Read part 1 here. Where are we today? Last month the FDA published a draft guidance document outlining principles of premarket pathways for combination products. The document lists 4 major types of combination products: A “single entity” combination product (i.e. a pre-filled...
Since the beginning of the 21st century, we‘ve seen a massive upsurge of innovative combinations between drugs, devices, biologics, and most recently software and AI. Drug-eluting implants, ingestible electronics, smart pacemakers, insulin pumps, patches and all sorts of wearables...
Why create the MDSAP? Since the foundation of the Global Harmonisation task force in 1993, medical device institutional bodies have been working to bring uniformity and simplicity to international accreditation, removing barriers to increased trade and improving patient access to...
“Biology and Technology are evolutionary processes in which the information processing tools of prior generations are used to make those of the next. As these tools improve, the time between advances in order and capability decreases exponentially” – Ray...
The answer is a resounding “well, it depends…” It depends on many factors including the specific circumstance, position, timelines and ambitions you have for your device and your company. This article summarises some of the key differences, positives and negatives...

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