shadowIT
08-28-2007, 10:37 PM
I wouldn't completely agree with Mr. Friedmans analysis of the Siemens/Intel project. I was IT director for a large donor/centralized transfusion service in the early 90's, when the FDA first decided Blood Bank software was a Medical Device, and started heavily enforcing the cGMP requirements on existing software installations. Frankly, most of the vendors that dropped out then were not a great loss.
Blood Bank software is, frankly, not that complicated. I currently sell, develop, and support laboratory systems. I am quite familiar with microbiology and blood bank (both donor and transfusion), and microbiology is more complex than blood bank, particularly if you include epidemiology. Blood Bank, particularly electronic crossmatch, certainly has greater potential to harm a patient - no argument with that assertion.
The primary reason there has been so little innovation of development in blood bank since the FDA brought the hammer down is primarily because the cost to enter the market (FDA 510k clearance ) is very high, and the limited size of the market, particularly on the donor side, won't support the investment required. Despite my experience, and a certain fondness for that environment (so I'm weird), I haven't been able to put a business plan together that can make money, even a little, developing a new system in the US for that market.
If the regulatory environment in Malaysia is less expensive than it is in the U.S., it could well be a great place to develop an innovative blood bank software product. RFID on the bags and the patient tubes (and on the patient armband) would be a fantastic way to close (or at least significantly shrink) many of the human error holes that exist in that environment today. If they are careful with their development methodolgy and paperwork, they could end up with a product to bring to the US market, and a revenue stream to support it while it makes its way through the FDA labyrinth.
Blood Bank software is, frankly, not that complicated. I currently sell, develop, and support laboratory systems. I am quite familiar with microbiology and blood bank (both donor and transfusion), and microbiology is more complex than blood bank, particularly if you include epidemiology. Blood Bank, particularly electronic crossmatch, certainly has greater potential to harm a patient - no argument with that assertion.
The primary reason there has been so little innovation of development in blood bank since the FDA brought the hammer down is primarily because the cost to enter the market (FDA 510k clearance ) is very high, and the limited size of the market, particularly on the donor side, won't support the investment required. Despite my experience, and a certain fondness for that environment (so I'm weird), I haven't been able to put a business plan together that can make money, even a little, developing a new system in the US for that market.
If the regulatory environment in Malaysia is less expensive than it is in the U.S., it could well be a great place to develop an innovative blood bank software product. RFID on the bags and the patient tubes (and on the patient armband) would be a fantastic way to close (or at least significantly shrink) many of the human error holes that exist in that environment today. If they are careful with their development methodolgy and paperwork, they could end up with a product to bring to the US market, and a revenue stream to support it while it makes its way through the FDA labyrinth.