How Data is Transforming Medtech

Let’s start with some not-so-fun statistics: one in eight men faces a lifetime risk of developing prostate cancer and over 68% of the prostate tumour volume is invisible to MRI. Receiving a cancer diagnosis is already difficult to come to terms with, but the next step — choosing the right treatment – is also fraught with challenges. It’s not uncommon for a clinician to send a patient home with a booklet of 20 different treatment options to discuss at a later date. 

This confusing and overwhelming process was Shyam’s starting point.

Driven by a vision to improve personalized treatment for prostate cancer, Shyam founded Avenda Health. Their team is at the forefront of transforming how we spot and treat prostate cancer by providing practitioners with advanced, AI-powered detection and prediction tools. In Shyam’s own words: "Avenda Health, quite simply, is all about building the next generation in personalized cancer care."

Not only is the developing technology intriguing, but it’s also promising for those who face the risk of prostate cancer. 

What about the person behind the company? Shyam started his journey as an academic. He holds a BSc in Computer Engineering and Japanese from UC Santa Barbara, and a MSc and PhD in Biomedical Engineering from UCLA. During his postdoctoral tenure at UCLA's Department of Surgery, he worked closely with Dr. Erik Dutson to refine minimally invasive surgical techniques.

Shyam also served as the program manager for the UCLA Business of Science Center. Members were responsible for creating and sustaining initiatives that engage and inspire students to pursue non-academic careers. He was also involved in founding and directing the UCLA Innovation Week and the Inventathon, a 24-hour healthcare competition.

Although he focused on prostate cancer in his PhD, he knew that identifying a problem is only the starting point. Once he honed in on the issue, he interviewed around 20 people every week over the span of a few months to get a comprehensive understanding. “Talking to other people and getting different perspectives really opened up my mind from my narrow world,” he humbly shares. 

Avenda Health was founded based on the following clinical dilemma: patients dealing with prostate cancer have an overwhelming number of treatment options, but insufficient data to make informed decisions. 

While at UCLA, Shyam and his team pioneered a method that merged MRI data with real-time ultrasound, which offered patients clearer, more detailed information on the localization of their prostate cancer. It was a seemingly small leap in image-guided diagnosis, but it completely changed the diagnosis process. It became not only a standard of care but also the cornerstone upon which Avenda Health was built. 

”Going from a needle poke randomly in the body to something that is a bit more image-guided and a little more precise totally changed our world in terms of how much information we're able to extract through images and diagnostics,” says Shyam.

With Avenda, Shyam took his seminal work several steps further by integrating artificial intelligence to map prostate cancer more accurately. He describes the technology as a way to fill in the missing pieces of a jigsaw puzzle. Conventional diagnostic methods often offer only partial information about the cancer, letting you see a fragment of a bigger picture. Avenda's technology consolidates these fragments — MRI scans, ultrasound images, clinical markers — and uses AI to create a comprehensive, accurate map of the cancer.

Their AI platform, Unfold AI, is a decision-support platform, which aims to provide a more accurate depiction of a cancer’s margins and its extension within the prostate. It helps doctors spare as much healthy tissue as possible while minimizing the risk of leaving cancer behind — a task that is particularly difficult due to the limitations of current imaging techniques. Avenda Health reports that Unfold AI has shown clinical promise with a 97% sensitivity rate at cancer detection, and it has led to a 28% change in treatment recommendations among urologists.

Six years into its journey, Avenda has secured two FDA clearances, a Breakthrough Device Designation, and has completed four clinical studies. Currently, it’s in the commercialization stage. 

The implications are staggering. With this technology, Avenda is poised to dramatically improve not only the diagnosis but also the treatment outcomes for prostate cancer patients. This shift towards highly personalized, data-driven decision-making can set a precedent not just in prostate cancer treatment but potentially in the entire oncology field, paving the way for a future where personalized cancer care is not a luxury but a standard.

Key Learnings From Shyam’s Experience

• Go deep, not just broad. Identifying a market need is only the beginning of an exhaustive investigative process. You must dive deeper to comprehend the root causes of the issue. Proceed to build a prototype only after you comprehensively understand the problem and seek mentorship proactively every step of the way.
• Don’t overcrowd your board. Fundraising in medtech requires a mix of politics, strategy, and clinical understanding. Be prepared to turn down offers that dilute your mission. And remember: it is a numbers game, meaning, expect to do hundreds of pitches before you secure the capital you need.
• ‍Cross disciplinary functions to adapt adjacent technologies. Look for ways to synthesize advancements in other fields, such as information technology, into your product. Putting the patient at the center of your mission allows you to identify how tools from adjacent disciplines can improve your product.

Accelerate Your Progress With Prototypes

Recognizing an unmet clinical need in healthcare is table stakes; digging beyond surface level is critical. "Just because you've observed a problem, you don't necessarily know at first if it's a widespread problem or if it's associated with technology, clinical workflow, or reimbursement," Shyam candidly shares. “The wrong decision has a huge burden on both the patient and the healthcare system.” 

