The healthcare industry is constantly evolving to maintain top-notch patient support. As such, medical device manufacturers are held to higher quality standards, are expected to stand behind their product quality, and must comply with FDA safety standards.
Manufacturers also have unique accounting and financial needs that are complex, regulated, and critical to the well-being of your business.
The combination of a challenging market and complicated business requirements means manufacturers are held to very high standards for tracking, reporting, and regulatory compliance.
Because of the challenges presented to medical device manufacturers, it’s worth considering medical device ERP software that enables your company to stay on top of business operations. We recommend the best-in-class Oracle NetSuite ERP platform. After addressing some of the challenges an ERP can solve, we’ll unpack why we recommend NetSuite.
Common Challenges for Medical Device Manufacturers
It can be challenging to stay up-to-date with quality control and compliance concerns for manufacturing and production while maintaining an effective supply chain and adhering to financial standards.
In fact, it’s acceptable for a medical device company to rely on other resources for critical business processes and financial responsibilities so you can better focus on improving manufacturing processes and producing quality devices.
Let’s look at three common issues that medical device manufacturers experience and how medical device ERP software can help you take on some of these issues.
1. Complying with Regulatory Standards
Medical devices are held to a higher standard than nearly any other consumer product. After all, they must be safe for use and traceable in the event of a negative outcome. For this reason, medical device manufacturers are highly regulated.
If quality standards aren’t met, it could be detrimental to the health of patients of all ages. Should something ever go awry, you also need to be able to trace down the portion of the manufacturing process or product that led to the negative outcome. As you can imagine, this is a challenging task, and it becomes more difficult to do the larger a company grows.
An ERP platform can help you manage, track, and report on all activity that goes into the production of medical devices.
- Track the raw materials used in the manufacturing process.
- Manage the supply chain to bring efficiencies to the process.
- Inform the business office of financial transactions during manufacturing.
- Centralize key data to generate reports for regulatory agencies.
Ensuring regulatory compliance isn’t just the right thing to do; it’s required. Manufacturers can be fined or shut down if they do not manage compliance appropriately. Using an ERP will help you produce data validating compliance with regulations.
2. Consistent Product Quality
There is no room for errors in the medical device manufacturing process. One wrong move could mean life or death for a patient. But, finding a way to produce similar results with consistent product quality can be tricky, even more so without the right software and technology.
Minimizing consumer recalls and patient complaints is critical to the overall success of a medical device manufacturer. So, heading off these issues before they arise or grow out of control is crucial to a business’s well-being.
Every device that a medical device company manufactures must be carefully tracked, noted, and submitted to the FDA for approval, which is why consistency is vital.
Using an ERP to track batch numbers, lot numbers, and serial numbers can help your company efficiently track down devices produced in a specific time frame when an unfortunate circumstance may have occurred. The process is very time-consuming when performed manually, but with an ERP, you can pull critical data in a few clicks.
3. Inadequate Business Processes
Above all, as a medical device manufacturer, your organization is a business at its core. While your mission is to support patients, your goal is to become profitable while adhering to industry standards and ensuring compliance.
Without the right software tools at your disposal, your efforts to manage processes, generate financial reports, and support operations will be tedious and prone to errors. The key to addressing this challenge is investing in ERP software that simplifies data-sharing:
- Generate cross-functional automation.
- Provide mobile access to documents and files.
- Ensure enhanced accessibility for end-users and stakeholders.
How NetSuite ERP Can Assist with These Issues
If you’re struggling with the concerns we identified, it’s time to consider a software platform such as NetSuite ERP. At Finlyte, we specialize in implementing NetSuite for healthcare companies, including medical device manufacturers.
We recommend NetSuite for healthcare clients for the following reasons:
- Can replace disparate pieces of software and cumbersome spreadsheets.
- Is easily accessible and securely stored for your team to utilize.
- Can serve as a vast database of your organization’s procedures, protocols, record-keeping, accounting, regulatory data, and other financial information.
By reducing the complexity of critical financial and business activity, your team will be able to focus on manufacturing-related processes and concerns while NetSuite takes care of the rest.
When you work with the Finlyte team to implement NetSuite, our implementation process follows a 90-day timeline involving key stakeholders in your company. We ensure that NetSuite is up and running quickly so as not to disrupt operations.
Start with NetSuite as Your Medical Device ERP Software
We have identified key challenges that NetSuite can help address in your company. There is incredible value in migrating to NetSuite to help improve the efficiency of your operations, which will enhance time-to-market and benefit your business financially.
We offer a dedicated NetSuite implementation solution specifically for clients in the healthcare industry. So, when you’re ready to make the jump we would love to hear from you. Let’s discuss your current challenges and identify a roadmap for success that fits your needs.
Contact us today to schedule a time for a consultation. Let’s get started on NetSuite as your medical device ERP platform to support your manufacturing processes.