Medical Product Development Process – Clinician and Technician
Traditionally the gold standard of hematoma detection is a CT scan performed by a $1.5 million stationary machine at a cost of $500 a scan. The handheld, cost effective Infrascanner can be used in many medical scenarios where accessibility to CT scan is restricted or in conjunction with CT scan by monitoring and triaging Traumatic Brain Injuries (TBI).
In order to save life and to preserve brain function, the treatment of Traumatic Brain Injury must start within the first “Golden” hour after the injury. The Infrascanner allows for effective diagnosis on the battlefield leading to faster triage of patients and earlier surgery.
Additionally, a CT Scan exposes the patient to 5 times the radiation of a chest X-ray. It’s no wonder many doctors may think twice before ordering a CT scan for a child (100,000 TBI cases/yr. in US) that does not show any signs of TBI. The medical product development team made sure Infrascanner can be used safely in these ambiguous situations to assess the necessity of further testing with a CT scan. The ability to detect hematomas in the patient’s room also allows greater safety for the patient since there is always a risk with moving a TBI patient. And the cost per patient for hematoma detection with the Infrascaner product is $10 (the cost of the disposable probe) versus $500 for a traditional CT scan. Finally, CT scans can require the patient be strapped down and enter a chamber that can sometimes cause claustrophobic response, a scan by an Infrascanner requires no preparations of the patient.
Recent statistics from US military activity in Iraq shows that: 18% of all Killed In Action (KIA) are “Potentially Preventable”, including 30% of patients who had head injuries. 30% of all Wounded In Action (WIA) had head injuries, of them, 40% developed brain hematomas. The relevance of the application of this medical product in combat operations is demonstrated by the fact that the United States Navy and Army have provided $1,100,000 in grants.
Patients often only get one CT scan per day because of the cost and risk of moving them from their room to the CT scan location. The Infrascanner product can be used every few hours to monitor a patient’s recovery. The development team also anticipated use at the scene of an accident and made sure the medical product can assist medical personnel to prioritize whether a patient will be better cared for at the further away hospital with an ICU experienced in TBI. Or in a military application, which of the 9 injured soldiers should get to go on the medevac helicopter when there’s only room for 4 people?
The medical product is designed to fit both right and left handed users. For ease of use and speed between patients, the medical product development team made the probe disposable and alignment and ease of attaching/detaching was given ample development time to achieve a fail safe user experience. Regarding the user and design of the product, the simplicity of the interface – one large blue button – makes operation possible by any medical personnel without the need to read an instruction manual or second guess operation.
The professional looking product propelled the company from a concept level, early stage start-up company to a level of a serious company with a real product. Patients have commented on the fun, friendly form with a tone of curiosity in their voice more than fear as they often do with unfamiliar medical products. The non-invasive, painless nature of the product puts patients at ease as does the disposable probe which insures cleanliness. This attention to detail during the product development process helped the company to raise funds and to start early sales overseas. Furthermore, the solution of the technical challenges allowed the company to begin multi-center clinical trials for FDA approval, accelerating the time to the US market.
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