He took nothing for granted when he decided to tackle prostate cancer diagnosis and treatment. Thanks to a PhD related to the topic, Shyam was already an expert on the issue. Yet, this didn’t stop him from interviewing around 20 people a week for almost two months. Thanks to his determined yet humble attitude, Shyam was able to truly identify all the facets of the problem. 

Identifying and deciphering market needs is the first step. The next step is action: getting your prototype in the hands of end users. This is the best way to discover areas for improvement, while at the same time, showing potential partners that your idea is implementable and worth developing further.

Unfortunately, the medtech industry is notorious for long timelines due to regulations and the nature of clinical trials. "Getting a prototype out is really, really important," states Shyam. “Clinical trials take a long time and a lot of capital, but it's really cheap and really easy to come up with a representative prototype,” reiterates Shyam. A tangible prototype can fast-track getting other parties on board and moving towards your next milestones.

An intriguing aspect of Shyam's leadership is his preference to tackle challenges in-house before seeking external expertise. For instance, Avenda conducts the initial clinical trials either internally or through a university partner. The primary benefits are better control of the process and stronger relationships with clinical trial sites.

The last advice Shyam has for entrepreneurs interested in a similar path is to value mentorship and proactively seek it. Medtech isn’t an exclusive community in that regard. Shyam says, “Everyone is willing to share because we understand the challenges."

So, leverage every experienced perspective to better understand what you’re grappling with. Every road has obstacles, and mentors can help you sidestep them on your way from concept to market.

Turning Ideas Into Capital

It's one thing to come up with an extraordinary idea that’ll bring relief to patients and alleviate healthcare bottlenecks. But it’s quite another to maneuver through reimbursement, regulation, and fundraising. 

Despite the inherent challenges, Shyam has managed to raise a remarkable amount of capital — almost $15 million. But this milestone didn't come without a host of lessons and challenges. Shyam recalls, "We were fortunate at the beginning to have a really strong group of investors that were tied to UCLA. They were basically our angels." They supplied funds as well as a foundational network and support system for Avenda Health, allowing Shyam and his team to forge their own path forward.

Shyam points out another intricate aspect of the industry: reimbursement. He shares that reimbursement was the most complicated process they encountered for a variety of reasons: It’s “a mix of politics, strategy, and clinical." When you create a device that’s novel, you have to figure out how to relate it to the public too. Unlike FDA guidelines, information on reimbursement isn't readily available; and your path depends on your clinical perfection, regulatory adherence, and even your company’s credibility in the sector. This is where the support you get from partners and investors proves invaluable.

Shyam’s overarching advice to entrepreneurs is to partner up with investors whose vision, mission, and experiences align with the project’s long-term goals. In Avenda’s case, the stakes are even higher as they are pursuing a Breakthrough Device Designation from the FDA, which makes the processes even more nuanced. 

However, Shyam makes it clear that maintaining board control, especially in the early stages, is critical. Turning down certain investors can be a strategic move to ensure the vision of the project stays intact. It gives the company room to grow and evolve without being encumbered by external pressures that may derail its original mission. In his own words, "It's not a tradition, but it seems like every time we've gone out and raised a round, we've had to painfully say no to a term sheet in order to maintain control." 

Perhaps one of the most transparent lessons from Shyam's journey is that the investor hunt is a numbers game. He candidly admits, "You just had to talk to a lot of people. I think we may have talked to 400 to 500 people.”

Innovating in the Information Age

Perhaps one of the most important virtues of an entrepreneur, especially in medtech, is having knowledge in different domains and being able to synthesize it to design a coherent, patient-focused strategy. Avenda, for instance, harnessed the power of AI by aggregating multiple forms of patient-specific data —MRI scans, PSA levels, biopsy, and pathology reports — and then applying AI algorithms to generate a personalized “3D Cancer Estimation Map.”

This 3D map serves as a decision support platform. It provides a comprehensive view of how far the cancer has spread within the prostate, thereby giving doctors and patients more accurate data to make better-informed decisions regarding treatment options.

AI can mean a lot of different things — the buzzword is often surrounded by ambiguity. Its full potential unfolds even as we speak. But what's important about it, according to Shyam, is that it illuminates the incredible value of data. 

Shyam believes that the road to medical device innovation is paved with devices that "learn, adapt, modify, improve over time." This suggests a new model for companies in the field, a model that regards AI not as the cherry on top but as a cornerstone. In his words, "You have to be an AI company in order to be a new medtech company." According to Shyam, data management and AI must be integral to any healthcare technology operation.

The medical device industry often progresses at a slow pace — especially when you compare it to the rapid speed of Silicon Valley. According to Shyam, there's much to learn from the latter to move at a higher pace and more efficiently. You can take this as a cue to keep an eye on tech trends and absorb what's applicable.

Lastly, for Shyam, the linchpin that holds everything together is the focus on the patient. "Always keep the patient in mind, always think about the patient because it's all about outcomes," he insists. This patient-centered approach not only serves as an ethical anchor but also as a strategic one. After all, the true merit of any technology lies in its utility and impact on human lives. 

In closing, he leaves us with one of the most time-tested pieces of advice, "Be patient. Good things take time."