If you showed the device to someone on the street, they would probably mistake it for something they could pick up at BestBuy. About 6 inches long and weighing just over a pound, it has the elegant, slim curves and shiny metallic facing of an Apple product, and the no fuss commitment to minimalism that characterizes modern industrial design: only three buttons are visible, one of which is the “home” button illustrated by the silhouette of a house so familiar to owners of Android phones.

At a quick glance, it might look like a new kind of tablet computer, the latest iteration of an iPad, but it’s not. Its target audience is not everyday consumers, it does not stream Netflix videos and is not cheap by home electronics standards. Although the public will never use it, it does, in its way, protect their health, and helps ensure doctors are able to diagnose illnesses and save lives. The device, called the RaySafe X2, is an X-ray quality assurance tool, used by medical physicists, state health department inspectors and imaging technicians to ensure radiography machines in hospitals and clinics are working properly and emitting safe doses of ionizing radiation. And its sexy modern looks, developed by a Swedish design firm, are no accident.

“Consumers have the same high expectations for the devices they use at home and at work,” says Kelly Fitzgerald, a marketing executive with RaySafe, the Billdal, Sweden-based company that sells the device and which claims to be the largest X-ray quality assurance equipment manufacturer by annual sales. “There is a convergence between the personal and the professional in that nobody wants to go to work and use a device that seems archaic in its design and function.”

Aesthetics and ergonomics are only part of the story, however. Hospitals’ biomedical departments are facing new pressures to contain costs and increase workloads. And perhaps most importantly, the spike in hospital consolidations could profoundly change how some biomeds work. As a result, companies that design biomedical testing equipment, from X-ray QA tools to patient monitor simulators and IV pump analyzers, are looking to make their devices cheaper, smaller and easier to use.

Coming together
Hospital consolidations last underwent a boom in the 1990s. Partly as a consequence, about 650 integrated delivery networks or health systems make up nearly 70 percent of patient care in the United States, according to Rob Reilly, chief marketing officer with GE Healthcare. But another growth spurt is happening.

“We think this next wave of consolidation underway right now probably makes the one that happened in the 90s seem small,” Reilly tells DOTmed News. “You’re probably going [from] 650 down to 150 in the next five or six years. We think we’re going to see a huge step function change in consolidation activity.”

The reason? There are a few. One is that the “sweet spot” for patient revenue is $8 billion to $10 billion, which requires a big integrated system, or what Reilly calls a “super- regional” model — not necessarily national, but possibly spanning several states. The University of Pittsburgh Medical Center, one of the country’s leading medical institutions, for instance, is built on a large regional model, and pulls about $10 billion in yearly revenue, Reilly says.

Another driver is access to capital, something smaller institutions have a harder time getting, especially as they struggle with reimbursement challenges and pressure from health care reform. “Even though there’s a lot of bliquidity out there, it’s hard to get,” Reilly says. “You need a good size chassis to get the financing you’re looking for.” Reform has another effect, too. As fee-for-service payment models transition to value-based payment ones, health care facilities will often need to work at population health, receiving payments or incentives for meeting targets with the patients in their area of care. But to play the “population health” game, you need a big patient pool, Reilly says.

“A million patients is the sweet spot to do population health, and you need a good size network to capture a million patients.”

Hub and spoke
The result is what Reilly calls a “hub and spoke model,” where you have a high-end tertiary institution, or the hub, surrounded by community hospitals, clinics and ambulatory health care centers — in other words, the spokes. This will have myriad effects on biomedical engineers, one of which is that larger, more consolidated institutions could use their biomeds to service not just one hospital, but all the outlying “spokes” that surround it. “If you think about investments they make in systems and tooling or training, you can really leverage them if you’ve got a bigger footprint or system to go after,” Reilly says.


And hospitals could even offer their “surplus capacity” — in other words, extra biomeds or their time — to other hospitals or clinics that aren’t even part of their network. “We’ve seen some biomed/CE departments get creative,” observes Greg Alkire, who works with Pronk Technologies, a nine-year-old manufacturer of test equipment. “Even though that outlying clinic might not be affiliated with the hospital, they’ll pick it up as a moneymaker. They’ll send a guy out in a van virtually every day to do testing outside the hospital.”

