Clinical & Regulatory

Clinical & Regulatory

Getting it right first time: reimagining the digital possibilities in the clinical laboratory



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Jay Snyder, vice president, Business Fields—Clinical Laboratory Platforms and Solutions, is responsible for working with product management, R&D, project leaders, and the life cycle team at Ortho Clinical Diagnostics (Ortho) to develop and execute a platform strategy for the company. 

Having started my career as a laboratory technologist in a busy regional community hospital many years ago, I’ve learned first-hand that clinical chemistry represents the greatest volume of testing in the clinical laboratory. Therefore, I believe that focusing on delivering innovation to clinical chemistry can drive a paradigm shift for the entire laboratory. Though I’ve seen in vitro diagnostics companies invest in innovation over the years, there is still a significant, untapped potential for efficiency gains in clinical chemistry – especially given the evolution of the clinical laboratory that I witnessed throughout my career.

Today’s clinical laboratory environment is fraught with significant challenges: labour pools and budgets are shrinking, while workload and regulatory burdens increase.  In addition to these obstacles, laboratorians are required to serve clinicians and patients with faster and more consistent turn-around times. This is driven by the crucial importance of diagnostic data from the lab, not only impacting the quality of care, but also the flow of patients through critical care areas of a hospital such as the emergency department or the surgical recovery room. Improving both patient care and patient flow directly impacts the bottom line in delivery of health care. Laboratories are searching for ways to become more efficient and, at the same time, deliver improvements in quality in a sustainable way.

The automation answer

In large part, laboratories have responded to this need by adopting lean principles and automating their testing as much as possible. As labs look for solutions, in vitro diagnostics companies are devising new ways to innovate by developing more efficient solutions and expanding their service offerings. The adoption of track-based automation solutions with pre- and post- analytical capabilities has been an increasingly popular solution. While leveraging automation is a trend that started in large-scale laboratories, mid-sized laboratories face many of the same challenges and are increasingly adopting scalable automation solutions to address their needs.

In addition to automation, digitization and miniaturization can also bring significant benefits to the clinical laboratory. As the entire world digitizes at a rapid pace – from smart phones to super-thin OLED and QLED televisions to the digital transformation of entire industries – it makes sense to leverage digital technology to help laboratories overcome their myriad challenges. Digitization can offer significant enhancements in the lab, including patient care and patient satisfaction, and can enable more effective data analysis while increasing efficiency and scalability.

A new solution

Introducing Digital ChemistryTM into clinical lab management is one of the most promising ways to help clinical laboratories keep pace with the shifting landscape of global health care. Digital ChemistryTM is an innovative detection system that leverages data intelligence, operational improvements and a new standard for quality and efficiency.

Why is this innovation so important to today’s health care industry? It is estimated that in vitro diagnostics influences 66 per cent of clinical decision-making. Therefore, new technologies are critically important to diagnostics because they support accuracy and precision for optimal outcomes.

These new technologies are revolutionising diagnostics in multiple ways, and one major benefit is the ability to reduce or come close to eliminating the use of water. From diagnostic nanotechnology to dry slide technology, industry advances make it possible to attain accurate results, the first time, without depending on the availability or quality of water. Waterless lab technology not only eliminates water quality concerns, it reduces a lab’s dependence on water. A typical laboratory with wet chemistry systems can use up to one million litres of water annually, while newer dry slide technologies require none.

The advantages that waterless technology offers in challenging working conditions have been recognized by governments around the world, with dry slide technology being used on hospital ships and aircraft carriers during wartime and humanitarian missions.

Errors in diagnostic results are tremendously costly for laboratories, hospitals and patients. In many cases, errors can be avoided, as new technologies are available that automate processes and eliminate the potential for human error. Additionally, new technologies are able to detect interfering substances and/or filter them out – further ensuring the clinical laboratory of today are producing high quality results.

Jay Snyder

How can these innovations be more widely utilised? The value of consistently attaining high-quality, reliable and precise results is well-understood in the field of diagnostics, but it is difficult to quantify. The implications of an inaccurate diagnostic test can be far-reaching. For the laboratory, there is the cost and time associated with investigating and resolving the root cause of the error. For the hospital and health care providers, there is the time and cost associated with any delay in treatment or delivery of the wrong treatment as well as the risk to reputation. But it is the patient who bears the greatest risk associated with lab error should there be a delay in diagnosis and treatment or a need to change the course of treatment.

Integrated, automated and sophisticated diagnostics testing that leverages the wide array of biomarkers available to clinicians today allow the clinical laboratory to play a vital role in diagnosis, monitoring and prevention of disease. However, the entire value proposition of a clinical laboratory hinges on the ability to produce accurate test results in a consistent and timely manner.

As new technologies continue to be adopted, we will continue to research, develop and share case studies to show value to all stakeholders in the industry.

About the author

With well over 100 years experience between us, we've been around the editorial and medical blocks a few times. But we're still as keen as any young pup to root out what's new and inspiring.

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