2020 was the year the world shut down, then, slowly and cautiously, reared its head to change the world as we know it. Suddenly jargon like “the new normal” has become commonplace language, bedrooms have been converted to home offices, and Zoom has replaced Friday nights out with friends. Fear seems to have laced every aspect of societal behavior, setting ablaze emotional response in every household, country, and industry. Indeed 2020 has been a year of crisis, but the true test of a crisis lies in how we deal with it: do you curl up in a ball and watch Netflix for the duration, or do you adjust, innovate, and act?
We’ve all watched in shock as strong robust healthcare systems around the world have nearly collapsed under the pressure of COVID–19. In the face of crisis, one must adjust and change, or become one of its casualties. Healthcare is no exception.
Our new reality: the healthcare system in the future will be different than the current healthcare system. The silver lining: ‘different’ can mean improved—improved healthcare, patient empowerment, and immense new business opportunities.
Allow me to paint a picture of the world post-COVID. Healthcare, including diagnostics, will be home-centered out of sheer necessity and demand. Patients will be active participants in their own healthcare, taking more control than formerly possible in decisions directly impacting their personal health. Our future healthcare system will have the needed tools and resources to help patients understand what is wrong, help them select a course of treatment, and guide them out of a place of fear and dependency and into a place of empowerment and active participation in their own healthcare. Current barriers such as price will be eased. As the healthcare system moves toward home-centered healthcare, prices will begin to drop thanks to the new tools and technologies that will emerge. The result of these changes will be a healthcare system that partners with patients in the healthcare process.
The current healthcare system is not set up for such an empowered partnership. We, as patients, no longer want to accept the status quo. Changing demands of the system present tremendous business opportunities as new products and services are needed to replace old methods that are no longer useful or accepted.
Let’s examine the diagnostic industry in the face of the global COVID-19 crisis. Diagnostic testing is an imperative tool in dealing efficiently with this unprecedented pandemic.1 Everyday a staggering number of COVID-19 tests are run, but we are only able to test a small fraction of the people that should be tested. “Our key message is: test, test, test,” said Tedros Adhanom Ghebreysus of the World Health Organization on March 16, 2020,2 and that is the seemingly unachievable goal with our current system. The pandemic has overwhelmed the world’s diagnostic testing system and shown us that the current system is not able to keep up with the needs of humanity. We, as patients, require more from the current system. In fact, it’s time we demand it.
Understanding how crises change the customer’s demands and how industries are forced to change in order to meet those demands is the key to help us anticipate what the future diagnostics industry will look like and help us to identify exciting new business opportunities.
What the Diagnostic Industry Can Learn from the Auto Industry during Oil Crises
The oil crisis of the 1970s illustrates how an enormous industry, such as the auto industry, can be transformed when a crisis changes customer requirements or forces them to adopt new ones. These shifting requirements force the market to change in order to meet them, bringing business opportunities. The example of the oil crisis in the ‘70s will help us understand how the COVID-19 pandemic will transform not only the diagnostic industry but also the entire healthcare system.
At the beginning of the 1970s, GM, Ford, and Chrysler, known as the “Big Three,” dominated the American car market. They sold nearly all the cars on American roads. Many people within the Big Three confidently assumed their market position would always be safe, since it was presumed Americans would never buy foreign cars. The cars manufactured in America throughout the ‘50s, ‘60s, and ‘70s were large, gas-guzzling, cool cars.
From the ‘50s to the ‘70s oil and gas were cheap and plentiful. However, over time and out of economic necessity, the United States became increasingly dependent on cheap foreign oil. Oil shipments to the United States and other countries during the 1970s were temporarily halted several times (in both 1973 and 1979). These stoppages caused fuel shortages, rationing, and oil price spikes in oil-importing countries worldwide. The price of oil in the U.S. and other oil-importing countries remained high even after the stoppages had ceased.
The oil crisis with its gas shortages, rationing, and high prices forced customers to start looking for more fuel-efficient cars. The Big Three were still making their large, gas-guzzling cars, which didn’t meet the customers’ new fuel-efficiency requirement. As a result, customers were forced to consider buying cars from different car companies they wouldn’t have previously considered. Foreign car companies were making smaller, fuel-efficient, less flashy cars that met the new need for fuel efficiency. Out of economic necessity, customers started buying foreign-made cars.3
Even with an oil crisis swirling around them, the Big Three gave little thought to making smaller cars. They falsely believed that once the oil crisis was over, consumers would get rid of their small foreign cars and return to purchasing their beloved, big cars once again. As we know, the customers never returned. They preferred the smaller, fuel-efficient, foreign-made cars. These cars, with their fuel-efficiency and higher reliability, saved the customer money both gas and maintenance.
