An Inside Look at i-STAT Alinity

The portable, handheld i-STAT Alinity delivers quick blood test results anywhere you are.

Every day, countless blood samples are tested to help diagnose and treat illness. With the volumes of blood tests conducted each day, people might consider the process to be simple or routine. However, behind the scenes, the process of developing those blood tests and analyzers is actually quite complex.

From concept to creation, 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, are providing a peek into the six-year journey that led to Abbott's breakthrough innovation of the i-STAT Alinity System. This new handheld, portable blood testing device can be used virtually anywhere and provide results within minutes, right next to a patient's side. Learn what sets i-STAT Alinity apart.

Abbott's R&D expert, Narendra Soman, Ph.D., shares his thoughts for how i-STAT Alinity, a new handheld blood testing tool, could help patients get healthier, faster.

What prompted or inspired your R&D team to develop i-STAT Alinity?

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 for many people on our R&D team, the inspiration for our work is the patient. It’s about helping families and helping those who arrive at a hospital and need rapid treatment decisions. We also want to do all we can to help the healthcare providers who treat these patients. 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, a family member, a loved one or even we have 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 while developing the next-generation product?

Bates: One of our main goals with i-STAT Alinity was to design a device that would withstand the test of time – that meant creating a device that was durable, reliable and could adapt to future needs. To do that, 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? How long did it take to develop i-STAT Alinity?

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 – to find out their pain points and needs to gain insight into where we could improve diagnostics.

From there, we observed providers using 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 different ways it could be used. This process took roughly six years, but we feel confident that 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 i-STAT Alinity stand out?

Bates: Our goal was to design i-STAT Alinity to be useful to the people who use it, whether a physician, nurse or 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 i-STAT Alinity sustainable for healthcare providers now and in the future?

Soman: We've designed i-STAT Alinity to run the broadest menu of tests on a single device. It was built to be "future-proofed," meaning that 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 i-STAT Alinity?

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 i-STAT Alinity will help improve patient care?

Bates: Many healthcare providers who use point of care testing are in highly pressurized, 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 for i-STAT Alinity, 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 an i-STAT. 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 25-30 minutes old. You could compare it to driving a car and only opening your eyes every 25-30 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.

To learn more about i-STAT Alinity, check out these resources: