Theoretical Bases And Organization Of Medical Devices

However, if the cost of “perfection” is so expensive that the company cannot be profitable, it is not realistic to spend too much on a zero defect mindset. Instead the company must first identify what an acceptable percentage of defects is and where the defect could have been prevented. Then the company can further quantify which cost of quality is presenting the greatest risk and put procedures and policies in place in an attempt to minimize defects. Since prevention costs many times are considered the least expensive and can have the biggest affect on non-conforming products most companies will focus its initial and largest efforts into prevention. The next initiative would be appraisal and last would be identifying

Driven by the financial losses in 1998 and 1998, competition on “Pill Hill”, and declining staff morale, VMMC established a set of goals to achieve its vision of becoming the industry’s quality leader. And to become the quality leader, VMMC needed to focus on the patient, work in a team environment, and embrace change. Kaplan was the person in charge of implementing change at VMMC to achieve that vision. To do so, he needed a system that focused on quality and the Toyota Production System (TPS) was the perfect fit for this organizational change. Previously, VMMC utilized systems such as Total Quality Management (TQM) and Six Sigma. However, TQM was not generating the result that VMMC was seeking, and Six Sigma allowed a defect rate, which was not acceptable at VMMC since “safety and perfection are paramount,” as administrative director Christina Saint Martin noted. In the healthcare world, Dr. James Bender explains that “no one should die because of something we could prevent (Bohmer & Ferlins, 2008).”

It will be a win-win strategy for every participant in the medical devices supply chain. In details, first, MTC could form a strategic alliance to hospital ‘innovators’, such as Cleveland Clinic, to develop new high tech device. Patent could create a new revenue stream for both parties. Moreover, MTC would know earlier and react faster about what surgeons really need from the company’s next devices. At the same time, hospitals would be willing to cooperate due to the gain through such early involvement program. Second, implementing low unit of measure (LUM) Lean/JIT systems between distributors and hospitals. RFID tags could provide information on locations of medical device. Accordingly, manufacturer/distributors would have visibility to hospital’s items and control the order lead time to maintain a least landed cost. It is a desired result for distributors since they are more willing to shift from the traditional bulk model of shipping inventory in full-case quantities of use. Third, a higher percentage of ‘on-contract’ purchase benefit the cost saving which has become an important supply chain metric in leading hospitals. Last, supply chain touch points create potential safety issues and unnecessary expenditure. MTC should give a scrutinize of current process, in addition, eliminate touch point such as off-site

According to the technology experts, 80-90 per cent of the start-ups fail to make it. In medical device arena, the rate of failure for start-ups is even higher. They have challenges

Jeff Goodman was a strong advocate for the product synthetic cartilage, and saw an opportunity to launch a successful company in the medical industry. His vast experience in the medical field helped to successfully create PFM Devices. As of 2002, Goodman, still CEO was looking to extend his product on a global scale. His final initiative before retirement was to increase global market share. It seemed as though the most significant way to increase global market share would be to acquire competing companies in new areas of the world. He decided to purchase a small company in France to hit the European market, and a fast growing company in Japan to access

Every year, millions of people in America are prescribed a drug or medical device. These devices and medications are designed to help us live longer and improve our quality of life. That is exactly what they do for the majority of people who take them. However, many people are injured by defective drugs and medications.

This includes design, manufacturing and marketing defects. For example, car defects which result in injury or death are a design and manufacturing defect. Improperly labeling or inadequate safety warnings are marketing defects. While there is no federal product liability law, every state has their own version. Having high safety and quality standards is simply inadequate to protect your company. Keep in mind that there are countless opportunities for liability lawsuits when it comes to products. The most infamous lawsuit, involving an elderly women who spilled hot McDonald’s coffee in her lap, resulted in a 2.7 million dollar settlement. Always promptly respond to any defect concerns with the help of an experienced

The purpose of this paper is to identify a quality safety issue. I will summarize the impact that this issue has on health care delivery. In addition, I will identify quality improvement strategies. Finally, I will share a plan to effectively implement this quality improvement strategy.

Technology has become smarter than they were before. They have improved in the medical field very much to the same skills as a surgeon performing surgery. Technology such as robots can work along with surgeons to perform surgeries on backs or any other surgery. Of course, the robots would be controlled by a professional doctor or nurse. Not only that, but new medical device can detect everything in your body from X-rays showing broken bones to detecting diseases in your blood. Furthermore, in an article called, “Design and Technology evolve together: Radical New Medical Device design have prompted radical new machining and laser processing technologies” by Erik Swain stated, “Medical devices are evolving, getting smarter…” This states that

Most manufacturers care about their consumers and subsequently, do not intentionally manufacture products that harm their users. However, injuries from defective products do occur, and they occur often. The United States Consumer Products Safety Commission (CPSC) estimates that in 2014, 78,906 product liability cases were filed in the US. Furthermore, product liability cases are second only to medical malpractice as having the highest median damage awards in all personal injury cases. Fortunately, the liability for these products and the injuries they cause lies on the individuals or companies individuals or companies responsible for manufacturing and distributing them. Product liability cases are often difficult, expensive, and time-consuming.

This paper analyse different cardiac implants recall reasons and different recall systems, based on an overview of the recalls of cardiac implant medical devices in the last decade. This study provides recommendations on how to avoid such recalls from a manufacturer perspective, as well as how to timely react to an adverse event from a post-surveillance system perspective.

In the article, my inference was: “medical devices manufacturers should be ashamed of themselves, and should foresee everybody else’s problems.” As evidenced by the introductory statement:

The quality group wields significant amount of power over a test group for the reason that QC inspectors can easily stop the shipment of the product until all procedures and standards are met, and all designated problems are resolved. According to the IEEE standard 610 [2], quality control refers to “a set of activities designed to evaluate the quality of developed or manufactured products” (Black, 2013) As such, quality control is a term applied in a hardware manufacturing or hardware environment, in which a large scope of physical items are produced and/or shipped. Each of the produced items has to be taken through a thorough testing process for the purpose of ensuring the quality of product is high enough for ship. Failure to meet high quality standards would result in the rejection of the product or system. Therefore, the quality control group within a manufacturing organization conducts a quality check, under the leadership of a quality controller. Quality control needs need to follow solid item library management that allows for traceability, uniformity predictability which are attained through testing of the design, the developed products, the product relationships, as well as the product system (Farrell-Vinay, 2008). The quality controls are crucial in

Our company should make sure that manufacturers deliver products with the highest design specification, in order to be order-winner quality conformance, by delivering products with no defects (Hill and Hill, 2012). Furthermore, improvements in quality lead to a decrease in cost for the company. According to (Evans, 1997) higher quality products lead to a decrease in costs for the company through higher productivity: ‘improvements in quality leads to lower cost because of less re-work, fewer mistakes, fewer delays and snags’ (Evans 1997, P.55).

Company wants to know that quality of product is under control limits or not and they want to detect assignable causes of variation and to remove those because the following reason. . They face the difficulty in the consistency in the quality. Company keeps the eye on the ISO-9001 certification implementation, so they want to check the quality assurance. They are facing the