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Biomedical subjects

J A Kates

Publications and source records attributed to J A Kates.

2 recordsLinked to original sources

Regulatory hurdles in bringing an in vitro diagnostic device to market.

We discuss the hurdles that developers and manufacturers of in vitro diagnostic devices face in obtaining regulatory approval to market their products in the US. A thorough understanding of medical device regulation and the early planning of a clinical and regulatory strategy are imperative in assuring successful and timely launches of new products. Finally, it is critical for manufacturers to establish a working partnership with the Food and Drug Administration to expedite their new product applications.

Consumer Product Safety↗

Developing mobile lithotripsy services.

Today's health care environment forces hospitals to seek competitive advantages over other providers in their area, yet circumstances and situations exist where cooperation among providers is the only way to ensure the effective and efficient provision of quality care to area residents. In the case of new and expensive medical technology, cooperation may be necessary to make state-of-the-art treatment modalities available to the patient population in an affordable manner. The role of outside consultants and legal counsel should not be overlooked. Independent consultants can be a valuable resource in dealing with planning agencies and in preparing a Certificate of Need. In addition, reputable firms can lend additional credibility to the conduct of feasibility studies and the preparation of financial projections. Continuity in terms of staffing and committee representatives is also extremely important. In a process that covered a three-and-one-half year time period, participants can lose sight of the original goals of the venture and even interest in the project. Hospitals and physicians in northeastern Pennsylvania combined to provide an alternative to surgical intervention for the removal of kidney stones. The process was a lengthy and complicated one, but one that resulted in a service which, above all, is of benefit to those affected by kidney stone disease. The delivery network currently includes seven facilities, five as partners and two on a fee-for-service basis, with an additional five making application to join the program in the future.(ABSTRACT TRUNCATED AT 250 WORDS)

Certificate of Need↗