The road to market implantable drug delivery systems: a review on US FDA's regulatory framework and quality control requirements.

The scope of Implantable Drug Delivery Systems (IDDSs) comprehends a variety of sterile therapeutic implements placed inside the body to exert a certain therapeutic action for extended duration. They are classified under different categories from pharmaceutical science and regulatory perspectives. The novelty and variety of IDDSs prevent the application of a uniform regulation for all IDDS products; therefore, sponsors face regulatory challenges to register and market their products. This review investigates pharmaceutical science literature and the United States Food and Drug Administration (US FDA) regulatory guidance to find how any IDDS is classified, regulated, and introduced in the market. The regulatory classification of any IDDS, as a 'drug', 'medical device' or a 'combination product', is the cornerstone in determining the regulatory pathway, which decides the quality control requirements preceding the marketing approval. IDDSs are generally recognized as combination products as they consist of two or more regulated components (drugs, medical devices or biological products) combined prior to use to function as a single entity. Although robust and defined US FDA regulatory pathways exist for each component independent of one another, the regulatory pathways for combination products are less formalized.

Price adjustment for traditional Chinese medicine procedures: Based on a standardized value parity model.

Traditional Chinese medicine (TCM) is an important part of China's medical system. Due to the prolonged low price of TCM procedures and the lack of an effective mechanism for dynamic price adjustment, the development of TCM has markedly lagged behind Western medicine. The World Health Organization (WHO) has emphasized the need to enhance the development of alternative and traditional medicine when creating national health care systems. The establishment of scientific and appropriate mechanisms to adjust the price of medical procedures in TCM is crucial to promoting the development of TCM. This study has examined incorporating value indicators and data on basic manpower expended, time spent, technical difficulty, and the degree of risk in the latest standards for the price of medical procedures in China, and this study also offers a price adjustment model with the relative price ratio as a key index. This study examined 144 TCM procedures and found that prices of TCM procedures were mainly based on the value of medical care provided; on average, medical care provided accounted for 89% of the price. Current price levels were generally low and the current price accounted for 56% of the standardized value of a procedure, on average. Current price levels accounted for a markedly lower standardized value of acupuncture, moxibustion, special treatment with TCM, and comprehensive TCM procedures. This study selected a total of 79 procedures and adjusted them by priority. The relationship between the price of TCM procedures and the suggested price was significantly optimized (p < 0.01). This study suggests that adjustment of the price of medical procedures based on a standardized value parity model is a scientific and suitable method of price adjustment that can serve as a reference for other provinces and municipalities in China and other countries and regions that mainly have fee-for-service (FFS) medical care.

Integration of new technology into clinical practice after FDA approval.

Development of new medical technology is a crucial part of the advancement of medicine and our ability to better treat patients and their diseases. This process of development is long and arduous and requires a significant investment of human, financial and material capital. However, technology development can be rewarded richly by its impact on patient outcomes and successful sale of the product. One of the major regulatory hurdles to technology development is the Food and Drug Administration (FDA) approval process, which is necessary before a technology can be marketed and sold in the USA. Many businesses, medical providers and consumers believe that the FDA approval process is the only hurdle prior to use of the technology in day-to-day care. In order for the technology to be adopted into clinical use, reimbursement for both the device as well as the associated work performed by physicians and medical staff must be in place. Work and coverage decisions require Current Procedural Terminology (CPT) code development and Relative Value Scale Update Committee (RUC) valuation determination. Understanding these processes is crucial to the timely availability of new technology to patients and providers. Continued and better partnerships between physicians, industry, regulatory bodies and payers will facilitate bringing technology to market sooner and ensure appropriate utilization.

Customer satisfaction in medical service encounters -- a comparison between obstetrics and gynecology patients and general medical patients.

