Future Path Medical, an Ohio based specialty medical product designer, received 501(k) FDA clearance in July of 2011 for its breakthrough product: the Ibag. The Ibag is a urine bag equipped with wireless technology that can take a reading urinary temperature and send a message to either a patient or caretaker when the urine bag reaches its full capacity and requires emptying.
This product may sound like an unnecessary gimmick item to someone not familiar with the serious problems related to incontinence in hospital bound patients. Given its proper context, however, the IBag is an extremely important and timely contribution to the medical community.
If either hospital staff does not empty an incontinent patient's urine bag with sufficiently frequency, the patient runs a serious risk of urinary tract infection. The nature of this particular infection makes it extremely dangers as it can result in sepsis, or blood poisoning.
Sepsis constitutes a serious health risk associated with bed ridden, incontinent hospital patients. A report issued by the Archives of Internal Medicine cited sepsis and pneumonia as the two most common infections bed-ridden patients suffered in hospitals. The two diseases accounted for over 48,000 deaths in 2006 and cost the state approximately $8.1 billion dollars.
The Ibag can help reduce the risk of sepsis in two ways. Not only does it reduce the risk of spillage; it also keeps track of urinary temperature. A spike in urinary temperature can sometimes be an early onset indicator of urinary tract infection.
Future Path Medical started in response to a personal tragedy and the noble attempt to prevent such personal tragedies for others in the future. Ty Bryant, the son of Future Path's chairman, Christopher, lived for eight years as a quadriplegic as the result of a diving accident. In 2008, he died of sepsis resulting from urine bag overflow.
The company intends to pitch the product first to hospital and home rehabilitation markets, particularly for quadriplegics or other severely disabled individuals. They predict the sale of approximately 40 million units a year in the home market and about 9 million to hospitals. The IBag will sell for approximately $9 a unit and Bryan predicts a $360 million market for the product.
In a press interview, Bryant referred to second product called UroSense, not yet approved by the FDA, which will target intensive care units. He declined to provide much detail regarding this second product plan, however. FDA standards are notoriously strict and grueling compared to medical regulations and clearances for health resources related products in other countries. If the UroSense does in fact gain clearance, Bryan predicts approximately a $160 million market for it.