And when it's a healthcare product, requiring ministry approval, it's definitely a challenge.
Maria Hayes explains in the final segment of her Open Wounds series.

Download Video: MP4, WebM, Ogg
HTML5 Video Player by VideoJS

Initially, Ontario's health ministry said the t-pot therapy would have to go through approval by the Ontario Health Technology Advisory Committee; then TSS was told it needed to apply as an independent health facility, but there would be no guarantee of acceptance.
To date, they are still unclear as to how to get the product out to the people who need it.