Maximize Market Opportunity, Minimize Feedback Loops
Interview with SAVA Co-founders Renato Circi and Rafaël Michali
Key Learnings From Rafaël & Renato’s Experience
Bringing a medical device to clinical trials, let alone commercializing them, is a massive challenge. You need a large enough market to justify the investment. Once you have an idea, leverage resources to iterate quickly and cost-effectively, and prove core functionality to win over investors and partners.
During the early development phase, staying under the radar helps shield you from external pressures and allows you to focus on proving your core functionalities. On the other hand, going public increases awareness of your company. A good time to exit stealth mode is when you reach a predictable development path, where major scientific risks are addressed and the technology is proven.
Don’t choose the easy route to market. Aim to address multiple use cases and market segments like SAVA is doing with its micro sensor platform technology. Seize the opportunity, even if it means navigating stricter regulatory requirements and securing more funding – as long as you're solving a clear gap that is disruptive in nature.
Rafaël Michali and Renato Circi met around ten years ago as biomedical engineering students at Imperial College London. With a shared passion for novel technologies, entrepreneurship and preventative healthcare, they began exploring innovative and less invasive techniques to learn more about the human body, eventually co-founding SAVA.
“The future of health is going to be preventative,” says Renato, and continues, “There's a lot that we can improve with information we can extract from the wearable movement.” At SAVA, Rafaël and Renato have developed a minimally invasive biosensing platform that analyzes molecules in the interstitial fluid, just under the skin. This aims to decentralize healthcare by providing users with real-time information about what is happening within their body, empowering users with their own health data accessible directly from a phone.
Wearable tech devices that collect health data aren’t new to the consumer market. We’ve seen products like Apple Watch, Fitbit, Garmin, or Oura Ring collecting bodily data and offering insight into health and wellbeing. However, “These are built for only peripheral metrics like heart rate, sleep, and basic activities. But the next dimension is molecules that flow inside your body. That's where things become very, very exciting,” Renato says.
At SAVA, the biosensor’s capabilities begin with blood sugar levels, for which continuous glucose monitoring (CGM) devices already exist. However, traditional CGMs don’t provide a user-friendly experience and can be uncomfortable due to the needle insertion process with occasional bleeding. They are also expensive – around $50 for a two-week use. What SAVA offers is a biosensor functionalized with tiny microsensors that are much smaller than the standard filament needle and sit just under the skin. This means no nerve endings and capillaries are touched, so the application process is painless and wear is much more comfortable. They also aim to cut the cost by a factor of ten versus current devices, making CGMs more accessible to those with diabetes or at risk.
Currently, the SAVA team is focused on developing this next generation microsensing platform for diabetes management. They've recently secured MHRA clearance to initiate clinical studies in Europe, specifically in the UK, to evaluate the platform's performance against existing CGMs. Rafaël and Renato expect to release initial clinical data by the end of 2024, and validate the platform’s value proposition.
Looking beyond just glucose, the biosensor has been built to monitor multiple molecules simultaneously within the body to provide a holistic view of a user’s health that has never before been possible in real-time with a wearable device. The opportunities are endless, including monitoring lactate, ketones, sodium, cholesterol, histamines, urea, or alcohol levels. This ushers in a new era of preventative healthcare.
Guest
Rafaël Michali and Renato Circi
Co-founders of SAVA
Rafaël Michali and Renato Circi, co-founders of SAVA, are biomedical engineers from Imperial College London. Both recognized in the Forbes 30 Under 30 list as some of Europe’s most promising young innovators in 2018, the duo raised $13M in funding and built a cross-functional team of now over 40 to develop a next-generation biosensing platform. Together, they built a thesis surrounding preventative health, from which SAVA was formed: redefining healthcare into a system that is accessible, personalized, and preventative.
Sponsor Message
We recently released the seventh volume of Medsider Mentors, which summarizes key learnings from the most popular Medsider interviews over the last six months.
We get it—keeping up with every Medsider interview isn’t easy. That’s why we created Medsider Mentors. These e-book volumes distill the best practices and insider secrets from top founders and CEOs, all in a downloadable, easy-to-digest format.
Check out the latest volume here. Premium members get free access to all past and future volumes, plus a treasure trove of other resources.
If you’re not a premium member yet, you should definitely consider signing up. We recently revamped Medsider with swanky new features, especially for our premium members. In addition to every volume of Medsider Mentors, you’ll get full access to our entire interview library, dating back to 2010.
You’ll also get Medsider Playbooks—curated guides packed with actionable insights on topics like fundraising, regulatory challenges, reimbursement strategies, and more.
And if you’re fundraising, don’t miss our exclusive investor database, featuring over 750 life science VCs, family offices, and angels. We’ve even created 3 custom packages to help you with your next fundraise.
Learn more by visiting Medsider Mentors.
Make Sure the Juice Is Worth the Squeeze
In medtech, developing a product that can enter clinical trials or full-scale market launch requires not just significant financial outlay but also a long-term commitment – easily spanning nearly a fifth of one's career, even under the best circumstances of a "fast" return.
That’s why the market's capacity and potential to sustain the investment is paramount. "When we started, we were comparing idea booklets. We had 20 or 30 ideas each, some in medtech, some in the consumer space," Rafaël explains. They ultimately chose a crossover between medtech and consumer health. "For the more challenging ideas, we thought, ‘Okay, this has to be able to revolutionize the way everyone interacts with their health. Otherwise, it's not really worth it.'" In other words, they knew that they needed a market that’s large enough to justify the venture-level investment.
