Silicon Valley Approach to Medtech

Key Learnings From Beth’s Experience

• Clinicians, regulatory bodies, and commercial stakeholders may have different requirements. Address each of them early in the development process. Engage with key decision-makers as soon as feasible to ensure your product is commercially viable.

• FDA can be your best friend if you engage the right way. Consider them a part of your team. However, before approaching the agency, evaluate whether it’s a real necessity for your product. Your solution might be eligible for a simpler and more straightforward pathway. 

• Fundraising for startups requires persistence, building relationships with a wide range of investors early on, and having a clear narrative about your technology. Engage with prospective capital partners even if they typically invest in later stages. And don’t limit yourself to investors strictly within your niche.

The irony is, as Beth puts it, “Healthcare is the fifth least digitized industry globally, just ahead of mining, where we're still using shovels. This is an industry that impacts everyone and is the largest part of most nations’ GDP. It's a trillion-dollar-a-year industry, and we're just ahead of shovels.” 

This is why Beth Rogozinski ventured into the space from the pure-play technology arena. She began her career in Silicon Graphics at Silicon Valley, where, after being on the digital media and entertainment teams, she joined the Visual Workstations team where her work raised the stock price by over a third. She later joined the team that built the digital video editing suite that became Final Cut and sold to Apple. Her resume is quite long and impressive, but ultimately, she transitioned to healthcare, when her work at a startup made her realize, in her own words, that healthcare was broken. 

She says, “The healthcare system is really well-designed for acute care. If you had a heart attack, you could be airlifted to a hospital, treated, and quickly return to normal life. However, the system isn’t well designed for chronic conditions, which today cause 90% of all morbidity and mortality.” What struck Beth the most was that, despite these odds, even in 2024, healthcare remains one of the least digitized industries. Inspired by this, she launched her first health app on Zen meditation to treat depression. 

Thereafter, Beth started working on clinical validation for these types of software-based interventions. She later joined Pear Therapeutics as Chief Product Officer, where they developed the first FDA-cleared software called reSET for the treatment of substance and opioid use disorders. From there, Beth helped spin up Oncoustics and stepped into the CEO role in late 2019.

At Oncoustics, the focus of Beth’s team is on chronic disease management using machine learning (ML) to analyze raw sound data from ultrasound devices, creating tissue acoustic biomarkers for early diagnosis and better management.

Currently, the startup is developing the OnX Liver Assessment Solution and is prioritizing liver disease due to its high prevalence and inadequate early diagnosis methods. Conditions like non-alcoholic fatty liver disease (now Metabolic Associated Steatotic Liver Disease, MASLD) are increasing globally, with up to 46% of the U.S. population potentially affected. 

Preventive diagnostics for liver disease are typically complex and invasive. Oncoustics simplifies this with a quick, painless, five-minute in-office test. Their liver assessment solution is pending FDA approval, and Beth envisions it becoming a standard in primary care settings, starting with hepatologists and endocrinologists.