Titan Medical Inc (TMDIF)

[66Mustang]

"Initial design freeze" is completely normal. They have to draw a line in the proverbial sand and decide that is what will be tested. They will still be looking for ways to improve the product, and there are always some things that surface during any intensive test phase such as pre-clinicals. Changes made after that point need to be well documented and an additional determination has to be made as to how each change will affect device performance, and what regression testing is appropriate afterwards. Otherwise, they would have to re-test the entire system even though the change was rather isolated to one area of performance. That would be a huge schedule hit.Initial design freeze just says "Here is our baseline" and they can move forward.

Some companies have issues getting to initial design freeze because every engineer or marketing guy who brings a good idea to the table wants to see it implemented. There is no end to creative input for a complex design, but if a company keeps modifying the design, they can never get to test.

Strive for excellence. If you strive for perfection, you will never get there.