Medical Devices
Medical Devices
For many patients, medical devices deliver valuable relief from critical, yet failing, anatomical mechanisms within their body. An implantable cardioverter – defibrillator (ICD) is one such device that, when implanted into the upper left torso, delivers high voltage jolts of electricity to patients who are at risk for life-threatening arrhythmias. Ultimately, they have the potential capacity to resynchronize one’s cardiac rhythm to the extent that imminent death may be averted. Although ICDs provide tremendous value within the context of medical care, they serve to represent an industry that is entangled in a web of wooly regulation, device flaws, and moral ambiguity in physician use and discussion of the device. In order to wholly depict the various facets of these three problems with ICD use, manufacturers, consumer advocacy organizations, the FDA, and hospital’s perspectives will need to be discoursed. Manufacturers in particular face many implications derived from these three problems.
Companies such as Medtronic, St. Jude’s, and Boston Scientific manufacture ICDs for patients around the world. These corporations, and others within the industry, face fierce competition in a declining market, implausible excise taxes, and product deficiencies leading to harmful outcomes. In an article written by Mark Hollmer in the Fierce Medical Devices magazine, competition between manufacturing companies is explicitly highlighted. “The fight amounts to a war of diminishing returns, considering that cardiac rhythm device sales have long been on a downward trend, battered by the global economy, reimbursement and pricing pressures” (Medtronic, Boston, Hollmer 2013). This competition has been problematic for manufacturers, as it has led to deceitful and misleading promotional campaigns in pitches to physicians and other product purchasers. With declining market demand and strong competition stressing budgets, a new excise tax was added, which added additional
For many patients, medical devices deliver valuable relief from critical, yet failing, anatomical mechanisms within their body. An implantable cardioverter – defibrillator (ICD) is one such device that, when implanted into the upper left torso, delivers high voltage jolts of electricity to patients who are at risk for life-threatening arrhythmias. Ultimately, they have the potential capacity to resynchronize one’s cardiac rhythm to the extent that imminent death may be averted. Although ICDs provide tremendous value within the context of medical care, they serve to represent an industry that is entangled in a web of wooly regulation, device flaws, and moral ambiguity in physician use and discussion of the device. In order to wholly depict the various facets of these three problems with ICD use, manufacturers, consumer advocacy organizations, the FDA, and hospital’s perspectives will need to be discoursed. Manufacturers in particular face many implications derived from these three problems.
Companies such as Medtronic, St. Jude’s, and Boston Scientific manufacture ICDs for patients around the world. These corporations, and others within the industry, face fierce competition in a declining market, implausible excise taxes, and product deficiencies leading to harmful outcomes. In an article written by Mark Hollmer in the Fierce Medical Devices magazine, competition between manufacturing companies is explicitly highlighted. “The fight amounts to a war of diminishing returns, considering that cardiac rhythm device sales have long been on a downward trend, battered by the global economy, reimbursement and pricing pressures” (Medtronic, Boston, Hollmer 2013). This competition has been problematic for manufacturers, as it has led to deceitful and misleading promotional campaigns in pitches to physicians and other product purchasers. With declining market demand and strong competition stressing budgets, a new excise tax was added, which added additional
References: Carreyrou, J., McGinty, T. “Taking double cut, surgeons implant their own devices.” Wall Street Journal online, October 8, 2011. Available at:http://online.wsj.com/article/SB10001424 053111904106704576582621677354508.html Carroll, L Economist, The. “Left to their own devices.” 400(8750):71-73, 2011. Available at: http://www.economist.com/node/21528644 Harris, G Hollmer, M. “Budget battles hold new FDA user fees hostage.” FierceMedicalDevices, March 4, 2013. Available at:http://www.fiercemedicaldevices.com/story/budget-battles-hold-new-fda-user-fees-hostage/2013-03-04 Kaiser Health News Meier, B., Thomas K. “Troubling flaws in heart device shake industry.” New York Times, April 7, 2012, p. A.1.http://www.nytimes.com/2012/04/07/health/flaws-in-st-jude-heart-defibrillator-shake-the-industry.html?pagewanted=all Reinberg, S Spencer, J. “Med-tech firms fight tax on devices.” Star Tribune, September 8, 2011, p. D.1. Available at:http://www.startribune.com/business/129425158.html Thomas, K