We have all seen virga, but you may not know the word.
Virga is rain that doesn’t reach the ground. In other words, virga doesn’t reach its destination. The word virga is derived from Latin meaning “twig” or “branch”. Virga is an especially dramatic sight at sunrise or sunset. It always amazes me how many tons of water can fall from the sky to get re-evaporated and go back up.
Class III = VIRGA
I think of Class III devices as virga. If you follow me, you know that I am not a fan of the Class III pathway in orthopedics. In my experience in orthopedics, I have witnessed too many Class III devices that never made it to market. Early on, they were all promising as they headed into PMA/IDE clinical trials. If successful, these startups would have had the ultimate barrier-to-entry, the PMA clearance. However, in the majority of cases, after 10 years and $100M spent, they never quite made it to regulatory clearance. Virga.
There are many reasons for this evaporation late in the game. Over a decade the FDA can be fickle, the FDA players can change every year, the clinical results can prove to be less than stellar, the business conditions can change, or investors can get fatigued and flame out. There is a long list of virga failures in orthopedics. A few illustrative examples are Spinal Restoration, Archus Orthopedics, Disc Dynamics, and Innovative Spinal Technologies.
Don’t be another virga casualty.
Class II = RAIN
I think of Class II devices as rain. I am a big fan of the Class II pathway in orthopedics. I listed regulatory simplicity as a key indicator of success in orthopedic startups. The Class II area is innovation that will reach the market. The Class II timeframe is one to three years. Less capital, less time, less risk.
There are endless innovation opportunities in the Class II space. Don’t be tricked into thinking that Class II = simplicity. At Ellipse Technologies, all of our cool remote control implant systems were cleared under 510(k)s including the magnets inside implant devices, the software, the electromechanical components and the patients treating themselves at home by family members.