People behind healthcare innovation: Interview with Michal Mark Danieli, CEO and founder of EARLY

As part of our work, we have the privilege to speak with many inspiring innovators. Although the business community usually focuses on companies, pitches, and valuations—and less on the innovator—we thought it would be interesting to learn a bit more about the people behind healthcare innovation. In this series, we’re sharing some of our conversations with innovators in a condensed format to gain insights into their experience, their opinions, and their learnings.

This latest conversation is with Michal Mark Danieli, PhD , CEO and founder of EARLY, a company that is pioneering a volatile markers (VM) test for early detection of cancer.

Gila: What’s your story, and how did you become an innovator in healthcare?

Michal: Being raised by an engineer and a PhD in biology, I was probably destined to become a scientist myself. The only question was in which field. When I finally decided to study biology, it was clear my passion was human genetics.

During my two decades researching cancer, I became fascinated with volatile organic compounds (VOCs)—especially scent molecules released by cancerous tumors into the patient’s bloodstream from the very early stages of formation, creating a unique odor signature. I was interested in their potential for early detection of cancer, so I studied the science behind VOCs to explore ways to utilize them.

I learned of different approaches for detecting VOCs using an animal’s olfactory abilities and how those have been harnessed for applications in homeland security and drug detection. I decided to explore whether similar technologies could be applied to medical use. However, I began to understand that spending so much time trying to learn the exact nature of the odor signature would be like prehistoric people not using fire for light or heat, just because they didn’t understand exactly how it worked.

With that realization, I came up with the idea for a VOCs-based early detection test and founded EARLY. I teamed up with a multidisciplinary team of scientists and started developing our unique platform: this combines biology and technology to harness animals’ superior olfactory sense to detect a cancer’s odor signature in human urine samples. This approach enables us to offer patients a wider range of treatment options and dramatically increase their survival rates and quality of life; at the same time, it drastically reduces diagnostic and treatment costs.

We decided to focus on lung cancer first, but will add more and more detection capabilities until we achieve our vision of a multi-cancer early-detection platform. Once the platform is operational, we will be able to collect the massive amount of data needed to crack the odor’s molecular formula, eliminate the dependence on animals, and offer a fully automated data-driven test.

Gila: How do you see cancer diagnostics developing in the next ten years?

Michal: Although cancer treatment has progressed immensely, the importance of early detection for saving lives, improving medical outcomes, and driving efficiencies in cancer care is clearer than ever. Technologies such as AI and machine learning present huge opportunities for healthcare systems to identify risk factors and create individual risk profiles for patients. But diagnosing the disease on time remains a challenge with the absence of safe, simple, cost-effective, and accurate testing methods.?Another fundamental challenge is the low uptake of existing screening approaches, due to low accessibility and other inequalities.

We will see ongoing efforts to develop new methods for screening and early detection, with an obvious emphasis on making tests as accurate as possible, as well as safe, simple, affordable, acceptable to patients, and accessible around the world.

Ultimately, for the future sustainability of health systems, we must achieve greater efficiencies in cancer care pathways, a world where patients get the right treatment at the right time and place—accurate screening can play an instrumental role in making this a reality.

Gila: Looking more broadly, what are the biggest opportunities and obstacles you see for innovation in the healthcare environment?

Michal: As healthcare and medicine are becoming more of a consumer product, demand for innovation and high-quality user experience is higher than ever before. As a result, companies and entrepreneurs who can accelerate time to market have plenty of opportunities. Yet this also poses a threat. Regardless of how important and justified this shift from “system centered” to “patient centered” may be, at the end of the day someone will have to pay for all these new treatments, tests, procedures, drugs, and devices. With budgets tightening and profitability decreasing, being innovative is simply not enough. New products and services must prove they can create significant value for all stakeholders across the diagnostic, screening, and treatment pipeline. No matter how innovative or effective a product might be, it will not succeed if it fails to prove its value to patients, payers, and providers alike.

No matter how innovative or effective a product might be, it will not succeed if it fails to prove its value to patients, payers, and providers alike.

Gila: When you look at the health system as a whole (pharma, providers, payers, doctors, patients), who do you see driving innovation the most?

