Part three of a three-part series explores the what the future of diagnostics could look like.

Charles Tschaggeny, Founder and Principal Consulting Engineer

April 13, 2021

10 Min Read
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Image by Tumisu from Pixabay

To fly in today’s world, we have to go through a TSA security check. In the future, that TSA health check will entail proving we are healthy enough for the flight and that we don’t need to wear PPE, like masks, during the flight.

Health checks will be required to visit people in nursing homes and hospitals. Many companies will require employees to take these tests to work at the office. Health checks will be required for any activity where large numbers of people congregate, such as concerts and sporting events.

Envision the following scenarios for diagnostics.

Scenario #1: Portable Testing

Bill travels a lot for his job. He flies numerous times a week. Bill has neither the time nor the desire to wait in long TSA health check lines, so he opts to self-test at home. The results of the self-test allow him to skip the health check screening at the airport. He is able to buy these tests online in bulk for very cheap. Bill buys these tests in bulk because the results are only valid for a few days. He carries them while he is on the road and will take them as needed, anywhere he might be while traveling.

When he takes the test, his identity is verified (connecting the results and data to his identity), he finds out if he is healthy or not, and the results are sent to his phone in the form of a QR code. When he goes to the airport, Bill shows his test result QR code, like we do for our mobile tickets, and he goes through the security check. People can do the health screening at the airport but this means that they need to come to the airport even earlier and can’t check their baggage until they have their test results.

Since Bill is regularly testing himself and has his results readily available, he doesn’t have to worry about testing when he visits his mother who lives in a nursing home or his daughter and her new baby in the hospital. Bill's wife doesn’t travel regularly and she doesn’t want to test at the nursing home when she visits her mother-in-law or her grandbaby. To avoid having to test at these places, she uses one of the tests Bill bought in bulk. Bill doesn’t mind since these tests are cheap and the test results are automatically tied to her identity.

Scenario #2: Healthcare

Bill isn’t feeling 100% but his travel health test shows that he is healthy, so Bill goes on his business trip. During Bill’s business trip, he still doesn’t feel 100%. He is worried and isn’t in the comfort of his home. Bill uses an AI-driven app connected to his health history, previous diagnostics tests results, and his smart watch, which continuously measures several critical health parameters (like heart rate and oxygen). This helps Bill understand why he isn’t feeling well, then gives him advice about what action to take. The app recommends that Bill get tested in more detail than the travel test can provide. Since Bill is on a trip, he doesn’t know where to go for the test, but the app locates a testing site near his hotel for him. The app also tells Bill what tests he should have and sends him corresponding QR codes.

At the testing site, Bill goes to a vending machine and scans the QR code. The machine dispenses a sample collection device and walks Bill through the process of collecting his sample. Collecting his sample is very easy and painless. The sample collection device provides Bill with sample collection instructions. Once the sample is collected, Bill places the sample collection device back into the vending machine. The testing will be done in the vending machine without the need to deal with a person. The test will take a bit of time, so Bill can either stay and wait for the results and then get whatever medicine he may need, or Bill can leave and have the results sent to him. Either way, the app that Bill used to schedule his test will provide Bill his results, help him understand those results, offer advice as to whether Bill needs to talk to a healthcare professional, and help him schedule an appointment.

In this particular scenario, Bill’s test results show that he isn’t sick but could benefit from taking vitamins and getting more rest. Bill doesn’t want to carry the vitamins with him so arranges for them to be sent to his house. The app also advises Bill to test again in several weeks' time. This recommendation worries Bill and he wants to talk with someone to help him better understand what might be going on. Bill schedules a phone appointment for that night after he is done with dinner with colleagues.

Business opportunities

As part one of “A Look into the Future of Diagnostics and Healthcare” concluded about the oil crisis of the 1970s, crises are prime business opportunities. While many people may think the only business opportunities in the post-COVID world will be limited to face masks and shields, the post-COVID pandemic presents a plethora of vast business opportunities.

To meet new patient requirements and expectations for fast, accurate, and affordable testing, new products and processes will be required.  For diagnostics products, new chemistries, new methods to collect patient samples, and new forms of connecting patients to health professionals will all need to be developed. New testing centers will be needed. New methods to connect pharmacies with the new healthcare system will be needed.

Everything is in play, which means that new players in the field will be jumping to develop products and services. Let’s go back to the TestUtah and NBA examples described in part one—who would have thought pre-pandemic that a Utah Silicon Slopes company and a professional basketball league would become interested in testing? However, they saw how the current solutions weren’t meeting market needs, so they took the lead and innovated brilliant marketable solutions.

“Innovation distinguishes between a leader and a follower.” -Steve Jobs

Obstacles

Dr. Martin Luther King Jr. stated, “Our very survival depends on our ability to stay awake, to adjust to new ideas, to remain vigilant, and to face the challenge of change.” Indeed, there will be obstacles, but no great innovation is void of roadblocks. Let’s examine a few:

  • Inertia: In physics, inertia is defined as something that continues in its existing state of rest or uniform motion in a straight line, unless that state is changed by an external force. Right now, we have a decent healthcare system but it’s neither fast, accurate, nor affordable. The players are established in the current system. Like the Big Three automakers during the oil crisis, players in our current system would love to return to the pre-COVID normal, but that never will happen. Evolution is a historical fact of life. The world has shifted. People's expectations and requirements have changed.

