The Biodesign Method: How Josh Makower Systematized Breakthrough Innovation

Dr. Josh Makower's career reads like a masterclass in turning clinical frustration into durable, scalable healthcare technology. A physician and mechanical engineer by training, NYU Med, MIT, Columbia MBA, he spent decades not just building companies but building the infrastructure that helps others build companies. As co-founder and director of the Stanford Mussallem Center for Biodesign, he created what's now known as the Biodesign Process: a methodology that has fundamentally changed how medical devices are invented and brought to market.

This is episode 40 of Inside MedTech Innovation, and the conversation covers a lot of ground: the origins of the Biodesign process, the story behind Willow (the first wearable breast pump), Josh's successful push for regulatory reform through FDASIA, his view of where the innovation ecosystem still needs work, and why he believes sustainable business and patient-centered mission are the same thing, not competing priorities.

[00:03] Introduction: Who Is Josh Makower?

Shannon opens by laying out the scope of Josh's work: 300+ patents, recognition from the National Academy of Engineering, a co-founded medical device incubator (Exploramed) with companies acquired by Medtronic and J&J, and the Stanford Mussallem Center for Biodesign which has trained innovators worldwide.

What makes Josh particularly relevant for this audience isn't just the portfolio, it's the ecosystem view. He's spent his career thinking about how to make the whole system work better, not just individual products.

[00:06] Origin Story: From Engineering to Medicine to Business

Josh was drawn early to the idea of using technology to impact health. He traces it back, somewhat charmingly, to The Bionic Man, a childhood inspiration that made technology feel achievable, not fantastical. That curiosity led him through mechanical engineering at MIT, then to NYU for medical school, and eventually to Pfizer, where he was regularly shown the door when business conversations started.

"I wanted to be in the room where it happened," he said. That drove him to pursue an executive MBA at Columbia, not to shift careers, but to learn the language of business so he could stay at the table.

It was a research assignment at Pfizer, studying how early innovators built companies from scratch, that gave him the framework he'd eventually formalize. As the son of two teachers, he was wired to break processes into teachable steps. The innovation process, he decided, was no different.

[00:13] The Biodesign Process: Discipline Over Intuition

The core tension in Biodesign is one most engineers recognize: the pull toward solving before you've really understood the problem.

"As human beings, we want to go to the safe place," Josh explained. "We don't like living in a lot of uncertainty. People find themselves racing to a solution because they can't live in that uncertainty for a while."

What Biodesign demands instead is discipline. The process starts with a single, deceptively simple question: who are you serving? From there, teams are required to observe, embed, and listen before inventing anything. The output of that phase isn't a prototype, it's a needs statement: a definition of the problem, the population, and the desired outcome, with no solution embedded in it.

"Once you've created a statement that does not have a solution embedded within it," Josh said, "then upon that, you can start inventing."

The needs statement also includes constraints, cost ceilings, safety parameters, what the ideal solution can't do. Inventions are evaluated against those criteria. Only ideas that clear the bar move forward. Then the process continues into patents, regulatory, clinical, and reimbursement, the more familiar terrain.

What's unique is the front end. And it only works if teams resist the urge to skip it.

[00:15] The Willow Story: How Two Men Built the Right Breast Pump

One of the most illuminating examples Josh shares is Willow: the first wearable breast pump, and one of the products he's most proud of.

It started with his co-founder John Chang returning from another collaboration and saying he wanted to do something good for moms. Neither of them were moms. So they got moms in the room, wives, colleagues, and ran a structured session.

"We allocated 90 minutes to this conversation," Josh said. "We're 60 minutes in and have not gone beyond this one issue."

Breastfeeding and breast pumping, the group said, was the dominant pain point, by a wide margin. When Josh tried to move on with 30 minutes remaining, the moms pushed back: "We have not talked enough about how bad this is."

That signal, the group's unwillingness to move on, was data. Josh and John came out of that meeting knowing they'd found something real.

But the actual breakthrough came from studying the physiology. John pulled up an ultrasound image of a baby feeding at the breast. The key insight: everything a breast pump needs to do is happening in the space of a baby's mouth. Small movements. Small energy. Right at the breast.

