The European Commission needs to be faster and more efficient in its implementation of the new EU Medical Device Regulation (MDR), say German manufacturers, watching the remaining months of transition time slip into single figures. A few economic operators have come clean about the pressure the MDR has brought to bear, but the suspicion is that many are choosing to keep quiet.   

Medtech companies brought in $2.3 billion in financing in Q1 2017, a slight decrease from Q4 2016; device M&A deals totaled $5.8 billion, a sharp decline from the prior quarter, but there were some billion-dollar deals. Q1 diagnostics financings – totaling $1.2 billion (thanks to a $900 million Series B round by cancer diagnostics company Grail) – showed a significant increase over the preceding quarter, as did the Q1 M&As at $700 million versus the previous $87 million.

Although thoracic endovascular aortic repair (TEVAR) is now routine for lesions like dissection of the descending aorta, the Big Three aortic endovascular companies are developing devices for the more technically challenging proximal and distal portions of the thoracic aorta while physicians refine TEVAR in the descending aorta. Insiders say endovascular techniques are overcoming limitations and physicians will soon be able to treat the entire aorta, from the aortic valve to the bifurcation.

The endovascular abdominal aortic aneurysm repair (EVAR) market is one of the brightest growth opportunities in the medical device arena today. As a result, the competitive landscape is heating up as several new entrants stake their claim for a share of this $1+ billion opportunity.