11 Reasons Why Elizabeth Holmes is the Manufacturing Technology Leader of 2015 Steve Jennings, Getty Images

11 Reasons Why Elizabeth Holmes is the Manufacturing Technology Leader of 2015

Why did we pick the 31-year-old Stanford dropout billionaire with the chemical engineering background and the secretive Silicon Valley pharmaceutical company as the biggest player in the field this year? There are plenty of reasons, actually.

1. She can command a room with her ideas, and her execution.

A year ago, when Elizabeth Holmes was still months shy of her 31st birthday, she walked across a stage at TEDMED in San Francisco, consciously dressed in black from neck to toes, and delivered a talk that outlined the last decade of her work and life.

"I believe the individual is the answer to the challenges of health care," she said. "But we can't engage the individual in changing outcomes unless individuals have access to the information they need to do so. The right to protect the health and well-being of every person, of those we love, is a basic human right."

If you have never heard Holmes speak, her voice might surprise you, its delivery an octave or so deeper than expected, her words deliberate, not an 'um' or 'uh' or 'like' to be heard. And if you have never heard of Holmes, if you are asking why she is on the cover of this magazine, why she is the 2015 IndustryWeek Manufacturing Technology Leader of the Year, consider the fact that in a little more than a decade she has developed a new technology that researchers decades her senior had never envisioned, and that she has used it to upend one of the larger industries in the country. Yes, that industry is health care, not traditionally tied to heavy manufacturing, but Holmes is a maker and her company, Theranos, is very much a manufacturer. Its stated goal is to provide an easier form of drawing blood, give us better information about our own health, and do so at lower and more transparent price points.

We will dive into Holmes' manufacturing technology and its potential effect on us all, but first, a return to that San Francisco stage, where Holmes' clothes blended into the background, her face a light, her voice a measured weapon for change. The rest of the room was quiet, every eye was focused on her.

"My own life's work in building Theranos is to redefine the paradigm of diagnosis," she said, "away from one in which people have to present a symptom in order to get access to information about their bodies and to one in which every person, no matter how much money they have or where they live, has access to actionable health information at the time it matters."

She pushed her hand into the pocket of her blazer and pulled out a bubble of glass smaller than a child's fingernail.

"We've made it possible," she said, "to eliminate the tubes and tubes of blood that have to be drawn from an arm, and replaced it with the nanotainer."

2. The nanotainer is just one of her more than 80 patents.

To understand Holmes and her potential, think about the reported 18 U.S. patents and 66 international patents already granted to her, the nanotainer among them.

The nanotainer is a key part of Theranos. Walk into any Theranos Wellness Center the majority of which are in Arizona for now, along with one in California and one in Pennsylvania, with thousands more planned for Walgreens around the country and sit down for bloodwork.

To understand Holmes and her potential, consider the reported 18 U.S. patents and 66 international patents already granted to her, the nanotainer among them.

Because of Holmes' fear of needles, she doesn't want to plunge them into anybody else's forearm veins, as she said in her TEDMED talk. She just wants to prick your fingertip and pull about 50 microliters of blood into a nanotainer. That amount is enough for her and her team to plug into the testing equipment they have designed and manufactured over the last 12 years, then run any of about 200 different tests, all of which are set to cost less than half the Medicare and Medicaid reimbursement maximums. (A cholesterol test, for example, runs $2.99, hematocrit and hemoglobin tests $1.63 each, and MMR immunity $28.13.)

The invention of something new is pure innovation, the economy of scale is a lesson in extreme lean.

3. She has found a seemingly better process that can save you and the federal government considerable money.

Things are manufactured, of course, and so are ideas and processes. The most incredible number associated with Theranos is not four, which is the number of hours typically needed for its results to be returned. The most incredible numbers are $98 billion and $104 billion. Those are, respectively, the amounts that the company said it could save Medicare and Medicaid over the next decade.

For reference, the most recent annual expenditures for Medicare and Medicaid were $476 billion and $549 billion, respectively. She could help them each trim about 2% of their total costs right now.

4. And she's doing it with automation.

Centuries of phlebotomy are riddled with human error, from the initial blood draws, to the physical transfer, to the medical analysis. Some of those 84 patents already granted to Holmes (with 187 more applications with her name on them and another 186 for Theranos on top of those) are for the automation process developed since she dropped out of Stanford as a 19-year-old sophomore and started working out of a spider-filled basement. Just like Henry Ford's production line, but without humans, and on a much smaller scale.

"Our platform is about automation," Theranos President and COO Sunny Balwani said last year. "We have automated the process from start to finish."

5. And with old-fashioned heavy manufacturing, too.

Theranos manufactures all of its own testing equipment, because of necessity  if you want to create a new technology and a new way to do something, you probably need to create the whole process, of course  and also because of regulations. Companies that manufacture their own equipment and neither sell it nor move it from their labs don't need Food and Drug Administration approval.

Theranos does still seek FDA approval, though, and gained two rounds of it as recently as July.

6. She has worked toward this for the last 31 years, give or take a couple.

Time for the obligatory biographical information about someone whose biography you will probably read in hardcover or paperback within the decade.

