Why Design Thinking is Crucial for Medical Device Innovation: Interview with Madorra CEO Holly Rockweiler

Holly Rockweiler thinks of herself as an activist in a lab coat. It’s an identity that she fell into, but one that she owns with pride.

Holly spent the first part of her career as a research scientist for Boston Scientific, focusing primarily on cardiovascular health. Craving a closer relationship with the patients she served, Holly enrolled in Stanford University’s Biodesign program: an incubator for the medtech industry.

There, Holly fully immersed herself in the world of women’s health. The program challenges participants to spend time identifying and understanding problems before looking for solutions.

Holly noticed one unmet need that continued to surface. Breast cancer survivors weren’t able to take advantage of the hormone-based treatment options for vaginal atrophy.

The initial response to Holly’s focus area shocked her. Many pointed out that she’d found a small niche. “I don’t know how [helping] 43 million women is a niche, but [that’s] interesting,” she says.

This oversight highlighted a significant problem — one which has become Holly’s career calling. Despite accounting for half of the global population, there is a considerable lack of innovation in the field of women’s health.

Holly and her business partner Ryan Krone developed a non-hormonal medical device, Madorra, to treat vaginal atrophy in postmenopausal women and breast cancer survivors. The invention received breakthrough device designation from the FDA in 2021.

In this episode of Medsider, Holly discusses how to use design thinking to further medtech innovation, the pros and cons of seed funding versus grants, and why listening to patients is essential for anyone in the medtech space.

Guest

Holly Rockweiler

CEO of Madorra

Holly Rockweiler spent the early part of her career working as a research scientist for Boston Scientific. In 2013, she took a fellowship at Stanford University’s Byers Center for Biodesign, where she met her future business partner, Ryan Krone. Through the fellowship, Holly and Ryan developed Madorra, a non-hormonal medical device that treats vaginal dryness. As co-founder and CEO of Madorra, Holly’s on a mission to improve women’s health.

Listen to the Interview with Holly Rockweiler

Key Learnings from Holly's Experiences

  • Don’t skimp on the discovery stage. Understanding your patients and the unmet needs your device will solve is essential for innovative design.
  • Working in medtech can be a slog. Having a greater purpose behind your pursuit will motivate you when things feel especially difficult. Getting to know your patients and seeing how your device improves people’s lives can bring joy to a taxing industry.
  • Finding the right regulatory and clinical trial consultants is an essential part of the process. Just as they can set you up for success, so can your patients. Hear what they have to say and apply it to your development process. Listening to others will help you produce a more viable product.

Design Thinking Fosters Creative Solutions

Stanford’s Biodesign program teaches design thinking to stimulate innovation within the medical device industry. The approach trains fellows to think creatively about identifying unmet needs and developing solutions.

Some of the program’s methodologies can feel counterintuitive, especially to those with engineering backgrounds, who are used to having a solution-based mindset.

One of Holly’s greatest takeaways from the program was the value of the discovery process. She learned to give herself time to understand the unmet needs before trying to solve the problem.

“They have this ethos that bright minds can solve anything together, but let’s spend that effort in the right place,” she says. “It was helpful to really evaluate the different projects we were working on. With so much time spent on understanding that unmet need, it allowed us to frame the problem in a new way.”

Through the extensive exploratory period, Holly developed a deep understanding of the patients whose needs weren’t being met, and was better able to design solutions to address patient pain points.

She credits Biodesign for much of her success, and is especially proud that the university is committed to making information accessible to all aspiring innovators, by giving free access to course teaching materials and video lectures.

Find a Cause You Care About

The medtech industry isn’t an easy one. Projects often take years of development before coming to fruition — or failing. As a result, you’ve got to care about your work, or you will run out of steam.

When Holly worked at Boston Scientific, her favorite day of the year was Quality Day: an annual event where the company invited patients to share their stories with its employees. The opportunity to hear directly from patients brought on tears, but also a sense of purpose.

Placing patients in the forefront has become an essential part of Holly’s work. Her desire for a stronger connection with patients drew her out of the lab and into the incubator. Today, she interacts with patients regularly, and has a strong understanding of how her work directly helps underserved people in healthcare.

“When I talk about this activism, I don’t see myself as someone who’s going to be marching on Capitol Hill, talking to lawmakers about stuff, but I am a medical device scientist. I’m an engineer …I can do my activism by creating this technology,” Holly says.

Hearing what the technology has meant for patients in the clinical trials has helped Holly endure the roller coaster ride of the industry. She keeps a note on her desk with quotes from women who’ve participated in Madorra trials, to serve as a reminder of her purpose on challenging days.

Holly and her team continue to discover ways that their device can support the medical needs of patients, especially those that are sometimes easily forgotten

Knowing that she can support people who have felt otherwise ignored by the healthcare system is one of Holly’s greatest motivators.

Frankenstein Your Funding

In terms of funding, Holly’s done it all. But unfortunately, she ran into a common pitfall in the early stages of development. To successfully solicit investors, she needed clinical data — but clinical data costs money.

Holly and Ryan were initially forced to take the grant route. Luckily, the connections they made during their fellowship opened doors for some small, but essential, preliminary university grants, which helped them get their foot in the door.

Those grants opened opportunities for additional non-dilutive funding, which came with name recognition and added credibility to their project. Having the support of well-respected organizations proved beneficial when Madorra pursued Series A funding.

Holly’s gotten creative with funding over the years, and has managed to pull off a thrifty approach to financing clinical trials. For example, Madorra completed one clinical trial in Australia, to take advantage of the country’s R&D tax write-off program. She also managed to partner with a well-connected clinical trial consultant in San Francisco, who had access to patients that fit the trial’s profile. This sped up the process, and therefore, made it more affordable.

