How workflow, IT integration, and reimbursement gaps stall promising devices—and what to do about it In 2011, when the early AI engine IBM Watson won a three-game exhibition tournament of Jeopardy, besting two human contestants who were widely considered to be the greatest ever to play the game, it was considered a real breakthrough for […]

Healthcare collects more data than any industry on earth. Most of it never gets used. Here’s why that paradox persists, and what has to change. Healthcare data is growing at 36% annually, faster than financial services, faster than media. Yet the majority of what gets collected sits idle, generating cost and complexity without generating insight. […]

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 […]

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.

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 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.

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 […]

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

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

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