3 Unique Business Challenges Medical Device Manufacturers Must Overcome

It is a well-known fact that healthcare is one of the most tightly regulated industries out there. This is for a good reason because matters in this field can quickly become life-and-death issues. The same holds for medical device manufacturing. 

It is the process of creating, assembling, and packaging medical devices or equipment generally used by healthcare providers. These products can be produced under various categories, including therapeutics, diagnostics, implants, and so on. 

As per Statista, the medical device manufacturing market in the US is expected to become $253.9 billion by 2029. The growth may seem slow, but it is only because of how challenging and complex the process of producing medical devices is. 

In this article, we will discuss three such challenges every company in this field must overcome. If not, the results can be devastating for the brand. 

Regulatory Compliance 

As mentioned earlier, the medical device manufacturing industry is highly regulated. Companies need to keep abreast with various compliance requirements before they can enter a market. 

This is especially true of those manufacturers that supply their medical devices internationally. There are several valid reasons behind the numerous regulatory frameworks. The most important of these is improving patient outcomes and well-being. 

Moreover, the aim is to enhance the originality and quality of the devices produced. If a medical device manufacturer fails to comply with the different regulations, they may face legal repercussions, suffer poor brand image, and find it difficult to enter into new markets. 

To tackle this challenge, it is important to stay up-to-date with organizations like the Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Also, businesses should house a team exclusively for compliance purposes. This team can even check a new country's compliance standards before expansion. 

Safety and Efficacy 

The truth is that safety and efficacy are requirements for any type of product manufacturing. They only become a lot more crucial in medical device manufacturing because these products can save or kill lives. 

By efficacy, we mean that a medical device should be able to perform exactly like its manufacturer has claimed. Let's take an example of this. Paragard is a fairly common medical device in the modern age used for birth control without hormonal intervention. 

Paragard IUD gained popularity because of its high success rate and fewer side effects compared to hormonal IUDs. Convenience is another plus point for the device as it works for years after being inserted in a woman’s uterus. 

However, another aspect to take care of is safety. This means Paragard should perform its function effectively without causing any serious complications. Sadly, this is where the device has failed. Patients have been severely injured by it. 

According to TorHoerman Law, patients have suffered from severe injuries and complications due to device breakage. Even worse, it may require surgical removal to prevent further damage. 

When something like this happens, what usually follows is litigation against the manufacturer. The same happened in the case of Teva Pharmaceuticals. Injured patients collaborated with a Paragard lawyer to file a lawsuit. The Paragard lawsuit states that the company was aware of the risks involved but chose to withhold the information from the public. 

Such problems can be overcome by focusing on regular staff training and integrating quality control measures within manufacturing. When a firm is proactive in these areas, it does not need to backtrack to fix issues or face legal troubles. 

Supply Chain Disruptions 

The two main areas that supply chain disruptions affect are product development and delivery. This process refers to an unforeseen event that ends up disrupting the normal flow of goods and services. Research has found that the 2024 supply chain is affected by technological advances and geopolitical developments. 

This will bring unique challenges in procuring the required raw materials. The process of manufacturing medical devices often requires specific materials. Losing access to any one of them can halt the entire production. When such issues arise, there is no single party to blame. 

They may seem inevitable at times but certain steps can lessen the impact. For instance, medical device manufacturers can diversify their vendor base instead of over-reliance on a single source. Moreover, tools like supply chain management software can be used to gain better control and visibility of the supply chain. 

This will enable the team to anticipate possible disruptions well in advance. Any issues can be mitigated or their impact can be minimized so that production or delivery are not delayed. 

According to McKinsey & Company, health system leaders often cite manufacturing shortages as well as inadequate forecasting as two of the greatest threats. This only shows how crucial timely production and delivery of medical devices is. 

In this article, we have discussed three of the major business challenges that this sector must overcome. Only then will medical device manufacturers be able to penetrate new markets, generate customers, and improve patient outcomes.