Building the First FDA-Cleared Skin Cancer Scanner for Family Doctors | Cody Simmons

Eight years. Tens of millions of dollars. Not one unit sold. That is what it took Cody Simmons and his team to get DermaSensor through the FDA, the first automated skin cancer detection device cleared for primary care doctors. And the first three people on the team are still working together nine years later.

Cody is the co-founder and CEO of DermaSensor. Time named it one of the best inventions of 2024, and it landed on Inc's list alongside Anthropic and NVIDIA. He did his graduate work in bioengineering at Stanford and spent four years at Genentech before joining his co-founder, a serial medical device entrepreneur, to turn a research technology into a company.

Skin cancer is the cancer you can see, and yet only about eight percent of the hundred million Americans at risk get the recommended annual skin exam. I know why people avoid it. I sat on a mole for a long time because I did not want to hear the answer. So we walked through the four things every founder building something hard runs into: regulation, capital, trust and scale. And Cody told me about the second patient ever scanned after clearance, a man who was sure his mole was fine. It came back a 10 out of 10.

What we get into:

• Why they went after family doctors instead of dermatologists
• From a microwave-sized desktop system to a one pound handheld
• Healthcare, hardware and the FDA, all at once
• How you hold a team together for eight years with no revenue
• Raising capital for something you are not allowed to sell yet
• The real objection: why not just use a photo and an algorithm
• A live demo, and how the device reads up to a millimeter beneath the surface of the skin
• Earning trust from people with far more training than you
• Not cutting corners on clinical data, and the pulse oximetry problem
• What broke first when they were finally cleared to sell
• Why Cody is now glad clearance did not come in 2023
• 300,000 primary care physicians at 140,000 locations, and why a small team cannot do it alone

Timestamps

• 00:00 Meet Cody Simmons and DermaSensor
• 01:27 The founding story
• 03:39 From a microwave-sized machine to a one pound handheld
• 04:31 Why family doctors, not dermatologists
• 06:35 What primary care doctors miss
• 08:34 The mole I did not want to look at
• 10:18 The second patient ever scanned
• 12:00 Zooming out: regulation, capital, trust, scale
• 14:36 Eight years of R&D before selling unit one
• 16:56 The three people who stayed nine years
• 18:39 Raising money for something you cannot sell yet
• 21:49 Why not just a photo and an algorithm
• 23:22 Live demo of the device
• 26:33 Five tissue samples and the risk scale
• 28:27 Earning trust from people with more training than you
• 31:43 The pulse oximetry problem and what the FDA asked for
• 34:17 What broke first at launch
• 35:39 Why the timing worked out better
• 36:18 Scaling to 300,000 physicians
• 39:19 How to reach Cody

About the guest

Cody Simmons is the co-founder and CEO of DermaSensor, the first automated skin cancer detection device cleared by the FDA for primary care doctors. Stanford bioengineering, four years at Genentech, and ten years into building DermaSensor. He is responsive on LinkedIn.

DermaSensor: https://www.dermasensor.com/

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

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