This is in turn, is putting pressure on manufacturers of equipment used by biomeds to ensure the devices are both easier to carry around and cheaper to buy. And in an effort to achieve the necessary ‘ities — affordability, simplicity, durability and portability — testing equipment makers are learning lessons from unlikely places. For instance, for two engineers at TriMedx, an asset management company, and one of the big nationwide providers of biomedical technical services to hospitals, inspiration for a new smaller, cheaper tool came all the way from India.

A simulator that fits in your pocket
This spring at the MD Expo, the company plans to unveil the PocketSIM, a smartphone-sized device for testing patient monitors and electrocardiography machines. The four-ounce device is the company’s first-ever foray into the world of commercial test equipment. “This is our first dive into the product development market,” says Dax Hafer, one of the engineers who designed the device, which is now out in a 100-print limited run as full-scale commercialization starts.

Indianapolis-based TriMedx is a subsidiary of Med- Excel, which is in turn owned by Ascension Health, the largest Catholic and non-profit health system in the United States. The company also runs the TriMedx Foundation, which carries out medical missions in places like Haiti, bringing U.S. biomeds with their expertise to train local techs or help fix equipment.

Last summer, TriMedx expanded its international reach, inking a deal with Indian heart surgeon Dr. Devi Shetty, who runs a chain of 14 cost-efficient hospitals in India, to provide biomedical services to other facilities in the country. Hafer and his fellow engineer and co-designer, Rob Cadick, said as they studied the situation in India, they realized local hospitals faced a huge barrier to setting up their own biomed shops: testing equipment costs too much. So, they reasoned, one way they could help supply Indian biomeds was by making their own equipment inhouse for less. If it worked, it was something U.S. hospitals would also appreciate.

With a small R&D team and limited resources, they decided to only target patient monitors and various ECG and respiration functions. “It became pretty apparent to us, that the most bang for the buck was going to be in patient monitors, because there are a lot of those in any given hospital,” Hafer says.

Keeping costs low
To keep it cheap, though, the engineers had to keep it simple. “A lot of the devices that are on the market right now have tons of functions and features built into them, but you don’t tend to use but a tenth of those,” Hafer says. Their device, which can handle five-lead ECGs, can test approximately 80 percent of patient monitors and ECGs on the market, Cadick says. It also tests 18 arrhythmia waveforms and half a dozen respiration waveforms.

This means 12-lead ECG carts are out, however, and many hospitals will need more multi-functional devices for annual preventive maintenance. But the PocketSIM could really excel at spot checks, its designers say. If a patient monitor is hooked up to a patient, and a nurse sees noisy waveforms, a technician can quickly be called in, carrying a PocketSIM, to check the monitor to see if it’s working properly.

The low price is important for this function, as there have to be enough PocketSIMs to go around. A typical biomed shop might have 15 techs but only three patient monitor simulators, the engineers say. They say they priced theirs low enough that a CE manager could buy one device for every one of their biomeds. The PocketSIM retails for $300 dollars, while typical ECG simulators run from $800 to almost $2,500, if they also offer non-invasive blood pressure functions, Hafer says.

How did they make it cheaper? “A lot of Google searching,” Cadick jokes. The engineers are choosing the same path, oddly enough, that video game consolemakers have: using off-the-shelf parts. Sony and Microsoft are both expected to release next-generation video game consoles this year at lower prices than in the past, largely because they’re mostly avoiding custom-built innards. “To have your own custom tooling done, your cost of development goes up $10,000 or $15,000,” Cadick says.

Simplicity and ease
Cheap is good, but there’s no substitute for intuitive, simple interfaces. The PocketSIM was originally designed with five separate buttons, but after getting feedback from TriMedx biomeds, the two engineers said they simplified it, so it can now be operated with the push of a single button. X2, the RaySafe-designed X-ray QA tool that was launched this year, was also created for ease of use, the company says.

“Honestly, a biomed who has never done a radiology reading before could walk into the room and get a reading,” RaySafe’s Fitzgerald says. “All they need to know is how to push a button.”

