Pharmaceutical Supply Chain Strategy

Pharmaceutical Supply Chain Strategy Student’s Name Institutional Affiliation Pharmaceutical Supply Chain Strategy Product design & Product specifics When designing an implantable electronic system, several general requirements are to be addressed. These are minimal size and weight, low power consumption, reliability, biocompatibility and minimal toxicity. Its function would be to regulate humans with heart disease when its natural regulating mechanisms break down and immediately relies a distress signal and contacts emergency services for immediate medical attention. This works by using electrical pulses to induce the heart to beat at a normal rate. It is a small box surgically implanted in the chest cavity and has electrodes that are in direct contact with the heart. The device can perform all these functions, thanks to it’s sensors that constantly monitor the patient's heart, and a battery that sends electrical shocks, when needed, through lead wires to the heart itself to stimulate the heart. Including the capability to send all data to a secure server where It is monitored by an algorithm to immediately recognize dangerous heart activity and notify both the patient and emergency services. All of these functions are powered by a non-toxic long lasting battery with a lifespan of 5 years and main circuit that controls heart monitoring sensors, voltage regulators, timing circuits and real time updates. Issues Due to the fact that this product is design to monitor and control a very vital function of a person heart, there are going to be various issues we have to deal with. Mainly the Development of new medical devices is governed by regulatory schemes. Mostly in the form of standards or extended pharmaceutical laws focused mainly on safety. According to the FDA “Implantable devices represent risks to patients and are classified as Class III devices” (FDA). Meaning this type of products require premarket approval which is often time consuming and expensive. Some of the potential issues we would encounter is the FDA governed by strict approval regulations.Thus, Receiving approval from this agency is a must if the product is to ever reach the consumers. We must meet the very high standards and continue to proactively ensure all laws and regulations are met. Another challenge can be the high cost of the device and ethical dilemmas applicable for expensive implantable devices that emerges for those who lack health insurance or whose plan don’t cover the whole procedure and therapy thereby restricted on financial rather than medical reasons. Our product is priced at $24,000 due to the extra features it has compared to standard pacemakers. Finally, the raw materials needed for the chips and wiring often include tantalum, tin, tungsten, and gold, often grouped together in mining industry as conflicted minerals, are vitally important to the industrial economy specifically in high-tech devices. The sourcing of these minerals often causes scrutiny due to their origin. Research and Development R&D of medical devices are considered ventures of high risk. The process from an idea to a practical clinical application is long and expensive. Research of our product will begin with extensive private research in collaboration with un...