Hindsight 20/20 is a new Q&A feature where medtech industry veterans share their long experience taking diverse businesses – be they start-ups or publicly-listed entities – from strength to strength and navigating through times of crises. This first instalment shines the spotlight on Raymond Cohen, who is currently CEO of venture-backed sacral neuromodulation company Axonics Modulation Technologies, Inc. The advice he gives includes not rushing into clinical studies too soon, try to go big with the fundraising and be very cautious when tackling a complex market like the US, among other things.

Medtronic’s Symplicity renal denervation system has won entrance into an elite group – it is one of the first devices to be selected for the joint FDA/CMS parallel review program, launched in 2011. That distinction could help the company quickly move the device into US clinical practice once it’s FDA approved.

Device firms closed the final quarter of 2012 with $1.1 billion in financing, led by Volcano’s debt offering. Takeovers of Gambro and PSS Medical topped the device M&A list. At $196 million, Q4 diagnostic financing was the lowest quarter of the year, but IPOs returned with three public debuts. Amgen’s $415 million acquisition of deCODE was the largest diagnostic M&A.

The prospective medical device tax, the continuing decline of venture investing, pricing challenges, austerity measures in Europe, and other headwinds continued to push against the medtech industry in 2012. But emerging clinical and geographic markets, along with an active M&A market, are providing the industry with some momentum going into 2013.