The industry has witnessed a fast-evolving series of technological advancements in clinical chemistry instrumentation. With each new system generation, novel features have been introduced, all of which are intended to help laboratories meet the needs of physicians and patients better, while creating efficiencies, driving quality, lowering costs, and addressing fluctuations in the workforce.
The IVD industry in India has seen immense progress. Major technological advancements and higher-efficiency systems have taken the sector to new heights. Advanced cutting-edge technologies are being used to understand disease prognosis, thereby strengthening the sophistication level of the participants in the sector.
The biochemistry sector is one of the fastest-moving sectors in Indian IVD industry. Currently, the biochemistry auto-analyzers are the backbone of major diagnostic chains in the country. In India, the emerging trend of corporate players, establishing diagnostic centers in small towns and rural areas, provides opportunities for the import of automated systems and reagents. For instance, Metropolis Healthcare plans to add 800 collection centers and 10 labs by the end of fiscal 2019.
Manufacturers are developing biochemistry analyzers with low-volume reagent consumption. The new instruments are able to automate repetitive sample analysis steps that would have otherwise been done manually. Manufacturers are customizing analyzers for use in smaller laboratories, use in very-high-volume situations, such as in a large hospital, or in the field. As software capabilities continue to develop, clinical chemistry analyzers will be able to offer increased testing speed and degree of automation. Moreover, as a result of the convergence of system engineering, automation, and IT technology, a significant change has been brought in the global biochemistry analyzers market. Advances in clinical chemistry analyzers will be concurrent with the development of new assays, further improving patient care. The need of the hour is to validate multiple biomarkers in the field of cancer diagnostics in order to bring molecular testing within the ambit of biochemistry analyzers.
Moreover, global IVD companies are expanding their operational footprint in India, which presents a growing market for their products like ready-to-use test kits equipped with features like high specificity and acute diagnostic analysis. Thus, the biochemistry market in India is growing at an extraordinary pace and the country has the potential to emerge as a global manufacturing hub in the medical devices space.
Computer technology has transformed clinical chemistry in two overarching areas: automation and informatics. Automation has touched every facet of clinical laboratory operation, enabling increased throughput to accommodate higher testing volumes; elevating quality by reducing human error and lessening the risk of sample cross-contamination; enhancing safety by reducing exposure to bio-hazardous materials; and improving workflow through greater system uptime and walkaway times.
Today, laboratories operate with greater efficiency than ever before. Processes that were, in the past, performed manually, now are performed via instrumentation. Full automation of pre-analytical, analytical, and post-analytical tasks enables laboratories to perform more work using less labor and fewer resources. Similarly, computers and microprocessor technology have enabled the creation of smaller-footprint units that accommodate higher test volumes. Today’s consolidated systems typically perform hundreds of tests on one platform, whereas preceding systems required a number of dedicated instruments, each performing only a few selected tests.
Automation, combined with cloud-based technology, has helped laboratories streamline daily operations and better manage patient information – all of which has become increasingly important because of trends in the workforce that have resulted in personnel shortages. Automating routine responsibilities frees the clinician to focus more on patient care and functions, for which they are specifically educated and trained. A pivotal area, in which laboratories have been able to improve uptime and avoid unplanned costs, is in automating inventory management. Cloud-based systems can help ensure timely ordering of reagents and consumables across an entire network, helping busy laboratories avoid workflow disruptions due to the potential inefficiencies resulting from manual inventory control processes.
In today’s world of big data, large amounts of information are available – but that can be more of a hindrance than a help to good practice if lab leaders do not manage the information effectively. Making that data relevant and usable for improving operations is important in helping laboratories achieve their continuous improvement goals. Today, lab directors need to coalesce actionable data into a single repository to drive decisions and provide valuable insights into laboratory performance network-wide. This can be accomplished via cloud-based analytics, and this will be increasingly important as the trend toward network consolidation continues to grow.
Quality has long been a driver of design and development. Advancements in software have had a profound influence on processing in the laboratory. Evolutions in software have opened pathways for automation, which heightens consistency and reduces operator error, and for fast and accurate analysis, predictive analytics, and data interpretation, which help to ensure the highest quality of results.
Science has enabled an increasingly rich understanding of the human body and the diseases and disorders to which it is subject – and of the biomarkers that offer objective evidence of those diseases and disorders. For clinical chemistry, that means that new and novel assays for use in the diagnosis and management of various disease states are being constantly discovered and developed. As highly specialized assays continue to become a part of the standard of care, analyzer design must keep pace with the accompanying workload demands.
Selecting an analyzer
Given all the benefits of modern instrumentation, the choice of an analyzer is not merely about the capabilities of the system. As with most technology, the choice should be based on user need. Laboratories must consider testing volume/throughput and the types of diagnostic tests that the system will perform. In addition, lab directors should think about the desired level of automation as well as pre-analytical sample handling and post-analytical data-management needs. Beyond instrumentation functionality, the laboratory must also examine space and cost constraints, taking into account footprint and system-operating costs.
While choosing the right instrument is important to ensuring successful laboratory operations, it is only part of the equation. Laboratories today are looking for knowledgeable partners to help them apply proven continuous improvement strategies – borrowed from the manufacturing industry – to healthcare. A partner who is able to offer a total laboratory solution beyond instrumentation placement can help the laboratory to achieve its patient care and operational-efficiency goals. This includes supporting the use of the instruments, identifying opportunities for automation, detecting workflow gaps, and helping to create efficiencies in managing resources.
Clinical chemistry has evolved greatly over time, driven by numerous factors – not the least being technological advancements in the world at large. Computers, microprocessors, and robotics have paved the way for automation and cloud-based technology. With this, laboratories no longer consist of small standalone, manually operated units that performed a handful of tests; instead, they have transformed into bustling hubs featuring large integrated platforms that produce thousands of tests per hour with sophisticated information-management systems. Future growth will build on this foundation, providing more capabilities in smaller-sized units. Instrumentation alone is only part of the equation. A strategic partnership can optimize laboratory performance, strengthening system advantages by integrating them into a total lab solution.
Biochemistry analyzers have come a long way during the last few decades, and the fast pace of technological development will fuel further technological enhancements. The drivers that affect development today will catalyze change in the future, accompanied by new, as yet unforeseen, drivers. It is anticipated that growth will be most robust in the areas of automation and software. Manufacturers will work to meet the laboratory’s need to manage increasing workloads with decreasing resources, simplifying labor-intensive tasks that are still performed manually today. Areas targeted for higher levels of automation will include instrument maintenance, system troubleshooting, and consumables management. Software development initiatives will target workflow inefficiencies and results processing. Cloud-based systems and integrated networks will enable patient histories to be recorded and recalled, regardless of where testing is performed. In addition to this, designers will continue the trend of downsizing units to reduce footprint, allowing more testing capabilities with smaller-sized machines. This will help laboratories save valuable space while still meeting the demands of physicians and patients. This will also pave the way for new technology in the area of point-of-care devices, reducing, for example, the need for large sample volumes.