Medical device manufacturers are truly innovators, playing an important role in the future of healthcare.  Whether you are a small medical startup or a growing manufacturer, your technology is cutting edge, so make sure your software can keep up. 

Here are 5 key things to look for when deciding on an ERP system for your business.

1.  Device record-keeping

Manufacturers developing new devices need strong recordkeeping via a device history record (DHR).  DHR assists with compliance a long with demonstrating a sound technical concept, benefits to the patient, attention to cost of materials and production, and long-term results. A successful DHR needs software to track everything.  A modern-day ERP solution, such as Acumatica, that incorporates document management, engineering bill of materials (BOM), planned process routing, cost estimating, and failure modes and effects analysis (FMEA). 

2.  Compliance, consistency and efficiency

In order to stay compliant, shorten development time, track applications, field test, and streamline payment approval processes a solid ERP system is critical. Any mistakes or miscommunications due to disparate software can cause costly delays in time-to-market. So it is more important than ever to ensure that business processes are efficient and built on a central system, a comprehensive ERP system. 

3.  Manage approval timeframes

Approval times can make or break a startup.  According to the US Department of Commerce, more than 80% of medical device companies have reported approval timeframes that can run for 10 years or longer.  With many startups having fewer than 50 employees and tight funding sources, getting to market relies heavily on current technology.  Older or disparate systems can make this process longer.  There’s no room for error so you need a capable ERP system with integrated engineering, purchasing, accounting and project management capabilities. With Acumatica you have real-time visibility into overall financials, R&D costs, project milestones, and status of agency filings to manage the “burn rate” of funding and assure investors that risk is being minimized.  

4.  No tolerance for errors

Proper planning of your ERP system can reduce the risk of errors and omissions.  This is crucial for your medical device business because even a minor problem can put the brakes on FDA approval or spark a major recall. Many systems require the manual transfer of information from one software system to another, which hinders quality control.  Current ERP software, such as Acumatica easily manages critical production process numbers, inventory and quality data; manufacturers gain real-time insights that minimize the risk of product errors. Using software tools to manage production quality can have strong financial benefits. For example, one medical device components maker reported that keeping tabs with these tools led to a 50% reduction in scrap material and $36,000 annual savings in overtime costs. 

5.  Track and trace for fast reporting

Surprise audits, product safety investigations, and recall actions quickly consume a medical device business.  By having an ERP solution optimized for medical device manufacturing needs, such as “track and trace” reporting, you no longer will be devastated by possible FDA investigations. Make sure your ERP solution allows fast, accurate extraction of material certifications and process traceability records to support any inquiry from a customer or regulatory agency—while limiting the scope of the investigation to only those products in question. 

Make sure your medical device startup business chooses a modern ERP solution so you are well positioned to balance the demands of medical device costs, availability, patients’ short- and long-term treatment experiences, quality assurance, and strict regulatory compliance.  

Benefits of Acumatica ERP for Medical Device Manufacturing Acumatica Logo

  • Fully integrate your processes, applications and data
  • Manage complex manufacturing and distribution models 
  • Meet deadlines and customer expectations 
  • Gain full traceability for regulatory compliance 
  • Control, track and analyze your true costs in real time 
  • Forecast budgets and demand with ease 
  • Easily add functionality as you grow and evolve 
  • Optimize and manage inventory and production 
  • Save money with UNLIMITED users 

Download the Acumatica Manufacturing Edition Datasheet and learn more how Acumatica can help you boost manufacturing efficiency, connect disparate business systems and processes, elevate the customer experience, and manage your entire business on a single, robust, future-proof platform. 

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