Building the Foundation Right: IEC 62304 for Medical Device Firmware Development

As medical devices increasingly incorporate digital interfaces and control systems, many development teams find themselves unexpectedly navigating software regulatory requirements. IEC 62304 provides a structured framework for developing safe, effective medical device firmware, but implementing it successfully requires strategic planning. Learn the key challenges in compliance, practical strategies for implementation, and how building the right foundation can turn regulatory requirements into a competitive advantage for your medical device development process.

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Product Creation Studio
Innovations at the Frontier: Highlights from UW WAFER 2025

UW's WAFER 2025 event highlighted remarkable research from women engineers across diverse disciplines. From Professor Choi's power conversion innovations to Professor Orsborn's co-adaptive brain-computer interfaces, Professor Luo's intelligent textiles, and Professor Jaques' human-aligned AI, these frontier technologies are converging to create unprecedented opportunities for corporate innovation.

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Product Creation Studio
Advancing Healthcare Through Innovation: PCS Co-Sponsors MedTech Track at LSINW 2025

Product Creation Studio is proud to announce our co-sponsorship with Triple Ring Technologies of the MedTech and Research Tools presentation track at the upcoming Life Science Innovation Northwest (LSINW) 2025. This premier life sciences conference brings together investors, researchers, entrepreneurs, and healthcare professionals to showcase groundbreaking technologies shaping the future of healthcare.

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Product Creation Studio
Innovation at the Intersection of Defense and Commercial Technologies: NATO DIANA Cohort Visit

We had the privilege of hosting a dynamic group of innovators as part of the NATO DIANA (Defence Innovation Accelerator for the North Atlantic) program. The visit, organized by the Pacific Northwest Mission Acceleration Center (PNW MAC), brought together six groundbreaking companies working on dual-use technologies that span both defense and commercial applications.

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Product Creation Studio
Complex Combination Products from Vision to Clinical Reality

Devices that incorporate a drug or biologic component present a unique set of challenges. They require a delicate orchestration of expertise, resources, and vision across multiple disciplines. At February's MD&M West 2025 in Anaheim, I joined Kristyn Aalto, CEO of Orlance Inc., to share our journey in developing the groundbreaking MACH-1™ system—a needle-free, pneumatic delivery platform for DNA and RNA vaccines.

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Scott Thielman
Robots at the Table: Dr. Taylor Kessler Faulkner’s Journey to Transformative Assistive Technology

At a recent Seattle AWIS event, Dr. Taylor Kessler Faulkner captivated an audience of healthcare and technology enthusiasts with her work on ADA, a robotic system designed to assist individuals with upper-extremity mobility impairments in one of the most basic but vital daily activities: eating.

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Scott Thielman
Beyond the Hype: Surprising Insights on AI in Product Development

While artificial intelligence continues to capture headlines, its true transformation of product development lies not in automation, but in the evolution of human-AI collaboration. Through candid insights shared by industry leaders at a recent Center Stage panel, we explore how successful organizations are moving beyond surface-level efficiency gains to forge deeper, more nuanced relationships with AI tools.

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Product Creation Studio