Medical device manufacturers are responsible for designing, developing, and producing medical devices that are used to diagnose and treat diseases. Medical devices are a vital part of our everyday lives. They are used in hospitals, homes, and other places where people need access to medical care. 

The medical device industry is one of the fastest-growing in the world, and it is expected to grow even more in the coming years

But the industry is confronting many challenges that can make things difficult for new or established companies. Fortunately, enterprise resource planning (ERP) software is available to meet many of those challenges and help medical device manufacturing companies grow. 

Read on how an ERP can help your business beat the competition.

What Are the Challenges Facing the Medical Device Manufacturing Industry?

The medical device manufacturing industry has faced many struggles, but some stand out more than others.

The cost of manufacturing

Cost is an issue for all industries, but the medical device industry has to deal with a much more sophisticated product. Medical devices are a very lucrative industry, but it is also a costly one to be in. 

The cost of manufacturing medical devices has increased dramatically over the years. This has been due to the increase in complexity and sophistication of these devices.

The regulatory environment

Medical device regulations are a highly regulated area. Medical devices are classified based on their potential risk to the patient, and the level of regulatory control required to ensure the safety of patients is proportional to the risk associated with that device. 

Many different types of medical devices need to be manufactured according to strict standards and guidelines to be allowed on the market. A number of health agencies around the world, such as the FDA, ISO, and ASTM, have developed these guidelines.

And it’s not just about having one set of standards that applies everywhere. These regulations vary from one country or region to another, depending on which agency has jurisdiction over them. Many companies cannot keep up with the evolving standards since they must constantly update their products.

Quality control

Making sure every single product that goes out is up to standard is literally a matter of life and death for medical device manufacturers. Minor defects or mistakes can lead to lawsuits, fines, and even closure. 

This means manufacturers have to spend extra time and money on quality control.

Research & Development 

R&D is always an essential part of any company, but it can be complicated in the medical industry. Medical devices are regulated by the FDA and must undergo extensive testing before they can be released to the public. This creates a lot of work for developers who want to create something that will help people and meet regulations.

Labor shortage

The medical device manufacturing industry is facing a shortage of qualified workers. The industry needs more than 1 million new workers to meet the demand for medical devices. The labor shortage is due to several factors, including retirements, an aging workforce, and an increased demand for healthcare products.

The U.S. Bureau of Labor Statistics says that there will be a need for more than 1 million new workers by 2024 in this field because many current employees are retiring, and not enough young people are entering to replace them.

How an ERP Can Help Your Medical Device Manufacturing Business

ERP stands for enterprise resource planning. This software provides a centralized database for managing data, information, and resources.

These systems are the backbone of any modern business today. They help automate and streamline the company’s various operations, leading to increased efficiency and productivity. 

These are the specific ways an ERP can help your medical manufacturing company.

Improve your bottom line

An ERP can help you to minimize your operating costs. It can help you to track the inventory, manage invoices, and forecast future sales. This reduces wastage and helps boost productivity. Most likely, you will eventually see a significant boost to your bottom line,

Adhere to regulations

In the medical device industry, regulations are critical. Using an ERP can help medical device manufacturers adhere to regulatory requirements and reduce errors in the manufacturing process.

An ERP can help to ensure that all regulatory requirements are met promptly, and it will also give visibility to potential issues before they arise. This is especially important for medical devices, as mistakes could seriously affect patients.

Improved quality control

A good ERP solution will be able to create detailed reports on the production process, which can help identify and correct any errors or omissions.

An ERP system can help manufacturers manage their quality control processes. It can automate many of the tasks involved in this process and streamline the workflow between departments. This will make it easier for manufacturers to identify any product issues before reaching consumers.

Streamlined R&D

An ERP can help with research and development by providing a central hub for all the information. It is a system that facilitates data flow between departments, including engineering, marketing, and production. In addition, the system helps manage various functions such as manufacturing cost control, product development management, etc.

With an ERP system, companies can keep track of all their operations without relying on paper records or outdated manual processes.

Combat the labor shortage

Improved efficiency means you won’t need to hire as many employees. An ERP will free them up from menial tasks through automation. This means they can focus more on the skilled aspect of production.


Healthcare is an essential industry, and medical device manufacturing is a crucial part of it. ERPs can be used to combat the significant issues facing the sector through improved efficiency, visibility, and productivity.

If you want to start using an ERP, Confianz can help you every step of the way. Acumatica’s manufacturing ERP will help you manage every aspect of your manufacturing business in one place, and boost efficiency with a comprehensive, mobile, manufacturing ERP designed for your unique needs. Confianz offers Acumatica consultation and help with Acumatica Implementation.

There are a number of different Acumatica Editions available for you to choose from which include Acumatica Distribution ERP, Acumatica Construction ERP, Acumatica Manufacturing ERP, Acumatica retail commerce ERP, and Acumatica service management ERP.

Acumatica Cloud ERP is the most powerful cloud-based ERP solution available for small to medium-sized businesses. If you’re wondering if Acumatica ERP is the right ERP for you, we can help! Our team of experts can help you choose the right ERP for you and guide you through implementation.

So give us a call today to get started!

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