Curis, much of what you assert is valid to some degree or...

Curis, much of what you assert is valid to some degree or another.  I could not concur with your view that his thoughts on CE mark is (are?) a fallacy. He may be over-egging the cake, but there is a fair amount of reasonableness in what he says. We could argue all day about is that 10% or 80%, but then that would by and large be down to different views and biases involved.

Lets look at this section;

4) Although a CE Mark opens the door to selling a product to “signatory” EU Countries, a fairly large market in aggregate, the individual country healthcare systems are very different and product roll-out in Europe is one of the most challenging, heterogeneous and complicated tasks imaginable. I often see companies pursue a CE Mark strategy thinking that is going to be easier to get to first product sales, but in almost all instances a US IDE pathway is a smarter and long-term more cost-effective pathway to a large, homogenous market with a fairly “uniform” insurance model*.

If you have followed SRX over the years you would know how hard the EU market is. The US market has grown at a fair clip, but the EU is a basket case. Even getting the marketing and product literature translated in so many languages is time consuming and costly. There is horrific price pressure in the EU, to the extent that even for a proven product, the NHI in the UK limits the number of procedures they will fund each year.

And then to market in each country, and then have medcos trained - everything has to be translated and validated in each language.

Could you accept that this section is reasonable?

I agree with the assertion that an IDE in the US would be far more valuable to OSL SHs, but a CE mark is a first step. I still can't work out why they did not progress the IDE a couple of years back.