Pharmacy & Therapeutics - June 2008 - (Page 358)

Evaluating and Standardizing Medical Devices stay, as well as improvements in outpatient revenue, cash flow, occupancy, and accounts receivable.5 Value and service packages might also go beyond supporting the physical features of a product and might aim to improve outcomes for postoperative infections, ulcers, cardiac arrest, gastrointestinal bleeding, and urinary tract infections.5 Other factors to consider are the time, expense, and convenience associated with training, maintenance, space requirements, ease of use, portability, access, storage, and the need for refrigerating or freezing the product in question. Sheri Dodd remarked, “As a smart manufacturer, we would have our submission packages to a hospital’s new technology committee try to address why our product would have a minimal negative impact on an operating room or a system.” Accreditation status and value-added services may be a means by which hospitals can base their choice of vendor whenever feasible. this trend beginning with baby-boomers, and we certainly expect it to continue with generations X and Y. For example, few women will accept an open hysterectomy as their only option in light of the myriad of alternative procedures available to them which are either minimally invasive, or—in some instances—uterus-sparing, which enable them to resume their normal, daily life in a matter of hours or days, as opposed to weeks. For us, the patient is clearly driving most of our innovation. Patients are acquiring more power in the health care supply chain, and their preferences are influencing manufacturers, physicians, and hospitals. Emerging Trends Whether all hospitals and systems will adopt a VAT or another type of in-house analytical committee remains to be seen.4 Group purchasing and consulting firms have created an industry around value analysis and product standardization.4 These services are increasingly being offered to hospitals as an alternative to internal product assessment.4 However, Dr. Nash sees these groups as not being “realizers.” He stated that “it’s a third-party action and a technology assessment rather than a P&T committee review, which would be more practical.” The role of agencies such as the FDA or the Agency for Healthcare Research and Quality (AHRQ) might also be expanded to provide uniform standards, guidance for product evaluation, and regulation of off-label use.4 However, physicians believe that national standards are not an adequate substitute for the local determination of product equivalencies.4 It is thus uncertain whether determinations of product equivalencies made by a governmental agency would be widely accepted.4 Rather than an increasing influence by regulatory agencies, patients are beginning to have more input in determining their medical care. Although physicians, hospitals, device manufacturers, and insurers have traditionally been the primary players in determining medical device usage, patients are playing an increasing role as they learn more about new technologies.13 Because of the ability to access information sources such as the Internet, patients are becoming more educated about choices of manufacturers, surgeons, products, and procedures.2 Patients are acquiring more power in the health care supply chain, and their preferences are influencing companies, physicians, and hospitals.4 Patients have become increasingly knowledgeable about— and expect minimally invasive (and, in some cases, noninvasive)—procedures that minimize scars and soft-tissue trauma and allow a more rapid return to normal life.2,9 Companies are working diligently to develop techniques and products that support such procedures.2 Christine Maroulis notes: There’s clearly a shift in the population. Patients are increasingly demanding minimally/noninvasive procedures, and they will actively seek hospitals and doctors who will perform them. We’ve seen Patient spending accounts and high-deductible health plans may also cause patients to become more vocal in expressing their preferences for certain products or medical procedures.4 They are often not as concerned about expense, because a high-cost medical device, unlike a drug, is a one-time expenditure that will often last the remainder of their life.2 Patients are driving demand, and a hospital’s failure to offer the products and procedures they expect may mean diminished access to those patients.9 Christine Maroulis observed: Most hospitals that are offering these really neat, innovative, minimally invasive surgeries are often doing it partly as a public relations strategy. It’s possible that these procedures won’t be financially attractive to them, but they often adopt them because they acknowledge that they will likely attract more patients and their families to the hospital because they offer these options for women. The trend of an increasing influence of patient demands also raises debate about direct-to-consumer (DTC) advertising by manufacturers.4 Spending for DTC advertising of medical devices grew from almost nothing in 1996 to nearly $50 million in 2005.4 More than 25% of medical device manufacturers now report engaging in DTC campaigns.4 As this practice attracts more controversy, it may trigger increased regulatory intervention that could inhibit commercial influence on patient preferences.4 Another emerging trend is the integration of other therapies, such as drugs or biologics, with medical devices to offer promising new products to surgeons.9 Dr. Vogenberg observed, “We are seeing an explosion now in biotechnology and nanotechnology that will really expand during the next 5 to 10 years that is based on research done in the late 1990s, so there is really a logical flow to how things move through the intellectual pipeline.” Sheri Dodd also commented: Drug–device combinations, biosurgicals, regenerating tissue, and other breakthrough innovations are the future for a lot of [devices], which will naturally follow development pathways that are similar to pharma programs (i.e., phase 1, 2, and 3 [clinical trials]) for safety and efficacy, with economic evaluation generated in real time. Next-generation cell therapy practices are expected to combine allogenic and genetically modified cells with advanced bio- 358 P&T® • June 2008 • Vol. 33 No. 6

Table of Contents Feed for the Digital Edition of Pharmacy & Therapeutics - June 2008

Editorial Aliskiren Reduces Plasma Renin Activity Medication Errors Prescription: Washington New Drugs/Drug News/ New Medical Devices Drug Forecast Challenges in Evaluating and Standardizing Medical Devices in Health Care Facilities California e-Pedigree Rules Pose Challenges For Pharmacies Pharmaceutical Approval Update American Psychiatric Association At a Glance: Dermatology Trends in Managed Care

Pharmacy & Therapeutics - June 2008

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