The Complaint: A Medical Device Manufacturer Challenged the Validity of Patents Covering Cardiovascular Delivery Systems

In an IPR proceeding before the PTAB, a medical device manufacturer challenged the validity of several patents owned by a medical technology company. These patents covered catheter-based delivery systems for replacing heart valves without open-heart surgery. Designed to be minimally invasive, the systems also featured unique mechanisms for recapturing and repositioning valves during procedures. The petitioner argued that the claimed innovations were either obvious or anticipated by prior art in the field of transcatheter aortic valve replacement (TAVR) technology.

The Ask: An Expert in Catheter-Based Cardiovascular Systems with Patent Litigation Experience

The patent owner approached WIT to provide a medical device expert with extensive expertise in cardiovascular medical devices, specifically catheter-based delivery systems and heart valve technologies. The expert should possess a strong understanding of fluid mechanics, minimally invasive surgical techniques, and experience with medical device development and FDA regulatory processes. Ideally, the expert should hold a PhD in biomedical engineering, mechanical engineering, or a related field. Prior experience testifying in IPR proceedings and the ability to clearly communicate complex technical concepts were also key requirements.

How WIT Was Able to Meet the Expert Need

In anticipation of an influx of patent disputes regarding medical devices, WIT actively recruited a diverse group of leading experts to support our clients in medical device litigation. For this case, WIT recommended an expert with a Ph.D. in biomedical engineering and over 30 years of experience in medical device research and innovation. The expert’s career highlights include serving as CTO of a startup specializing in structural heart and TAVR technology and Vice President of Applied Research at a major medical device company, where he led the development of cardiovascular advancements. His expertise spans fluid mechanics, hemodynamics, and minimally invasive delivery systems. He holds an impressive patent portfolio with over 40 issued U.S. patents and more than 60 pending applications in related fields. The expert’s extensive contributions to cardiovascular device innovation, combined with his experience leading R&D teams and developing groundbreaking TAVR-related technologies, positioned him to provide valuable insights into the technical aspects of the disputed patents.

How WIT’s Experts Can Assist in Medical Device Disputes

At WIT, we focus on industries with increased risk of litigation and build expert teams comprised of world-class academics, industry executives, and former government regulators. Our medical devices expert team assists counsel on a range of medical device matters concerning issues involving product design, manufacturing processes, regulatory compliance, market dynamics, and intellectual property disputes.

Contact us to learn more about WIT’s medical device experts and our expert teams across other life sciences and technology sectors.

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