The medical device industry is unique with its need for an ERP system. In fact, the industry contains two major groups. The first segment produces consumables, while the second one makes medical imaging and cancer machines equipment. These groups follow different processes such as sales, manufacturing, and FDA. The FDA processes, in particular, vary depending upon whether the device is used for diagnosis or surgery. So the quality and regulatory needs might vary for companies. And that drives the features and processes these companies need in their ERP systems.
The most critical features for medical device companies include the process for electronic signatures and device history records. The other features, such as vendor approval and end-to-end traceability, are similar to aerospace and automotive industries but with some more restrictions. The validation requirements might require you to validate the software with each change but might not apply to every company. There might be further complications with the CRM processes as the different markets may follow different timelines and require controls with your quoting process. You are only scratching the surface of the features medical device companies need. So which are the ERP systems that are most suitable for medical device companies?
This article outlines the top 10 medical device ERP systems that should be part of your evaluation. To finalize this list, we have analyzed hundreds of ERP systems and their capabilities through publicly available information. The list also relies on our teams’ experience in evaluating these ERP systems for our customers.
The purpose of this article is not to recommend them. Instead, you must carefully analyze your requirements and find a suitable product from this list or a list from your industry/market segment.
SYSPRO targets small distributors and manufacturers with a heavy focus on food and beverage distributors. It’s a unique product in its category as it can also support formulation management and process manufacturing features. These features require ad-hoc arrangements on top of other vanilla discrete ERP systems. In addition, SYSPRO has solid finance and distribution capabilities and has an “SAP” feel to the product. This feel includes native support for features such as activity-based costing and complex UoMs.
Strengths:
Weaknesses:
Considering the pros and cons, SYSPRO lands at #10 on our list of the top medical device ERP systems.
Similar to SYSPRO, Deacom targets smaller process and F&B manufacturers. While Deacom is a small product, its cloud-native capabilities are impressive as it was born in the cloud. Deacom targets businesses that might be on QuickBooks and under $10 mil dollars in revenue.
Strengths:
Weaknesses:
Considering the pros and cons, Deacom lands at #9 on our list of the top medical device ERP systems.
Oracle ERP Cloud targets large medical device manufacturers with more than 20-30 entities and more than $1B in revenue. It would be suitable for companies that prefer financial control in the ERP system over operational capabilities at the plant level. It will also be suitable for organizations that plan to develop the core medical device manufacturing compliance and regulatory capabilities on top of the core platform.
Strengths:
Weaknesses:
Considering the pros and cons, Oracle ERP Cloud lands at #8 on our list of top medical device ERP systems.
Microsoft Dynamics 365 F&O targets large medical device manufacturers with more than 20-30 entities and more than $1B in revenue. F&O comes pre-integrated with the leading MS CRM known for its tighter object model to accommodate global controls such as restricting sales for a product in specific regions. It also has a superior field service module pre-integrated at the database layer.
Strengths:
Weaknesses:
Considering the pros and cons, F&O ranks at #7 on our list of the top medical device ERP systems.
Epicor Kinetic targets mid-market discrete medical device manufacturers. It would be suitable for lighter assembly-centric medical device manufacturing companies with a focus on vendor collaboration and supply chain. However, it would not suit medical device manufacturers with complex equipment and quality and compliance needs.
Strengths:
Weaknesses:
Considering the pros and cons, Epicor Kinetic is at #6 on our list of the top medical device ERP systems.
Rootstock targets smaller discrete medical device manufacturers. The product is ideally suited for the medical device manufacturing companies in the $10-$100 mil range and that are heavy Salesforce users. However, the product is not a fit for companies that might require deeper financial controls and large companies with over $100 million in revenue.
Strengths:
Weaknesses:
Considering the pros and cons, Rootstock ranks at #5 on our list of the top medical device ERP systems.
SAP S/4 HANA targets large medical device manufacturers with more than 10-20 entities and more than $1 billion in revenue. Therefore, SAP S/4 HANA is suitable for organizations with deep financial control needs, such as public companies. However, it is not suitable for smaller companies that need deeper operational functionality at the plant level.
Strengths:
Weaknesses:
Considering the pros and cons, SAP S/4 HANA ranks at #4 on our list of the top medical device ERP systems.
Sage X3 targets large process manufacturers with limited discrete manufacturing capabilities compared to other solutions on this list. Therefore, while Sage X3 might be suitable for companies that might have products that might be more process Centric than discrete, it will not be suitable for hardware-centric companies.
Strengths:
Weaknesses:
Considering the pros and cons, Sage X3 ranks at #3 on our list of top medical device ERP systems.
QAD targets upper-mid to large medical device manufacturers. It is especially suitable for companies that need global supply chain capabilities to collaborate with international vendors. But it is not suitable for companies that care for larger ecosystems and vendor support for the product.
Strengths:
Weaknesses:
Considering the pros and cons, QAD ranks at #2 on our list of top medical device ERP systems.
Infor CloudSuite Industrial targets small to mid-sized medical device manufacturers with fewer than ten entities. It’s especially suitable for large equipment manufacturers with thousands of dependent components and sub-assemblies. However, it’s not suitable for companies that are primarily distributors and may perform lighter manufacturing or assembly.
Strengths:
Weaknesses:
Considering the pros and cons, Infor CloudSuite Industrial ranks at #1 on our list of top medical device ERP systems.
Medical device companies have very involved operations due to the FDA compliance requirements and quality needs. The medical device companies also need deeper CPQ capabilities to control the global release process of equipment. Finally, they need mixed-mode manufacturing capabilities if they might be developing a combination of drugs and devices or consumables and capital equipment.
You need an ERP system designed to support most medical device processes natively. Using an ERP system not designed for the medical device industry might require significant customizations and additional testing time for unnecessary configurations that may be prepackaged with other ERP systems. So make sure that the ERP system that you choose is designed for the medical device industry. And hopefully, this list can help you narrow down some options.
The medical device ERP systems prepackage the last-mile functionality required for medical device manufacturers and distributors. By contrast, the vanilla ERP systems would require substantial configuration, customizations, and testing, which increases the costs and technical risk of the ERP implementation.
The life science industry consists of several micro-verticals, which have different needs for an ERP system. For example, the system designed for the pharmaceutical industry would not be a right fit for the medical device industry as the medical device would follow discrete manufacturing processes, whereas pharma would be process manufacturing. Similarly, the diagnostic laboratories may have discrete or process manufacturing methods depending upon the type of device they might manufacture.
Yes, medical device distributors have very different quoting processes, levels of inventory, UoMs, and supply chain networks than manufacturers. They might also have lighter assemblies and quality of the incoming products than medical device manufacturers. On the other hand, medical device manufacturers have multiple layers of sub-assemblies with their BOMs. They would require a much tighter collaboration of their engineering, quality control, and manufacturing.
Search Our Blog
Categories
Aerospace & Defense Automotive Chemicals Construction Consumer Goods Distribution Enterprise Architecture ERP Food and Beverage High Tech & Electronics Industrial Manufacturing Life Sciences Retail Service CompaniesArchives