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Large MedTech organizations and university founded startups alike often fall into the same trap. A promising innovation prototype fails to make the transition from a “working” blockbuster idea into a commercially successful product. It is frustrating. Shouldn’t demonstrating its critical clinical or technical capabilities represent the ultimate key to unlocking a product’s success? Unfortunately, this...
While the Predetermined Change Control Plan (PCCP) framework for making changes to medical devices was highly anticipated, many regulatory and medical device manufacturers have opted ‘no thanks’ given the immense upfront overhead of predicting the future of changes and how to validate the future changes after launching AI/ML devices. Instead, companies are sticking with locked algorithms and...
AI has rapidly become a standard tool in medical device product development, offering the potential to dramatically accelerate documentation, testing, and design activities. But without formal policies and governance, MedTech organizations face risks to intellectual property, product quality, and ultimately patient safety. Thoughtful AI governance enables development teams to capture efficiency gains while maintaining the...
Despite economic and geopolitical turmoil, medical device manufacturers remain cautiously optimistic about the future of the industry.
While medical imaging leads the way with AI in healthcare through improved diagnostic accuracy, the rest of the industry lags behind the broader market. It is clear that AI is more than a fad, and as opportunities abound, pressure mounts to continue innovating amid relentless competition.
Artificial intelligence is often celebrated for its ability to generate code, but its true value lies in reducing friction across the entire software development lifecycle—improving efficiency, communication, and outcomes.
Surgical robotics leaders must focus on early integration, continuous risk management, and comprehensive verification planning to successfully navigate complex development programs and bring innovative medical devices to market efficiently.
Artificial Intelligence has been around for a long time, decades. So why all the hype now? The confluence of cheap computing, abundant data, and consistent connectivity has provided the right ingredients for AI to become a practical reality...
Nearly 30 years ago, in 1996, the Health Insurance Portability and Accountability Act (HIPAA) became law and the right to health information privacy in the U.S. was born. Needless to say...
The interconnectedness of medical devices, which generate data that can be distributed to multiple systems that are often managed by different policies, presents privacy concerns that device manufacturers must address, said Adam Hesse, CEO of Full Spectrum…