Michal: In today’s competitive business environment, innovation is necessary across the healthcare system. However, from my perspective, it’s the patients, who previously weren’t so much a part of the innovation agenda, that drive change. As patients become more informed, they become more empowered to take active control of their own health—and they question everything. Healthcare innovators must look at patients as consumers, with unique preferences and behaviors, rather than expecting them to blindly obey their doctors’ orders.

Moreover, measuring?the effectiveness of a treatment or procedure no longer depends solely on its medical outcomes. Procedures must be acceptable to patients on a number of levels, some of which were not previously taken into consideration by systems and innovators but are now regarded as a new quality paradigm. For instance, an analysis of 3,000 US hospitals[1] found that medical quality and patient survival rates have a negligible effect on overall patient satisfaction. The same goes for medical tests. Patients are looking for tests that are not only accurate and reliable, but also simple, accessible, and convenient. In many cases, they will refrain from a complicated invasive test, even if it means endangering their own life, but will be much more willing to take a non-invasive one, like a urine test, particularly if it can be carried out in the comfort of their own home.??

Gila: How has COVID-19 affected receptiveness to innovation in healthcare?

Michal: Ultimately, it created a huge backlog in almost every system-patient process, from doctors’ appointments to diagnostics and treatment. The use of home tests, digitalization, and other technology applications will lead to a new paradigm of healthcare delivery. We have all been impacted by COVID-19 in various ways, but I think the world has learnt three key things from the experience. First, the pandemic underlined the importance of preventative health and how crucial a healthy lifestyle is to our ability to cope with illnesses (as reflected?in increased demand for out-of-hospital services, home-testing, telemedicine, and medical apps). Secondly, we learned that, if the world’s greatest minds collaborate and focus their efforts, great things can be achieved for humanity. Lastly, patients and healthcare professionals now recognize that many healthcare services can be delivered remotely—as such, home-based tests are much more likely to be accepted and considered an advantage.

We learned that, if the world’s greatest minds collaborate and focus their efforts, great things can be achieved for humanity.

Gila: The COVID-19 crisis has raised awareness around health equity issues. What role do you think innovators should play in addressing health inequities?

Michal: COVID-19 proved once again that the world is a global village. It is not enough to address only a portion of the population, or just the needs of specific groups, since the implications of health issues extend beyond national borders. EARLY was founded on the belief that cancer screening is a right, not a privilege. In our ambitious plan to “Screen the World,” we strive to make our test available and accessible to all who need it.

Gila: What do you know now that you wish you had known when you were starting out as an innovator and entrepreneur?

Michal: One thing I have learned is that HealthTech is not so different from other industries. Since health innovation aims to improve or save lives, we innovators sometimes feel we can skip the basics of pitching to clients or investors—what it’s for, how it improves the current situation, who would want to use it, and why they would want to use it, assuming these are self-explanatory. However, this is not the case. Never be afraid of stating the obvious, since “obvious” is never an objective term, even when it comes to matters of life and death.

I have also learned that it is important to identify not only your customers but also the entities your product might affect. You need to consider the challenges of navigating through healthcare ecosystems and work backwards from the final sales stage, in order to design and develop your solution with a “future seeing” approach.

Gila: There are not many women in the world of entrepreneurs or in digital healthcare. Do you have any advice for other women wanting to work in innovation?

Never stop expanding your network of clever and experienced people from whom you can learn and by whom you can be challenged.

Michal: The best advice I can give anyone wanting to start working in innovation—especially women—is not to try and fit into a stereotype of what an entrepreneur should look, act, or sound like. Leadership takes many forms and people respond best to authenticity. They want to feel inspired, engaged, and involved. If they buy into what you’re saying, they will follow you and help you reach your goals. Lastly, never stop expanding your network of clever and experienced people from whom you can learn and by whom you can be challenged.

Michal Mark Danieli is CEO and founder of EARLY , and holds a PhD in Cell Biology & Immunology. Michal is an ex–senior researcher at Sheba Medical Center and has founded several startups in the health-cancer space.

[1] Cristobal Young, Xinxiang Chen, “Patients as consumers in the market for medicine: The halo effect of hospitality,” Social Forces, Volume 99 Issue 2, December 2020.

Disclaimer: The views and opinions expressed in this article are solely those of the author and guest contributor and do not reflect the views of McKinsey & Company.