Humidification Class II medical device designed to moisten air and control humidity

By meticulously reviewing the original product and approach, the Sunrise team was able to leverage learnings to develop an ergonomic solution that incorporated readily available, low-cost technologies that meet rigorous cybersecurity standards. This strategy directly addressed Pro2Health’s needs for affordability and user-friendliness.

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 […]

Navigate Key Risks to Bring Your Product Vision to Life Every new product comes with risks—are you prepared? Learn how to navigate the challenges of new product development with our whitepaper, “New Product Development: Managing the Risks”.

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.

The healthcare industry has been trending toward health monitoring in the home environment, and since COVID-19, this trend has significantly increased. Medical device manufacturers are experiencing many new opportunities and additional challenges in designing medical devices for a more diverse user population and less controlled use environment. In this Sunrise Labs podcast, Alex Therrien and Kelly Catale […]

The FDA reduced regulatory barriers for remote patient monitoring devices during the COVID-19 crisis.

A set of Bluetooth LE vulnerabilities, collectively known as SweynTooth, brought attention to some straightforward attack vectors.

Sunrise Labs has prepared an outline of the medical device business, development, and regulatory efforts required for the commercialization process.

Eric Soederberg discusses ways to invest in your company’s future and create a culture of continuous improvement. Building a company culture of continuous improvement and investing for the future sounds like an obvious recipe for success, but it is easier said than done. Eric Soederberg, CEO of Sunrise Labs, joined Tyler Kern on this episode of […]

Perhaps no state is more renowned for medicine than Massachusetts. The Commonwealth is host to leading hospitals, medical centers, and medical device companies that are maturing next-generation technologies. But Medtech enterprises large and small need representatives to ensure that innovations in the space can thrive. That’s where Brian Johnson comes in. He is President of the Massachusetts Medical […]