Elizabeth Anne Holmes was born February 3, 1984, to a father who worked for government agencies for much of his career and a mother who gave up a career on Capitol Hill to raise her and her younger brother. She was precocious, as you might expect, designing a time machine that her parents took seriously when she was 7, reading Moby-Dick when she was 9, learning Mandarin when she was in middle school, starting some classes at Stanford when she was still in high school.

Because of Holmes' fear of needles, she doesn't want to plunge them into anybody else's forearm veins. She just wants to prick your fingertip and pull about 50 microliters of blood into a nanotainer.

She applied to no school other than Stanford, earned acceptance and studied chemical engineering. She gravitated toward Channing Robertston, then a dean at the engineering school. As a freshman, she persuaded him to let her work in the lab alongside Ph.D. students, and the next summer, she traveled to the Genome Institute in Singapore, where she worked on testing for SARS. She figured out how to perform a number of tests at the same time from a single drop of blood, monitoring it wirelessly and transferring it to a doctor in real time. She filed her first patent.

Not long after she returned to Stanford in the fall, she realized she was focusing all her time on that idea and skipping her classes, and told her parents and Robertson that she wanted to develop it into a business. They encouraged her to do so.

7. Though she worked in stealth mode for 10 of those years.

Holmes moved into that basement with the spiders, hired her first employee, dived into her work … then disappeared for the next decade or so.

She developed the name Theranos  a combination of the words therapy and diagnosis, because she figured people have negative ideas about the word cure  and ultimately raised hundreds of millions of dollars from investors and collected an impressive board that now includes cardiac surgeon Bill Frist and former Secretary of State George Shultz, former Wells Fargo CEO Richard Kovacevich and Henry Kissinger, another former secretary of state.

As recently as two years ago, when San Francisco Business Times reporter Ron Leuty wrote the first major story about the company, Holmes, Robertson, current and former employees, collaborators, competitors and backers remained mum. "Some," Leuty wrote, "cited sweeping nondisclosure agreements they had signed with the company."

Terrence Grindall, the community development director who worked with Holmes and Theranos as they moved into their headquarters, called them "the most secretive company I've ever dealt with. … That's not all bad. They said they have competitors and their technology is invaluable."

8. There is a place for open source, but your personal health probably isn't it.

"We needed to make the chemistry such so that it would only require small volumes of blood," Holmes told USA Today last summer. "We had to redevelop that analytical system to handle small volumes. We had to build the infrastructure around it all through software and automation to minimize the involvement of humans, where manual error could be great.

"It's software, hardware and chemistry. There's no shortcut."

9. She has impressed plenty inside and outside of manufacturing.

The venture capital firm Draper Fisher Jurvetson, which has previously funded Tesla and SpaceX (and 2013 IW Manufacturing Technology Leader of the Year Elon Musk), was an early investor. So was Oracle founder Larry Ellison, the fifth-richest person in the country, according to Forbes.

(Holmes herself is tied for 360th on that list, worth a reported $4.5 billion, which makes her the richest self-made woman billionaire in the world.)

As for that board: "We aren't exactly a group of people who give away our time lightly," Kissinger said. "But we are impressed with her commitment to lowering health costs and bring this advance to developing nations."

10. When Time named her to its annual list of the 100 most influential people in the world, Kissinger called her ethereal.

Which is both beautiful and appropriate. Something ethereal is, by definition, extremely delicate and light in a manner too perfect for our world, and while Holmes herself might not be definitively ethereal, her idea, her company, her inventions the nanotainer, the microliters of blood, the idea that we own our health certainly are.

11. She acts in part like a tech leader and, because of that reported net worth you just read, she draws comparisons to some of the greats.

Years before he surrendered a pair of endowed chairs at Stanford to work for Holmes at Theranos, Robertson understood the power of her personality and her mind.

"When I finally connected with what Elizabeth fundamentally is," he told Fortune senior editor Roger Parloff, "I realized that I could have just as well been looking into the eyes of a Steve Jobs or a Bill Gates."

The former is the comparison bandied about most often, and the one Holmes herself seemingly prefers. Like Jobs, she dresses in a uniform, normally the black mock turtleneck, black blazer, black slacks and black flats she wore during her TEDMED talk last year. Like Jobs, too, she has a powerful focus, working 16 hours every day.

Jobs was 21 when he founded Apple with Steve Wozniak and weeks shy of his 29th birthday when the Macintosh was introduced with its famous Super Bowl XVIII commercial (which aired just one time, less than two weeks before Holmes was born). Holmes was 19 when she founded Theranos and 29 when she finally lifted the veil on her work in a September 2013 story in the Wall Street Journal. The parallels are obvious if you want them to be.

And then there is the matter of her office wall.

On August 24, 2011, the day Jobs stepped down as the CEO of Apple, Holmes printed his biography from the company's website, and later framed it. It hangs there now, in a Palo Alto building formerly occupied by Facebook and Hewlett-Packard, a reminder of actuality and potentiality.

"She has sometimes been called another Steve Jobs," Theranos board member and former Defense Secretary William J. Perry told Ken Auletta for story published in The New Yorker in December. "I think that's an inadequate comparison. She has a social consciousness that Steve never had. He was a genius. She's one with a big heart."

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