In this episode of MedTech Smarts with Rita, regulatory strategist Rita King breaks down what it means to operate as a true medical device company, beyond just building a product. She explains how understanding FDA definitions, designing with compliance in mind, and aligning your marketing language can help founders move faster, gain investor confidence, and build lasting credibility in the MedTech space.

On this episode of MedTech Smarts with Rita, Anna Crooke, Rita King, and Shavini Fernando dive into the realities of bringing a medical device to market. Drawing on Shavini’s journey with OxiWear, a pioneering pulse oximeter, the conversation explores the hurdles of FDA submissions, the pressure of investor expectations, and why early collaboration is critical. The discussion highlights how transparency, strategic planning, and strong partnerships between founders, investors, and regulatory experts are essential to turning innovation into lasting success in the medical device industry.

This week on MedTech Smarts with Rita, the panel tackles today’s toughest funding challenges in MedTech, from shrinking venture capital to limited grants and the impact on commercialization timelines. Special guest Nikin Shah reveals how creative lending and strategic partnerships offer fresh pathways for growth, while experts Rita and Richard share actionable insights for leveraging regulatory planning as a business asset. The episode spotlights tools like LuminLogic, showing how robust compliance systems can boost investor confidence and accelerate execution. Whether you're a founder or investor, this discussion delivers strategies for navigating the capital crunch and building scalable, resilient MedTech companies.