Bringing a new product to market is an exciting journey—but one filled with risks that can derail even the best-laid plans. In our latest blog, Navigating the Product Development Maze: The Essential Role of Risk Management, we explore how proactive risk management helps teams stay focused, informed, and aligned at every stage of development. Learn how setting clear goals, evaluating multiple concepts, and building a flexible project plan can drive your product’s success. For an in-depth guide to mastering each phase, download our whitepaper, New Product Development: Managing the Risks.

The landscape of medical device cybersecurity has officially changed. The transition from a framework based on “shoulds” to one defined by “musts” has raised the bar for regulatory compliance, security rigor, and patient safety. The FDA’s updated guidance on cybersecurity in medical devices. At Sunrise Labs, we are proud to announce that our Secure Product […]

In the rapidly evolving landscape of medical device development, risk management is a fundamental process that ensures patient safety and regulatory compliance. An effective risk management strategy not only identifies potential hazards early but also streamlines development by reducing costly redesigns and regulatory hurdles. Understanding Risk Management Risk management, as defined by ISO 14971, is […]

Bringing a new medical device to market is a complex and high-stakes endeavor. Companies face numerous challenges, from securing funding and managing product development to navigating stringent regulatory requirements. Success requires a strategic approach, combining innovation with disciplined execution. 1. Identifying the Right Problem to Solve One of the biggest factors in MedTech success is […]

Developing safety-critical medical devices is a complex process that requires careful planning, rigorous testing, and cross-functional collaboration. The stakes are high—not only because of regulatory and market risks but also because patient safety depends on every design decision. Below, we explore key strategies that can help ensure the success of safety-critical medical device development. Understanding […]

The future of healthcare is being shaped by incredible advancements in medical device product development. From wearable monitoring devices to cutting-edge diagnostic tools, innovation is revolutionizing the way we approach healthcare. These developments are enabling personalized medicine, enhancing patient outcomes, and improving the efficiency of healthcare delivery. In this article, we will explore the latest […]

In the rapidly evolving landscape of software development, Continuous Integration and Continuous Deployment (CI/CD) have emerged as pivotal practices, especially within the medical device industry. These methodologies are not just buzzwords; they are revolutionizing the way we approach medical device development, offering a beacon of efficiency and reliability in a sector where precision and quality are non-negotiable.

Teams who develop medical products must develop a deep understanding of the underlying physiology as well as the use and misuse challenges related

The medical device development process goes through five phases and comprises various steps and procedures to ensure the safety and efficacy of the device.

Design Verification of Medical Devices can be overwhelming. One of the simplest, most effective techniques is just to have someone else check your work.

Some challenges and considerations related to product architectures that might include Machine Learning

Before you design a new digital application, you must consider how the physical screen it will be displayed on affects the experience