Whether you are a medical device start-up or a growth-orientated medical device company, most likely you began your business with an idea: An innovative product designed to help people who are sick or injured. And while bringing a medical device to market should be an engineering problem, many owners also have to deal with managing the business side of their medical device company in order to realize success.
Commonly, many new and established medical device companies want to focus on the product, not scalable day-to-day front office and production capabilities, so they eschew advanced business management systems and end up operating a growing company with paper, spreadsheets and QuickBooks. Soon the business is too large and too fast paced to be managed by these ad hoc solutions and the company’s very success puts it at risk of not being able to fulfill demand and meet regulatory requirements.
Replacing QuickBooks with an ERP Solution Can Minimize Your Liability Risk
Fortunately, there is hope: A comprehensive, easy-to-use medical device-specific ERP solution can manage your business success, minimize your product liability risk and increase your time to market. The key is not to wait. Every day that you delay implementing an ERP solution is another day of wasted time and money. What four areas of your business are at the greatest risk if you do not implement an ERP solution right away?
Quality and Regulatory Conformity: There is no need to belabor how critical quality conformance and adherence to ISO, CFR and FDA regulations are to running a medical device company. But passing quality audits, impressing customers with your quality procedures, earning ISO certifications and having the proper device lifecycle documents in place in the event of a recall are complicated and difficult with paper-based filing systems and disparate spreadsheets.
Fortunately, a comprehensive ERP solution offers a single version of the truth. With a medical-specific ERP solution, all product master requirements are captured and tracked from sales order to shipment. By automating your document and information management, you can generate all the necessary documentation and reports to pass your audits or get an offending product off the market as quickly as possible.
Shop Floor Processes: Another way to maintain part quality and minimize risk is with process monitoring tools that handle complex manufacturing operations, offer end-to-end lot and serial traceability and increase production visibility and control. A process monitoring system links directly to your work centers and high value production equipment at the PLC/sensor level and collects every important variable that relates to production: Temperature, pressure, dimensions, weight, thickness, fill rate, date, time, operator, lot numbers, etc.
If you are using a comprehensive ERP solution, then this detailed information is automatically populated on a historian database where it is easily accessed by your ERP solution for tracking and analysis. This two-way communication between the ERP solution and your work center eliminates breaks in the product genealogy. The real-time, automated benefits of the process monitoring package ensure that there is no need to manually rekey data and production details are uploaded as they occur, with no delays or batch transfers.
Business Operations: Besides quality and shop floor control, there are other operations that need to be addressed in order to be successful. A comprehensive ERP solution not only handles the manufacturing side of your company, but also all other business-related responsibilities, such as:
• Inventory control and material purchasing
• Shipping and distribution
• Sales orders, quoting and forecasting
• Supplier and vendor management
• Time and attendance and payroll
An ERP solution helps you manage not only the production of quality products, but it also makes sure you have inventory on hand to make those products and that everyone gets paid at the end of the week!
Employee Productivity: Manual systems such as spreadsheets and paper filing systems are incredible time wasters. If your sales reps are tracking down documents, scanning or faxing orders, searching for PO numbers, etc., then they are not spending time selling. If your quality team wanders around all day chasing approvals and signatures, then they are not spending their time inspecting parts.
Additionally, multiple spreadsheets mean lots of re-entry of data. The more manual your operations, the more errors, omissions and delays. If the average benchmark of manual data entry is 1 percent (or one error for every 100 keystrokes), what does that mean for the accuracy of your data? With an automated, comprehensive ERP software, you can get rid of your time-consuming, paper-based tracking system and free up employees to focus on what they do best.
Let’s look at an example: Collecting the information required for a medical device traveler (materials consumed, processes and equipment utilized, quality data collected, exceptions, rework and electronic signatures, etc.) can be a pain. Without an ERP solution, you have to go to each of your different systems, run individual reports and then try to collate and analyze the data. Comprehensive ERP offers that information all in one central location, for detailed analysis, risk capability and improved decision making.
It is clear that an ERP solution can greatly help you manage your business success. But not all ERP solutions are created equal. To make the most of your ERP investment, you need a comprehensive ERP solution with medical-specific features and modules. The key word here is comprehensive. With an end-to-end system that covers every aspect of your business, from ERP to MES, MRP, financials, order management, WMS, CRM, quality management and more, your entire business is visible, traceable and efficient.
Many ERP vendors try to sell best of breed ERP as the ultimate solution. While integration of third-party programs into a core ERP system can work, it won’t give you the end-to-end traceability and visibility required by many customers and regulatory organizations. Not to mention, the integration is typically fraught with challenges such as duplicate data entry, information delays and silos, interface issues and customization expenses.
Finally, a comprehensive software design is not enough. Your ERP software also needs to be medical-specific. With features and tools designed specifically for your industry, such as lot and serial traceability, product lifecycle management, process monitoring and an embedded quality management system, you can increase visibility, traceability and ultimately, profitability. Let a comprehensive, medical-specific manufacturing ERP solution help you better manage your business success.