Fixing Healthcare Bottlenecks from First Principles
Interview with Enspectra Health CEO Gabriel Sanchez
Key Learnings From Gabriel's Experience
If you’re an academic with a good idea, here’s a roadmap: Assess whether your idea addresses a real, pressing need, not just something people want. Adapt your technology to align with this pressing need. Dive into prior work, even failed attempts, for inspiration and insights. And finally, be prepared to go all in. Entrepreneurship is not a part-time job.
Start by identifying the biggest challenges in your field and target areas where your technology can create meaningful change. Take a step back and look upstream in the process to spot inefficiencies that contribute to downstream bottlenecks in healthcare. Instead of simply patching issues, think about how you can prevent the problem by addressing inefficiencies earlier in the workflow.
Academics naturally speak the same language as FDA. If you don’t qualify, bring in specialists who can address complex questions to make sure they understand you’re on the same page with patient safety and the claims you’re aiming to make. Use FDA’s Q-submission process to accelerate your regulatory progress.
While grants preserve equity, they can be time-consuming to secure. Pairing them with venture funding keeps operations moving while leveraging non-dilutive funding to amplify your progress. Pitch to investors by emphasizing how grants extend their capital, and present grant agencies with the momentum and validation provided by investor interest. This dual-funding approach not only reduces dilution and increases runway but also enhances your project’s scope and scalability potential.
Gabriel Sanchez, co-founder and CEO of Enspectra Health, earned his bachelor’s degree from MIT and his master’s and PhD in mechanical engineering from Stanford. With his graduate studies on neurodegenerative diseases, Gabriel’s plan was to become a professor. He served as an instructor in Stanford’s bioengineering department as he was completing his PhD. Soon after, however, he realized his research had the potential to solve long-standing challenges in imaging.
Gabriel seized the opportunity, took the plunge and left academia, and launched Enspectra. That was about 10 years ago. Fast forward to today, he has licensed several patents, raised funding, and transformed his research concept into an FDA-cleared product for assessing skin.
Traditionally, evaluating a suspicious skin spot involves a dermatologist performing a biopsy. The tissue is sent to a lab—often via FedEx—where it’s sliced, stained, and mounted on slides. Results can take anywhere from a few days to weeks. Gabriel points out that of the 16 million biopsies performed annually in the U.S., around 50% are benign. “That’s millions of unnecessary scars in places people really don’t want them, not to mention the stress and waiting involved,” he says.
Enspectra’s solution, the VIO platform, is an imaging device that looks beneath the skin's surface at a cellular level to examine structure and molecular composition. The device captures high-resolution images that are digitized and reviewed by trained clinicians, such as dermatologists. The team calls this process a “virtual biopsy.” Unlike traditional histopathology, it’s non-invasive, works in real-time, and provides digital results directly at the point of care.
Enspectra’s VIO is the first new imaging modality cleared by FDA in over 25 years. “Imaging tools are really old,” Gabriel notes. “Microscopes for histopathology date back to the 1800s, X-rays over 100 years ago, ultrasound 70 years, and MRI and CT 60 years. Most of these were grandfathered in before the FDA even existed.”
Looking ahead, Gabriel envisions AI tools further streamlining computer-aided detection and diagnosis applications. In fact, this vision was a key factor in Enspectra’s recent FDA breakthrough designation. “Our goal is to digitize the entire process,” he explains. “Dermatology is overwhelmed—there are more annual dermatologist visits than diabetes patients in the U.S., with about 44 million office visits. It’s like if the only way to get your mail was to visit the post office—the traffic would be chaos.”
Since raising a Series A in 2019, the Enspectra team has focused on building the clinical version of VIO. Now, they’re preparing for commercialization. The immediate priority is raising funds to support an initial launch with key opinion leaders. This phase will help refine clinical workflow integration into dermatology practices. The ultimate goal is for VIO to advance patient care by becoming part of the standard of care for both clinical and aesthetic dermatology.
Guest
CEO of Enspectra Health
Gabriel Sanchez is the co-founder and CEO of Enspectra Health, makers of VIO, the first FDA-cleared imaging modality for dermatology in over 25 years. This novel technology enables high-resolution, noninvasive imaging beneath the skin’s surface. Gabriel holds a B.S. in mechanical engineering from MIT and an M.S. and Ph.D. from Stanford University, where he also served as an instructor in bioengineering and launched Enspectra to commercialize his groundbreaking research.
