Medical Device Daily

When Howard Baker's friend recently had a liver transplant, upon discharge she had to stay close to the hospital and come into the emergency department every day, sometimes multiple times, to have her vital signs checked. The inconvenience and associated costs were an accepted part of her recovery.

Baker, president/CEO of VivoMetrics (Ventura, California), is seeking to eliminate the onerous time and financial burdens associated with monitoring patients post-op as well as those with chronic conditions by advancing the company's LifeShirt a wireless remote patient monitoring (RPM) system melded into a shirt to the commercial market within the next year. In the 10 years since its introduction, the shirt has been used for research purposes only.

But combine that decade of experience with more than 50 studies published on everything from chronic heart failure to neuromuscular disease, and LifeShirt, he said, is ready for prime time.

"Taking this technology and driving it into the ambulatory market is a natural," Baker told Medical Device Daily.

After less than two years as CEO of VivoMetrics, and with a resume that includes various executive positions at Medtronic (Minneapolis), Positron (Fishers, Indiana), SpaceLabs Healthcare (Issaquah, Washington), C.R. Bard (Murray Hill, New Jersey) and Abbott (Abbott Park, Illinois), Baker's got the know-how to push LifeShirt out of the clinic and into homes. Add that to President Barack Obama's healthcare technology agenda and VivoMetrics, with just the one product to pitch, would seem to be on the brink of big advances.

"It's almost like our president wrote our business plan," Baker said. "There are a number of discreet solutions already on the marketplace. By the year 2012, the RPM market is expected to exceed $8 billion globally. But we will provide the first fully integrated garment that's simplistic and comfortable. The patient won't have to do anything but put the shirt on. It's a natural play. It will provide a higher quality of care to more people and reduce healthcare costs."

In the company's work to streamline LifeShirt, making it more affordable (the research model costs up to $10,000) and viable for commercial launch, VivoMetrics has partnered with OBS Medical (Carmel, Indiana), a developer of automated early warning technology. OBS and VivoMetrics are building a decision-assist software platform to continuously integrate wirelessly collected vital sign data into a dynamic index of health status. That data will help healthcare professionals to spot early warning signs of potentially life threatening health conditions.

No wires, sticky electrodes or zippers. The fabric will be styled like an athletic garment, but with integrated fabric electrodes and an electronics unit about the size of Blackberry that fits in the shirt pocket. Remove the unit and the LifeShirt can be machine washed.

"Originally the system would collect lab-quality data to be analyzed after it was collected," said Alexander Derchak, PhD, VivoMetrics' vice president, science, technology and development. "The new system will be focused on real-time data transmission allowing a group of medical professionals to monitor patients under their care continuously. Bluetooth, ZigBee and GSM (all wireless technologies) communications modules will allow us to push data across the Internet."

The goal is to have a simpler unit with actionable information.

Baker said he expects to move LifeShirt into a patient study later this year as the company seeks 510(k) clearance.

Along the way, VivoMetrics is making use of a variety of companies' expertise and products, rather than trying to develop everything in house.

"The goal is to integrate best-in-class technology, even on the distribution front," Baker said. "We will partner with manufacturing companies. Our company won't become a large mega structure."

Among other studies, LifeShirt has been used (Medical Device Daily, Jan. 4, 2005):

• To study such topics as anxiety, autism, stress in college students and a wide range of physiological performance data.

• The Australian Olympic rowing and British cycling teams have used the technology to assess the impact of training on their athletes.

• In pharmaceutical trials, to measure the effects of drug candidates on a variety of parameters ranging from respiratory rate to tidal volume, temperature to pulse rate, oxygen saturation to ECG and EEG.

• Military personnel and first responders used the technology to gather critical life signs data during high-stress situations.

A study by economist Robert Litan found that remote patient monitoring could be the key to cutting healthcare costs by nearly $200 billion in the next 25 years if used to track the vital signs of patients with chronic diseases. The report, titled "Vital Signs Via Broadband: Remote Health Monitoring Transmits Savings, Enhances Lives," was funded by AT&T (San Antonio) and Better Health Care Together (Washington), a nonprofit consortium that promotes healthcare reform (MDD, Nov. 5, 2008).