What recent FDA actions, device recalls, and enterprise breaches are telling medtech executives about the state of product security governance. On June 8, 2026, iRhythm discovered that a threat actor had gained unauthorized access to data maintained on third-party-hosted business applications. The following day, the company received a ransom demand threatening to release stolen proprietary […]

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 […]

Transforming Healthcare with Connected Medical Devices Discover how connected medical devices are revolutionizing patient care. Our whitepaper, Connected Medical Devices: Are You Connected?, delves into the integration of Bluetooth Low Energy (BLE), mobile apps, cloud platforms, and Artificial Intelligence (AI) / Machine Learning (ML) to enable real-time monitoring, secure data exchange, and personalized care. Learn […]

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”. For additional perspective beyond this risk-management whitepaper, explore The Keys to Medical Device Project Success. This related POV […]

A Systems Approach for efficient and compliant design and development of Medical Devices What are you trying to build? How will you define “success”? How will the product be used? Do you know how to test the product? How will the architecture be organized? What do you need for regulatory clearance or approval? This whitepaper […]

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

This whitepaper outlines how to evaluate technology readiness for new concepts, and offers methods to improve the odds for successful commercialization.

Download this whitepaper to learn how systems engineering can help you optimize your medical device development process, improve quality, and reduce risks

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

This whitepaper discusses the rigorous systems engineering approach Sunrise Labs uses to quickly assess your situation and advise you on corrective measures.