When the Big Three realized their customers were not coming back, they were forced to either start producing smaller, fuel-efficient cars or become obsolete. Their first small, fuel-efficient cars like the Chevy Vega, GMC Gremlin, Plymouth Cricket, and the Ford Pinto were truly terrible cars. While these cars were fuel-efficient, they were appallingly unreliable and looked as dull as their foreign competition. These cars destroyed the reputation of the Big Three. Even today, the cars from the Big Three are still known for being unreliable even though there is no longer any significant difference in quality between their cars and foreign cars. 4,5
The auto industry’s transformation shows us that when an industry can’t meet customer requirements, customers will go elsewhere to meet their needs. If the new solution has better performance than the old solution, the better performance level becomes the new standard.
The oil crisis changed the automotive landscape. The market needed new cars and new supply chains, thus providing huge business opportunities for new car manufacturers, new suppliers, and dealers.
The diagnostics industry initially delivered a Pinto-like solution to COVID-19 testing—slow, lacking in real value, and very unreliable—the prime example of what not to do.
Before the COVID-19 pandemic, diagnostic testing was used as a tool to support medical professionals in diagnosing illness so that the patient (customer) could get further needed healthcare. Patient requirements for diagnostic testing were to be able to receive timely, accurate, and affordable results.
The diagnostic testing processes involved a patient visiting a medical professional (doctor, nurse practitioner, etc.), sample collection, sending the sample to the lab, testing, sending the results to the medical professional, followed by the medical professional reviewing the results then recommending further treatment. This can be a long process and often results don’t support the medical professional’s diagnosis due to time lag or inaccuracy. The system was able to meet the affordability attribute since insurance paid for the majority of testing. However, the system struggled with the timeliness and accuracy attributes.
The affordability attribute is the dominant attribute of the requirements, since testing must be paid for. The other two attributes, timeliness and accuracy, are less critical because the results are used to support the diagnoses of medical professionals. Diagnostic test manufacturers used these two attributes to differentiate their products.
Our current pre-COVID system, by design, was largely reactive in nature: the patient saw a healthcare provider after experiencing symptoms, received a diagnosis, and was treated.
Enter COVID-19 on the world scene. As soon as the show-stopping pandemic took center stage, diagnostic testing jumped to the forefront as our principal diagnostic tool in identifying those who had been infected with COVID. The patient requirements for this diagnostic testing were still to receive timely, accurate, and affordable results. However, due to its nature of unprecedented severity and rapid spread, timeliness and accuracy became urgent attributes as the world has raced to contain the illness. It became dire to know exactly who needed to quarantine and receive medical care and who didn’t. The affordability requirement is still important, but thanks to U.S. government programs such as the Families First Coronavirus Response Act (FFCRA), the patient is relieved from having to pay for the COVID-19 test and any associated costs.6
At the onset of the pandemic, the diagnostic testing process was not capable of testing everyone who showed signs of a COVID-19 infection, due to basic supply and demand. Therefore, only those with severe signs of infection were tested and those with mild symptoms were left wondering.7 Supply and capacity issues decreased as the pandemic continued, but the U.S. healthcare system was slow to relax testing restrictions against testing people with mild or no symptoms.
Today, the speed at which patients receive their test results is still often problematic. For COVID-19 testing results to be accurate and legitimate, they need to be returned in less than 72 hours. However, 40% of the tests take longer than this to return results, and many people throughout the U.S. have had to wait 7 to 14 days to get their test results.8,9 The accuracy of COVID-19 testing also continues to be problematic. Some COVID-19 tests return a false negative result of ~ 33%.10,11
Except for affordability, which was helped by the FFCRA, the system hasn’t been able to meet the accuracy or the timely attributes. The diagnostics industry realized that they weren’t meeting the customer's needs, so they developed new tests, began to do pool testing, and tried to streamline their sample collection processes.12
The pandemic brought new attention to the diagnostic industry and efforts to improve the testing process. For example, TestUtah saw a need to streamline the sample scheduling and collection process so they developed a mobile app to improve scheduling and collection by setting up drive-through sample collection locations.13 The NBA had a need to test players rapidly and affordably, so they could continue playing so they provided financing to develop quick saliva COVID-19 reagents.14
Patients are now more aware of the diagnostic industry and the benefits of diagnostic testing than they were before the pandemic. Such awareness will change expectations of diagnostic testing and will attract new innovators to the industry. TestUtah and the NBA are two prime examples of new players entering the diagnostics market.
