Failing Forward in Medtech

With a deep background in medical device engineering and product management, Mara McFadden’s career has spanned industry giants like Johnson & Johnson and Philips Healthcare. She has also taken some interesting turns, including a detour into consumer tech.

After graduating as a mechanical engineer from the University of California at Berkeley, Mara found herself in Johnson & Johnson’s innovative Global Operations Leadership Development program — a fortuitous start providing her extensive business exposure. From there, she moved on to their Cordis division, which allowed her to learn the world of endovascular stent manufacturing. 

After earning an MBA from the Tepper School of Business at Carnegie Mellon University, Mara transitioned into a product management role at Philips Healthcare. The position gave her the opportunity to manage a global P&L and launch various products, thus honing her skills in the business side of medtech.

Mara then pivoted to a consumer products startup called 4Moms. This presented Mara with the perfect chance to dabble in entrepreneurship. She built their product management group, led multiple commercial launches,s and garnered a lot of direct-to-consumer business experience. It was a rewarding venture, yet Mara felt the draw of medtech, where she could create products that had the potential to save lives. Turning back to the medical device space, she advised a few small startups and worked with a medtech incubator, where she met her co-founder, with whom they started Endolumik.

Endolumik’s flagship product is a gastric calibration device that uses near-infrared light to improve visualization in the GI tract during surgery. A simple yet ground-breaking tool, Endolumik promises to enhance precision and safety in patient care. And according to Mara, it’s only the tip of the iceberg.

Endolumik’s first device was granted FDA 510(k) clearance in March 2023. Now, Mara and her team are preparing for U.S. commercialization, while continuing to execute their product development roadmap. 

Key Learnings From Mara’s Experience

• Fail fast, fail often, and fail inexpensively. Don’t obsess about perfection during the prototyping phase. Your first iterations are bound to have flaws, but there are also valuable lessons in each phase of testing. 

• The success of your startup greatly depends on what kind of culture you cultivate. Build a supportive, enthusiastic, and passionate environment with a customer-oriented approach to everything you do. 

• You need to understand the numbers from the perspective of your investors when it comes to fundraising. Focus on capital partners who are comfortable and have experience in your industry. You’ll save time and energy by making sure your investors align with your company’s vision.