Never Waste a Good Audit: What Submissions and Compliance Really Demand of R&D Leaders One week into my first large-scale R&D leadership role, I was feeling good. I had gone from leading a team of five or ten to inheriting a group of about seventy. I was still learning names, still building trust, still figuring […]

Three numbers from the latest Medtech Big 100 and what they should change about your FY27 planning Three numbers from Medical Design & Outsourcing’s most recent Medtech Big 100 analysis are worth putting side by side. Aggregate revenue across the world’s largest device companies hit a record $486.7 billion, up nearly 3 percent. R&D spending […]

New product development processes that are overly siloed are stifling medtech innovation. Here’s why and the steps you can take to get engineering, clinical, regulatory, marketing, and manufacturing all working in parallel from day one.

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 Suntra MedTech, 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 […]

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 […]

This checklist is intended to capture the major activities necessary for a successful program with the appropriate expertise needed to guide design tradeoffs from concept to launch and beyond in the most efficient manner possible