COVID has quite literally changed the world. People now understand how a disease can bring the world to its knees and are willing to take all necessary steps to prevent another pandemic and protect themselves. People will be more cognizant about exposure to diseases, and as a society we will take actions to limit both our own exposure and that of others. Public mask wearing and social distancing, once foreign concepts, are now common place in daily life. Testing is now also used for more than the treatment of illnesses. Negative COVID-19 test results are required for entry into certain destinations, such as Alaska, the United States, and many European countries.15 People now also want to be tested as a conscious effort to avoid unnecessary spread of the virus for the social good of protecting others.
The entire world is aware of the diagnostics industry with both its strengths and shortcomings. We can expect that these changes will increase patient expectations for test availability, speed, and accuracy because they will be using the results for more than simply treatment of illness.
The Future of the Medical and Diagnostics Industries
What will the future of healthcare and diagnostics look like? If we can answer this question, then we can strategically place ourselves where the market will go. As Wayne Gretzky said, “Skate to where the puck is going to be, not to where it has been.”
We have established the three diagnostics requirements: timeliness, accuracy, and affordability. No longer will customers allow the industry not to deliver on these attributes. The industry must change to meet the changing demands of customers, or someone else will enter the market and do so. The healthcare world as we know it is going to change as a result of COVID. We can either be part of this change or be left behind.
The Home Pregnancy Test Case Study–An Insight to the Future of Diagnostics
One diagnostics product that has already totally shifted to the home is the pregnancy test. The evolution of the pregnancy test shows how market shifts occur and which testing attributes are valued. It also provides an example of a path that today’s diagnostics could take.
A lot happens in the first few weeks of pregnancy. The fetus’s most important organs and structures develop in this time, as it grows faster during this phase than any other. The sooner pregnancy is confirmed, the sooner the mother can take steps to properly care for herself and ensure fetal health. Traditionally, a woman wouldn’t know whether she was pregnant until she missed one menstrual cycle, the realization of which could take five or six weeks. As far back as ancient Egypt, people were looking for ways to confirm a woman was pregnant sooner than waiting for a missed cycle.
The first modern pregnancy test was developed in 1927. This test was complicated, took experimentation with five lab mice, required a week for results, and could only detect pregnancy about two weeks after a missed menstrual cycle. In the lab, they would inject a pregnant woman’s urine into a sexually immature female mouse, causing its ovaries to grow and produce eggs. The use of animals and the lengthy test process meant that the test was expensive; only a few labs could perform it. Women had to wait until at least a month after conception, visit a doctor, mail urine to a lab, and then wait at least another week to get the result of the test. Pregnancy testing in this era was not routine and only used by the wealthy or those who needed to know if they were pregnant for medical reasons.
In the 1960s, tests were developed that didn’t require animals and could be done in a doctor’s office. These tests used different methods (blood and antibodies) to determine pregnancy, and they were less expensive and more accurate than their predecessors. These tests could give doctors results in as little as a few minutes and up to several hours. Finally, pregnancy testing was made mainstream.
Shortly after, the first at-home pregnancy test hit the market using the same blood and antibody technology. These tests were complicated and took several hours to perform, but for the first time a woman could confirm she was pregnant without ever contacting the doctor. If used correctly, it was 97% accurate for a positive result, but only 80% accurate for a negative one.
Our current stick tests, developed in 1988, are much easier to use and are extremely accurate: 99% for a positive result. They are cheap and readily available. Women today usually find out they’re pregnant just after (and sometimes before) missing a menstrual cycle in the comfort of their own bathroom, without ever involving a doctor. This is a drastic historical improvement from the 1970s, when women relied on doctors to tell them if they were pregnant.16,17
Picture of a vending machine that sells pregnancy tests
The home pregnancy test demonstrates how the diagnostics and medical industries will change. When modern pregnancy testing started, you had to send a sample to a lab and wait for results. The tests weren’t very accurate, and you had to be fairly far along to get precise answers. Over time, the science behind the pregnancy test evolved, improving both accuracy and timeliness and decreasing cost. These improvements helped the pregnancy test move from a laboratory, to the doctor’s office, and then finally to the comfort of our homes. Other diagnostic testing should follow this path to meet patients’ evolving expectations.