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Transitioning from Academia
Academic work often stems from research curiosity, whether scientific or intellectual. While these pursuits can advance knowledge, they are not inherently marketable.
For an academic putting on the hat of an entrepreneur, the first step, according to Gabriel, is to assess whether your idea addresses a real, pressing need. Here, playing to your strengths is essential, but so is staying flexible enough to adapt your technology to where it’s truly needed.
Gabriel explains: “The key to any successful venture in this space is addressing a core need,” and adds, “It’s great if people want what you’ve built, but if they need it, you become essential.”
Enspectra’s foundational technology, multi-photon microscopy, is a great example of this principle. These versatile microscopes have been a mainstay in academic research for 30 years, used to study everything from breast cancer to colon and lung cancer. The problem is, they are massive 500-pound systems, basically impractical outside of lab use.
“There are thousands of peer-reviewed papers on multi-photon microscopy,” Gabriel shares. However there are no marketed solutions utilizing them effectively. When Gabriel started, he knew he had a new way to image tissue using these systems, but his initial research followed a similar trajectory as these papers—it wasn’t heading in a commercially viable direction.
A side note on Gabriel’s approach: unlike the standard Stanford Biodesign philosophy—a program Gabriel has attended and deeply respects—which often advises keeping your mind clear and independent to avoid being influenced by existing solutions, Gabriel believes studying prior work can inspire and inform you. That’s why he dove deep into peer-reviewed literature, past FDA filings, and efforts by some of the best optical groups in the country—looking for where they fell short and figuring out how to overcome those challenges. “Failures are often the most informative,” he notes.
Apart from shifting perspectives, starting a company also meant taking the plunge for Gabriel. He co-founded the company with two colleagues who are still professors at Stanford, but they realized they couldn’t raise funding without someone going all in. That someone was Gabriel.
It wasn’t an easy decision for Gabriel, who had a young family at the time. But he felt it was necessary. If you want to do this, you need to be at least risk-tolerant, if not risk-driven,” Gabriel says, and further adds, “You’ve got to be a little delusional too.” He didn’t know much about running a company, but that was actually an advantage. “It insulated me from the challenges just enough to be able to push forward with drive and gumption.”
Narrowing Down the Focus to a Single Product
"The product development phase is the most fun part of the journey, but it’s also the most tenuous. You have no money, no resources—it’s just you and maybe one or two other people grinding it out,” Gabriel explains.
First of all, don’t try to jam your technology into a problem that doesn’t fit. The saying goes, “When you’re a hammer, everything looks like a nail.” But for Gabriel, most problems are screws. “If you’ve ever tried to hammer a screw, it doesn’t work well. You need a more sophisticated, nuanced approach,” he says.
To decide on a use case for his technology, Gabriel stepped back and asked, “Where are the biggest challenges in imaging?” His answer landed here: diagnosis through histopathology. This process, which relies on technology developed in the 1870s, remains largely unchanged. While innovations like digital pathology have modernized certain aspects, the workflow is the same: cut out tissue, mount it on glass slides, stain it, and scan it.
So he focused on accessing that same information non-invasively. The most common application is disease diagnosis. The most prevalent type is cancer. And the most abundant cancer is skin cancer—it makes up a shocking 80% of all cancers in the U.S.—8 million cases annually out of 10 million total. Plus, the skin is on the outside of the body, which presents a potential to image it non-invasively.
Gabriel uses a funnel analogy to analyze healthcare challenges. In the case of skin cancer, the narrow part of the funnel—the bottleneck—is the most resource-intensive stage: biopsies, pathology reviews, and diagnoses. Counterintuitively, addressing this bottleneck directly doesn’t solve the inefficiencies upstream, where the bulk of patient flow begins.
Instead of focusing solely on the limited capacity of dermatopathologists to handle biopsies, Gabriel’s solution integrates imaging and AI tools at the point of care. This reduces the need for biopsies altogether, creating a more efficient, scalable system that prevents bottlenecks before they even form. As he puts it, “There's a lot of movement around point-of-care ultrasound, and we're thinking of this as point-of-care pathology. I believe this will be the first true digital pathology platform because we're not taking samples out. We're going directly from tissue to a digital representation with no steps in between.”
On that note, keeping the healthcare workflow in mind, Gabriel prioritizes designing systems from scratch to meet clinicians’ needs. “Traditional systems in our field are big, clunky, and don’t image the way doctors want. They often produce flat images instead of cross-sections, assuming doctors will learn to adapt. But that’s not realistic—they don’t have time to relearn histopathology.” he explains. “We knew we had to stay faithful to the need and create a system that fits seamlessly into their existing workflow. That’s what drove us,” Gabriel adds.