What the SAVA team did to ensure their device would be viable was to address three key pain points over existing CGMs: improved user experience, lower costs, and multi-molecular monitoring beyond just glucose. This way, SAVA can truly transform wearable biosensing.
Once you decide to go down a certain road, you have to find ways to do more with less. This includes being as resourceful and scrappy as possible. This also means actively seeking help, leveraging existing resources, and exploring every possible avenue with the goal in mind to stretch every dollar and use what is readily available to your advantage.
A medical device often stands out because of a few key features. Renato suggests asking yourself, “What is the critical thing that you have to demonstrate to have people believe in your idea? When you start painting the picture about what is truly unique about your product, you can distill it to a core few things, and that's the only thing that you have to focus on.” In many cases, you don’t have to demonstrate every feature – especially with an MVP. A common pitfall is over-diversifying your efforts, such as investing heavily in peripheral aspects like a sophisticated app, before the main features are fully developed.
Rafaël acknowledges that certain medical device classes, like stents, face stringent guardrails. However, there are still ways to adopt faster iteration processes. For instance, as a company developing a Class II medical device in both the U.S. and Europe, SAVA optimized development speed by co-locating cross-functional teams within a single building. Housing researchers, material scientists, and engineers together shortened their iteration cycles significantly. “You can literally go from one floor to the other and just close that iteration loop,” Rafaël says.
Finally, while developing your key functionality, Rafaël and Renato emphasize that you shouldn’t neglect the data aspect. Hard evidence is a must for proof of concept. Ultimately, you’re trying to show that you can achieve what others have questioned or failed to do.
The Right Time to Exit Stealth Mode
Rafaël and Renato built SAVA in stealth mode for five years because, as they put it, "Once you go public, the expectations become much more concrete, and in the early stages of science, it’s tough to be precise about those expectations. That’s just the nature of creating something that’s never been done before."
According to them, the timing of a medtech company's public debut should be planned strategically. During the initial development phase, keeping a low profile keeps external pressures at bay, letting you focus on proving your core technology. On the other hand, going public raises awareness of your company – you can’t really run a marketing strategy in stealth mode.
For Renato and Rafaël, there's a crucial moment when a company shifts its focus from R&D to commercialization. That’s also when you reach a clear, predictable path in the project's development, where major scientific risks are mitigated, and the technology has been de-risked. This is when it’s easier to manage stakeholder expectations, compared to the initial R&D phase where you’re working on proof of concept. “We chose a moment to come out of stealth when our route to market and to launch is on a linear path more than it has ever been,” Renato shares.
Having said that, even if you choose to operate in stealth during the development phase, you shouldn’t isolate your company from your key stakeholders. “Being in stealth does not mean that you're not speaking with people. It's just that you're not shouting on a microphone” says Renato. It’s vital that early-stage backers and the core team are aligned on the long-term vision and the challenges involved. Active communication with key stakeholders – end users, market participants, and investors – is critical. However, the nature of your project should determine how discreet you should be. Most of the time, focusing on gathering feedback without widely broadcasting project details is a good idea.
The Opportunity Justifies Your Clinical Pathway
For Renato and Rafaël, if one wants to build a platform capable of disrupting various industries, exceptional performance is non-negotiable. In SAVA’s target CGM market, which is its initial indication, there are a few benchmark products, like Abbott’s FreeStyle Libre and Dexcom. “We have to show that our novel approach reaches those performance standards, so that we can, then, capture other use cases from there instead of doing it the other way around.”
The easy route would be launching an OTC device with similar or slightly improved features. But the co-founders have ambitious aspirations beyond this single market. “Ultimately, our goal is to create a platform that can transform every conceivable use case and disrupt healthcare monitoring in general,” explains Renato. The goal is to build a comprehensive healthcare monitoring platform that can cover a range of use cases – from chronic medical conditions to general wellness and performance optimization.
To achieve and surpass current industry standards, SAVA committed to meeting rigorous regulatory requirements, such as obtaining clearance as a Class II device – the class for those that have moderate to high risk to the patient and/or user. This involves collecting a significant number of data points to demonstrate efficacy and accuracy.
The rationale behind their decision to cover every imaginable use case with their biosensor is the significant potential they see in the market. “If you're building something so complicated, the end goal has to be a massive opportunity,” says Renato. With these endpoints, the SAVA team is aiming to disrupt multiple aspects of healthcare monitoring.
Sponsor Message
After raising over $40M from corporate venture and cardiovascular key opinion leaders, FastWave Medical has progressed rapidly in the development of its next-generation intravascular lithotripsy (IVL) systems for complex calcific disease.
The market size for IVL is over $9 billion and the only player in the space was recently acquired for over $13 billion. So naturally, there’s a lot of investor interest in FastWave.
Given the continued demand to invest in FastWave, their team has opened up an investor waitlist for anyone interested in potentially owning a piece of the company.
The last time the company opened up an private placement, it closed nearly $20 million in less than a month. So if you’re interested in investing in one of the hottest cardiovascular startups, opt into their investor waitlist here.
You May Like These Articles
Medsider Premium
Become a premium member and unlock access to exclusive Medsider benefits.