Experimental Design

To evaluate our cardio pacemaker fully, we used two different experimental designs. One is
laboratory part which in the process of development and the second is clinical part which helps us to see
the pace maker in action in a real human. Since the trial involves human’s study of the pacemaker, we
submitted a proposal to The Instructional Review Board (IRB) to protect the rights of subject involve and
Food and Drug Administration (FDA). With the approval of both group we continued on with our
research in clinical studies. In the laboratory experiment we modified the current battery in the market,
for instance, our new battery last longer and better performance. We have placed ICD in patients so
they could read their own information.

We conducted two short-term clinical trials to identify a suitable device configuration and assess energy
requirements. We evaluated four subcutaneous ICD configurations in 100 patients who were candidates
for ICD implantation and subsequently tested the best configuration in 50 additional patients to
determine the subcutaneous defibrillation threshold in comparison with that of the standard Trans
venous ICD. Then we evaluated the long-term use of subcutaneous ICDs in a pilot study, involving 6
patients, which was followed by a trial involving 55 patients.

Wireless reading Primary risk

(radio software programing)
Determine if patient has an ICD Yes Privacy
Determine what kind of ICD patient has (distance.. Yes Privacy
how far can it read)
Obtain DATA from ICD Yes privacy
Obtain Private data and history Yes privacy
Identify patient Yes Privacy
Change or disable therapies Yes Integrity
Deliver common shock Yes integrity

To successfully measure the effectiveness of our device, we study the heart rate with our market
competitors to check which device is more idealistic. The pacemaker battery provides energy required
for the operation of the circuitry of a pacemaker, which includes the control, sensing and pulse-
generating units. A major concern in using battery is its longevity. For our laboratory research we
modified our battery in such a way that it recharges itself from the body heat.