Mirador Biomedical Seeks to Prevent Hospital Errors with Simple Digital Sensor

7/20/10Follow @xconomy

Justin Hulvershorn learned in medical school about one of the everyday procedures done in hospitals, when a patient has a catheter inserted into a central vein to deliver fluids or drugs. In one memorable moment from about 10 years ago, the medical professional missed the vein and hit one of the biggest arteries that carries blood to the lower half of the body, the femoral artery.

Blood was everywhere.

“It was horrifying,” Hulvershorn says. “It stuck in my mind.”

Mistakes like that one, and the life-threatening emergency it created, are what Hulvershorn and his colleagues are seeking to prevent at a Seattle-based startup called Mirador Biomedical. The Seattle-based company has developed a low-cost pressure sensor designed to be incorporated into a syringe and guide wire used to insert the catheter. This tool provides doctors with a digital readout on the pressure of the blood flow in the vessel it has reached, which provides an obvious readout that can show the difference between a high-pressure artery and a low-pressure vein. This sort of tool could be incorporated into central venous procedures that are performed 6 million times a year in the U.S., and could have potential to prevent thousands of mistakes that can cause severe complications, or even death.

The company, with a shoestring budget and just a $1.1 million investment in March, has pulled together a business plan, intellectual property, prominent medical device advisors like Pathway Medical founder Tom Clement and NeuroVista CEO John Harris, and an application to the FDA to start marketing its simple product, possibly as soon as the end of this year. It’s not a classic blockbuster opportunity of the kind that venture capitalists like to bet on, but Mirador hopes that it can get this first product on the market generating revenue, and then build follow-on products to help the company grow.

Karl Schmidt

Karl Schmidt

“There’s nothing else out there like this,” says Mirador CEO Karl Schmidt. “It’s a simple product, but nobody has come up with it.”

Mirador got started in some grim circumstances. Schmidt, 38, and Hulvershorn, 36, got to know each other when they worked together at Seattle-based Northstar Neuroscience, which shut down in January 2009 after its lead product candidate failed in a clinical trial. Schmidt was the head of global marketing, and Hulvershorn was the director of research. They found they had complementary skills at Northstar, and when the company started winding down, they decided to try creating a startup.

They scoped out various university tech transfer offices for ideas to license, but nothing there really grabbed them. Then they started combing through scientific literature to brainstorm about other ideas, and started homing in on errors in hospitals that threaten patient safety. Suddenly, the vivid memory of what happened to that patient came back to Hulvershorn when he started investigating the problems of catheter insertion.

Traditionally, medical pros who insert central vein catheters (“central lines” in hospital lingo) would look at the color of the blood flowing back into the syringe. If it was dark blue, that meant it was from a vein. Bright red meant the line was in an artery.

This method wasn’t entirely reliable, so doctors over the past couple decades have been using tubes filled with blood that will visibly rise or fall based on how much blood pressure pushes through them. Scientists have shown this is a more reliable method for avoiding serious errors, and hospital administrators often push for it to be the standard procedure, but it’s cumbersome, Schmidt says. A doctor has to do the pressure test, and then re-insert a guide wire for a catheter, which can sometimes introduce a new error, Schmidt says.

Big medical suppliers like Becton Dickinson (NYSE: BDX) and General Electric (NYSE: GE) also sell pressure sensors that can help doctors do this procedure, but the Mirador co-founders learned that doctors often find using these devices to be a hassle because they require additional cabling, an extra set of hands from an assistant. These devices also require a doctor to look away from the patient to see a monitor the pressure sensor is connected to.

So Hulvershorn and Schmidt, after connecting with Doug Swartz, an experienced medical device entrepreneur, embarked on the classic journey of building a simpler tool in a garage. Based on a lot of conversations with doctors, they decided that a new device would be helpful if it was simple, easy to use, and integrated into the doctors’ workflow. They gathered data on the standard specs for syringes, and designed a simple commodity pressure sensor to fit together, with a digital display that a doctor could read right near the front of the needle. It’s about 2 inches long and 1.5 inches wide (picture something the size of a pedometer).

Within the first year, they’d built the device, and crafted an intellectual property strategy around the tool. They ran some basic bench tests to see if their device was accurate at sensing pressure, and then ran an experiment in pigs to verify the result. They didn’t need to run time-consuming, and expensive clinical trials. Instead, they submitted an application to the FDA through its 510(k) approval pathway, in which devices can sometimes be cleared for sale if they demonstrate they are substantially equivalent to something already on the market.

Justin Hulvershorn

Justin Hulvershorn

The Mirador co-founders have attracted some prominent people in the local medical device world to their cause. Clement and Harris have joined the Mirador board. The company has been getting advice from doctors at Virginia Mason Medical Center and the University of Washington. If all goes well with the FDA, the company could have its product, the Compass Vascular Access, approved for the U.S. market by the end of the year.

Clement was willing to listen from the start, because Schmidt had once worked for him as an engineering technician at Heart Technology. He liked Schmidt’s business sense, the energy and focus of the team, and that Mirador had developed an “elegant solution” to the problem of central line insertions.

“I really like the potential for the reasons above and most especially because they are thinking about the business as a series of smaller successes (“singles” if you will) rather than the classic blockbuster model,” Clement says. “This may pose some financing challenges since it isn’t the normal VC deal, but it looks to me like a model that should be considered for these economic times. Add to that the fact that the clinical need is real and the technology appears to be straightforward, as does the regulatory path.”

Of course, these are still early days for Mirador. The company which has six full-time employees and a few other contractors, plans to make the devices, but not necessarily market them. Most devices like this tend to be bought by hospitals in kits. And a low-cost, high-volume tool like this, which Schmidt says will sell for “more than $20, but less than $100″ isn’t enough of a big-ticket item for Mirador to build its own sales force. That means it will most likely need to form a marketing and distribution deal with one of the big medical device suppliers, Schmidt says.

If Mirador can pull off a partnership like that, it could be an unusual device startup that starts generating real product revenue in less than two years. If that happens, Mirador has its sights set on other applications, in which a simple digital pressure sensor could be useful in the hospital. The company has its eye on lumbar puncture procedures (known as spinal taps), as well as epidural anesthesia delivery to pregnant women, which can be problematic. Each of the initial markets could be worth $100 million or more over time, Schmidt says.

“We think this could be the new standard of care,” Schmidt says.

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