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Jedi medical device product design:
Lightsabers don’t come in pink

Kate Stephenson holds a PhD in Mechanical Engineering from Stanford and, just as impressively, earned a black belt in Jiu-Jitsu while becoming a Jedi Master in medical device product design and innovation strategy. Yes, the Force (of innovation) is strong with this one. Always has been.

Years before heading off to Stanford—and well before becoming an expert in medical device product design and additive manufacturing, and founding her innovation and engineering consultancy–Dr. Stephenson founded a dollhouse company. She was 12.

Coming from a long line of machinists, Dr. Stephenson spent hours in the garage learning to articulate minute details of her miniature models in various media and, outside the garage, how to sell them. By the end of high school, Dr. Stephenson had saved enough money to buy seven tool-boxes full of her own tools… and her first set of fencing equipment. Every Jedi needs her lightsaber: “an elegant weapon for a more civilized age,” as Obi-Wan Kenobi would say.

At 18, she packed it all up to head to Stanford University, where she became the first of her family to attend a major university. At Stanford, she competed nationally on the Division 1 fencing team, while completing her degree in Product Design. The daughter of a machinist and a teacher, Dr. Stephenson’s upbringing was full of tools and books that supported her endless curiosity in how things worked and were built.

“The common legend of mechanical engineers is that they started working on cars and taking apart radios; for me, it was dollhouses,” said Dr. Stephenson. “I was constantly stealing stuff out of my dad’s toolbox to build things and cutting my fingers to ribbons while learning how to use X-Acto knives. But I got very, very good at building very small things. And that’s why I had seven toolboxes when I left for Stanford.”

Going to university, Dr. Stephenson, a big SciFi fan, felt like a certain Starfleet Captain, going where no family had gone before–and few from her hometown, for that matter. 

“I grew up in a small town called Modesto. It was somewhat famous nationally in the first decade
of the 21st Century as one of the five most miserable cities in the country, according to a Forbes magazine article. It had one of the nation’s lowest education rates and highest car theft rates. It’s changed a little bit in the last couple of years, but it’s unfortunately still a rough place to be… There were actually a lot of dropouts in my high school, and only a handful moved away to a four-year college after graduation. Culturally it was a very difficult place to be for a nerdy kid who wanted to go to college but didn’t really know what that entails. But I had big dreams: I wanted to start companies and design products. I just had no clue how to do that because I didn’t know anybody who had ever done it before.”

She was a little nervous to tell the news of her college acceptance to her father, who’d spent 30 years at Lawrence Livermore Labs working with brilliant physicists and scientists who he said did not know how to use a screwdriver. No matter. Her parents were both incredibly proud. To prepare her for the trip, her father built her a sturdy wooden chest with a lock on it to protect her valuables from all the mischievous frat kids and thieves he’d heard might steal his little girl’s belongings.

“Going to Stanford was probably one of the best things I could have done, partially because it was my first real opportunity to meet people who were lawyers, professors, doctors, and know them personally, rather than just as something you saw on TV.”

An outside observer might interpret her upbringing as a benefit to becoming an innovator. Invention and innovation often is a story of exploring new frontiers without the burden of old ways of thinking. Dr. Stephenson grew up accepting that she was just wired differently from those around her. She went through childhood excited to learn and do things other girls didn’t think were fun—like slicing up her fingers and getting dirty building stuff in her garage.

Lightsabers don’t come in pink

She remains unafraid of being unusual. As the founder of a technical innovation consultancy, Dr. Stephenson applies her academic and medical device experience towards turning good technology into well-designed, successful products. Part of that is understanding how to use emerging technologies like 3D printing for prototyping. And part of it is embracing her perspective as a woman with an untraditional background. That diversity adds real value to product design and innovation strategy.

“Usually I walk into a room and everybody’s older than me and the opposite gender,” she said, adding that she’s proud to often be one of the few women in a room full of male engineers.

At a recent event, she sat in the front row (as always) between a serial entrepreneur and the venerated former head of a major academic hospital. She is constantly meeting with startup founders, investors, doctors and academics. Getting wonderful new ideas from very different backgrounds is a primary reason she goes to conferences, as a speaker or attendee. The other?

It’s my own bit of a fight for feminism. Part of the reason I go to these events is it’s a chance to connect and meet with the women in my field. The medical device field is still predominately male, so when you make a point of sitting in the front of the room you tend to get noticed. When I was debating whether or not to return to Stanford for my PhD, I learned that less than one in 10 mechanical engineering PhD graduates were women. While many of the other STEM-focused departments have gradually become more balanced, mechanical engineering is still one of the most gender-biased professions out there.”

