- 30 November 2016
Manufacturing medical devices and equipment is one of the most vital types of production, but it’s also one that comes under heavy scrutiny. Stiff regulations exist across the board when it comes to creating medical devices, and for good reason – a faulty or inaccurate product could be the difference between life and death.
In order to maintain strict quality control, a manufacturer needs plenty of checks and tracking put into place, and ERP is perfectly suited for solving this exact requirement.
Some medical device manufacturers are dissuaded by the challenges involved in their industry — namely cost of implementation, individual patient treatment, and availability — but in reality, it’s quite possible to appease regulations and still make sure your system checks are running smoothly with ERP. Here are some key steps and considerations for implementing an ERP system into your medical device manufacturing company:
Deploy a Single ERP Database
In an industry as time-sensitive as the medical device field, every production day counts – and delays can be costly. Although it’s easy to blame software tools for errors (they can and do happen), problems are often due to simple disorganization. A good example is SHL Group, a creator of auto injectors and pen injectors for medical use. SHL Group found their operations to be incredibly demanding and in need of heightened efficiency. After making the switch to an ERP system, the company found it could successfully integrate all regions and functions of its business into one, simple and direct platform.
Having a single ERP database is the key to keeping all software processes and files in one location.
The FDA is looking to implement reviews of device designers’ applications in order to shorten development time, which is why it’s valuable to organize everything into a single common ERP database for quick and easy access. It’s especially useful when investors need to get an overall view of financial information and production costs.
Get Your FDA Regulation Checks in Place
No matter the size of your medical device business, or how long it’s been in operation, the FDA requires that all medical devices be produced to strict quality standards. And it’s not just the final product that needs FDA approval – it’s the entire manufacturing process, as well.
Multiple ERP modules exist to help product control and quality assurance, which is necessary to get medical devices approved and to market. In order to meet FDA requirements for both software and your production operations, research different modules available, and choose one that includes features for compliance monitoring, quality management, and supply chain management.
Error-Proof the Production Process
Even with FDA requirements met, there’s still a risk for errors during manufacturing. ERP systems have the capability to flag potential problems as they occur, and to halt production if the system senses something is off.
When this happens, work on a specific project is paused, and the ERP system requires an operator to validate that the materials, tools, and packaging are all correct before allowing production to continue. This creates a forced review of the process when the system senses an abnormality, allowing more opportunities for technicians to catch problems early that could otherwise cause major disruptions later on. ERP makes it possible to alert your system to any issues, so nothing problematic slips by without notice.
Once you’ve got your ERP systems and software properly tested and in place, it’s time to train your employees on how to use them. The systems automate many of your manufacturing processes, but they can’t operate solely on their own. Because ERP can touch almost every facet of production, it only takes one untrained employee to throw everything off.
In the medical manufacturing industry, one small mistake can result in hours of production delays — time you simply don’t have. It’s imperative that you get every member of your staff on board with ERP software, by offering thorough training sessions and ample opportunities for employees to ask questions and develop an understanding of the system. It makes a big difference, especially when you’re working under tight timeframes to get an intricate device to market.
Delegate to ERP
Once you’ve invested in proper employee training and your ERP system is fully set up, use it. Initially, it may not come naturally to you to delegate so many management processes to a software system — especially if you’ve previously managed most of production yourself — but once you adjust to having the support of ERP, there’s no turning back.
When you manufacture highly complex and essential medical devices, you’re already under a lot of pressure to make sure your products release in a timely manner, your projects stay within budget, your offerings are widely available, your devices adhere to FDA regulations – the list goes on, and on.
ERP takes some of the stress off your shoulders, by grouping all your files and processes in one central hub, and ensuring your medical devices are produced under the highest quality control. You’ve got enough to worry about, so hand off some of those processes to ERP and know you’re putting your medical device manufacturing in good hands.