Why Your 'Kitty Hawk Moment' Matters

Interview with Elucid CEO Kelly Huang

Key Learnings From Kelly's Experience

  • Strip your innovation down to the essentials before getting carried away with anything else. In other words, what’s the one breakthrough or functionality you absolutely need to show to prove the viability of your concept? Don’t overcomplicate it. Resist distractions, avoid unnecessary bells and whistles, and put every resource into demonstrating that your technology works. 

  • To secure reimbursement, collaborate with physician societies and industry groups to present a unified case to payers, backed by robust clinical and economic data that shows how your product improves outcomes and reduces costs. And don’t see competitors as enemies—when you’re building a new market, collaboration often works better than going at it alone. Together, you can build a stronger case for reimbursement.

  • Adoption starts with trust and proof. To earn it, focus on making your technology transparent and supportive, not a replacement for physicians. Engage key opinion leaders (KOLs) who can validate your product, invest in rigorous clinical trials to back up your claims, and demonstrate clear health economics to show payers it’s worth the investment.

Kelly Huang, CEO of Elucid, is a scientist at heart. He earned a PhD in chemical engineering from Stanford. After graduating, Kelly began his career at Johnson & Johnson, where he spent 15 years. “J&J is a fantastic talent development organization that invested in me, enabling me to transition from R&D to general management,” he reflects. After J&J, Kelly served as President of HealthTronics - a former division of publicly traded Endo Pharmaceuticals and General Manager of publicly traded Obalon Therapeutics, when it was a U.S. aesthetics subsidiary of  Nestlé Galderma.

“At Elucid, we’re working to eradicate preventable heart attacks and strokes,” Kelly says. Heart attacks claim 18.5 million lives annually. According to the WHO, 80 to 90% of these deaths are preventable. To address this, Elucid is developing non-invasive CT imaging analysis software based on histology. The technology, PlaqueIQ, may help identify higher risk plaques. It is the first FDA-cleared software that can quantify and classify morphology based on ground-truth histology, the gold standard for characterization of plaques. In essence, Elucid has developed CT Virtual Histology.

Here’s how it works: Patients visit their cardiologist. After an initial evaluation of symptoms, the doctor might recommend a cardiac CT scan, known as a CCTA—a non-invasive test that takes about 30 minutes. The patient lies in a CT scanner, the machine captures images of their heart, the scan is sent to Elucid where the PlaqueIQ software analyzes the scans for compositional information on atherosclerosis, or coronary plaque buildup. If the plaque is heavily calcified, the lesion may be considered stable and be less concerning to the physician. PlaqueIQ provides plaque composition detail to physicians that may enable them to make personalized therapeutic decisions for patients, based on their unique plaque composition detail and other patient-specific characteristics as determined by the physician. A physician may choose to do an additional CCTA in the future on patients with a higher risk profile so changes to the volume and composition of plaque -- and, importantly, the success of a chosen therapeutic strategy-- can be monitored.

The company has recently initiated its limited market release for PlaqueIQ after receiving FDA clearance on the software late last year. It’s also working on following up PlaqueIQ with an FFRCT product, which will help physicians identify and objectively measure the degree of stenoses or blockage, based on histology.

President and CEO of Elucid

Kelly’s journey to Elucid spans nearly 30 years of leadership in healthcare, with expertise in driving innovation and growth across medical devices, diagnostics, health IT, and consumer health. Before Elucid, he served as COO at Cardea Bio, leading its successful acquisition by Paragraf, and as CEO of Obalon Therapeutics, where he introduced noninvasive medical devices to expand treatment options for physicians. Kelly's career also includes senior roles at L-Nutra, Nestlé/Galderma, Endo Pharmaceuticals, and Johnson & Johnson.

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Building Toward Your Kitty Hawk Moment

“One of the concepts that has always been helpful for me with a company trying to do something for the first time, is the Kitty Hawk moment,” Kelly shares, referring to the Wright Brothers’ 12-second flight in their Wright Flyer, also known as the Kitty Hawk, which proved human flight was possible.

For a CEO bringing an innovation to market, the ‘Kitty Hawk’ moment translates to focusing all your resources on achieving a breakthrough or proving that the technology works for the first time. This is paramount, especially in early-stage development.

“You really have to figure out what are those two or three things you need to prove to show you could fly for 12 seconds,” Kelly explains. “Everything else after that is just optimization.” For the Wright brothers, it was proving lift, power, and control. For you, it’s the distilled-down version of your endpoints and claims.

In other words, you need to simplify, avoid distractions, and resist the temptation to over-engineer. This is how you set the context around the most important things. Focus all resources on proving your foundational capabilities. Expanding before that is out of the question. Kelly uses this as a reality check: “If you’re designing the beverage cart for the Wright Flyer when you haven’t proven you can fly yet, pause and focus—what do we need to prove to know we’re on the right path?”

Having experience in both R&D and commercialization, Kelly has learned that these two phases demand very different approaches. The former is where you explore and learn, and the latter requires an even tighter focus on execution.

When you’re in R&D mode, there could be, in Kelly’s words, “a swim lane” for each department with independent workstreams. As the company moves towards commercialization, workstreams should shift from independent efforts to interdependent, collaborating units. “Get the key decision makers in a room,” Kelly suggests, “talk about technical challenges with the business people and sales challenges with the technical people.” This kind of collaboration helps you see what you need to focus on next and better allows for the alignment of priorities.