That disparity results in poor product design. Sometimes, ludicrously so. She once worked on a wearables product meant to be taped to a woman’s forehead. She brought up the fact that women have hair on their foreheads, contrary to the fashion magazines’ depiction of smooth, perfect hairlines, but to no avail. At a workshop, a male engineer stuck a prototype to her forehead, as she was the only female in the room.

“He made sure to miss my eyebrow, but he slapped it right on there. A few minutes later, he rips it off without warning. I literally yelled at him. Bewildered and slightly apologetic, he said, ‘I didn’t think women had hair there.’”

Another time, she was the only woman on a team designing a breast biopsy device. She described it as “an X-Acto knife fixed to the end of a shish kebob stick that sounded like a dental drill.” With an 8-pound insertion force, it would penetrate the skin up to six inches to sample suspicious breasts lumps. It was also pink. Because it was a woman’s device.

The term “shrink it and pink it” is a common derogatory phrase used to describe the stereotypical “customization” of existing products for women. It is a mystery why a technique that was applied poorly to ballpoint pens was considered appropriate for a medical device.

“All the male engineers didn’t think twice about it, while I was like, ‘What?’ The really funny part was when at one point, we had this prototype death-stick device strapped into a bench testing structure. We were using chicken breasts to simulate breast tissue. The very gruff masculine male engineer next to me grabs the device and says, ‘All right, let’s stick this chick…’ then realized who was standing next to him…’ EN. Chicken, we are sticking a chickEN.” He looked horrified; I was rather amused.”

“You have to have a very good sense of humor as a woman in medical devices, working with teams of men on a woman’s medical device project.”

From pre-med to medical devices

Her childhood sense of intellectual adventure informed her transition out of pre-medical studies. Medicine promised a fascinating career, and she loved the courses. But Dr. Stephenson was concerned at how miserable her fellow pre-med students were. She wanted to be around others who felt the same joy of study and work that she did.

“I had a pack of friends, including my boyfriend at the time, who would spend Saturday nights alternating between building and blowing stuff up behind the dorms. It turned out they were all engineers.”

She entered the job market following the 2001 dot-com collapse and entered the startup world. Interestingly, her experience building dollhouses as a kid helped her secure her first job. The company’s product was the size of a sugar cube, and they needed someone capable of building very small things in exquisite detail. She continued working startups in Silicon Valley for several years before heading back to Stanford for a Master’s degree to transition her into medical device design. It was a bit of a shock even to herself that she was going back to school.

“I actually wrote in my application letter to Stanford that I was not an academic, I had no intention of staying on for a PhD because I loved working in the industry.”

Not a bad idea

Life had other plans. One Master’s degree and seven years in the medical device industry later, Dr. Stephenson went back to Stanford for her PhD. At that point, she’d spent 15 years teaching a martial arts program to autistic children. Her background with fencing and martial arts—along with her expertise in medical devices—got her thinking about all the huge needs facing kids with behavioral, emotional, cognitive and physical challenges. But these areas were also the least popular for new products in the traditional medical industry. She was driving down highway 101, running between San Jose and San Francisco, when an epiphany struck.

“I remembered a conversation I’d had with one of my friends about a communication challenge he had with teaching kids with special needs. I started thinking through how I would actually engineer the solution for it. It would involve new research and a multi-stage, highly strategic approach. At that moment, the sun came from behind a cloud, hit my windshield, and the thought ‘Oh my lord, that’s a PhD’ rang in my head. Once home, I got out of my car practically shaking and I walked through the house to my husband. He was sitting in a chair relaxing. Slightly dazed, I told him, ‘Sweetie, I’m thinking about maybe doing a PhD.’ He just looked thoughtful for a minute, then said, ‘You know, that’s not a bad idea.’”

Not a bad idea. Dr. Stephenson is literally writing a book with that title. She needs to because, she said, over the next five years, she acquired a books’ worth of crazy stories covering the bizarre experiences of carrying two small children through a Stanford engineering PhD program and raising $300,000 to fund her PhD while exploring the eternal “why?” of medical devices. Why do certain medical devices get made? Why don’t others? And what are the processes driving those decisions, both successful and otherwise?

Emerging technology, gender, and commercial context for product design

That light of epiphany she experienced on the 101 highway continues to illuminate her perspective, revealing the full commercial context of product design in the high-stakes industry. And she took her perspective as a woman to further uncover new insights. For one thing, according to the US Bureau of labor statistics, 90% of licensed nurses are female, while 95% of mechanical engineers are male. She interviewed nurses with decades of experience working in medical wards to understand how they could leverage that experience as entrepreneurs.

