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When the Abbott MitraClip system was created, the world saw what was possible in repairing leaky mitral valves (mitral regurgitation). Building upon the proven success of MitraClip, a team of researchers, scientists and doctors specifically designed TriClip to treat the tricuspid valve’s complex anatomy on the other side of the heart. Hear how harnessing the experience and technology from one solution led to developing a device for a condition that can severely impact quality of life — but for which limited treatment options existed.
Upcoming regulatory changes and quality issues—PFAS, EtO sterilization, QMSR changes, LDTs, and cybersecurity requirements—will require large-scale remediation of your on-market products. In this session, you will learn effective strategies to manage and streamline your remediation program and to navigate complex business decisions that span multiple functions to ensure cohesive planning and successful compliance outcomes.
As the medical device industry becomes increasingly connected, robust cybersecurity is no longer optional—it’s critical for market approval and patient safety. This session unveils the insider knowledge gained from Blue Goat Cyber’s extensive work with hundreds of premarket submissions. Attendees will explore the most pressing cybersecurity challenges medical device manufacturers face and walk away with actionable strategies to strengthen their devices’ security posture. From navigating complex regulatory landscapes to managing vulnerabilities and supply chain risks, this presentation offers a clear roadmap to mastering cybersecurity for successful market entry.
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In the rapidly evolving landscape of medical devices, the more novel the applications become, the more creative we must be from a design, development, and testing perspective. For example, when developing complex catheters for robotic surgery, how do you approach design verification when the interventionalist is one step away from the catheter? During this engineering theater presentation, Kate Soojian, VitalPath Senior R&D Manager, will explore the unique challenges that engineers are facing on these next generation device projects and how to use an innovative problem-solving approach to ensure project success.
Sponsored By
It’s no secret that technology reaches the masses when it is miniaturized to become smaller and more scalable. Could the same finally be true for soft tissue surgical robotics? In this session, John Murphy will share how Virtual Incision plans to leverage their MIRA Surgical System to bring RAS to any patient, anytime, anywhere.
Defining success can be variable for medical device companies, but once understood, and for all innovations, there are waypoints and markers where companies must consider and find best practices and protect their onward pathways. This panel will highlight some of the key points where medical device pioneers and even those established in the industry must understand the lay of the land and how to move forward including when to consult outside experts and on what topics. Our diverse panel of speakers include industry experts and attorneys who have first hand experience with intellectual property (when and how to protect), regulatory, legal (including understanding the relationship between process and potential liability risks) and commercial/financial. This panel will also highlight this using examples about how artificial intelligence and other aspects of the industry have changed and continue to change at warp speed.
In this presentation, Mary Beth Kossuth will discuss the latest innovations in bioresorbable technology. She will also share insights and lessons learned from the multi-year development and approval process for a first-of-its-kind system for treating an unmet need in the peripheral anatomy. By attending this session, you will:
Better understand the latest innovations in bioresorbable technology.
Learn about the benefits of bioresorbable stents for addressing unmet patient needs, especially in the peripheral anatomy.
Gain insights gleaned from a multi-year development and approval process for a first-of-its-kind medical device system.
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For registration or logistic questions, contact events@wtwhmedia.com
Colleen Sepich
Events Sales Director
csepich@wtwhmedia.com
857-260-1360
Heather Herbert
Event Sales Manager
hherbert@wtwhmedia.com
512-760-0570