"By studying how babies feed," Josh said, "we realized that the whole thing can be done quietly, with very small movement and very small energy, and can be right up against the breast, which means we can now make it wearable."

Incumbent manufacturers had been iterating on the same box design, making it smaller. Nobody had asked how breastfeeding actually worked. The Biodesign process forced that question.

Willow launched, created the wearable breast pump category, and got dismissed by incumbents as "a toy." Today, Josh says, wearable breast pumps outsell traditional ones. The major players have since launched their own.

And Willow itself, now 70–80% women-run, built the product with moms at every step.

"It was not two men making a product for women," Josh said. "It was two people who understood the process of innovation, understood how to identify a need, understood how to apply technology to it, and understood how important the voice of the customer is."

[00:25] Mission and Money: The Ecosystem Argument

One of the more direct exchanges in the episode is Shannon's question about cognitive dissonance: how do you hold a pure patient mission alongside the requirements of capital markets?

Josh doesn't see a contradiction. His view is that sustainable businesses that return capital to investors aren't in tension with serving patients, they're the mechanism by which you earn the right to serve the next patient, and the one after that.

"If you want to solve medical problems in a durable and sustainable way," he said, "you must create an exciting business that returns capital to investors, that's gonna keep the ecosystem going."

He also put it the other way around: if you're in MedTech to make money, you probably chose the wrong field. It's hard, slow, and doesn't always pay. The reason to be here is patient need. Patient-first isn't just altruism, it's the condition for having a business at all. "You don't even have a business unless you solve the patient need."

The ecosystem lens matters here. Josh watches when investors lose money on failed companies and conclude they're done with MedTech. That ripple, lost capital, lost confidence, is what slows the flywheel. Biodesign, he argues, is partly in the business of preventing those failures by making sure innovators are solving real problems before they raise real money.

[00:44] Measuring Impact: 18 Million and Counting

Shannon asks how Josh measures what Biodesign produces. His answer is patient outcomes, not just company counts.

Biodesign trainees, while still in the program, not after, have created technologies that have touched over 18 million lives. By the end of next year, Stanford alone will pass 20 million. When you add global programs (Josh highlights BioInnovate in Ireland as a notable example), the number likely multiplies two or three times.

What's interesting about how those numbers accumulate: programs typically show exponential curves. Early cohorts work through animal studies, pilot trials, clinical work, reimbursement. Then things start to scale. The curve goes up sharply after the first few years, which is what Josh is trying to sustain through the endowment campaign he's currently running.

"This is not a charity," he said earlier. "We have to set up something that has the independent sustainability and growth potential, and the ability to reward risk investors."

The same principle applies to the institution itself.

[00:52] Where FDA Still Has Work to Do

Josh has spent years as a constructive critic of the FDA, and he was a key driver behind FDASIA (the Food and Drug Administration Safety and Innovation Act), the 2012 law that reset many device review practices and restored the "least burdensome" principle that had been abandoned in the post-2008 regulatory environment.

His current assessment is notably positive. "The things that I might improve are really nitpicky," he said. "They've mostly been solved."

But one thing stands out: consistency across reviewer groups. Same data, same device category, and a company's path can vary significantly depending on which reviewer they draw.

"It is still very much like: you get one reviewer, you've got this great path. You get another reviewer, it's difficult."

His proposal is essentially a quality system modeled on the patent office, metrics, performance review, oversight, applied to device review. Not to make it easier. To make it predictable.

He also flagged that the device side has improved substantially under recent CDRH leadership, but that the cell and gene therapy side of FDA is showing some of the same transparency and predictability issues the device world experienced circa 2010. Worth watching.

Where to Find Josh Makower

Stanford Mussallem Center for Biodesign: biodesign.stanford.edu Exploramed: exploramed.com

LinkedIn: https://www.linkedin.com/in/josh-makower/

Inside MedTech Innovation is hosted by Shannon Lantzy. Subscribe wherever you get your podcasts. This content was created with AI assistance from the full episode transcript.