Devices & Diagnostics

Follow your heart & head when innovation leads beyond comfort zone

For 35 years, Worrell Inc., a Minneapolis design firm has hummed along helping marquee clients like Johnson & Johnson, General Mills, Pepsi and Medtronic develop and market products. Then last year something happened. Quite by accident the company came up with a product. A product that appears to have all the elements sorely lacking in […]

For 35 years, Worrell Inc., a Minneapolis design firm has hummed along helping marquee clients like Johnson & Johnson, General Mills, Pepsi and Medtronic develop and market products.

Then last year something happened. Quite by accident the company came up with a product.

A product that appears to have all the elements sorely lacking in today’s healthcare:

  1. It reduces costs by preventing needless ER visits
  2. It is a snazzy communications tool that would connect patients or concerned caregivers to care providers instantly
  3. It would help those providers make certain medical decisions remotely

Most importantly, the patient would be smack-dab in the middle of it all.

It’s a telemedicine and remote-monitoring tool on steroids that is simple enough to be used at home. The product has something that is conspicuous by its absence in healthcare: a rich user experience.

Here’s the story of how innovating on behalf of others landed Worrell in a spot where it now has its own intellectual property. As a result, for the first time in its history, the company is bearing the risks of commercializing a healthcare product internally called DocBox.

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A Deep-dive Into Specialty Pharma

A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.

It all began last fall when the company made a video about its experience in understanding how emergency medicine worked at the UC San Diego Health System. The goal was to come up with a new model of delivering care in the ER.

The company discovered that the ER at UC San Diego worked quite well. The real question was how could emergency medicine be reimagined so that patients would not need to come into the ER at all. How can care be delivered where patients are?

Designers at Worrell began to brainstorm, and the video they created chronicled the story of a worried mother with a sick child. She opens a laptop-like device that actually is a medical kit. She uses the thermometer in the kit to take the child’s temperature, and  then uses the device to connect to a nurse. The kit also contains a camera, blood pressure cuff and test strips to test for flu, and monitor EKG and pulse oximetry. After initially collecting identifying data, the nurse talks with the mother and recommends they stay at home while she continues to monitor the son overnight.

“This concept is just one example of a new care model,” says Kai Worrell, CEO of Worrell, at the end of the video. “But we are at a moment in time in healthcare where we have the opportunity to rethink how we serve patients.”

The video was published, and then came the deluge of phone calls, Worrell said in a recent interview.

They came from clinicians mainly, even from Johns Hopkins, Worrell says. They were thinking, mistakenly, that the product was available.

Worrell says that the company never intended to make a product when the video was made, but now feels it has both a moral obligation and a commercial opportunity to try to build one.

Some questions have been answered already — the company will not sell the intellectual property of the so-called DocBox and intends to commercialize the medical device itself.

“Perhaps we are too close to our college years to give up doing this ourselves,” Worrell said. “We really want to see this in the hands of people in the real world.”

He imagines a price point of several hundred dollars instead of several thousands, which is what medical devices typically cost.

Worrell won’t discuss specifics of the product except that it would be different than what the video portrayed and that there would be separate devices for separate disease states. A three- to four-month clinical trial will begin sometime in June at Children’s of Minnesota to answer some basic questions. For instance, who at the hospital will answer the call that comes in the middle of the night from a concerned parent? Another clinical trial at UC San Diego will begin in September.

Another question is if the product will “create avoidance,” Worrell said. In other words, will having this tool prompt people to use it in lieu of coming to the ER?

Worrell is also exploring the concept of cost — who will pay for such a remote-monitoring tool? He would only disclose that he is looking at unconventional ways of paying for this and that it would involve integrated health systems who are both healthcare providers and health plans.

A big, unanswered question obviously involves the U.S. Food and Drug Administration. The product uses simple communications technology, but the software (at least in theory) is capable of transferring health data.  The kit could also contain a flu test. As such, it is not clear whether the FDA will view this as a Class I or Class II medical device.

Worrell added that the closest competing device would be Intel’s Health Guide, which combines an in-home patient device with online capability that allows two-way video communications and remote monitoring.

Despite the uncertainties that lay ahead, Worrell believes in the product’s potential to revolutionize healthcare.

“We feel we can make an impact through this,” he said. “Imagine this product globally in places like China. It would solve the problem of access.”

Only time will tell what happens when the vivid imagination of Worrell Inc. employees collides with the hard reality of the market. For now, Worrell and his team aren’t looking back.

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