The medical device industry has been experiencing considerable growth over the few years. However, it faces challenges and disruptions for different reasons as setbacks slow the rate at which enterprises operate, from the supply chain to financial expectations. Here are a few of the biggest setbacks being faced by the industry of medical device manufacturing.
Cyber Security Concerns
The industry has been introduced to digitalisation methods such as artificial intelligence and robotics, thanks to the fourth industrialisation causing things to be easier, faster and efficient. Nonetheless, the same technological advancements have paved the way for cybersecurity threats. For example, in 2017, the National Healthcare Service UK attack immobilised the country’s healthcare department’s computer systems. The vulnerability of these systems causes potential security breaches as hackers would be able to access and tamper medical devices, negatively affecting product quality and recall rates as patients’ lives are at stake. Counterbalancing these threats and vulnerabilities is impossible.
As a form of resolution, authorities put specific reporting tools on devices so that performance and risks can be tracked and identified easily.
Since May 2020, the Coronavirus has infected over four million people, affecting the medical industry tragically. With such strains, efficacious delivery of medical services is demanding. Medical device manufacturers are hindered as well. Before receiving authorisation and certificates, most medical devices undergo several clinical trials, both pre-market and post-market. The ongoing pandemic has become challenging to make informed decisions concerning the supply chain, general market, products, and regulatory obligations.
Productivity is also affected during the pandemic. Some firms cut quality costs to downsize, making it difficult to maintain productivity.
Intricate Regulatory Requirements
Medical device manufactures have to follow thorough guidelines. For example, all manufacturing professionals must report any adverse issue urgently. Furthermore, firms must maintain a high public sanitation and health level while keeping patient safety in mind.
Healthcare industries would find it hellish to deliver excellent service in emergencies.
High Cost of Production
Manufacturers have to cater to rent, quality costs, materials to make the device so that the product is ready to be introduced in the market. Therefore, the average cost of the device will be decided through a combination of all these costs in the end. This is not the only project companies focus on, causing a strain in funding.
One in every ten medical devices is of substandard quality, causing a challenge to the industry. With compromised devices making their way into the market, faulty end products are forcing legit businesses legally vulnerable. As a result, these fraudulent products would make buyers lose their trust in the industry as they already have such products to work on.