The focus on simplicity informs most of the product’s design, according to the company. The X2, which has a 10-hour battery life and can store about 10,000 exposures, doesn’t need to be oriented in an X-ray beam to take a reading. Also, waveforms can be seen on the device’s built-in display, so there’s no need to work off a laptop. For now, X2 only works with rad/fluoro, but future editions should be able to do mammography and CT, Fitzgerald says.

With a push for efficiency also comes a need to reduce downtime — something even testing equipment is subject to. Every year, QA devices have to be sent back to RaySafe for calibration. For the X2’s predecessor, the whole device had to go, which meant biomeds couldn’t use it for the seven to 10 business days it took to arrive, be recalibrated, and sent back. “It’s kind of like you giving up your laptop for seven to 10 days,” Fitzgerald says. “What am I going to do with myself?”

For the X2, RaySafe made a change — now, only the detachable sensor needs to be shipped back for re-calibration, meaning the company can keep several sensors on hand to eliminate downtime. The sensors are also much cheaper than full backup kits, Fitzgerald says, as the X2 lists for about $12,700.

The “biggest thorn” in their side
Portability is also essential for a new tool that aims to help biomeds tackle a tricky mainstay of their work: the testing of infusion devices.

“The IV testing that’s happening in the industry, it’s probably the biggest thorn in everybody’s side,” says Greg Alkire, with Pronk Technologies Inc.

The average 300- or 400-bed hospital has nearly 1,000 pumps that need to be tested once a year, Alkire says. In general, hospitals either test all their IV pumps in one month in a marathon preventive maintenance cram session, or they spread it out over the year, with possibly one person in the biomed shop dedicated to testing pumps every day over 12 months.

Usually, Alkire says, the pumps are schlepped down to the biomed shop, but engineers can be called to spotcheck wonky equipment; and, with the increasing focus on biomeds doing work outside their hospital, having pump testers that are smaller, lighter and more durable has become increasingly important.

“Getting out of their car 10 years ago was miserable because they had heavy pieces of equipment that had to be dragged to an outlying clinic,” Alkire says of biomeds in the past.

The company’s new 5.5-inch-long pump tester, called FlowTrax, launched in wide release in March, though the device has been out in a limited production run of about 60 units since last year. For the one pound device, Pronk, like many other developers, aimed for multi-functionality, in order to further lessen a biomed’s load: FlowTrax is an IV pump analyzer, a full feature pressure meter, a temperature meter and a digital stopwatch.

Alkire says, as with most of their products, they spent the first six months letting a few customers play around with it. Then based on feedback, they made a few tweaks – for instance, customers wanted to capture not only maximum, but minimum pressure. This means now everything from “medair” vents in a patient room down to suction pumps can be tested.

Accuracy and speed were other challenges. Pump analyzers are hard to develop, because the flow pattern varies between different models of infusion pumps, Alkire explains. “So FlowTrax has to be able to take into account ‘pushes’ and ‘pauses’ of fluid that occur during the infusion in order to calculate an accurate flow rate in 3 minutes or less,” he says.

Automation is important, too, for ease of use. The FlowTrax “primes” by itself, meaning it senses when the fluid starts and stops, and tracks flow time automatically, the company says. “It’s smart enough to know when the fluid starts moving and knows when the fluid stops,” Alkire explains.

The device costs $1,995. As with TriMedx, the company says one of the determiners of the price was to keep it low enough so a shop could buy one device for every biomed.

Of course, portable devices are prone to a hazard endemic to their kind—dropping. Pump analyzers like FlowTrax are especially vulnerable, as they contain glassware used to sense fluid movement. But Alkire says the FlowTrax was built with the occasional small fall in mind, and he drop tested it 53 times from a height of 3 feet without any harm. He says he actually got a bit obsessed about this, and stayed up until 2 or 3 in the morning making a video of the test. Naturally, he then set the video to Beethoven’s 5th symphony. “We need to put it on YouTube,” he says.

DOTmed Registered DMBN May 2013 - test equipment Companies

Names in boldface are Premium Listings.
Domestic
Sean Saad, california labchoice, CA

International
Notwen Cardozo, Endoscopy Solutions, Brazil