Legal And Regulatory Environment Of The Medical Device Industry

Moreover, people tend to be healthiest when they have faith in their safety, supported and connected to and can trust others in their families, neighborhoods, workplaces, and communities. The three stages of medical technology are review by regulatory agencies, technology assessments by insurance carriers, reviewed by purchasers, clinicians, and consumers. Review by regulatory agencies is the most recognized of the three stages and is administered by the Food and Drug Administration (FDA). The FDA is responsible for protecting and promoting public health by regulating pharmaceutical products and medical devices.

One technological change that may have the largest effect on our lives today is the rapid growth of medical technology development. Three main effects that medical technology has impacted our modern society are prolonging lifespan, improving quality of health care and promoting nation’s economic growth. The three stages of medical technology are review by regulatory agencies, technology assessments by insurance carriers, and review by purchasers, clinicians, and consumers. Review by regulatory agencies is the most recognized of the three stages and is administered by the Food and Drug Administration (FDA). The FDA is responsible for protecting and promoting public health by regulating pharmaceutical products and medical devices. Each product must go through a series of approvals, clinical trials, and post market surveillance protocols in order to ensure its safety and effectiveness. www.nap.edu

Medical technology encompasses a wide range of healthcare products and is used to diagnose, monitor, and treat diseases or medical conditions that affect humans. This may included but not limited too, pharmaceuticals, vaccines, and medical equipment. Such technologies are intended to improve the quality of healthcare delivered through earlier diagnosis, less invasive treatment options and reductions in hospital stays and rehabilitation times. Recent advances in medical technology have also focused on cost reduction. Medical technology may include medical devices, information technology, biotech, and healthcare services. The impacts of medical technology may involve social and ethical issues. For example physicians may seek objective information from technology rather than listening to subjective patient reports. A major contributor of healthcare expenditure in America is the advancement of medical technology. According to several studies it is shown that there is a correlation between the nation’s gross domestic product (GDP) and money allocated to healthcare. One of the leading theories is that medical technology is growing faster than expected.

Many factors prompt the innovation of new technologies: Consumer demand, clinical accountability, medical advancements, research agendas, population health targets and the capacity and resources

What an exciting time to become part of the health care industry! Medical research makes new discoveries to improve the quality of patient care and save lives on a daily basis. Health care reform is gaining momentum, revolutionizing the industry and requiring many administrative changes, such as the creation of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). Rules and standards evolved from this act provide a way to ensure your protected health information remains confidential. In this digital age, it is particularly relevant. The digital evolution impacts many areas. Digital TVs, computers, smart phones and iPods have totally changed the way we do business and enjoy entertainment. In the medical industry, the

Consumers in the health care field value competition in many circumstances due to the fact that it assist that it can decrease costs, improve quality of health care delivered and promotes latest technology and innovation. Therefore, it is the Federal Trade Commission’s (FTC) duty as a law enforcer to thwart firms from engaging in anticompetitive behaviors that could potentially prevent the above described from happening and ultimately harm consumer. Additionally, the FTC provides proper guidance to physicians, health professionals, hospitals and providers to assist in obeying the nation’s antitrust laws (Gamble, 2014).

The health care industry has become increasingly reliant on technology. From medical translation tools to mobile apps, these devices are helping healthcare institutions save money and improve patient treatment.

The health care industry is one of the most dynamic and delicate industries in the U.S. having experienced healthy and substantial changes for the last thirty years most of which have aimed to improve health care management and services delivery to the patients. The changes have enabled the integration of technology into the industry such as in the area of informatics, science and research and payment services and clinical treatments. The health care sector has introduced various changes to address disease and health care management such as the Modernization Act of 2003, the Patient Protection Act and Affordable Act, which aim at improving health provision and most

One of the main challenges regarding the growing use of medical technology in the United States is the growing costs that go along with these changes. These state of the art machines as well as new drug and biological developments come at huge costs which in turn are partially paid by patients and consumers. This has led to huge increases in the average costs of healthcare (Begay, “Technology” Lecture, 10/31/17).

Health information technology (HIT) has become a growing phenomenon in the past sev-eral years. Healthcare providers, organizations, policymakers, and patients all share a similar vi-sion of a healthcare system powered by information technology. These visions stem from the Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009, which authorizes grants and incentives to promote the use of electronic health records (EHRs) by pro-viders. In the past couple of years, with the implementation of HIT and EHRs, the healthcare field has had an increasing amount of medical malpractice lawsuits. Unfortunately, with technol-ogy advancing more rapidly causing medical professionals a difficult task in identifying and ad-dressing medico-legal issues before they occur. Therefore, healthcare teams are in need of con-sidering how to fix the underlying problems of HIT in order to ensure malpractice lawsuits do not continue to happen in practice.

. The company 's mission is to reduce the cost of healthcare by providing the best quality medical devices at the lowest possible price. "We are proud to have a significant and sustainable impact on healthcare by delivering technologies that enhance clinical care and satisfy the pressing economic needs of our customers" ("Applied Medical", n.d., para.1) . Applied Medical has demonstrated that takes its social responsibility seriously through different initiatives that benefit customers and the community.

A Physician Operated Distributorship (POD) is a medical device company that a physician owns, and they also control the distribution process of the medical devices that they manufacture. Since the physician plays both roles for the company, they handle the selling of the devices to hospitals. After the devices are available within the hospitals the physician then gets twice the amount of money since they are getting paid for the device and then for potentially performing the surgery where the device is being used. Since the Physician that distributes the device controls the price it can drive the cost of a surgery to go higher for the patient by exponential amounts. POD’s can cause the price of a pedicle screw to be 1,566% higher than the cost of manufacturing one.

future, however the demand and knowledge for these types of products is not as well-known as

Regulation plays a major role in the healthcare industry and healthcare insurance coverage. Through various regulatory bodies, the Department of Health and Human Services protects the public from a number of health risks while providing programs for public health and welfare. Agencies like the Centers for Medicare and Medicaid (CMS), Health Insurance Portability and Accountability Act (HIPAA), Agency for Healthcare Research and Quality (AHRQ), the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and many others protect and regulate public health

Overview: Johnson & Johnson (J&J) operates in 265+ companies throughout 60+ countries, with a workforce of 126,500+ employees throughout three business segments (Johnson & Johnson, n.d.). From 2006-15, J&J’s total sales improved from $50.5 to $70.1 billion, and total net earnings climbed from $10.1 to $15.4 billion (Johnson & Johnson 1, n.d.). The medical device* segment amounted to 35.9 percent of 2015 total revenues (Johnson & Johnson 2015, n.d.). This analysis shall review the supply, demand, and market equilibrium, as well as production costs and the market structure, for an artificial hip implant.