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 universities and consultation with the innovators in the industry. FOcusing on biotechnology,engineering, and medical innovation to achieve our goal.Following that can we move to device development, testing and finally production and distribution. Specific process for our device will be costly and can take a years to accomplish and develop the technology. Extensive testing is needed to monitor, capture malfunctions, and correct them. A study done by Stanford university “Identified the cost of bringing a medical device to market assessed at $30 million to $94 million” ().  A large chunk is spent on research and development the same study found that after the launch is successful 12-15 percent is reinvested into R&D. This phase is extremely important because if the later fails our new products may cause serious medical problems for the individual and financial disaster for the producer. The high costs of R&D is the reason our device starts at $24,000 but hopefully with improvements to the products next generation will bring this price down.  Supply and Demand   Good inventory planning will help our company minimize our inventory, reduce costs, and protect our competitive advantage. This procedure is not easy to do when sales deviate with historical trends. To Prevent stock outages, high inventory costs, and poor customer satisfaction, we must implement a system that increases visibility of our material requirements to enable better allocation of resources as well as more efficient inventory planning and safety stock. This is especially true in our industry as inventory cost is often high because these devices are expensive to make and maintain. Some of the practices would include the synchronization of demand of finished goods with the required materials and components. Thus,establishing order parameters for each location with replenishment systems in place. Develop multi what-if analysis to explore different planning scenarios and see the effects on your bottom line. In addition, we will have a strong demand planning and inventory planning functionality across all supply chain processes built in with IA to help make more accurate decisions based on real time data. This system would view and manage all inventory in the supply chain network, constrain orders by size, seasonality, labor and warehouse availability. While feeding real-time data to update demand forecast with the aid of powerful Business Intelligence in the form of powerful algorithms. This system incorporates many inputs to help ensure detailed, accurate sales forecasts. Namely, because of the complexity of our product it is important to have the required raw materials to match the demand. Because production of the device is expensive optimizing and creating more accurate forecasts can help our manufacturing plants produce the most efficiently.  Product Implementation  A product launch represents a major investment in revenue and profit for a company. A successful product launch can yield new market and access to new customers. Before even thinking about a launching date we will take the time to properly assess our regulatory situation and define our strategy for premarket submission and device launch. Assess regulatory environment and ensure the product is compliant. Following that we will Develop a Product Launch Plan. This plan will set a date for the official launch of our product where customers can begin purchasing/order. When developing our launch plan, we need input from all processes in the project and ensure all members a...