The iPancreas

Every day, my 8 -year-old son trusts his life to a 1.2 ounce, egg-shaped lump of plastic called the OmniPod that could soon change the lives of diabetics around the world.

The wireless insulin pump is the sole product of Insulet Corporation, a 7-year-old start-up based in Bedford, Massachusetts, that just held its initial public offering. Insulet?s offices sit in an average corporate park, a casualty of the dot-com bust where the ?for lease? signs outnumber the occupied offices. Two of those offices belong to John Garibotto, a quietly intense guy with a soul patch, and his hyperfocused colleague Robert Campbell, who took the lead in developing the OmniPod. Thanks to their efforts, Insulet has grown into more than just another company counting down its days in an abandoned office complex. Garibotto and Campbell have created a business and a product that could thrive for years to come.

Like my son, more than 1 million Americans suffer from type 1 diabetes, a disease that inhibits the body?s insulin production. While scientists remain unsure about how people develop diabetes, nobody doubts the end result: a pancreas with a hunk of dead cells that can no longer produce the essential hormone. Without insulin, your body can?t turn the food you eat into the energy you need. Constantly hungry, you starve to death, no matter how much you consume. Before the early ?20s, type 1 diabetics lasted weeks, sometimes months, or, through near starvation, occasionally a year or two.

But the invention of pharmaceutical insulin in 1923 reversed that course, and with it, diabetes became the first illness modern medicine fought to a draw. Even now, a type 1 diabetic wages this battle every day, all day, with no rest. When the first insulin pumps hit the market more than 25 years ago, they did help. The handmade precision machines were designed to last, on average, around four years. Insulin fed through a length of tubing into a disposable infusion set that users inserted by hand every three days, saving diabetics from a lifetime of needle sticks. But most type 1 diabetics thought the pumps weren?t worth the hassle; only 20 percent to 25 percent of patients used them. And they didn?t have any shortage of complaints: the tubing snagged, everyone saw the ugly pump, it stayed with you in the tub, inhibited physical activity, and don?t even get started on the intimacy issues. Flawed as they were, old-fashioned needles still had appeal.

The debut of the OmniPod in 2005 changed all that. Traditional pumps were bulky, cell-phone sized devices that contained the electronics, the pumping mechanism, the control interface, and three days worth of insulin, all connected by a length of tubing. The OmniPod, by contrast, consists of two parts joined together wirelessly: a Personal Diabetes Manager (PDM), a Blackberry-like gadget the patient uses to program insulin doses and check blood sugar, and the Pod itself. Worn on the arm, abdomen, or lower back, the Pod is a marvel of miniaturization that does all the hard work of pumping insulin into the body. Shaped like one half of a hardboiled egg, the white plastic shell contains an insulin reservoir, a drive motor that weighs less than half a gram yet is accurate to within five ten-thousandths of a milliliter, batteries, an auto-inserting shunt, and the electronics to control it all. Users discard the pods every three days. And with the tubes finally out of the way, they?re free to perform everyday activities with ease.

Noting the explosive proliferation of iPods, iPhones, and Blackberries, Insulet knew that wireless wouldn?t be enough. They needed style. The OmniPod?s sleek package, indistinguishable from a small mp3 player, inspires patients to desire?much less dread?wearing it. Other medical suppliers are also catching on. Take, for example, the Cardiopocket, a tasteful leather wallet concealing a basic wireless ECG transmitter. Alive Technologies recently introduced a wireless, Bluetooth-enabled heart monitor barely distinguishable from a PDA. Even hospital clipboards haven?t been spared. Intel?s Mobile Clinical Assistant program recently spawned two competing tablet-based mobile medical computers. Both units?one from Phillips and the other from Motion Computing?sport sleek, sterilizable cases and a plethora of wireless connectivity options. Wi-fi, Bluetooth, and radio frequency identification should allow medical professionals to get your test results, transmit observations, and double check that the leg they?re about cut open is the right one?all while grabbing a smoothie in the cafeteria.

