Are Medical Devices an Area of Great Promise or Peril?

Jun 21, 2024
Medical DevicesMedical Devices


Medical devices have been the boon of modern healthcare as they help in the accurate diagnosis and management of diseases. Companies manufacturing such devices bear the heavy responsibility of ensuring their efficacy and safety. 

In the US, the Food and Drug Administration (FDA) regulates the circulation of such devices. The same is handled by the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK. 

For decades, these devices have helped medical professionals to serve patients better. As per Statista, the market for such tools continues to grow at a CAGR of 5.71%. Despite such statistics, is the world of medical device manufacturing and usage all-rosy?

In this article, we will discuss both sides of the scale. Read on to find out whether medical devices are a promise or a peril to healthcare providers and patients. 

Significant Contributions Made to the World of Healthcare 

Let’s begin by discussing the different contributions medical devices have made to the world of healthcare. These are the reasons why they have been an industry staple for decades. 

Better Patient Outcomes 

Every healthcare institution strives to improve patient outcomes through more advanced and effective treatment options. From cardiac pacemakers to ear implants, the world of medicine has progressed light years towards robotic surgery systems and power diagnostic tools. 

These technologies and devices are designed to enhance a patient’s quality of life despite major health conditions or injuries. Overall outcomes improve in the following ways –

  • Early detection of life-threatening conditions becomes possible. 
  • With early disease diagnosis, relevant treatment options can be made available. 
  • Surgeons can perform less complicated surgeries but more successful ones. 
  • Healthcare providers can track their patients’ progress remotely. 
  • Even medical management becomes easier with smart drug deliveries and adjustable drug dosages.  

Reduction of Errors 

Any medical activity solely conducted by humans is vulnerable to inaccuracies. Though technology may also glitch, the instances of errors are significantly reduced with medical devices. 

One key area where healthcare professionals, like nurses, made mistakes often was the administration of anesthesia. Occurrences of over or under-administration were commonplace. The rate of these errors may be reduced with smart medical devices. They come equipped with in-built safety features that regulate the dosage. 

Lower Healthcare Costs 

It is important to note that the upfront cost of purchasing a medical device can be considerable for a healthcare institution. Some of the costliest equipment for the medical industry are PET scan machines, surgical robots, Proton Beam Therapy Systems, and CT scanners. 

Then there are relatively smaller and less expensive ones like oxygen concentrators and ultrasound machines. Whether big or small, such devices are designed to reduce staff involvement to a large extent. As hospitals save on labor costs, they can redistribute the expenses associated with the devices. 

This is why the overall outcome is such that healthcare costs for patients may be reduced. What’s even more cost-effective is the possibility of availing home-based healthcare instead of a clinical setting. 

The Scares Involved 

Though medical devices have much to offer, they can also come with many downsides. Let’s look at a few of them. 

Design Defects 

At the end of the day, medical devices are a form of technology prone to defects or flaws during the manufacturing stages. Poor quality control measures can make any device high-risk as it leads to debilitating injuries. 

One example would be the Bard Power Port, a catheter port used for therapies requiring vascular system access. As per TorHoerman Law, it is believed that the port’s body, made of a polymer called Chronoflex AL, disintegrates. 

As it breaks apart, it migrates to different areas of the body, thereby causing deep vein thrombosis, necrosis, and other serious issues. In some cases, the manufacturer, Bard Access Systems, kept even healthcare providers in the dark about such complications. 

The injured have filed the Bard Power Port lawsuit to seek legal justice. The litigation is still ongoing, with over 200 cases awaiting resolutions. On average, attorneys believe that the Bard Power Port lawsuit settlement amount may range from $10,000 to $250,000. 

This product came into much negative light as the Food and Drug Administration (FDA) issued Class 2 recalls for three different models. Today, the device is available even across the UK, albeit warnings have been issued. 

Supply Chain Disruptions 

Any product that is sold commercially only reaches its customer when the supply chain moves undisturbed. Sadly, this may not always be the case. Medical device vendors may struggle with supply chain disruptions that threaten to delay or stop supply altogether. 

Besides unexpected delays, disruptions may persist due to the following reasons –

  • Labor challenges or shortages 
  • ‘Dearth of raw materials 
  • Constraints on sterilization 
  • Shortfalls in the order 
  • Unforeseen surges in demand 
  • Natural disasters 

Let’s wind up with a surprising piece of information shared by the World Health Organization. The current medical device market houses over two million different products across 7,000 generic categories. 

There is no doubt that such devices have made modern healthcare a blooming success. However, all this does come at the cost of occasional perils that affect the patient, healthcare facility, as well as the device manufacturer.

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