DermaSensor has developed the first FDA-cleared, AI-powered skin cancer detection device specifically designed for primary care physicians. After spending $27 million on R&D over eight years and conducting 15 clinical studies, the company received FDA clearance in January 2024. Using elastic scattering spectroscopy, the device analyzes cellular and subcellular structures in skin tissue—the same characteristics pathologists examine under microscopes—to provide objective skin cancer risk assessments in under 30 seconds. In this episode, CEO Cody Simmons sha...
DermaSensor has developed the first FDA-cleared, AI-powered skin cancer detection device specifically designed for primary care physicians. After spending $27 million on R&D over eight years and conducting 15 clinical studies, the company received FDA clearance in January 2024. Using elastic scattering spectroscopy, the device analyzes cellular and subcellular structures in skin tissue—the same characteristics pathologists examine under microscopes—to provide objective skin cancer risk assessments in under 30 seconds. In this episode, CEO Cody Simmons shares the journey from Boston University research lab to commercial deployment across hundreds of medical practices.
Topics Discussed:
- DermaSensor's eight-year development journey from 30-pound research devices to handheld commercial products
- The FDA clearance process requiring five pre-submission meetings and over 10,000 pages of documentation
- Strategic decision to target primary care physicians rather than dermatologists based on competitive intelligence
- Clinical validation showing device accuracy matches in-person dermatologist assessments
- Commercial launch strategy achieving coverage from major media outlets without a major PR firm
- Rapid adoption by hundreds of private practices within the first year post-clearance
GTM Lessons For B2B Founders:
- Learn from competitive failures before choosing your market: Cody observed companies spending "literally hundreds of millions of dollars" targeting dermatologists with similar devices, only to see them "commercially immediately fizzled out" within 2-4 years. Dermatologists, being experts, were confident in their existing processes and questioned why they needed additional tools. This competitive intelligence led DermaSensor to target primary care physicians who welcomed objective second opinions. B2B founders should study why similar solutions failed in adjacent markets and identify underserved segments where their value proposition resonates more strongly.
- Align your commercial strategy with regulatory requirements years in advance: Cody emphasized that you must "align your plan like your commercial plan with your study" and your FDA indication for use, determining "who's actually approved to use the device for what purpose." This planning must happen years before approval since clinical studies are designed around the intended commercial application. B2B founders in regulated industries should work backwards from their go-to-market strategy when designing regulatory pathways, ensuring clinical evidence supports their target market and use cases.
- FDA clearance itself can be your biggest PR moment: DermaSensor achieved coverage on ABC, NBC, CBS, Fox, Forbes, Reuters, and Time Magazine's Best Inventions list primarily because "the FDA clearance itself was so big" for a first-in-class device addressing "the most common cancer." They worked with only an independent PR consultant, not a major firm. B2B founders should recognize that major regulatory milestones, especially for novel technologies, inherently generate media interest and plan their launch communications accordingly.
- Prioritize speed and simplicity when displacing manual processes: The device works in "less than 30 seconds" from pickup to result, addressing primary care physicians who previously had to rely on visual assessment with minimal dermatology training (only "two to four hours of training in medical school"). The combination of speed, objectivity, and ease of use made adoption attractive to non-specialists. B2B founders should design solutions that are dramatically faster and more accurate than existing manual processes, especially when targeting users who lack specialized expertise.
- Private practices adopt faster than health systems but both are essential: Cody noted that "private practices, because they make decisions so quickly" with "one or two doctors that run the practice" were able to rapidly adopt the technology. However, health systems provide validation and scale. The company focused on building "that whole ecosystem" where "health systems using a private practice, using it. Dermatologists are aware of it." B2B founders should sequence their go-to-market to capture quick wins from agile smaller customers while simultaneously pursuing enterprise accounts for long-term growth and market credibility.
//
Sponsors:
Front Lines — We help B2B tech companies launch, manage, and grow podcasts that drive demand, awareness, and thought leadership.
www.FrontLines.io
The Global Talent Co. — We help tech startups find, vet, hire, pay, and retain amazing marketing talent that costs 50-70% less than the US & Europe.
www.GlobalTalent.co
//
Don't Miss: New Podcast Series — How I Hire
Senior GTM leaders share the tactical hiring frameworks they use to build winning revenue teams. Hosted by Andy Mowat, who scaled 4 unicorns from $10M to $100M+ ARR and launched Whispered to help executives find their next role.
Subscribe here: https://open.spotify.com/show/53yCHlPfLSMFimtv0riPyM
View more
