Focus on clinical training as a tool

Clinician Training Tool

The go-to-market strategy is to focus initially on teaching hospitals. Teaching hospitals comprise roughly 20% of all hospitals in the US. Once clinicians are trained using a tool, they have a strong preference to continue using that tool in their practice.

The BrightPoint™ Epidural system will be introduced as a useful training tool for new clinicians. Most new clinicians (anesthesiology residents and nurse anesthetists) are initially trained on rubber models and then on living patients. It typically takes a junior clinician about 50 to 100 “practice” patient procedures under the supervision of a senior clinician before they are ready to perform epidural procedures on their own.

Since epidural procedures are performed 100% by hand tactile touch and feel, it is difficult for the senior clinician to know how the junior clinician is progressing beyond watching the depth marks on the needle. Since the training procedure is being performed on a live patient, in most cases they must keep conversation to a minimum so as not to disturb the patient. Use of the BrightPoint™ Epidural device provides the senior clinician with a real-time visual aid on the location of the tip of the needle and allows the trainer to provide better guidance to the trainee. This can help provide better outcomes during training procedures and reduce the overall number of required training procedures. This benefit was pointed out to us by clinicians at our physician focus group meetings.

In addition to a range of statistical bench performance testing, Lumoptik is conducting a live animal study (porcine) and a live human trial to support the benefit as a training tool and secondary confirmation to LOR in our FDA 510(k) submission. These studies are focused on use of the BrightPoint™ device as a training tool for new clinicians.

Lumoptik plans to introduce BrightPoint™ through hospital teaching programs. There are approximately 1,170 teaching hospitals in the US. This represents about 21% of the total hospitals in the US.