It’s no secret that manufacturers in the medical supplies and devices industry face real challenges. The overarching challenges include significant competition (especially with low barriers to entering the market), safety regulations that continue to strengthen rather than weaken and pandemic-related supply chain issues. However, there are five specific challenges that manufacturers deal with daily.
The Top 5 Challenges (and Solutions) in Medical Supplies/Devices Manufacturing
According to IBISWorld statistics, there are 998 medical device manufacturing businesses in the US in 2021. The statistics also show that the number of manufacturing businesses has grown 4.1% per year on average over the five years between 2016 and 2021.
Those that have chosen to dip their toe into the industry obviously feel that growth and profitability are achievable, but they need to be aware of the top five challenges they will face in today’s digitized and global market. Here are the challenges (which can overlap) and the corresponding solutions provided by cloud-based ERP solutions with medical supplies and devices software.
- Lack of Visibility into Inventory
Manufacturing and distributing medical supplies and devices is only possible if you’re able to efficiently manage your inventory. Do you know how much you have, where all the parts (and there are many) are located, and can your employees find them? Companies using archaic management systems can’t answer these questions—or at least not answer them easily and accurately.
Solution: With a Cloud ERP solution, these same questions are not a problem. Manufacturers will be able to track inventory in real time. They’ll also be able to track each part of a final product by serial/lot number and expiration date, eliminate manual counts and improve forecasting, which results in reducing waste. And every department will have access to current data.
- Inefficient Warehouse Processes
One of the major components of any manufacturing business is warehousing. Inventory, item quality, pick and pack processes and shipping all must be handled effectively for the business to succeed. In the case of manual management, the result is often a time wasting, human-error-prone process with delays, inaccuracies and headaches. It can also increase costs significantly.
Solution: With a Cloud ERP solution, inventory counts, warehouse transfers, item location and shipment logging processes are automated. For example, using scanners to verify against sales orders and grouping orders through batch picking (and having all data flow through the ERP for visibility by warehousing staff as well as finance and accounting) creates a lean, efficient business.
- Compliance with Strict Industry Regulations
FDA approval is necessary before selling medical devices. Per the FDA, the basic regulatory requirements include establishment registration, medical device listing, premarket notification 510(k) (or premarket approval), investigational device exemption (IDE) for clinical studies, quality system (QS) regulation, labeling requirements and medical device reporting (MDR). There are also ISO, GMP and more regulations to comply with, which are not static.
Solution: With a Cloud ERP solution, manufacturers have integrated quality management functionality, can store documentation measures and automate quality checks/audits. Program alerts let users know of upcoming deadlines and/or potential issues. Changing regulations are no longer a major roadblock but something that can be dealt with accordingly.
- No Traceability and Lack of Product Recall Management Capabilities
As specified in challenge #3, compliance is huge for manufacturers in the medical supplies and devices industry. Recalls happen and more often than manufacturers would like. Tracing every part of a medical device back to its source is essential if they want to stay both in compliance and in business.
Solution: With a Cloud ERP solution, complying with FDA standards and global regulations, managing laboratory approval standards and documenting all transactions (e.g., receiving, replenishment, shipping, returns, transfers, kitting and assembly) is done from one, integrated system. Accurate data is maintained in the same system that also ensures end-to-end traceability throughout the entire supply chain.
- Inability to Effectively Manage Clients
Without clients, there’s no business. Attracting clients is important but retaining them is just as critical. Client management with a legacy solution is an uphill battle with lack of integration resulting in inaccurate customer data and an inability to communicate well with each customer.
Solution: With a Cloud ERP solution, medical supplies and devices manufacturers can:
- Utilize integrated CRM for streamlined client management
- Perform marketing, quoting and sales tasks directly within the system
- Manage delivery and post-sales support to maintain strong client relationships
- Maintain current and accurate customer data
- Use automation features to support better communication with customers, helping grow the business and boost its reputation
- Streamline payment processes with eCommerce integration capabilities
What Cloud ERP Solution?
Recognizing that a Cloud ERP solution with medical supplies software and medical devices software is necessary to overcome the common challenges in the industry is only half the battle. The other half is deciding which solution is best for a business’ specific needs.
NexTec Group’s ERP Selection Guide: Medical Supplies and Devices, which breaks down the top five challenges discussed above, suggests businesses set up a review team, and with help from a consulting partner, identify areas that would benefit from a connected business management system. From there, compare ERP options.
We recommend including Acumatica Cloud ERP for your medical devices management needs. From real-time collaboration, reporting and analytics to future-proof functionality, Acumatica’s cloud-based ERP solution, which also includes integrated inventory management software, warehousing management software and distribution software, has the industry-specific functionality, along with the ability to integrate with third-party applications, that medical supplies and devices companies need. In addition, because it’s based on mobile technology, every team member can access the solution from anywhere and at anytime using a web-enabled device of their choice.