Having said that, while the team narrowed down their initial focus to skin cancer, they haven’t lost sight of the broader potential of their platform. Gabriel compares it to ultrasound: once the foundational technology is cleared, it opens the door to countless applications. “But we had to be disciplined and pick a starting point where we could make an immediate impact,” Gabriel emphasizes.
How to Collaborate Effectively with FDA
With a more narrow focus, Gabriel was able to build a clear regulatory roadmap thateventually led to an FDA breakthrough designation. To achieve this, Enspectra conducted two clinical trials over the last few years, studying close to 200 patients.
The first step was a preliminary evaluation of healthy skin. This trial aimed to baseline the technology and understand how normal tissue looks under the microscope. The second trial was a targeted study, refined through the FDA’s Q-submission process, to validate the imaging modality for observing histopathological features in living tissue. In other words, they imaged tissue on patients who were undergoing biopsies for a clear comparison.
To do all these, in practice, medical assistants were trained to use the device to capture images, which dermatologists could then interpret. Currently, interpretation still requires dermatopathology expertise, but the company envisions AI tools simplifying and automating this process.
Using data from these trials, Enspectra developed several AI prototypes focused on oncology features. These prototypes were designed to streamline interpretation and support decision-making for clinicians. In June 2024, Gabriel’s team submitted this data as part of a breakthrough designation package—and received the designation.
Gabriel’s experience with people at FDA is quite positive. “FDA is full of very smart people,” he says, who approached the process very collaboratively. As a clinical or PhD founder, Gabriel feels he had an edge. “The FDA is staffed with clinical scientists who understand things like biological variance, P-values, and study design. As scientists, we speak their language, and that makes a big difference.”
He emphasizes the importance of making a strong first impression. If you don’t have the expertise to answer their questions, bring someone who does. When you’re venturing into uncharted territory, credibility is key. Showing the agency that you’re aligned on priorities like patient safety, clear data, and claims validation builds trust and collaboration.
Reflecting on his journey, Gabriel offers three pieces of advice for working withFDA:
Utilize Q-subs: Engage early, ask questions, and use their feedback to shape your studies. “Their goal is to ensure public safety while enabling innovation, and they’re generally good at finding that balance,” he says.
Stay patient: The process can be frustrating, but that’s part of ensuring safety and efficacy.
Be prepared and credible: Bring the right people to your meetings with FDA in order to answer questions and provide clarity.
Complement Grants with VC Funding
Enspectra raised both dilutive and non-dilutive funding, and Gabriel sees them as complementary. Non-dilutive funding, like grants, is great for preserving equity, but it isn’t free money. Grants require resources and come with obligations—specific aims and deliverables. If the grant doesn’t align with your company’s strategy, it can pull you off track and waste valuable time.
That’s why it’s crucial to target grants that fit your long-term goals. “Don’t chase grants just for the money,” Gabriel suggests. Instead, align applications with your corporate strategic initiatives.
Gabriel’s grant track record is impressive now, but it didn’t start that way. “It took me six tries to get my first one,” he shares. If you’re facing rejections, don’t be discouraged—it’s part of the process. Success comes from learning how to tell your story in a way that resonates with grant agencies. “It’s very different from pitching VCs,” Gabriel explains. “With grants, you only have your written application. There’s no chance to clarify or explain in person, so it needs to be crystal clear.”
When applying, Gabriel projects a position of strength by disclosing: “We’ve already raised venture funding and are pursuing this goal anyway, but your support will help us move faster.”
On the other hand, grants alone can’t sustain operations. Pursuing dilutive funding in the meantime is critical, because grants are not only hard to nail, they take time—sometimes 9 to 12 months from submission to funding, even for successful applications.
Gabriel’s strategy was to layer them together, telling investors, “You're going to get more bang for your buck, ” while positioning grant applications with, “Investor interest means we can bring this to patients faster.”
That said, this isn’t a one-size-fits-all strategy. Some agencies, like the National Cancer Institute (NCI), view investor interest as a positive because it shows momentum and reduces their risk. Others, like NSF, may prioritize funding early-stage projects that lack other support. Understanding each agency’s mindset is crucial.
“For us, NCI has been a great fit. They have ambitious goals, solid budgets, and a focus on innovative technologies. It resonated with them, and we’ve built a strong relationship over time. But it took trial and error to find the right fit,” Gabriel reflects.
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