The coronavirus outbreak has caused unprecedented levels of chaos and disruption around the world. As the global need for protective equipment, intensive care and infection prevention has grown exponentially, the medical device industry has become instrumental in the battle...
Just over a month ago, when the WHO announced that the number of coronavirus cases outside China was officially bigger than inside-China infections, we began to see the implications of COVID-19 for businesses and the global economy. As of today,...
With the rapid spread of the coronavirus pandemic all over the globe, most companies have now implemented a full-time work from home policy until further notice. While for some people this way of working is nothing new, for most...
The global medical device industry enjoyed another dynamic year in 2019. The past 12 months were marked by a spectacular rise of new trends and technologies, notably across digital health, wearables and robotic surgery, as well as regulatory upheaval. As...
What are the biggest medtech news and key developments that have marked 2019 so far? Let's take a look at some industry highlights across regulatory approvals, innovation and clinical trials, funding and M&A as picked by our medtech community: 1. Implantable...
‘De Novo’ “starting from the beginning; anew” A key tenet of the 1997 Food and Drug Administration Modernization Act (FDAMA) was the creation of the De Novo pathway for medical device accreditation. The De Novo pathway was designed to enable streamlined...
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 Last month the FDA published a draft guidance document outlining principles of premarket pathways for combination products.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...

Recent Posts