By Bob Marshall, Chief Editor, Med Device Online
Who says, “You can’t take it with you?” People often use this adage as an excuse for spending money before they die. But, what if you could take it with you?
No, I’m not talking about money; what if you could take healthcare with you, to your home, and minimize or eliminate hospital stays for certain conditions? The goal of both hospital admission and stepping up to the plate is to get "home" as soon as possible. And, in both cases, doing so quickly is preferable. Well, that is the focus of work being done by Dr. David Levine, MD, MA, a physician and researcher in the Division of General Internal Medicine and Primary Care at Brigham & Women’s Hospital (BWH) in Boston.
For two months, Levine and co-principal investigator Jeff Schnipper, MD, MPH, piloted “The Home Hospital” project at BWH and Brigham & Women’s Faulkner Hospital (BWFH). The pilot sought to compare the cost, quality, safety, and experience of at-home, hospital-level care to traditional hospitalization. You can see and hear Levine briefly discuss the program in this Home Hospital Video.
Twenty-one adult patients participated in Levine’s randomized, controlled study. The patients came to the BWH or BWFH Emergency Department (ED) seeking care for problems including infections, heart failure, asthma exacerbation, and chronic obstructive pulmonary disease (COPD). If the ED determined a patient required admission, eligible individuals could enroll and be randomly selected for either the home hospital or traditional hospital admission.
At home, patients were visited by home hospital physicians and benefitted from state-of-the-art technology, including a remote vital-sign monitoring device, enabling their doctor or nurse to check their heart rate and other vital signs with a skin patch. Vital signs were remotely monitored using new technology from VitalConnect, a medtech company founded in 2011 and headquartered in San Jose, Calif. The VitalConnect VitalPatch consolidates eight critical vital signs into one wearable, wireless biosensor, and incorporates predictive data analytics. VitalConnect is led by chairman and CEO Nersi Nazari, Ph.D., and we discussed the market for his product and its development pathway.
Nazari talked about results from a multi-center observational study of 100 congestive heart failure (CHF) patients across four VA hospitals. In this study, subjects were provided the VitalPatch for use over 90 days, as well as a smartphone, prior to discharge. VitalPatch was used in patients’ homes to continuously transmit physiologic data (via the smartphone) to the cloud. AI-based analytics applied machine learning algorithms to the multivariate set of continuous vital sign data to “learn” the individual’s dynamic vital sign patterns and establish a personalized baseline.
“The study showed this technology could predict [whether] a CHF patient was going to develop a condition requiring readmittance to the hospital — six to eight, or even 10 days — in advance of [the patient] developing the condition. This provides an opportunity for changes such as diet, movement, or other at-home interventions, which may prevent admission to a hospital,” Nazari noted. “In ten years, I believe there will be more patients admitted to the hospital that are actually outside the walls of the hospital, or admitted to home.”
One Size Must Fit All
I asked Nazari about some of the challenges VitalConnect had to overcome in developing this technology. He started with the hardware itself.
“The Biosensor itself is very difficult to make, and it’s not just that it has to be accurate. It has to be comfortable and biocompatible, it has to stick to people for long periods of time, and it has to be easily disposable,” Nazari said. “If you just look at our biosensor, it appears deceptively simple: you just put some electronics in the plastic case, add some adhesive, and it works. But we’ve gone through years of learning and evaluating many different conditions to make our biosensor work accurately on the varying patient population.”
“Patients with high body mass index (BMI) of .35 and even higher presented a challenge to obtain accurate signals. There were issues with electrostatic discharge — if we didn’t design it carefully, when someone walks on a carpet the entire signal would be buried in the electrostatic noise,” he continued. “There were design challenges dealing with the 60Hz AC power lines in the home, which can interfere with signals from the biosensor. Mitigation for all of these had to be done in a systematic fashion to ensure solving one issue did not create a different issue. Some solutions were mechanical, some were electrical, and sometimes, we had to use algorithms in the software.”
“In the beginning, we thought about a larger package, but [we] were afraid it would become detached from the user. When we thought about making it very small, we were afraid the signals would not be strong enough. We even made an adjustable prototype but, ultimately, we solved all of the various challenges to make a one-size-fits-all biosensor to work across the patient population,” Nazari said. “Our VitalPatch has more immunity to people walking or running around than expensive ECG machines. We had to design our system for mobility, in addition to patients lying on their back.”
Software Can Be Hard
Nazari also spoke of specific challenges related to the system software.
“The area of the software that was challenging to develop was the user interface and the usability aspects of it. In the end, if our product contains software that is not intuitive for nurses and caregivers, it’s not going to be used,” he explained. “We brought in nurses that had never seen our product and taught them how to use it in 30 minutes. We then gave them the software to use with a written test they had to pass for us to release the software.”
Obviously, VitalConnect is on board with current expectations regarding human factors in medical device development.
Putting The Device “On Trial”
I also talked to Nazari about other uses for the VitalPatch. He discussed its utility in supporting a “fail fast” strategy to control costs during drug development and clinical studies.
“The cost of developing a new drug can be as much as a billion dollars. It’s a huge investment, and if you are going to find out the pharmaceutical has some issues, you better find out sooner rather than later. Perhaps you can know it’s not going to work after spending only $600M,” Nazari said.
“The VitalPatch can enable detailed monitoring of vital signs on subjects to see intended and unintended consequences of the drug being used in the study. So, if the drug is intended for people with a high heart rate, or people who have breathing problems, do these conditions come back to normal? Alternatively, if the drug is for cancer, does it induce some other conditions that can be tracked? Accurate measurements of vital signs during a clinical trial may be able to help a drug company know if the drug is effective, and [whether] it produces any side effects,” he concluded.
The potential to provide comprehensive, real-time, continuous vital sign monitoring in a remote manner holds a lot of promise for reducing healthcare costs, improving outcomes, and providing better patient satisfaction. Hospitals are fine when we really need them, but VitalConnect and its VitalPatch are helping to make healthcare a “home run.”