By Joyce Laird
November 2, 2018
Patient-centric care means faster, more accurate, painless and hopefully, failsafe delivery of medical care to patients with the smallest margin of error possible. This type of care is continuously evolving.
A number of companies have created systems that personalize patient care while ensuring all data regarding each and every patient is accurate, protected, and easily accessible 24/7. In an industry that is so huge, one thing modern technology brings back to the medical arena is personalized care—but with the accuracy, speed, and interface of modern technology.
Headquartered in Sunrise, FL, MDLIVE has developed a comprehensive telemedicine platform (Figure 1) that connects patients to physicians 24/7/365. Lyle Berkowitz, MD, CMO & EVP of product strategy, is a primary care physician with a background in both biomedical engineering and computer programming.
“Many patients do not have easy access to a brick and mortar facility, but they all have access to a computer or mobile device, so we make it easy for them to use either to connect with us. We also have physician-facing tools that allow them to connect with a patient in a secure manner, and then document and prescribe medications in a highly usable fashion,” says Dr. Berkowitz. “Hospitals, clinics, and medical groups can power our technology with their own doctors, as well as use our provider network anytime. MDLIVE also has options for larger medical doctor groups to use their technology strictly for their own patients.”
The MDLIVE Medical Group is one of a few medical group practices in the nation that can handle patients across fifty states 24x7x365. “We have also developed a virtual guide called Sophie, an AI Chabot who can help patients navigate our system in an increasing number of ways. Today, Sophie helps register and connect patients with a doctor, but in the near future, she will be able to ask an array of medical questions to help with the diagnosis and treatment of our patients in a hyper-convenient manner,” he says.
Continuous patient monitoring
Medical personnel often struggle with incomplete data records when patients are transferred from one department to another, making it difficult to get a com- plete view of patient data when making care decisions. Philips, a multinational technology company focused in the area of healthcare, set out to develop an intuitive technology to help avoid losing data during the delivery of patient care. Peter Ziese, business leader, and patient care and monitoring solutions for Philips healthcare, explains, “Our goal is to improve patients’ quality of life, and also create an opportunity for a better, safer patient/physician relationship with a main focus on patient safety.”
One of Philip’s innovations includes the IntelliVue X3, a portable monitor (Figure 2) used during in-hospital transport and at the bedside. The X3 enables continuous monitoring during transport for gap-free data records and reduces transport preparation time. It offers commonly required measurements that are built-in, with no user setup necessary for typical use (ECG, SpO2, NBP, invasive pressures and temperature, and CO2 monitoring). The Dynamic Wave area features waves that automatically adjust in size depending on the number of waves configured, and capture and review diagnostic 12-lead ECGs at the monitor before submission. It even prints cardiograph-type diagnostic 12-lead ECG reports from the bedside, with both wired and wireless networking regardless of patient location.
There are hundreds of new patient-centric innovative devices on the market today, many in development and even more on the drawing board. The following are examples of patient-centric technologies that have met the goal of being both a benefit to patient care and comfort, while simultaneously helping address what the medical side needs for better integrated patient care.
Leuko, a startup company that focuses on improving lives for chemotherapy patients, has two locations in Massachusetts, USA and Madrid, Spain. Carlos Castro-Gonzalez, PhD, co-founder and CEO of Leuko, received his doctoral education in Madrid and brought his vision of developing a novel way to help fight the negative effects of chemotherapy to the USA.
“Doctors desperately needed a way to screen for severe neutropenia, which is a dangerous depression of white blood cells in chemo patients,” says Castro-Gonzalez. “Patients already weakened by cancer are left exposed to other illnesses. Our mission was to develop a device that could monitor for this condition.”
PointCheck, a small microscope on a camera that captures high-resolution, high-frame rate videos through the skin on a patient’s finger (Figure 3), was Castro-Gonzalez’s answer.
“White blood cells can be observed flowing in real-time by the camera. The data is sent to a laptop, but the goal is to have all data sent to the cloud where all verified users can access it,” says Castro-Gonzalez. “All the computing will happen in the cloud, along with transmission to the doctor and the patient.”
“We have studied chemo patients before, during and after therapy. By looking at our data and videos, we were able to tag those patients that were at high-risk. Those clinical tests were successful, and the results have recently been published in the prestigious journal Nature Scientific Reports. Our next step is to develop our laboratory prototype into a production unit so we can submit for clinical trials for commercialization. We are planning to finish our product development by 2019, and go into production so our product can start clinical trials by 2020.”
Wind tunnel technology fights lung disease
Headquartered in Westlake Village, CA, 4DX developed a medical technology that has the capacity to simply, safely, and effectively view lung air flow function in fine detail. Andreas Fouras, CEO of 4DX, and a mechanical engineer by training, is behind this innovation. While working at a major university in Australia in wind tunnel research, Fouras (Figure 4) developed an imaging method where they could actually see the way air was flowing over aircraft models. He saw how this technology could benefit the medical industry for lung diseases, like asthma, cystic fibrosis (CF), and COPD.