This study is concerned with the "service encounter", and seeks to describe, by use of the Service Encounter Evaluation Model, how the processes involved in the service encounter affect customer satisfaction. Its findings have implications for management practice and research directions, and recommendations are made. With the implementation of a national health insurance scheme, an ever-prospering economy and continually improving educational levels in Taiwan, demand among citizens for good health and medical care is ever increasing. Obstetrics and gynecology patients often differ greatly from general patients, in terms of their moods and emotions. This research involved an empirical study, whose subjects were 590 customers of general clinics and 339 customers of gynecology clinics, in various medical centers in southern Taiwan. By factor analysis, the study established four influencing factors, which were "Medical professionals", "Nursing professionals", "Service personnel" and "Space and facilities". Using the Linear Structural Relation Model (LISREL), it found that medical professionals, nursing professionals, service personnel and space and facilities were effective predictors of medical treatment satisfaction. We also found that the greatest positive impact on overall medical treatment satisfaction resulted from rises in satisfaction with medical professionals, but that the least impact was achieved in relation to service personnel in the general and gynecology clinics.

User friendly web site a winner. San Diego's Sharp HealthCare provides wealth of information.

The Sharp HealthCare, San Diego, web site, a winner of the 2002 Medicine on the Net Web Excellence Award, provides a wealth of information without wasting space or confusing the visitor. The web site, www.sharp.com, can be viewed in both English and Spanish, a valuable consideration for those living in the California-Mexico border area served by Sharp. The integrated health network operates seven hospitals and three medical group practices. It has 2,541 physicians on medical staffs and more than 11,000 employees.

Spartanburg attracts moms-to-be with a variety of media. Campaign pieces have won numerous awards.

Spartanburg Regional Healthcare System, based in Spartanburg, S.C., uses a variety of media to attract moms-to-be and other women to its many services. The award-winning campaign was cited by The National Federation of Press Women with nine awards and a First Place Sweepstakes Award.

Unsubstantiated claims in patient brochures from the largest state, provincial, and national chiropractic associations and research agencies.

OBJECTIVE: To determine the presence or absence of claims for the clinical art of chiropractic that are not currently justified by available scientific evidence or are intrinsically untestable. DESIGN: A survey of patient education and promotional material produced by national, state, and provincial societies and research agencies in Canada and the United States. METHOD: Patient brochures were solicited from the 3 largest provincial, 3 largest state, and the 3 largest national professional associations in the United States and Canada. Similar requests were made of 2 research agencies supported by the national associations. Brochures were reviewed for the presence or absence of unsubstantiated claims. RESULTS: Of the 11 organizations sampled, 9 distribute patient brochures. Of these 9 organizations, all distribute patient brochures that make claims for chiropractic services that have not been scientifically validated. CONCLUSION: The largest professional associations in the United States and Canada distribute patient brochures that make claims for the clinical art of chiropractic that are not currently justified by available scientific evidence or that are intrinsically untestable. These assertions are self-defeating because they reinforce an image of the chiropractic profession as functioning outside the boundaries of scientific behavior.

Regional health systems address many audiences. Baptist uses language of the bard.

Regional health systems address many audiences. The winners in this category are: Baptist Health Systems of South Florida, Coral Gables, Fla., first place; Memorial Hospital & Health System of South Bend, South Bend, Ind., second place; and Orlando Regional Healthcare, Orlando, Fla., third place.

Strategic positioning. Part 1: The sources of value under managed care.

Part 1 of this series organizes and discusses the sources of value against a background of an evolving managed care market. Part 2 will present, in more detail, the marketing and financial challenges to organizational positioning and performance across the four stages of managed care. What are the basic principles or tenets of value and how do they apply to the health care industry? Why is strategic positioning so important to health care organizations struggling in a managed care environment and what are the sources of value? Service motivated employees and the systems that educate them represent a stronger competitive advantage than having assets and technology that are available to anyone. As the health care marketplace evolves, organizations must develop a strategic position that will provide such value and for which the customer will be willing to pay.