The Hippocratic Oath and its famous dictum, “First, do no harm” (primum non nocere), have been part of the medical world for centuries, a telling sign of medicine’s long-standing commitment to prioritizing the welfare of the patient.  But what it meant to “first, do no harm” back in the day when care was dictated almost […]

In emergency medicine, minutes matter. But behind every “rapid response” clinical innovation is years of disciplined systems thinking, engineering rigor, and regulatory foresight. One of the most complex challenges facing trauma care today isn’t treatment, it’s access. Plasma, a critical component in emergency transfusions, has traditionally been constrained by freezing, storage, transport logistics, and slow […]

There’s no longer a debate about AI having an impact on healthcare. While we’re still in the early stages of the AI revolution, it’s now the rare clinician or patient who has not encountered an FDA-approved AI solution for some aspect of medical care, such as interpreting MRI images or analyzing electro-cardiograms. The problem is […]

On November 6, Suntra MedTech Solutions President Bryan Gilpin joined Paul LaViolette, Managing Partner at SV Health Investors and former COO of Boston Scientific, for a fireside chat hosted by MassMEDIC. The discussion brought together decades of experience, sharp insights, and a shared commitment to shaping the next era of medtech innovation.

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 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.

At Sunrise Labs we are frequently tasked by clients to design and build — or rescue —medical imaging systems