The Stanford Mussallem Center for Biodesign has trained innovators whose inventions have touched over 18 million lives while they were still in training.

Most people think breakthrough innovation is magic or unpredictable. Dr. Josh Makower proved otherwise. As co-founder of the Stanford Mussallem Center for Biodesign, he created a systematic methodology that breaks innovation into learnable steps: identify who you're serving, understand their needs through direct observation, define the problem without embedding a solution, then invent against clear criteria. The result is a repeatable process that dramatically increases the probability of success.

In this episode, Shannon Lantzy talks with Dr. Makower about his journey from mechanical engineering and medical school to founding ExploraMed, an incubator that launched companies like NeoTract and Willow. They discuss how two men created the first wearable breast pump by studying how babies actually feed, why regulatory reform requires empathy on both sides, and what it takes to sustain the innovation ecosystem through capital returns while serving patients.

Timestamps:

00:00 – You must return capital to investors to keep the ecosystem going

03:00 – From The Bionic Man to biomedical engineering

06:00 – Learning the language of business to stay in the room

09:00 – Why sustainable businesses, not charity, solve medical problems

12:00 – ExploraMed and the biodesign process in action

14:00 – The hardest part: keeping engineers from racing to solutions

16:00 – Creating the first wearable breast pump

19:00 – How two men learned to solve a problem they don't have

23:00 – Why outsiders can see what insiders miss

26:00 – The golden era of medical devices and what changed in 2008

28:00 – Getting FDASIA passed: fighting for regulatory reform

32:00 – Breaking innovation into learnable steps

35:00 – When needs statements should (and shouldn't) change

37:00 – Disease burden as an invisible, unmeasured problem

40:00 – How to prioritize: outcome severity multiplied by people impacted

44:00 – Who biodesign serves and why the ecosystem matters

47:00 – Measuring impact: 18 million lives and counting

52:00 – Are we over-engineering healthcare?

56:00 – What FDA still needs to improve: consistency across reviewers

01:00:00 – Empathy on both sides of regulation

Follow Shannon and Josh:

Connect with Shannon: 

LinkedIn: https://www.linkedin.com/in/shannonlantzy

Website: https://www.shannonlantzy.com

Connect with Josh: 

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

Website: https://biodesign.stanford.edu