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PharmaJet Finally Gets Unstuck

After years of struggle, Kathy Callender is starting to make her do-gooder dream look like a great business.

Nigel Cox

The Point Standard needle syringes. The World Health Organization estimates that reuse of needles spreads disease 24 million times a year. The Medicine is the Needle A PharmaJet injector loaded with a cartridge. The injector shoots vaccine or medicine directly into the skin.

Kathy Callender was in a São Paulo hotel room in August 2008, nervously preparing for a demonstration of her needle-free injector, a device she planned to manufacture cheaply enough to replace the 6-cent needle syringes that are used the world over.

Getting costs at her company, PharmaJet, low enough to do that would require huge volume, and Callender was hoping Brazil, a nation of nearly 200 million, would be among the first to use her injector in mass vaccinations. Nine months of building relationships with Brazilian officials had preceded the meeting.

The PharmaJet device, a simple assembly of 25 parts, eight of them screws, was working fine. So Callender and two colleagues made the 20-minute walk from Hotel Oscar Freire to the University of São Paulo's teaching hospital. It was muggy out. Hospital officials had gathered test subjects ranging in age from 18 to 70; they were to be injected, and then ultrasound images of their arms would show how effectively Callender's injector delivered its payload.

In the hospital's ultrasound clinic, surrounded by half a dozen Brazilian physicians, Michael Royals, PharmaJet's chief science officer, held the injector in one hand and -- as he had done thousands of times before -- reached with the other for a plastic cartridge filled with saline solution to snap it into the injector. Then he hesitated.

"He said, 'Kathy, it's not fitting,' " Callender recalls. "I said, 'Here, give it to me.' "

She tried, then looked back toward Royals: "I can't do it, either," she said.

"We panicked," she says. "We're talking in English. And everybody's watching, talking in Portuguese.

"All this down the drain," she continues. "It's like you're onstage for your singing debut, and you open your mouth and nothing comes out."

The São Paulo flop is one of a series of setbacks Callender has endured, and overcome, on the way to becoming the most unlikely leader in a growing movement to replace needles worldwide. A 69-year-old former dental hygienist from Golden, Colorado, competing against better-funded, better-credentialed medical-device developers, Callender has implausibly positioned PharmaJet to have the best chance to replace the most needles.

That alone would be a tremendous public-health success, because needles are one of the main culprits in the global spread of HIV and hepatitis. And it is helping the poorest people avoid deadly infection that most motivates Callender. But her strategy could also prove to be the best business approach. By insisting her device be cost competitive with the cheapest needles so that poor countries can afford it, Callender may also end up with a huge advantage in rich countries, able to underbid rivals to supply pharmaceutical companies that sell billions of dollars a year of pricey injectable drugs. She has raised $14 million from investors and is attacking a vast market: Some 15 billion to 20 billion injections are made globally each year.

PharmaJet's needle-free injector is one of several on the market. Held against the skin, the device expels liquid medicine out a narrow passage with enough force to turn the medicine itself into a needle-like stream that penetrates the skin to the desired depth. When it's done, in one-third of a second, you toss out the little plastic cartridge that held the medicine and touched the skin. There's no needle to stick and potentially infect a nurse. No needle to be fished out of the trash by a drug addict. No needle to be reused by a health care worker short on supplies in the developing world.

The PharmaJet cartridges are filled from medicine vials using a disposable plastic adapter. Its sharp end, used to pierce the seal of the vial, never comes in contact with the patient. For mass production, the cartridges will be prefilled, as many syringes are today.

For years a hygienist and business manager in her husband's orthodontia practice, Callender has been stuck by needles herself. "If you're in health care, you've been stuck," she says. "You just hope and pray you don't get really sick."

I first encountered PharmaJet at a conference put on by Springboard Enterprises, which brings female entrepreneurs together with venture investors, last October in Madison, Wisconsin. Heather Potters, PharmaJet's chairman -- commanding onstage, notably fashionable, a private equity investor based in Warsaw, Poland -- made the company's pitch to VCs, and it was the day's most polished. Disruptive technology in a huge market. Big potential returns. A clear exit strategy.

Afterward, I was introduced to Callender, PharmaJet's founder -- bangs curled over her forehead, a formless Eileen Fisher jacket around her thin shoulders, a soft voice and softer manner -- and I was surprised. What an unusual pair. I've seen pretty much every start-up team archetype -- the crazy inventor and the uptight financier, the supersalesman and the keep-the-trains-running operator -- but Callender and Potters didn't make sense to me as a team.

Later, over dinner in Chicago, Potters explained to me, almost apologetically, "Kathy's my mother." She doesn't initially advertise that for fear of scaring off investors wary of family companies.

Callender's unassuming demeanor encourages her skeptics. At PharmaJet's office in Golden, she sits nearest the front door and could easily be mistaken for the receptionist, perhaps a Social Security recipient making ends meet by working. "It's one of the biggest hurdles I've seen at PharmaJet," says John Bingham, the company's chief designer. "How can this older lady from Golden, Colorado, do what she says she's doing?"

As I talked with her, however, it slowly became clear to me that Callender's brains and willpower are what have propelled PharmaJet. She draws strength -- a motivating chip on her shoulder, even -- from those who doubt her. For years, she says, "I didn't talk about what I was doing, because people thought I was nuts. Frankly, even my sister. They thought it was just a little thing to fill up the time. Orthodontist friends would give me this little smile -- uh-huh. Patronizing."

In São Paulo, with her carefully planned demonstration falling apart, Callender turned on the charm and persuaded her hosts to keep the test subjects around. Royals headed for the hospital's maintenance department to borrow a drill, then carefully widened the opening in the injector. And soon they were injecting Brazilians as planned. The humidity, it turned out, had caused the nylon used to make the injector to swell. Before Callender was back in Colorado, Bingham was already working with a new plastic highly resistant to water and heat.