The intersection of informatics, COVID-19 and the laboratory
By Guest Blogger – Leslie Williams, MT (ASCP), Marketing Content Writer and Expert in Medical Device Product Management
Your lab has data
Looking for some big data? Look no further - the coronavirus pandemic has delivered big data in spades, mountains of data that public health officials will be dissecting for years to come. And even then, after the best epidemiological minds have gone through the data and determined some meaning from it all, we still may not fully understand what has happened, or what we need to do to arm ourselves for the next pathogen. And believe me, there will be another one.
History has shown that global pandemics happen on a regular basis, yet this coronavirus still took most of the world by surprise. And while COVID has certainly made its presence known, disrupting the global economy and quarantining large swaths of the population, it has been relatively minor compared to a much more virulent pathogen like bubonic plague. The next pandemic could be bigger, badder and bolder by far, infecting a much broader portion of the population and presenting a much higher mortality rate. Big data is the only real defense we have against the next global pathogen, and precisely what we need to effectively safeguard ourselves against the next outbreak.
Laboratory Professionals – coming out of the shadows
For the laboratory industry, the coronavirus has been a confusing mix of unprecedented recognition and unregulated opportunity. With laboratories of all sizes making plans to ramp up test capacity, the immediate impact for some technologists could be job security. Prior to the outbreak, laboratory technologists remained largely hidden from public view, with a good portion of the population thinking that doctors and nurses performed all testing. However, the coronavirus exposed the lab as one of the key pillars of healthcare and brought new appreciation to the thousands of techs working for hours each day processing COVID-19 samples in gear worthy of a Biosafety Level 4 laboratory. While some labs did furlough staff due to closure of non-essential healthcare units and facilities, the sheer volume of coronavirus testing to be performed meant a rise in open positions – and in some cases, a rise in pay to correlate with then-feared hazards of working with samples from COVID patients.
Impact to you.
Know your value – in most cases laboratory professionals are experts in data analysis across many diagnostic disciplines. Seek out professional challenges and learning opportunities that will enhance your career – you are needed to ensure data integrity and transformation to its highest quality.
Lab testing explosion – take advantage of this rare opportunity
All this increased demand means that laboratories in the US are currently performing between 400,000 and 500,000 COVID-19 tests per day - that is some big data right there. As of this writing, nearly 19 million analyses have been performed, and with the new interest in serologic testing that number will continue to skyrocket. These are astonishing numbers, even for large commercial laboratories with capacity to process thousands of samples a day, and most labs have increased testing volume without the benefit of federal relief funds. Despite the financial burden, forty-two percent of labs are investing in expansion of their space and test menus to meet current and future demand, so the med tech job market – already flooded with unfilled positions – will stay robust for some time to come.
As you know, any crisis presents opportunity, and this viral crisis has been no different. Opportunity for technologists to be part of a much bigger picture than they normally are, to have an impact on patients outside their own facility, and opportunity for med tech manufacturers to improve their bottom line.
Since the epidemic began its march across the US, dozens of new COVID-19 screening test methods have been released to the market, most with little to no regulatory oversight and shockingly little substantive method validation. Under normal circumstances, this lack of performance data would stop a manufacturer’s progress toward 510k approval in its tracks, but the FDA’s Emergency Use Authorization process allows medical devices and test methods to come to market – for a limited time - with less regulation and review than normal in the event of a public health emergency. Some of these methods have already been placed on the FDA’s do-not-use list because of growing concerns about the validity of the results and questionable sensitivity and specificity values.
Lab professionals – Producing Big Validation Data for the Future
Medical technologists will play a role in ensuring the accuracy of those kits that do manage to remain on the market. Performance data means big data, and manufacturers looking to keep their coronavirus test kit on the market for the long term will have to follow the standard 510k submission process, and that means gathering real-world performance data. The millions of test results being generated every day will serve as the real-world validation studies manufacturers need, and all thanks to the technologists analyzing all these screening and serologic samples.
And this coronavirus has proven itself a bit of a free spirit, with its behavior has flying in the face of conventional wisdom and existing viral models and muddying the link between disease state and test results. The millions of molecular and serologic test results being generated every day will help establish medical and epidemiologic consensus – which does not yet exist - on what the test results really mean, or what the false negative rate and lack of generalized screening means for the calculated mortality and morbidity rates.
Inspire you.
So med techs take heart - the next sample you run could be the one that helps health experts define a better predictive model or a manufacturer to improve the specificity and sensitivity of their method. You understand the intimate details that are critical to process and valued decision making that benefit patient and healthcare. Answer the call and get involved in supporting your data initiatives – you could help bring the next innovation to market to save lives.
Resources:
Access industry dashboards to understand where COVID-19 infection is accelerating. The examples of COVID-19 dashboards below illustrate the data being gathered for COVID-19 by the US government, specialty research organizations and industry specialists.
1. CDC COVID-19 Dashboard
https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/testing-in-us.html
2. Regenstrief Dashboard for the State of Indiana
https://www.regenstrief.org/covid-dashboard/
3. John Hopkins COVID-19 Dashboard
https://coronavirus.jhu.edu/map.html
4. HC1 Lab Testing Dashboard
References
2. https://www.medtechdive.com/news/coronavirus-lawmakers-push-hhs-to-fund-clinical-labs/579430/
about Leslie Williams
Leslie directed her interests in English, science and medicine to a Bachelor of Science in Medical Technology from Northeastern University in Boston, MA. She spent seventeen years in a clinical setting, working in hospital laboratories and being promoted to supervisory positions. Leslie was then recruited to work for Bayer Healthcare, where she spent nine years learning the corporate side of medical devices and moving from technical service up to fourth level IT and installation support. She refined her marketing skills during her six years as a product marketing manager for Sysmex America before establishing her own consulting business. She provides marketing content management and creation services to companies in the medical device, regulatory and healthcare industries.
Start a conversation with Leslie at: linkedin.com/in/lesliewilliamswrites