Medical marketplace

The results presented in these papers, and the methodology underlying the results, came at a crucial time, the initial stage of the chemotherapeutic revolution, during which hundreds of new drugs would enter the medical marketplace. Elixir Sulfanilamide had waved the warning flag of toxicity, and in response FDA... 

FDA—The Unites States Federal Drug Administration oversees and regulates the introduction of new drug products into the medical marketplace. 

The agency s policies continue to evolve, in response to newer forms of communications and new needs of the medical marketplace. However, a few basic principles have been at the foundation of the FDA s regulatory approach.f ... 

Medical equipment and devices can cost millions of dollars, have a limited service life, and involve complex electronics and computers. Models with improved features are constantly being released into the medical marketplace. Some medical instruments, devices, and supplies—including surgical drapes, scalpels, and sutures— are consumable or disposable. Production of these items supports multimillion-dollar industries. 

Nordion attracted considerable interest from the private sector. Its employees themselves found financial backing and entered the bidding with an offer. The winning bid came from MDS Inc., a Canadian health-care services company. Founded in 1969 as Medical Data Sciences Ltd, MDS had been publicly owned since 1973. It operated a number of businesses that offered technolo -based products and services to the medical marketplace. However, it had no experience with radioactive products. Consequendy it looked for joint owners who had this expertise. Amersham International of the United... 

The pharmacist or physician can report any problems experienced with dmg products and medical devices. In cases where the PDA and/or manufacturer finds that a marketed product constitutes an actual or potential threat to the safety and welfare of the pubhc, that product must be withdrawn from the marketplace, ie, recalled. Several classes of recalls exist, depending on the relative danger that the product exhibits. C/ass I dmgs pose a serious health threat and may require withdrawal at the consumer level C/ass II dmgs pose a possible or potential health problem that usually means withdrawal at the pharmacy or wholesaler levels and C/ass III dmgs may present a remote hazard to health and safety. 

Two statutory provisions of Tide 21 govern the introduction of new medical devices into the marketplace. Section 515 estabHshes a premarket approval appHcation (PMA) containing data and information demonstrating the safety and effectiveness of a device. Section 510(k) estabHshes a premarket notification process. Under this process, a manufacturer is required to file with the EDA, 90 days before a new device is to be marketed, a premarket notification demonstrating that the device in question is substantially equivalent to a device that was on the market before enactment of the 1976 Amendment and therefore marketable without formal EDA approval. 

The cardiovascular health care marketplace is highly competitive. This works to the advantage of medical device companies. Hospitals are engaged in intense competition for those who might be candidates for cardiovascular therapies. Therefore, hospitals are anxious to offer the best treatment possible, having the newest devices. Medical specialties are also competing for their share of the same patient population. 

Lasers were still tools of elite scientists, though. Moving the technology from the lab and into the marketplace took years. The first devices produced in significant quantities were military systems in the early 1970s, followed by a small but growing number of industrial and medical lasers. The laser s time had finally come. 

Pharmacotherapies contribute greatly to human health and longevity. As such, researchers in the public and private sectors make an enormous investment in drug design and refinement and preclinical and clinical testing. Such efforts often result in a marketed compound that expands the options for the treatment and prevention of human diseases. However, on rare occasions, medications associated with adverse effects - ranging from undesirable to potentially fatal - that greatly reduce or even eliminate their therapeutic utility reach the marketplace. 

Under the Medical Device Amendments of 1976, the FDA is responsible for premarket evaluation of all laboratory testing devices (in vitro diagnostics) intended to be commercially marketed in the United States. There are two major pathways for introducing a medical device into the marketplace the premarket notification [510(k) clearance] and the premarket approval (PMA). The purpose of the 510(k) is to establish that a device is substantially equivalent (SE) to a legally marketed (predicate) device. The purpose of the PMA evaluation process is to establish the intrinsic safety and effectiveness of a new device. Unless specifically exempt, a sponsor must have an approved PMA or cleared premarket notification [510(k)] by the FDA before a device may be legally marketed for IVD use (Fig. 1). 

Research participants are the true pioneers of medicine. Through their participation, novel therapeutic cures and treatments have been made possible. Furthermore, their participation also protects the public from approval of drugs that have a poor benefit-to-risk relationship. Thus, data obtained via research volunteers may be used to provide medical advances or to protect against insidious drugs entering the marketplace. 

The business model of the innovative pharmaceutical industry is to transform the results of basic medical research into products that provide health benefits to the patient. This model is characterized by a high risk of failure in the development of new products, coupled with the benefit of market exclusivity for a number of years if a product can be successfully developed and is approved by the regulatory agencies. Only very few chemical entities complete the development process from drug discovery to a commercial product. But those products that do reach the marketplace have to yield sufficient financial rewards to assure that the... 

The Australian community expects that medicines and medical devices in the marketplace are safe, of high quality, and of a high standard comparable to other countries. It is governed by the Therapeutic Goods Act of 1989, which came into effect in February 1991, to provide a national framework for the regulation of therapeutic goods ensuring the quality, safety, and efficacy of medicines. 

This distinction finds parallels in other trades as well. Artists, for example, could work either by selling individual paintings or (more rarely) by obtaining appointments as court painters likewise, some medical practitioners worked as court physicians, while empirics hawked cures in the marketplace. 

Medication therapy costs continue to rise as a percentage vs. prior year(s) and have risen slightly as the total percentage of health care spending overall to 13% of GDP. New drug therapy products continue to enter the marketplace just as other improvements have occurred in the health care delivery system. The resulting changes in care impact the relative component costs of treatment, such as medication therapy. 

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