For Medical Device companies, often the key competitive edge is Research & Development. In markets where diverse consumer requirements drive medical device development, companies need to position a variety of solutions to cover all the nuances of customer needs. Maintaining records, quality control, and tracking unique requirements all the way to design decisions, Design History Files, (DHF), Bill of Materials (BOM), Device Master Records (DMR) are critical to enable Medical Device companies to use the Unique Device Identification (UDI) system well. 

 

Osstem Implant, a Korean dental implant maker, identified that to be the highest market-share owner in the dental implants market, they needed to prioritize their Unique device Identification systems and all the business processes that are related to it. 

 

Compliance guidelines set by the United States Food and Drug Administration (FDA) to establish a Unique Device Identification system indicate that they need to capture several types of information. 

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• Manufacturing date 

• Expiration date 

• Lot and serial numbers…to name a few 

 

However, simply tracking the UDI information in a large Excel sheet is not productive, nor is it going to make anyone the top of their market. To own majority market share, Medical Device companies need to step up their game and thing big-picture. While preparing for 510(k) Pre -Market Notification or Pre-Market Authorization (PMA) submissions, or dealing with adverse events due to issues with the device after it’s in the market, Medical Device companies need to think two steps ahead about how their UDI system can help them stay on top of their design and production, and adverse events reported by patients and physicians. 

 

And that’s what Osstem did. They streamlined not just their UDI system, but aligned it with design and licensing information to tie their requirements, BOM, Device Master Record (DMR), quality, and version control.  

 

What this allowed them to do is with an integrated UDI management system, they were able to not just improve quality control of their products, but they were able to track problems on any particular device or production issue simply by checking the UDI and trace it back all the way to the root cause. 

 

Read the full case study to grasp how the 3DEXPERIENCE platform helped Osstem Implant be on their way to being a market leader. 

 

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Compliance with FDA guidelines about managing and maintaining design controls, requirements, Design History Files (DHF), Device Master Records (DMR), production plans, V&V plans and quality plans is an absolutely critical aspect of giving your medical device solutions a fair chance to enter the market. Preparing dossiers for 510(k) or PMA submissions  

 

On Nov 19 and 20, 2019, Aventec in partnership with Dassault Systèmes is launching Accelerate: a Medical Device Innovation Summit with the goal of helping Medical Device companies ensure compliance, quality, and innovation remain the central pillars of your success. Learn more about the event to see whether you should attend. Register while spots are open. 

 

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