“Clinical trial recruitment can really stall things out. The overhead of the trial just starts to add up,” warns Holly.

But Holly also believes the rapid response to clinical trial recruitment efforts is a testament to the reality that there’s a high demand for devices like Madorra. The company experienced many women eager and willing to sign up for the trial.

Madorra just launched its Series B fundraising round, a step that keeps Holly up at night — partly through anxiety but also excitement.

Lessons Learned Along the Way

Holly’s learned a lot since she first enrolled in Stanford’s incubator program in 2013. She shares her top four pieces of advice for those new to the industry:

1. Prioritize your efforts.

Your top priority must be your company’s most significant risk. At Madorra, they had a great concept, but investors needed to know if it would actually work before they were willing to finance the project.

Developing a fancy device may feel like the first step, but Holly and her team knew that before they could create a prototype worthy of hitting the market, they first needed to prove it would work. Critical viability was most important for Madorra, which meant that getting the clinical trial off the ground was the company’s top priority.

2. Don’t aim for perfection (at least not at first).

Most likely, companies will go through multiple prototypes. They won’t all be perfect, but that’s OK.

Holly recalls the early models of Madorra’s device: “It was clunky. One lady told us her granddaughter thought it was a telephone, which was hilarious.”

Instead of focusing on flashy design, aim to address the critical functions of your device, collect feedback, determine if the device works, and then move on to fine-tuning.

3. Listen to your patients.

Staying connected to your patients will not only bring you a lot of joy but will also lead to a better-designed device.

Staying in tune with patient needs empowers user-driven solutions.

4. Find the right consultants.

Holly found success at multiple stages of Madorra’s journey by finding the right partners.

Her Bay Area clinical trial consultant helped keep costs low by having the right connections with the right patient group.

And Holly also struck gold when she partnered with a regulatory consultant with a strong reputation and experience in women’s health. Holly credits the partnership for Madorra’s breakthrough device designation.

At the core of Holly’s success lies a common theme: a knack for listening to teachers, investors, consultants, and of course, patients.

You May Like These Articles

  • Recent
  • Featured
  • Related

How Medtech Companies Should Approach the Consumer Health Market: Interview with Movano CEO John Mastrototaro

Movano CEO John Mastrototaro talks about how medtech companies can build a successful consumer-facing brand while developing products that meet the needs of payers and providers.

How to Apply an Engineering Mindset to Your Medical Device Startup: Interview with Access Vascular CEO Jim Biggins

Access Vascular CEO Jim Biggins shares his strategies for developing a clinical research roadmap, creative commercialization models, and the reasons why clinician access is crucial for medtech entrepreneurs.

4 Key Considerations to Win Over Investors: Interview with Glympse Bio CEO Caroline Loew

Glympse Bio CEO Caroline Loew discusses her “early-and-often” approach to dealing with regulatory issues and shares four things to consider ahead of conversations with potential investors.

Building Relationships, Raising Capital, and Establishing Reimbursement Codes: Interview with Oculogica CEO Rosina Samadani

Oculogica CEO Rosina Samadani on the importance of relationships in the regulatory and reimbursement processes, why first-time entrepreneurs shouldn’t be intimidated by complex procedures, and lessons learned from her experiences raising capital.

Conquering the Coverage and Reimbursement Landscape: Interview with Bruce Shook, President of Intact Vascular

In this interview, Bruce Shook discusses medical device insurance coverage and reimbursement, as well as advice for other healthcare entrepreneurs that need to raise money.

Why Curiosity and Persistence are Crucial Characteristics for Medtech Entrepreneurs: Interview with the Legendary Dr. John Simpson, Executive Chairman of Avinger

In this interview, the legendary Dr. John Simpson shares what drew him to the field of cardiology, his approach to building a medtech team, and why knowing your strengths and limitations is key to making a difference in the lives of others.

After Selling 2 Cardiovascular Companies for Over $1 Billion, Duke Rohlen is Now Hoping to do the Same with Spirox and Advanced Cardiac Therapeutics

In this interview with Duke Rohen, he discusses how he successfully led two early-stage medtech companies at the same time and the major lessons he learned raising money for 4 different medical device companies.

Having a Heart Attack? There’s an App for That! The Incredible Story of How Dr. David Albert Brought the ECG iPhone App to Market

In this interview with Dr. David Albert, we learn about his incredible journey in bringing the first iPhone ECG app to market with AliveCor.

How Medtech Companies Should Approach the Consumer Health Market: Interview with Movano CEO John Mastrototaro

Movano CEO John Mastrototaro talks about how medtech companies can build a successful consumer-facing brand while developing products that meet the needs of payers and providers.

How to Apply an Engineering Mindset to Your Medical Device Startup: Interview with Access Vascular CEO Jim Biggins

Access Vascular CEO Jim Biggins shares his strategies for developing a clinical research roadmap, creative commercialization models, and the reasons why clinician access is crucial for medtech entrepreneurs.

4 Key Considerations to Win Over Investors: Interview with Glympse Bio CEO Caroline Loew

Glympse Bio CEO Caroline Loew discusses her “early-and-often” approach to dealing with regulatory issues and shares four things to consider ahead of conversations with potential investors.

Building Relationships, Raising Capital, and Establishing Reimbursement Codes: Interview with Oculogica CEO Rosina Samadani

Oculogica CEO Rosina Samadani on the importance of relationships in the regulatory and reimbursement processes, why first-time entrepreneurs shouldn’t be intimidated by complex procedures, and lessons learned from her experiences raising capital.