What Issues Do Medical Device Companies Face?

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Medical device manufacturing is a highly lucrative industry. Yet, it can also be incredibly difficult to navigate. 

On the one hand, there’s an ever-increasing demand for medical device technology, which points to a reasonably bullish industry. While on the other hand, the medical manufacturing business constantly faces numerous headwinds that often threaten its efficiency. These challenges range from stringent regulations to inhibitive product costs, quality control issues, and supply chain management problems, to mention but a few.

Understanding how to overcome the various challenges in the medical supply business is essential before diving into the industry. That’s regardless of how you wish to invest in the sector. 

This article details all the major issues commonly faced by medical device companies, along with recommended solutions. But first things first.

Why the Interest in Medical Device Manufacturing?

As we’ve already indicated, the medical device business is among the world’s most successful industries. Medical supply manufacturing is the central pillar of the global healthcare sector. 

The past few years have witnessed a tremendous demand for medical device technology, with the United States accounting for much of this demand. 

According to 2021 market research, the medical device market may hit USD 657.98 billion by 2028. This study cites an increased senior population and a growing trend toward therapeutic and rehabilitative treatments as the market’s fundamental driving forces. 

With such tremendous growth potential, it’s not surprising that millions of investors worldwide have their eyes fixed on medical device manufacturing. However, stakeholders in this lucrative sector can only realize meaningful gains if they’re adequately prepared for the market’s everyday challenges.

Issues Facing Medical Device Companies

1. Quality Control Problems

Quality control issues are closely related to regulatory obstacles. Medical equipment that does not meet the required quality threshold is always subject to recalls or discontinuation. 

Now, there are numerous medical device manufacturers like Quasar who strive to produce premium-quality gadgets. But considering the high-stakes industry in which the medical device business operates, there’s always room for errors and oversights. 

There will be times when medical gadgets leave the manufacturing plants with software malfunctions, and non-conforming components, among many other quality issues. Problems may also arise during routine inspections, resulting in a temporary hold on a company’s operations. 

Again, this underscores the importance of having medical devices inspected thoroughly before leaving the industrial plants. Manufacturers should also implement routine inspections to ensure their products remain in peak condition.

2. Regulatory Obstacles

Medical device manufacturing operates within a constantly-shifting legal environment. Therefore, keeping abreast of the industry’s ever-changing regulations may be challenging. 

Manufacturers have to contend with inconsistent language and product standardization. Such discrepancies make it exceedingly difficult to determine whether a device meets the minimum regulatory threshold in a given jurisdiction before shipping it there. 

The most effective solution to this challenge is to aim for the highest quality levels for each product. Manufacturers can also consider setting up regulatory compliance committees that offer invaluable insights into the prevailing laws and regulations. 

Below are some of the main regulations that medical equipment manufacturers must adhere to;

  • ISO 13485 – A compliance standard requiring medical device manufacturers to implement a quality management system at all times.
  • ISO 14971 – A standard requiring manufacturers to apply risk management to their products. 
  • 21 CFR 820 – This regulatory standard refers to the safety and efficient application of medical devices. 
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3. Counterfeits and Imitations

This is another pervasive challenge faced by medical device manufacturers, and it has a lot to do with the increasing demand for these technologies. 

The biggest threat posed by counterfeits and imitations is that they redirect revenues from genuine medical device makers. If these gadgets are made from substandard technology, they can also endanger the lives of their end users. 

Medical device manufacturers can overcome this challenge by implementing an efficient system verifying their product’s authenticity.

For instance, manufacturers can deploy blockchain technology to assign their products a unique code. Suppliers and end users can then utilize the technology to verify the authenticity of a product before receiving it.

4. Inhibitive Healthcare Costs

It’s essential to manufacture high-end medical supplies. But if the end-user cannot afford the associated healthcare costs, these devices may never yield the projected return on investment (RoI). 

It’s an open secret that healthcare costs remain inhibitive in the United States and many countries worldwide. And part of the problem is linked to the high cost of producing and operating medical equipment. 

Unfortunately, lowering the upfront cost of most medical gadgets isn’t something that can happen overnight. That’s because the cost of producing these devices largely depends on the relevant taxation policies. 

One practical solution to this dilemma would be to lower the cost of operating expensive medical equipment by sponsoring operator training programs. Manufacturers can also look in the direction of disposable as opposed to reusable products. 

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5. Supply Chain Issues

The COVID-19 pandemic uncovered how fragile the medical device supply chain could be. Various COVID-19 containment measures across different countries resulted in massive medical equipment supply disruptions. 

Without prompt interventions, these disruptions can easily cause delayed deliveries of medical devices, further reflecting negatively on the supply costs. Besides, the delays may prevent raw materials from getting to medical device manufacturing plants, causing production bottlenecks. 

Manufacturers can overcome supply chain issues by opting for more flexible logistical chains. This entails obtaining raw materials from multiple sources while collaborating with numerous distributors. That way, a disruption in one supply chain will not cause logistical nightmares. 

There’s also the option of implementing Internet of Things (IoT) technologies in the supply chain for efficient tracking of shipments.

6. Cybersecurity

Cybersecurity is a real threat to medical device manufacturing. Initially considered the bane of financial institutions, the scourge of cybersecurity has since penetrated healthcare institutions. It’s no longer uncommon for hackers to gain unauthorized access and tamper with confidential patient records. 

The problem of cybersecurity in medical device manufacturing primarily results from the implementation of innovative factory technologies. As companies opt for cutting-edge security technology, they inadvertently grant more access points to malicious hackers. 

To navigate these bottlenecks, medical equipment manufacturers should consider hosting IoT gadgets on separate networks from their machinery database. 

Other practical interventions include frequent software updates and training employees on basic cybersecurity. 

Final Word

Medical device manufacturing is a complicated sector that requires a careful approach. Therefore, manufacturers must constantly collaborate with other industry stakeholders, such as the government and technology solution providers, to increase efficiency.