What does quality really mean in the medical device industry?

In this episode, Mark McCarthy sits down with Mark Dykowski, Head of Quality at Resolution Medical, to discuss how quality systems, regulatory standards, and continuous improvement shape the development and manufacturing of complex medical devices.

With nearly 20 years of experience in the medtech industry, Mark shares how Resolution Medical approaches quality through transparency, authenticity, innovation, and integrity. The conversation explores how regulatory standards guide operations, how technology supports quality management, and how customer feedback and risk assessment drive continuous improvement.

From certifications and quality management systems to validation, testing, and risk mitigation strategies, this discussion offers a behind-the-scenes look at how quality is built into every stage of medical device development and manufacturing.

In this episode of Pursuing the Pulse, host Mark McCarthy is joined by Alex Gustafson, Director of Product Development, and Kelly Szczeck, VP of Product Development & PMO at Resolution Medical, for a deep dive into the Development phase of medical device innovation.

Alex and Kelly discuss how Resolution Medical designs and develops complex catheters and active implantable devices while balancing technical challenges with cost, quality, and timelines. They explore how iterative testing, simulated use models, and early clinical insight help teams learn faster, reduce risk, and make better design decisions.

The conversation also covers key industry trends shaping the future of active implantables, including miniaturization, power efficiency, AI, closed-loop stimulation, and brain-computer interfaces. You’ll hear how evolving regulatory expectations influence development strategies and how early planning and transparency help programs succeed.

Whether you’re navigating early development or scaling advanced implantable technologies, this episode offers practical insight into how strong engineering, collaboration, and clarity drive successful outcomes.

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In this episode of Pursuing the Pulse, host Mark McCarthy sits down with Kate Radzwell and Aaron Opbroek from the Concept Development team at Resolution Medical to explore how early-stage ideas become functional, testable prototypes.

Kate & Aaron discuss the wide range of customers they work with, from universities and early-stage startups to global medtech companies, and break down what the prototyping process really looks like. They share how their team uses brainstorming, rapid iteration, and in-house materials to accelerate prototype timelines, avoid unnecessary cost, and create devices that meet key performance goals.

Whether you're in R&D, product development, or early-stage innovation, this episode offers valuable insights into how concept development drives medtech forward.