In this phase, you also should be hiring for both technical skills and motivational fit. “Being purposeful about the culture is important as you add all these new people,” Kelly notes. “If motivations don’t align, you’ll spend a lot of emotional capital trying to make it work.” Adding 50% more people in six months is like adding appendages to a body. Without alignment, your system risks rejecting the new parts.

Finally, Kelly suggests viewing regulatory constraints creatively. If you can really understand the parameters for regulation guardrails, and develop innovation in a compliant manner within those guardrails, you can actually use these "constraints" to build a defensible market position.

Working Together to Push Reimbursement Forward

Even if you have a great product, you have to ensure someone will pay for it. To do that, you have to collaborate with others. Kelly emphasizes that, in medtech reimbursement, no one succeeds alone. Working alongside physician societies and industry organizations is incredibly valuable to be able to present a unified case to payers. 

Elucid works with physician societies and groups like the Society of Cardiovascular Computed Tomography (SCCT) and the American College of Radiology to present clinical data, outcomes, and health economics that support reimbursement milestones. They also collaborate with industry groups like AdvaMed and MDMA for market access insights. Kelly stresses the importance of proof—not just that your technology works, but that it delivers clinical and economic value. “You need to justify and prove that this is a win, both clinically and economically,” he says. The proof in question is robust data that resonates with payers, clinicians, and policymakers. This is a reminder for entrepreneurs to think beyond the lab. Yes, technical breakthroughs matter, but payers want to know how your product will both reduce costs and improve outcomes. In short, always think about how you can align your data with the specific pain points of the healthcare system. 

Kelly also points out that timing can be everything in securing reimbursement. Elucid benefits from “tremendous Medicare and commercial payer tailwinds,” with CMS granting the category a Category I CPT code just a year after market entry. This level of support is rare in medtech, since collecting data for new technologies usually takes up to five years. Kelly points out there are tailwinds, especially in a space with growing momentum—be it payer interest, regulatory clarity, or public health focus. You can use this momentum to your advantage.

Lastly, Kelly’s take on competition is refreshing. For him, they can be collaborators, especially when building a new market. He says, “When you're going into a market where you're trying to develop a new technology, these competitors are really like great neighbors.” To this end, Elucid, along with companies HeartFlow and Cleerly, have joined together to positively affect these monumental changes in reimbursement. While this doesn’t mean ignoring competition entirely, as there’s still a race to stand out, when it comes to establishing reimbursement frameworks and advocating for new technologies, Kelly believes there’s strength in numbers: “Together, you’re keeping the parks clean and the streets safe.”

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3 Keys to Drive Adoption

“I'm never in a business to disintermediate the physician. I'm always in the business of enabling better clinical decision support for the physician,” says Kelly. There’s little doubt that AI is proving to be helpful in this area. Studies on cancer and X-rays show that expert graders are about 70% accurate, and AI can achieve the same accuracy after just a few months. The catch is, 10 years from now, expert graders will still be 70% accurate, but the AI algorithm could improve to 95% accuracy. With improving algorithms and improving trust and understanding of the technology by physicians, patient care will be dramatically improved.

However, adoption starts with addressing a key concern: physicians don’t trust AI’s "black box" models since they don't offer clarity or visibility. That’s why Elucid’s PlaqueIQ doesn’t just provide conclusions—it gives physicians layered information starting with the raw CT scan. As Kelly puts it, “The demand for care is so much more than the access to care. Technology like AI is going to be the way that that's going to be solved. We're not going to all of a sudden get a million new doctors next month, but AI can help make the million doctors we have a lot more productive.”

The platform identifies problems in the vessel, disaggregates the data, and pinpoints exactly where the issue is. For example, when a doctor sees a stenosis in a vessel that corresponds to calcified plaque on CT, they can confirm the findings and get even greater specificity about the plaque composition from Elucid's software. “The algorithm isn’t there to replace a physician’s judgment but to support it,” Kelly explains. This non-threatening approach is critical since the technology aims to address the imbalance between the demand for care and limited access to physicians.

Kelly also outlines a clear playbook for driving adoption, based on lessons from other technologies he’s commercialized:

Engage KOLs early: Start by working with a small group of KOLs who will use your product, show it gets great results, and prove how effective and efficient it is. Their backing goes a long way in building trust and credibility.

Invest in rigorous clinical trials: Retrospective studies are a great starting point—they help you spot patterns and test ideas. But to really make your case, you’ll need to invest in large-scale, prospective trials. While they’re costly and take time, they're the gold standard for proving your algorithm delivers better outcomes.

Prove health economics: Make sure you’ve got case studies and research that show payers your technology is worth it. They want to see how it cuts costs and improves outcomes. If you can prove both, you’re much more likely to win their support.

These three elements—KOL support, clinical data, and health economics—are critical for gaining adoption, acceptance, and ultimately, payer support. And this isn’t just about AI; these principles apply to any new technology looking to succeed in the healthcare market.

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A Guide to Widespread Adoption in Medtech

In medtech, developing novel, impactful technology is often just the starting line. The real race begins when you try to integrate your solution into the often-resistant healthcare system – a hurdle that has tripped up countless promising companies. Here are the key strategies and lessons from five veterans in the medtech space on how to overcome this hurdle.

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