In the world of insulin pumps, some doctors wanted manufacturers to take a page from Steve Jobs. ?It would sure be nice if we had an iPancreas,? says Dr. Aaron J. Kowalski, research director of the Juvenile Diabetes Research Foundation?s Artificial Pancreas Project. ?Apple took technologies that already existed and transformed the way you looked at music.? Now, Kowalski?s iPancreas has arrived. With the OmniPod, Insulet fundamentally rethought the insulin pump for the first time in 25 years. And by cutting the umbilical cord connecting diabetics to their pumps, they gave birth to a whole new market.

The story of the OmniPod doesn?t begin with a think tank or a bunch of white coats in a sterilized lab, but with a frustrated, and well-funded, father. A few years after his son developed type 1 diabetes in 1992, one of Insulet?s financiers, John L. Brooks, checked out the options on the market and decided it was time for a change. A venture capitalist with Boston-based Prism VentureWorks, Brooks gathered together a group of smart folks he?d worked with in the past. The assignment? ?Here?s a million dollars,? says Garibotto. ?There has to be a better way.?

Insulet went to work, starting with no set design parameters. Before long, they?d brainstormed a concept that they thought could prove revolutionary. And then came the hard work. Within a year of its founding in 2000, Insulet decided to produce a wireless product. After two years of engineering, focus groups, and false starts, Garibotto and Campbell had their first working prototype. The gap between that and a commercial product took three more years to bridge. Insulet secured initial FDA clearances, performed clinical evaluations, and finally, in October 2005, after yet another round of FDA oversight, offered the first generation OmniPod to patients.

Insulet prepared itself for the unique challenges that production would pose. ?Once we decided on the disposable razor-blade model, we realized that our ability to manufacture would drive our ability to sell,? says Garibotto. By placing the pumping mechanism into a self-contained shell, Insulet set themselves quite a daunting task: They had to mass-produce at low cost what their competitors were making by hand and retailing for more than $5,000. Since each Pod would last only three days and would cost $35 apiece, Garibotto and Campbell jettisoned anything that made the OmniPod more expensive than a traditional insulin pump over a four-year lifespan, while still maintaining all of the safety features and functionality of the pricier pumps on the market.

After some trial and error, Insulet was ready to test the market. The company rolled out the OmniPod on a region-by-region basis as it increased manufacturing capacity through automated manufacturing systems and supplier partnerships. And for good reason. ?We give every patient 122 pumps a year,? says Kevin Schmid, Insulet?s vice president of manufacturing. ?Our patients depend on each OmniPod working properly,? he says. ?We?re basically building a disposable Swiss watch.?

Despite their initial success, burgeoning reputation, and legions of customers eager to evangelize about the OmniPod, Insulet is being canny about how it grows. Seventy-five percent of its customers have never worn a pump. But according to early returns, their strategy of reaching the 700,000 pump-shunning type 1 diabetics is working. The main issue, according to Schmid, is to make sure the supply keeps up with the demand. As Insulet?s manufacturing capacity increases, the company adds sales force and infrastructure to support it. By the time the first half of the year closed, sales had jumped $4 million compared with the first half of 2006. Insulet expects $13 million in sales by the end of 2007.

Sales will increase even more if Insulet can break into the global market. The OmniPod could also gain a following among the growing demographic of type 2 diabetics worldwide, a market 21 times larger than the type 1 market. Insulet might also try to fit the OmniPod into therapies for cancer, HIV, pain relief, and infertility. But for now, type 1 diabetes will remain the company?s primary focus. The shared experience of living with type 1 diabetes is part of Insulet?s ethos. Several of its customer service operators use the OmniPod. When they say they understand, they really do.

And so do we . After an endless litany of problems with our traditional insulin pump, we decided to let our son give the OmniPod a try. And with every day he uses it, we watch him become less and less a patient, and more and more just a kid wearing an egg-shaped lump of plastic that changed his life.