Explore news & insights from us

A definitive technical guide to navigating the MedTech EVT-DVT transition. Learn to prevent common EMC and reliability failures, align with FDA Design Controls (21 CFR 820.30), and avoid costly launch delays.

Viewing DfM and DfR as opposing forces is a strategic error. In modern medical device development, they must be a symbiotic partnership. The most reliable design must be manufacturable to reach the market. The most manufacturable design must be reliable to earn and maintain trust.

Master the medical device design transfer process with our comprehensive checklist. Learn to avoid costly manufacturing delays and regulatory pitfalls, turning your design handoff into a true competitive advantage.

Breaking into the U.S. MedTech market is a milestone for SEA startups, but FDA approval is often tougher than expected. This case study shares five lessons: the importance of systems and documentation, proving consistency over invention, the power of clinical data, realistic timelines and budgets, and the value of early partnerships. These insights help founders better navigate the journey from prototype to FDA clearance.

Choosing a MedTech engineering partner? Discover why ISO 27001 compliance is non-negotiable for protecting your intellectual property (IP), ensuring patient data privacy, and achieving regulatory success. Learn how to vet your partner's security.

This article provides a comprehensive strategic framework for navigating the critical make-vs-buy decision for core technology. Moving beyond simple cost analysis, we explore how to identify your essential intellectual property (IP), assess the Total Cost of Ownership (TCO), and manage risk in complex MedTech and IoT product development. Learn when to build in-house to protect your competitive advantage and when to partner for speed and efficiency, ensuring compliance with standards like ISO 13485 and IEC 62304. This guide offers a data-driven methodology for technology leaders to make informed choices that balance control, cost, and time-to-market.

This article provides a deep dive into the root causes of MedTech project failure from strategic and managerial to technical and introduces a comprehensive framework to diagnose, recover, and get projects back on track without sacrificing IP or market timelines.

For a MedTech startup, a successful funding round is a critical milestone. However, before investors commit capital, they conduct rigorous due diligence, with Intellectual Property (IP) at the forefront. A weak or poorly managed IP portfolio is a major red flag that can derail a deal. This article provides a comprehensive checklist for founders to audit their entire IP portfolio—including patents, trade secrets, data, and code—ensuring they are investor-ready. It highlights common pitfalls and positions ITR as a strategic partner that helps startups build a defensible and valuable technology asset, addressing key investor concerns from day one.

The DHF is not an administrative task, but a strategic asset. It is the story of your innovation, written in the language of certainty and value that investors and strategic partners seek. Investing time and resources into building a thorough DHF is not an expense, but a direct investment in the value and future of your startup.