Titan Medical Inc (TMDIF)

[66Mustang]

I would say that this announcement was more thorough than most. With so many people expressing distrust for Mr. McNally, if they didn't bring the full story to light, folks that don't understand Design Freeze as a hardware task will claim he was lying when software updates are released.

I've been working on a complex hematology analyzer for the past five years; initial regulatory approval was in 2016. Continued software development efforts were called Life Cycle Packages; a normal part of marketing and supporting such a device.

The software has to be complete enough to support full hardware functionality for Qualification, V&V, etc. but can and will still evolve after that.


Message in reply to:
Let me ask a simple question. What would be your thoughts if Medtronic or BioTronik announced a design freeze on a new pacemaker or defibrillator but the software was still evolving... most would realize that a device that is 90% software based in its function and safety features it’s not complete until the software is frozen.

I’ve been in this industry for almost 30 years and never seen an announcement or design freeze with a caveat. If it is standard that the software would evolve prior to launch then it wouldn’t be mentioned.

You can read it how you like but those are the facts. It may work out in the end but there’s a reason that was put in writing... in case their is a software delay.

BelizeMe