Every day, countless blood samples are tested all around the world for one purpose: to help diagnose and treat medical conditions. From the couple eagerly awaiting the results of a pregnancy blood test to a worried cancer patient hoping for more answers, diagnostic blood tests give vital insight into what's happening underneath the skin.
When Every Minute Matters
In those times of need, every minute matters. Fast results make all the difference, and waiting days for a lab report just won't do, especially when you need to know now.
Enter the i-STAT Alinity system. As a handheld, portable blood testing device available by prescription, it can provide results within minutes virtually anywhere, from hospitals and nursing homes to the sidelines of sporting events.
To create it, innovators from Abbott's research and development (R&D) team spent six years designing prototype after prototype until they found a breakthrough solution that would stand the test of time. Here's their story, as told by Matt Bates, Ph.D., divisional vice president, R&D and Narendra Soman, Ph.D., director, R&D for Abbott's Point of Care Diagnostics business.
What prompted or inspired your R&D team to develop this device?
Matt Bates: At Abbott, we're very proud of our existing i-STAT device and the expertise we have in the point-of-care (testing that takes place with-patient) industry. However, we knew we could do more to push the boundaries and develop an even better with-patient device that could make a difference in the healthcare industry.
For me and many people on our R&D team, the inspiration for our work is the patient. It's about helping families and those who arrive at a hospital needing rapid treatment decisions. We also want to do all we can to help the healthcare providers who treat these people. Our team knew there was more we could do to make often scary healthcare moments — from a potential heart attack to the need for dialysis — a little better. That's how we began developing i-STAT Alinity.
Narendra Soman: When our team thinks about our customers, we often imagine ourselves or our families. At some point or another, we or a family member or loved one has been in the hospital. Knowing how that feels, we want patients to be treated faster and more accurately so they can return home and continue living their best and healthiest lives. Our goal is to help healthcare providers diagnose, treat and send patients on their way in the quickest and most efficient way possible.
What was one of the biggest challenges the R&D team faced?
Bates: One of our main goals was to design a device that would withstand the test of time. That meant creating a device that was durable, reliable and able to adapt to future needs. We needed to anticipate the needs of tomorrow, which was a real challenge. How do you prepare for diagnostic tests or innovations that don't exist yet — how do you develop a device that won't become outdated when new technologies arise? On top of that, we needed to be mindful not to lose sight of the features and capabilities people rely on with the current i-STAT device.
What went into the R&D process for this solution?
Soman: Our first step was to understand exactly what clinicians needed in a with-patient testing device. We spent countless hours interviewing our customers, including doctors, nurses, point-of-care coordinators, respiratory therapists — a wide variety of healthcare providers — about their pain points and needs to gain insight into where we could improve diagnostics.
From there, we observed providers who used our current i-STAT system in operating rooms, emergency departments, intensive care units and other locations to understand how they use the device. We took this information and developed many designs, which were narrowed down to several prototypes and then tested by our customers to determine which suited their needs best. When we landed on a final prototype that seemed to work for the clinicians, our Abbott researchers conducted a summary study that put the device to the test, demonstrating all the ways it could be used. This process took roughly six years, and we feel confident we got it right.
Bates: A significant R&D project like this touches every aspect of our organization. It took the collaborative efforts of a cross-functional team to develop i-STAT Alinity. This process has been a priority for many people for multiple years, so to see the final product and anticipate how it can help patients and providers alike is very rewarding.
What key features make this device stand out?
Bates: Our goal was to design it to be useful to the people who use it, whether a physician, nurse or emergency medical technician (EMT), so they could get timely information to make informed treatments for patients. From the color touchscreen to the upgraded software to the durable design, every aspect of the device allows the user to have better control. It has a rechargeable battery, can scan 2D barcodes, offers on-screen guidance during the testing process and can identify problems and potential solutions in real time. i-STAT Alinity also makes it easy for healthcare providers to understand results quickly. Colors, lights and sounds all make it clear when results are in a critical range and require immediate action, versus just providing abnormal or normal ranges. i-STAT Alinity was designed to withstand the realities of different clinical environments and was built to be robust, durable and reliable.
Soman: Similar to our current i-STAT System, i-STAT Alinity only requires a few drops of a person's blood, and the majority of tests can provide results in two to three minutes. These abilities allow for faster, simpler blood testing and analysis, which could be less taxing on both patient and healthcare provider.
What makes it sustainable for healthcare providers now and in the future?
Soman: We've designed it to run the broadest menu of tests on a single device. It was built to be "future-proofed," meaning it's compatible with a variety of testing cartridges, including those designed for our current i-STAT platform, as well as tests that will be developed in the future. In fact, we've designed i-STAT Alinity with the ability to add more testing cartridges and capabilities over time, such as ones that may be developed in the future like for concussion, blood clotting or molecular tests, allowing healthcare providers to conduct an even broader range of important tests with one handheld platform.
Where can healthcare professionals use the device for blood tests?
Bates: Portability is one of the biggest advantages of with-patient testing with Abbott's i-STAT Alinity. You can take the device into almost any setting — on the sidelines of a sporting event, in an emergency department or a rural healthcare facility — and it can give you rapid, accurate results without having to leave the patient's side. This could lead to quicker treatment decisions and could help people get healthier, faster.
How do you think it will help improve patient care?
Bates: Many healthcare providers who use point-of-care testing are in high-pressure, highly charged clinical environments. Being able to use a simple device that provides quick and easy-to-understand results can be valuable not only for them as medical decision-makers, but also for their patients. When healthcare providers use i-STAT Alinity, patients could be treated more quickly, spend less time in the hospital and could be on their way to better health sooner.
Soman: When we were conducting our research, I had the privilege of observing a kidney transplant. During the procedure, the surgical team was using one of Abbott's current i-STAT Systems to test the patient's blood gas levels, which in turn dictated how they adjusted his oxygen levels to keep him stable during surgery. I asked one of the nurses what they would have done without it. She said that someone would have had to run down six flights of stairs to the hospital's core laboratory to deliver the patient's blood sample for testing, then return to the operating room with the results. By that time, the results would have been 25 to 30 minutes old. You could compare it to driving a car and only opening your eyes every 25 to 30 minutes to know what's going on. i-STAT Alinity has the amazing ability to improve healthcare outcomes, and we're really proud to be a part of that.
For in vitro diagnostic use only. Not all products are available in all regions.
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