The medical device industry has been experiencing notable growth over the past few years. However, like in any other industry, it is also faced with challenges and disruptions for different reasons. These setbacks slow the rate at which industries operate, from the supply chain to financial expectations.
Here are some of the most prominent challenges facing the medical device manufacturing industry
1. Cyber Security Concerns
Thanks to the fourth industrialization, the industry has been introduced to digitalization methods such as artificial intelligence and robotics. These have modernized the process, making things easier, faster, and more efficient. However, the same technological advancements have paved the way for the cybersecurity threat. For example, in 2017, the National Healthcare Service UK was attacked, paralyzing all the country’s healthcare department’s computer systems.
These systems are vulnerable. This potential security breach can be a leeway for hackers to access medical devices and tamper with them. Such cases of technological insecurity can negatively affect product quality and recall rates. There is a high likelihood for patients to get harmed.
It is impossible to neutralize these threats and vulnerabilities. However, responsible authorities are going the extra mile to eradicate it by making it mandatory for specific reporting tools to be placed on the devices. This way, the performance can be tracked and risks identified.
2. COVID-19 Pandemic
By May 2020, more than four million people had already been infected with the Coronavirus. The world experienced distractions, and so did the medical device industry. The healthcare industry was overwhelmed, making delivering medical services to patients challenging. Medical device manufacturers, which heavily rely on these healthcare facilities, were also impacted. Before receiving authorization and certificates, most medical devices must undergo several clinical trials, both pre-market and post-market. As the pandemic continues to unfold, these forms find it hard to make informed decisions concerning the supply chain, general market, products, and regulatory obligations. As much as it would be easier to take the headless action, such protocols still have to be followed. This is the time when quality matters most.
Another effect of the pandemic was on productivity. Most firms had to make changes to maintain productivity while still abiding by the COVID19 guidelines. Some even had to downsize to cut workmanship costs.
3. Intricate Regulatory Requirements
There are rules, government guidelines, and regulations that medical device manufacturers have to follow. For example, all manufacturing professionals must report any adverse issues and events as early as possible. The firms must also maintain a high public sanitation and health level while keeping patient safety in mind.
However, other regulatory requirements are complicated enough to tamper with medical devices’ availability to the public. In the long run, this affects the healthcare industry because it becomes harder to deliver quality service during emergency health conditions.
4. High Cost of Production
It takes a lot of mental and financial effort to develop a medical device from just an idea to a realization. Many expenses are incurred before the product is ready to be introduced to the market. Manufacturers must cater to rent, workmanship costs, materials to make the device, and many others. Therefore, the general price of the device will be dictated by all these costs in the end. No wonder people find some of these devices too expensive.
Apart from paying the costs, the company must cater to other projects and research processes that need funding.
5. Counterfeit Products in the Market
Did you know that one in every ten medical devices is substandard? This is a big challenge to the industry, especially from a risk perspective. Compromised devices have made their way into the market, leading to faulty end products and making legit businesses legally vulnerable. When they work with these fraudulent products, buyers lose their trust in the industry.
Even though there are so many uncertainties surrounding the industry, it is still standing strong and ready to face the new world ahead.