The puzzle of innovation was complex, but satisfying to complete. She looked at how 3D printing had fundamentally changed the design and development process in the industry. She examined funding cycles, budget allocation, patent law and clinician training. All the pieces clicked to reveal many of the reasons behind the success and failure of the design decisions she’d participated in during her seven years in the industry. Many had nothing to do with the design and engineering of the device itself.

Strategy focuses on creativity

Following her PhD, Dr. Stephenson transitioned into a partnership role at yet another design firm, then moved on to found Dyad earlier this year. Dyad is an innovation and engineering strategy consulting firm focused on medical products. There, she advises companies in a wide range of sizes on how to think strategically about their new product creation process.

“Strategy” is often applied to a company’s business model or clinical approach, but few tend to associate it with their creative process.  It’s not just about coming up with great ideas, but coming up with great ideas that are technologically feasible, and mapping a path to make sure they reach the next stage.

Innovation jester

After building a career of working on innovation in a range of contexts, Dr. Stephenson understands that external resources are vital to getting fresh ideas for products and for the company as a whole. Research has shown how teams that work together over long periods of time will gradually lose their ability to produce a diverse range of ideas. We are social creatures and will naturally adjust our behaviors towards what will minimize conflict in a group. But conflict can be an indicator of a disruptive idea, one that challenges the status quo. If a team goes day in, day out without conflict, and nothing new is being innovated at the company, it’s a sign that a new perspective needs to be brought in.

A key role for an outside consultant, she believes, is something akin to that of a medieval jester, or Fool.

“People usually think of a jester as the funny guys who entertained the king. The jester was also there to bring up potentially politically disastrous ideas to the king that no nobleman wanted to risk their life (or career) on. But the jester, who everyone already thought of as an idiot, could freely bring up ideas without concern over what it would do to his political aspirations.”

Being a jester is thus a crucial role for a consultant. Dropping wild ideas into conflict-averse rooms requires a thick skin. People are apt to react strongly, saying the ideas make no sense or don’t apply to the company. But the goal is not to receive immediate acclaim for a great idea. It’s to give them something that they will go home, sleep on, and still be thinking about the next day.  

“The jester plants a seed of an idea that eventually will sprout into something that changes the company. And I really love that role.”

Embrace time travel

Once the idea takes shape, it needs buy-in to take flight. First, Dr. Stephenson gets the product design right by employing the basic principles of design thinking: discovering who the users are and deploying tools that help engineers understand what users need.

But the next piece of the internal innovation project puzzle is a soft skill that carries hard consequences: communication. It’s vital to understand what key decision-makers need to know in order to move the innovation project forward. This will change from project to project, company to company, and leader to leader.

Her goal is to expand people’s perception of being “innovative.” It could be how a company goes about adopting emerging technology or training their team in product design or getting rapidly unblocked on technical challenges. Because technical and commercial landscapes are constantly changing, every endeavor will require creative solutions for the hundreds of different problems that are sure to come along. It’s possible that a solution built for today will be useless tomorrow due to a competing product announcement or a regulatory change. The only way to address those risks is to make sure you have the capability to always generate “one more solution.”

 “Whenever people start brainstorming potential ideas and identifying current problems, I ask them to in some ways be a time traveler. In five years, will this problem still exist? In medical devices, due to the long lead times, I never want to  work on a product for a problem that’s not going to exist three to five years down the road.”

“…An innovator just needs a problem.”

She was a natural problem solver at Stanford. For instance, after being repeatedly unable to find a parking spot for her car for the first half of her PhD, Dr. Stephenson noticed the large number of empty motorcycle parking locations. After comparing the costs of buying yet another parking pass against purchasing a motorcycle, she signed up for classes the next day. She had her alternate 2-wheel transportation within a month and a whole new favorite past-time ever since.

Innovation can be taught, but there’s an innate aspect to it. Also during her PhD, Dr. Stephenson learned that nurses were as valuable as they were overlooked when it came to product design. She loved working with nurses because so many had developed the intellectual muscles of innovators. Day in and day out, they were concentrating on how to work around or fix problems instead of waiting for somebody to define the problem for them. They’d learned to think differently and act creatively.

“That’s really the difference between an innovator and an engineer: an engineer needs specifications. An innovator just needs a problem.”

Dr. Kate Stephenson is a Stanford University Mechanical Engineering PhD with over 20 years of design experience, 15 of those spent exclusively in new medical device products. She is the founder of Dyad Engineering, a consulting firm that provides highly personalized, strategic consulting services to accelerate new medical technologies to their next milestone. Built on both deep technical knowledge and broad industry experience acquired from over 40 device projects, Kate focuses on short-term, high-value projects that de-risk new initiatives, and provide clear, actionable pathways for growth. She is interested in start-ups and new product initiatives, where she can provide service as an on call technology executive to fill the “gap” between founding and funding that can support a high quality, full-time hire.

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