of latex particles, ferrous microparticles, or other technologies adopted by reagent manufacturers. Such substrates—the solid portions of an assay—are usually selected by the reagent manufacturer based on cost, sensitivity, ease of test design, and other factors specific to the tests of interest. Emerging areas of interest in the IVD industry include microchip-based detection systems and molecular diagnostics.
Although genetic research and the development of related technologies have been under way for many years, these efforts have only recently received extensive attention in the lay press and financial circles. Given the significance of recent accomplishments in the field—including completion of the Human Genome Project—there is good reason for this interest. Over the long run, continued work in this field will result in the development of many new systems for understanding gene expression, developing new therapeutic agents (pharmacogenomics), and, ultimately, diagnosing a wide range of diseases. Such systems will combine the vast information found in the genome database with the latest in fluidic, mechanical, and software technologies. One key to the success of these new systems will be the use of Web-enabled technologies that are capable of linking clinical laboratories to genomic database information, as well as providing test results to healthcare providers in emergency rooms, operating rooms—or wherever else they may be.
Laboratory automation continues to arouse the interest of many IVD manufacturers—in part as a means of supporting the sale of proprietary reagents. Instead of pressing on with the marketing of costly total laboratory automation (TLA) systems, however, some manufacturers have turned their attention to the development of modular automation units. Such modules commonly focus on the most labor-intensive and error-prone processes in the lab, affording 90% of the functionality of TLA systems at 10–20% of the cost. Examples include modules capable of selectively decapping sample tubes, sorting sample tubes, and creating aliquots from primary sample tubes. Because such modular systems cost significantly less than TLA systems, they are much more likely to be the purchase of choice for small- and medium-sized hospitals and laboratories.
A Systems View
To fully see the value of this year's buyers guide, it is useful to look at it from the perspective of the essential subsystems of a complete, instrumented IVD test system. The basic functional components of such a system may include any or all of the following subsystems: specimen input, sample preparation, assay processing, signal detection, data detection algorithms, and information management. Looking at each of these functional areas in turn will help focus on how the buyers guide can be used.
Specimen Input. This is the subsystem where patient samples are placed, typically using microsample cups or draw tubes of varying standard sizes (e.g., 13 X 75 mm, 13 X 100 mm, 16 X 100 mm). The specimen input subsystem must have the ability to perform a variety of activities, all under automated robotic control. These include moving tubes to a location where an aliquot of the specimen can be dispensed into daughter tubes, labeling daughter tubes with bar codes, aspirating sample for subsequent processing, and archiving sample tubes for reflex or repeat testing. Key components of this subsystem include motors and motion controls, sensors, and instrumentation software that coordinates the movement of the sample and the system itself. This is also the subsystem where TLA or modular automation systems interface with the instrument. Such interfaces can be simple or quite complex, depending on the design of the instrument and how much automation is required. The success of a specimen input subsystem design demands compliance with NCCLS standards AUTO–1, –2, and –5.
Sample Preparation. It is during the specimen preparation phase that any dilution or other nonchemistry activity occurs. This is typically accomplished by robotic mechanisms that aspirate sample from the specimen tube and deliver it to the reaction chamber or location. Key components here include fluid-handling parts, motors and motion controls, sensors, and instrumentation software. TLA and modular automation systems commonly require little sample preparation, but nucleic acid–based systems may require significant preparation, including the thermal cycling necessary to perform amplification via polymerase chain reaction (PCR).
Assay Processing. Each of the various technologies has different methods for completing the assays. In almost all cases, some phase of the reaction process involves a "solid" portion, which is often the building block of complex proteins that ultimately leads to a detectable signal. As the system processes the assay, the solid portion is retained throughout the reaction process until the detection step. Almost all assay processing requires some form of temperature control, fluidic transfer, robotics, and motion control. Each of them also requires some form of instrumentation software.
Detection. There are a handful of different excitation and detection methods for IVD systems, many of which use common components. Each manufacturer will often tune the methods to maximize signal and minimize noise. Key areas of interest are optics, transducers, and software.
Detection Algorithms. This area is purely software and embodies the basic concept of taking the data from the detector and distilling them into clinically useful information. This distillation process may be as simple as using a ratio, or involve the complexities associated with digital signal processing. In all cases, the algorithm must be tailored to the specific type of IVD system in use and the specific assay being performed. Because detection algorithms are so very specific to the individual assay being processed, they are often created by the reagent manufacturer on a trial-and-error basis. When a complex detection algorithm is needed, product developers may need to seek out firms that have experience developing similar algorithms (see Section 8: Contract manufacturing).
Information Management. This area is mostly software, and encompasses all the systems programming necessary to record, transfer, or display such information as the patient name, hospital ID, tests to perform, test results, quality control results, and so on. The design and manufacture of software for IVD systems requires knowledge of both good design procedures and the regulatory process—beyond what is necessary for nonmedical applications.
Now that the Internet is a critical part of virtually every business, many IVD systems developers are focused on the issue of connectivity, utilizing standards such as HL7 and NCCLS AUTO–3. To facilitate such device connectivity, some contract engineering firms have developed tools that function as software components in IVD systems. The major challenge to the IVD and medical device industry at large will be to carry out the validation and verification required for the adoption of Web-based software.
The information management arena also offers opportunities for the development of user interfaces, including those for visualizing test results, tracking patient data, and handling quality control information. Many such interfaces are also Web-enabled, allowing laboratory personnel to review test results from remote locations using simple Web browsers. The tools available today for developing user interfaces are vastly improved over those of a decade ago.
Design Complexity
The basic functional subsystems of today's clinical laboratory instruments involve a wide variety of different components. In addition, the infrastructure for such systems imposes requirements for components such as chassis, cables and connectors, displays, input devices (including keyboards and bar code readers), power supplies, and printed circuit boards. Each of these plays a key role in the design of an IVD system, and adds to the complexity of the development of such instruments.
Because of these complexities—which are sometimes beyond the expertise of firms that specialize in assay development—many IVD companies choose to use contract engineering firms or contract manufacturers for this kind of design work (see Section 8: Contract manufacturing). Such firms offer expertise that is focused on the engineering aspects of IVD system design and development, enabling the manufacturer to focus on the reagent side of the picture. Both contract engineering firms and IVD manufacturers with internal engineering resources will find this year's buyers guide of great assistance in selecting components for their systems.—Rick Muller, RELA Inc. (Boulder, CO)
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