Is Breakthrough Device Designation actually a breakthrough for device innovators, investors, and patients? Does the program expedite timely access to the US market, reduce investor capital risk and increase investor confidence, and elevate brand value for your medical device or portfolio? Should you pursue Breakthrough designation for your medical device or stay course with a traditional regulatory pathway? In this session, MedTech innovators, investors, and former regulators will provide you guidance on whether the Breakthrough Device Program will bring value to your device or portfolio investment based on their experience in the program, industry research, and novel insights from the 95 devices that have obtained FDA market authorization to date. 

The Early-Stage Capital Panel will explore the best practices or tips for improving access to early institutional financing. What are the common mistakes? Is partnering with a Strategic early on viable? The panel will feature perspectives from entrepreneurs, venture capitalists, and strategics.

While the med tech IPO market has been dormant for the past 30 months, the sentiment of both investors and companies is changing. There are 40 plus private high growth med tech companies with the financial profile to consider an IPO path over the next 12 to 18 months. The same profile that qualifies these companies for IPO also makes them attractive acquisition targets ($50+M of sales, high growth, high margins). This panel will dive into the board room and discuss the decision making process of IPO, M&A or dual-path. We also have the opportunity to hear from one of the leading strategic consolidators in the med tech space on their views of the med tech landscape and implications of an open IPO window

A strong foundation of clinical evidence is integral to commercial success, enabling a company to secure regulatory clearance, support reimbursement, drive physician adoption, and create a durable competitive advantage. This panel explores what it takes to establish a novel technology as the new standard-of-care, with focus on strategies for clinical trial design, execution, and data analysis/communication, as well as the resilience and adaptability needed when plans go awry.

The panel offers a deep dive into the symbiotic relationship between software and hardware within the healthcare industry. From wearable devices to diagnostic tools, this intersection is reshaping patient care, treatment paradigms, and healthcare delivery. We will explore the transformative potential of this convergence and its implications for patient outcomes.