Please see the next article, "The COVID Effect: A Look into the Future of Diagnostics and Healthcare, Part Two," which explores the five pillars of the future of diagnostics.
- Docea, Anca Oana, et al. "A New Threat from an Old Enemy: Re-emergence of Coronavirus" (Review), International Journal of Molecular Medicine, pages: 1631 1643, March 27, 2020 doi.org/10.3892/ijmm.2020.4555 https://www.spandidos-publications.com/10.3892/ijmm.2020.4555
- Mackenzie, Ruairi J, "Exploring the Coronavirus Pandemic: Why Is Testing So Important," Apr 21 2020, Technology Networks, www.technologynetworks.com/tn/articles/exploring-the-coronavirus-pandemic-why-is-testing-so-important-333717
- Gordon, Ed. "The Decline of the ‘Big Three’ U.S. Auto Makers," May 4 2005, NPR, www.npr.org/templates/story/story.php?storyId=4630187&t=1597407108655&t=1615624469180
- Eisenbrey, Ross. "Management – Bad Management – Crippled the Auto Industry’s Big Three, Not the UAW," May 24 2012, Economic Policy Institute, www.epi.org/blog/bad-management-crippled-auto-industry-big-three
- Smith, Laura, "What’s Bugging the Big Three," Quality Digest, November 2005, www.qualitydigest.com/nov05/articles/01_article.shtml
- Pollitz, Karen. "Free Coronavirus Testing for Privately Insured Patients?" Apr 20 2020, Kaiser Family Foundation, www.kff.org/policy-watch/free-coronavirus-testing-for-privately-insured-patients
- Slabodkin, Greg. "Labs Warn COVID-19 Testing Demand Will Soon Top Capacity as New Hotspots Emerge," June 29 2020, Medtechdive, https://www.medtechdive.com/news/labs-warn-covid-19-testing-demand-will-top-capacity-hotspots-new-surge/580690/
- Ryan-Mosley, Tate. "Why Some COVID 19 Tests in the US Take More than a Week," MIT Technology Review, April 5 2020.
- Tirrell, Meg. "Forty Percent of U.S. COVID-19 Tests Come Back Too Late to Be Clinically Meaningful, Data Show," CNBC. Aug 15 2020. www.cnbc.com/2020/08/15/forty-percent-of-us-covid-19-tests-come-back-too-late-to-be-clinically-meaningful-data-show.html
- Haseltine, William A. "The Challenges of Testing for COVID-19," Forbes, April 23 2020. www.forbes.com/sites/williamhaseltine/2020/04/13/the-challenges-of-testing-for-covid-19/?sh=55033ccc749b
- Ferran, Maureen. "COVID-19 Tests Are Far from Perfect, But Accuracy Isn’t the Biggest Problem," Popular Science, May 7 2020 www.popsci.com/story/science/covid-test-inaccuracies/
- Woloshin, Steve, et al. "False Negative Tests for SARS CoV2 Infection – Challenges and Implications," The New England Journal of Medicine, August 6, 2020 www.nejm.org/doi/full/10.1056/NEJMp2015897
- Baird, Robert P. "How Utah’s Tech Industry Tried to Disrupt Coronavirus Testing," The New Yorker, June 13, 2020 https://www.newyorker.com/tech/annals-of-technology/how-utahs-tech-industry-tried-to-disrupt-coronavirus-testing
- Lowe, Zach. "Saliva-Based Coronavirus Test Funded by NBA, NBPA Gets Emergency Authorization from FDA," ESPN, August 15, 2020. www.espn.com/nba/story/_/id/29667299/fda-allowing-saliva-based-test-funded-nba
- Testing and International Air Travel. February 18, 2021. Centers for Disease Control and Prevention
- Braunstein, Glenn. "The Long Gestation of the Modern Home Pregnancy Test," Clinical Chemistry, Volume 60, Issue 1, 1 January 2014, Pages 18–21, https://doi.org/10.1373/clinchem.2013.202655
- Tyssowski, Kelsey. "Pee is for Pregnant: The History and Science of Urine-Based Pregnancy Tests," August 31, 2018. Harvard University. sitn.hms.harvard.edu/flash/2018/pee-pregnant-history-science-urine-based-pregnancy-tests