You're right HC, they can't keep tweaking it. But I'm quite sure the plan at this point is to run with what they have. They went from proof-of-concept hardware to prototypes which they have been playing with and doing minor upgrades to since Mr. McNally came on board. The design changes going into the confidence build have rolled in all the surgeon feedback which they deemed appropriate, while updating the hardware to regulatory-compliant, current-spec hardware. For production, they need modern electronics which will not go obsolete in the first couple years of production, and they need the requisite traceability for medical device hardware. They have been working closely with the FDA for years, but even more closely since Mr. Jensen came on board. They know what they need for hardware and documentation, and that is what they are currently building (probably done building by now but waiting for another raise to be ready before they announce completion - I too am skeptical about a few things).
If MORE improvements are merely desired, as you suggest, there is no way they will interrupt the program flow for things that can wait for Gen 2. All of the "nice to haves" are in there now, or they aren't going into Gen 1 (production). If there are any showstoppers from a regulatory standpoint, they would need to tweak the design accordingly, but their close relationship with the FDA should preclude any such necessity. They should already have a full understanding of what hardware is needed; from here they are only going to hash out details of clinical testing (the who and what and how many, based on things like predicate device comparison).
Much of the investment world doesn't fully understand the medical device development process, and as the normal development process has been playing out over the past two years, some of these very normal things have been misconstrued by the investment world as negatives, when they are in fact completely normal. Medtronic slipped about a year. Normal. We slipped half that much, and it's viewed as a catastrophe. In reality, it's GOOD news, because when a schedule slips, most companies add a buffer so it doesn't happen again. Like Medtronic, Titan should now be on a safe, conservative schedule.
Whereas my area of expertise is NOT the investment world, I have not always (or ever) shared the hyper-critical viewpoint which is now so common here. Of course I am disappointed in the current share price and what it means for imminent dilution; that is very frustrating. As an investment, this has not been pretty, but from a hardware perspective, the future is extremely bright for this platform. All I can do is keep averaging down as much as possible in the meantime, probably shortly after the next raise as it will likely be timed well with my next SEP IRA contribution.
The confidence build means a lot more than you are giving it credit for; it is effectively the final product. Design freeze typically means the FDA has given sufficient feedback on the clinical trials that they can freeze the design officially to start production planning, with extremely limited risk of needing further tweaks.
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They cannot keep tweaking it...I guarantee you that once the confidence build is over and testing commences at the 3 sites - that MORE improvements will be desired...at some point it has got to stop.
Why should PPS go up when they need more $$$ inside of 3 months? A confidence build means nothing because they still have to start testing the final product and a design freeze doesn't happen until the 50+ nice to have's added to the "final" list are dwindled down to a dozen or so and the device is retooled.
