You Must Chill … Now
The faster a doctor can cool the body of a stroke or cardiac-arrest victim, the better the chance of saving the patient’s vital organs or brain function from trauma, and ultimately resuscitating the patient. Speed is essential.
The faster a doctor can cool the body of a stroke or cardiac-arrest victim, the better the chance of saving the patient’s vital organs or brain function from trauma, and ultimately resuscitating the patient. Speed is essential. The same is true for a medical device startup company: The faster a firm gets a product out (despite the rigors of the FDA regulatory process) the better its chance of survival.
Bob Schock knew this well when he co-founded Life Recovery Systems (LRS; www.life-recovery.com). He’d been designing medical devices for over 20 years, 15 of which he spent at healthcare company Datascope (www.datascope.com), where managed the R&D Group in the Cardiac Assist Division, but LRS was his first startup.
The small LRS team had one key product in mind: the ThermoSuit, a form-fitting, emergency care apparatus that uses ice water to induce hypothermia – dropping the body temperature from 98.6° F to 93.2° F in about 20 minutes. Their plan: get it to market in four years. (Stat doesn’t begin to describe the aggressive timeline).
Yet LRS was able to move from pencil sketch designs in 2003, prove its concept with a federal grant by 2004, develop and test a clinical-quality device in 2005, pass FDA scrutiny in 2006, and ship its first units to hospitals in February 2007. The lynchpin was the speed at which a prototype could be made.
“Having SLA, CNC-machined, and cast parts to assemble the prototypes for testing in 2005 was a key factor in not only clearing FDA review, but ultimately having a production-ready model by 2006,” says Schock, LRS vp for R&D.
LRS isn’t standing still, as it is busy working on the next-generation suit.--SEA