  • Adaptability: Building a new system is expensive, and some existing players aren’t going to be able to adapt to the changed system. They won’t adapt because they lack the ability to see where the industry is heading, not only in this present moment but also in six months, a year, ten years. The new healthcare system of the future is for visionaries. For example, the big push in the diagnostics industry is point-of-care (POC) testing, which to the ‘old boys’ is in the doctor's office. The push towards home-centered diagnostics and healthcare moves the location of POC from the doctor’s office to the patient’s home. If a company has invested large amounts of money in the development of their POC system, how willing will they be to walk away from this investment?

  • Regulation: Health products are regulated by government agencies, like FDA in the United States, and will continue to be regulated by government agencies. These regulations ensure products can meet minimum levels of safety and efficacy.1 Agencies will continue to oversee the health-related products in the future. Their oversight isn’t going to go away; in fact, they may have increased oversight in the future as a result of COVID. FDA used Emergency Use Authorizations (EUA) to allow unapproved medical products and unapproved use of approved medical products to be utilized during the pandemic; many of these medical products and uses had issues, requiring FDA to remove them from the market during COVID.2 Jumping through regulatory hoops is a barrier to market entry. However, the oversight that these agencies provide on health-related products is not going away in the future.

  • Our current payment system: Our current system is based on treatment and not prevention. Who will pay for treatment and care in the future? Healthcare providers get paid from insurance and government programs based on treatment and reactive healthcare. How do we incorporate non-diagnostic data that is indicative of potential issues into the current system? There needs to be financial incentives to maintain current good health as opposed to treating declining health. Diagnostics should be used to measure treatment, allowing the patient to pay by potential issue.

The healthcare system is being revolutionized before our very eyes, even if we can’t perceive it. While many in the healthcare system are waiting for the pandemic to subside and the world to go back to what it was like pre-COVID, there is no going back—the world has changed.  We can embrace the fact that the world and the customer are changing and start today to develop the world of tomorrow, or we can insist on selling our large, gas-guzzling, cool cars to a world that needs fuel-efficient cars.  

We can keep having a phlebotomist draw blood the old fashion way with needles or we can automate this procedure, so that there is no phlebotomist involved in the process at all and pain is eliminated.  We can continue to be blind about our health trends or we can development tools that allow us to continually measure, track our health trends, and react properly.

We Will Be Able to Measure, React, and Repeat

The developments of the future will transform our reactive system into a preventive system—a system where the patient doesn't need to wait until a yearly insurance-paid checkup to understand what is going on with them. Our healthcare system will allow patients to be active participants in their own healthcare because they will have the tools to practice preventive healthcare; they will be able to measure, react, and repeat.

Conclusion

The healthcare and diagnostics world of tomorrow will be built on five pillars: home-centered, data, automation, price, and supply chain. By building technology and systems on these five pillars, we will anticipate and meet what the customer needs, and in doing so, develop the gold standard technology of tomorrow. Change means innovation to those who choose to act; to the victor goes the spoils. If you want to be a part of transforming/revolutionizing this future, the time to act is NOW. The future is here. We’re taking action.

Interested? We are currently highly engaged in designing solutions for tomorrow’s diagnostic and medical problems. We’d love to have an open conversation with you and share our respective visions for the future in more detail.

If I’ve grabbed your attention, here are some additional questions for consideration and discussion:

  • What do the travel tests look like and how do they verify the identity of the test taker?

  • What do the vending machines at the testing centers look like and how do they function?

  • What do the testing centers look like? Are they part of a pharmacy? Are they in a drug store? Are they part of Insta-Care clinics?

  • What type of healthcare professionals are you dealing with during telehealth? Are they doctors, physician’s assistants, and nurse practitioners? Or are they a new type of healthcare professional that we currently don’t have?

  • Where do we cap the test price point?

  • How can the costs of these tests be driven down?

 Here are parts one and two if if you missed them:  The COVID Effect: A Look into the Future of Diagnostics and Healthcare and The COVID Effect: A Look into the Future of Diagnostics and Healthcare, Part Two.

References

  1. "Regulation of Drugs and Devices: An Evolution," Merrill, Richard, Health Affairs, Summer 1994, https://www.healthaffairs.org/doi/full/10.1377/hlthaff.13.3.47

 

About the Author(s)

Charles Tschaggeny

Founder and Principal Consulting Engineer, Tschaggeny Design

Charles Tschaggeny is the Founder and Principal Consulting Engineer for Tschaggeny Design. He has spent more than 15 years in industry and well over a decade in the medical device diagnostics field, developing and producing cutting-edge diagnostics products. He received a bachelor's and master’s degree in Mechanical Engineering from the University of Utah. 

Tschaggeny was a major contributor to the design, development, and commercialization of the market leader’s BioFire Diagnostics's FilmArray Pouch. Before entering the medical device field, he worked as a mechanical engineer at the Idaho National Laboratory, where he designed unmanned aerial vehicles and automated mechanisms and systems for high-radiation environments. 

Tschaggeny is fluent in German and can speak Russian at a conversational level.

Tschaggeny Design is a full-service solution provider for product development and manufacturing with a special emphasis on medical products and lab automation. If you have the need for design or engineering services or would like to know more about the direction of diagnostics, please reach out to Tschaggeny Design.

 

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