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The Dark Side of Selling Fast Hope in Medical Devices

The world has seen an explosion of new research in medical industry, but every barrel has its rotten apples.

Over the past decade, the world has seen an explosion of new research and the invention of medical devices that offer hope to patients who had none before. Market demand is a driving force in the fast-track approval of new medical devices, but there is a dark side and now we are confronted with the question of how fast is too fast and at what cost. It is a deadly game when the device is implanted in a patient, only to discover down the road that the device was recalled.

Low Hurdles for Approval

In an effort to reach their most valued target audience, device manufacturers use a number of popular media forms for advertising. Sufferers of the condition will see the ad and rush to their physician demanding the relief from both chronic and life-threatening conditions that these devices offer. Many times, these are the people who are battling the serious chronic illnesses like T1 diabetes, Alzheimer, and other conditions that leave them in a constant struggle - and will do just about anything to make their daily lives at least a little more bearable. However, there is more to the story than they often realize.

The consumer assumes that medical devices must undergo the same rigorous scrutiny as medications and pharmaceuticals, but this is not necessarily the case. The UK is currently in a transition regarding the introduction of guidelines that offer more rigorous vigilance and reporting requirements for medical device manufacturers than the relatively low standards.

Theranos Fraud Case

The Theranos Fraud Case is perhaps one of the best examples of the types of deception that can occur when the desire to make profits overrides attention to placing the patient first.

Research and development is the most capital-intensive stage of the development process for medical devices. This is true both in the US and the UK. This creates investor pressure to get the device out onto the market so that the company can become profitable as quickly as possible.

In the Theranos case, Elizabeth Holmes was a rising star and CEO who committed one of the biggest cases of investor deception, nearly destroying the company in the process. In this case, Holmes claimed that she invented a device that eliminated the need for going to a lab and having large amounts of blood drawn for tests.

She claimed that her device would allow patients to have laboratory-grade results with a small amount of blood from the prick of a finger. Of course, the medical community was excited about this invention and invested close to US$700 million. In the end, it turns out that there was no such device and she was having the samples sent off to a standard laboratory for analysis.

A System in Need of Overhaul

The Theranos Case is an example of a system that is in need of an overhaul and stronger oversight on both sides of the Atlantic. One example is the implantation of hip and knee replacement devices. Nearly 160,000 people in England and Wales undergo total hip and knee replacements every year. Due to the high short-term rate of failure of some devices, hospitals must now send records to a national registry to determine failure rates for specific devices.

In the past, no such registry existed and when it came to litigation over the failure of a device, it was often difficult to prove manufacturer defect or inadequate engineering. Many patients suffered irreversible bone damage, soft tissue damage, and exposure to high levels of metal in their bloodstream as a result. These new regulations are one step closer to giving consumers the power of knowledge regarding these procedures and devices.

Medical device manufacturers that rely on consumer trust in the medical profession as their main selling point may face more difficulties as new regulations raise the standards for medical device approval and failure tracking. The rush to give patients hope and end their suffering has resulted in the system that has failed patients on many levels, including undermining their trust of the medical establishment.

These new regulations will create a new atmosphere where medical device manufacturers will shoulder full responsibility for their actions. This may slow the flood of new medical devices coming to the market, but in the end, the patient will have the benefit of peace of mind that these devices are safe and reliable.

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