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The introduction of the EU Medical Device Regulation (MDR) marked a major shift from the previous framework, the Medical Device Directive (MDD). Adapting to MDR has been – and remains – a substantial challenge for the industry. The implementation of the new regulations has faced persistent issues almost from the outset, compounding the difficulty of … EU MDR: Latest Developments, Challenges, and What You Need to Know

As sensor technology continues to evolve, its integration into catheter products is revolutionising minimally invasive medical devices. Sensors are increasingly vital components, offering new possibilities for improving patient outcomes by providing real-time data to guide procedures, enhance clinical decision-making, and monitor treatment progress. However, successfully integrating sensors into catheters requires careful design to ensure safety, … Design Considerations When Integrating Sensors into Catheters

It is not enough when designing a new medical device product to just create a design based on an initial ideal before moving straight to testing and real-world evaluation. In fact, most medical device products go through several iterations during the design and development process to get to the final design. Often, this final design … The Importance of Prototyping When Developing a New Medical Device Product

Stent delivery systems, particularly those that involve balloon catheters, have been used in a range of different medical procedures for many years. This doesn’t mean innovation in this area of medical device design has stopped. Quite the opposite, in fact, as new and highly innovative solutions continue to be developed. This includes stent delivery systems … An Introduction to Stent Delivery System Design Considerations

2025 is a year full of opportunity for innovation and growth, especially in the medical device industry. While businesses across all sectors face ongoing challenges such as tariffs, economic shifts, and supply chain disruptions, these headwinds are also driving fresh thinking and progress. For medical device companies, now is the ideal time to move forward … 5 Essential Reasons for Progressing Your Medical Device Design Project in 2025

A medical device CDMO (contract design and manufacturing organisation) can bring a range of benefits to your company, whether you are a start-up, academic spin-off, or established medical device brand. Those benefits include expertise benefits, infrastructure benefits, and commercial benefits. How do you choose the right CDMO partner? The following essential considerations should factor into … Essential Considerations When Choosing a Medical Device CDMO