Fouras says, “Spirometry tests how much air a patient can forcefully exhale, but doesn’t show which lung regions are most affected. The very closest the poor lungs get to high-tech today is the CT scan, but X-rays and CT scans are best for solid things, and even MRI’s are best for moist subject areas. The lungs are basically air, a non-solid and non-aqua gas.”
“We turned to machine tool scanning technology as a means to make lung scans better. A CT scanner has some built-in problems, so we thought, what’s faster and has less radiation, and actually, it’s the old X-ray machine. It’s pretty fast, low cost, and low radiation. So, we decided to build technology on top of that concept.”
Talking to doctors around the world, Fouras discovered that what they were truly interested in was airflow. “For a wind tunnel engineer, I saw this as the natural next step for the technology. On top of how we monitored the lungs movement, we added technology to show where the air is going, not going, where it’s getting quickly, and where it takes a long time to get to. When we showed doctors that capability, they loved it and wanted to get involved.”
Fouras adds, “The biggest challenge was if you can measure something that nobody else has ever been able to measure, how do you prove that you are measuring that? To test it outside of a hospital, we had to build a mass X-ray machine and a breathing human lung; a robotic humanoid. Then, we put this robotic lung into an X-ray scan and used this as proof that the technology worked.”
4DX has been doing a number of clinical trials for two years and are expecting that they will have enough clinical data by the end of 2018 to take the product to the FDA. “We hope to have 501k clearance by the early part of 2019. But, a number of US hospitals are already using our technology even though we don’t have the FDA clearance, which is exciting. When we have the clearance, we plan to substantially expand within the US and across the world.”
Biosensor monitors critical signs
VitalConnect, San Jose, CA, was founded in 2011 with a vision of changing the paradigm of healthcare with a single device: VitalPatch. The tiny wearable device (Figure 5) consolidates eight critical vital signs into one wireless biosensor: single-lead ECG, heart rate, heart rate variability, respiratory rate, skin temperature, body posture, fall detection, and activity. It connects patients to physicians and nurses with continuous monitoring.
Nersi Nazari, PhD and CEO of VitalConnect, has been involved in many startups over the past 30 years. “VitalConnect came to me originally as an investment opportunity. But, I liked the company concept so much, in 2011, I became a co-founder,” he says.
Nazari explains the device itself is about as big as a band-aid; less than an ounce in weight and when wearing it, the patient completely forgets it. “It even passes through security scans at airports. It is attached to the upper left chest to be sure we accurately measure the ICD,” he says. “It has had FDA clearance for a whole year. We chose a battery that is green, so there is no issue when disposing of the patch. Just toss it out.”
VitalPatch requires a simple relay device such as a smart phone or tablet. Once connected to the relay, data is transmitted automatically and stored on the patch in case the patient is not near the relay. “We did a two-month trial with patients 65 and older just to make sure there was no problem in using this, even for patients with disabilities such as palsy in their hands. All could work with the device,” Nazari adds.
The system is cloud-based, and the data is automatically transmitted and then accessed from anywhere with proper credentials. It is backed-up with warning signals to indicate if anything has gone wrong, and pinpoints exactly when, where, and what happened, so corrective actions can be taken.
“We first developed a prototype design of the product that would actually do the job, but to do this we simultaneously had to develop a new chip, which we call VitalCore. It is the CPU—the brains of the product. The chip is smaller than the size of a dime and had to be able to do all we needed while using very little power. This is important because high power would make the device get too hot. Once that was certified, adding all the rest followed.”
“VitalPatch is designed so the parameters can be set and customized for a specific patient,” Nazari says. “We are already working to also provide predictive and analytical capabilities.”
Needle-free blood collection
Eric M. Stone, CEO and co-founder of Velano Vascular, has a long and honored history in the healthcare industry, both as a patient advocate and serial healthcare entrepreneur. He says the company was basically started when a patient asked Dr. Pitou Devgon, co-founder, CMO and device inventor, “Instead of sticking me repeatedly with a needle to draw my blood, why can’t you just get blood from the IV that is already in my arm?”
The Velano answer was PIVO™, a breakthrough needle-free, blood collection device (Figure 6). By accessing the IVs already in place in most hospital patients, it removes the need for painful needle blood draws. It also improves practitioner safety and provides hospitals with a smarter financial solution for vascular access. Stone notes that needle blood collection also poses other issues. “These range from mild to severe. Complications that can arise from venipuncture include hematoma formation, nerve damage, pain, iatrogenic anemia, and more.”
“PIVO is a single-use device that acts as a tube-within-a-tube to solve this problem,” says Stone. “The PIVO tube is inserted into an already indwelling peripheral catheter, enabling a nurse to draw blood in a matter of seconds to a few minutes. After blood samples are collected into tubes or syringes at the back end of PIVO, the PIVO is removed, thrown out, and whatever fluids were being pumped in before can be restarted. Patients may sleep through it, and for the nurse there’s little risk of being stuck with a needle containing a blood-borne pathogen.”
PIVO received its third FDA 510 (k) certification in 2017, according to Stone.