Tour of Pyng's Operation - FAST1 Design
The current design of FAST1 could well go into volume production with few problems. However, the staff set aside 3 weeks to brainstorm any final improvements. The commitment to the FINAL final design should be in place by the end of May. (I think management has learned that giving specific dates and time frames can create problems for investors, particularly when there are so many unknowns and uncertainties.
There is no design flaw (someone asked) in the current device. In my opinion, it could go to volume production with minimum recalls. However, management wants to explore all the improvement possibilities that they can generate while maintaining the integrity of the specifications in the FDA approval and the more than 100 specific criteria set by the company.
While I am opposed to fine-tuning at infinitum, there can be substantial benefit in this brainstorming period. For example: The current device has a surgical steel portal (tip) which penetrates the bone to reach the marrow. Getting the portal in can be easier than removing it. The current device has the inside of the steel portal finely threaded. The remover is a long fine surgical steel rod that is has a threaded end. When the IV is no longer needed, the remover is inserted through the tubing and threaded into the portal. The portal is then withdrawn.
The finely threaded portal and the threaded surgical steel remover are expensive to produce. Also, the remover must travel with the patient to the operating room and perhaps to a ward in the hospital so that the portal can be removed at the appropriate time. Can you imagine going through an airport metal detector with a tiny portal lodged in your chest?
One modification to the device, which seems very likely, is to bond a stronger type of tubing to the portal so that removal is completed by simply pulling on the tubing. If successful, as management expects, this modification would reduce the cost and increase the efficiency of removal.
While I want to get the show on the road, I do support the 3-week brainstorming period as long as we do not lose an inordinate amount in redesigning the FAST1.
Regards, Ed
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