About the Guest
Deanna Harshbarger is the CEO of Cala Health, developer of the Cala kIQ® System, a prescription wearable therapy for action hand tremor. She holds a degree in chemical engineering and brings more than 20 years of commercial medtech experience to Cala. Before joining the company, she held senior leadership roles at Johnson & Johnson, Boston Scientific, and Medtronic, and helped develop and commercialize technologies across interventional cardiology, neuromodulation, and diabetes care.
Interview Summary
After more than two decades in medical devices at both strategics and startups, Deanna joined Cala in 2021 to lead product, medical affairs, and customer success before becoming CEO in 2024, as the company prepared to commercialize a new category of at-home therapy.
When Cala entered the market, treatment options for tremor were largely limited to pharmacological therapies or invasive procedures. The FDA-cleared Cala kIQ® System with TAPS® Therapy delivers transcutaneous afferent patterned stimulation therapy for action hand tremor associated with essential tremor and Parkinson's disease, using personalized peripheral nerve stimulation that patients can administer independently at home.
Cala TAPS® Therapy is clinically validated, with more than 2,000 patients studied across clinical studies, has secured Medicare coverage in 2024, closed an oversubscribed $50 million financing later that year, received FDA clearance for the next-generation Cala kIQ® Plus system in 2026, and added a separate $50 million growth capital facility from Trinity Capital to support commercial expansion.
Top Takeaways
Build an operating system that scales decision-making. As startups grow, CEOs become the bottleneck when every decision requires executive involvement. Create shared operating principles that help teams make sound decisions independently: financial literacy, transparency, patient-centric thinking, and a bias toward acting on the best available data instead of waiting for certainty.
Design your evidence strategy by looking around the corner. Build evidence sequentially so each study reduces the uncertainty of the next. Use feasibility studies to establish trend lines, confirm the mechanism, and enter a Randomized Controlled Trial (RCT) only when the earlier evidence tells you what outcome to expect. Continue generating real-world evidence after launch to strengthen physician confidence, advocacy, and reimbursement. With limited resources, prioritize studies that deepen today's indication while reserving capital to explore future options.
Make patient experience part of the design process. When developing patient-operated therapies, bring the entire product team as close as possible to end-users and study every step of how the device works, from setup and training to everyday application. Put early versions into patients' hands, learn from how they use it, and refine the product before a large RCT or full commercial launch. Making therapy easier for patients also makes it easier for physicians to prescribe and support confidently.
Raising capital is both a sprint and a marathon. Investors should understand both your next inflection points and your long-term vision. Build financial models around defensible assumptions, demonstrate your ability to execute, and choose investors whose expectations align with your company's objectives. Alignment established during fundraising becomes most valuable when difficult operating decisions inevitably arise.
Sponsors
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