Medical Device Manufacturing: Can Traceability be Seamless across Disciplines?

[Editor’s note: Julie Fraser is a medical device industry watcher, who has previously share insight into the UDI compliance challenges for medical device manufacturing. Today, she outlines the complexity of traceability requirements for medical devices, which ensures any changes made to medical devices and software throughout their development and manufacturing process are documented and confirmed acceptable with given parameters.]


How easily can you trace every lot, batch or unit of product? The answer is important. In fact, it will be a factor that defines your medical device company’s ability to prosper.

Between the FDA’s requirement for unique device identifier (UDI) and the regulatory scrutiny of device history records (DHRs), traceability is always a hot topic in the medical device industry. But the challenge is, no single department or system has the entire answer. Traceability requires information from across all aspects of the operation.

Fortunately, modern information systems can reach across the organization to collect, collate and assemble the DHR automatically, without paper – creating the electronic eDHR. But this is not a straightforward IT issue, and is one that standard enterprise IT applications such as enterprise resource planning (ERP), business intelligence (BI) and quality management systems (QMS) are not likely to be able to handle. These applications aren’t designed to handle the huge volume and numerous varients of DHRs across an organization, and QMS are typically strutured around documents, which doesn’t deliver any benefits beyond quality control and compliance

The best way to generate eDHRs is by means of manufacturing execution or manufacturing operations management (MES/MOM). Much of the core DHR information comes from the production plant (e.g., dates and quantity manufactured and released, acceptance records, labels). MES/MOM are not document management systems, but rather focus on the data. Why? Because MES/MOM systems are first and foremost designed to provide visibility, enforcement and control to the production process. They generate these compliance records as a by-product.

Now having full control inside the production floor does not necessarily guarantee complete traceability will be available. So the best modern MES/MOM systems have a broad footprint to include quality and maintenance. They also can pull in data from other systems. In fact, all of the elements required in an eDHR can be recorded by this type of MES/MOM system, and that will delight auditors. Beyond that, the MES/MOM will enforce standard operating procedures to improve compliance, while also making data about the product and process available instantly.

Record benefitsWhat purposes might you find for this type of system and the data it produces?
For planning to update actuals, materials usage and scrap rates, enable personnel scheduling and planning, financial planning and forecasting for both costs and revenues timing, and customer order promising based on a far more accurate view of what is likely to be available to ship when.
As production proceeds to guide operators, technicians, quality and engineering activities and prevent production and documentation errors; also to see production status, materials or parts problems, actual-to-plan as it changes, and performance per plant, operator, product, or piece of equipment.
After the fact to analyze for best practices, and in other departments to make critical decisions about new product design, introduction into various regional markets, outsourcing readiness, supplier and parts performance, and all sorts of weekly, monthly and quarterly reporting by operations and finance.
In predictive mode during technology transfer, joint venture planning, capital planning, new plant expansions, financial warranty reserve planning, and new product development.

Buried in this list is a potential benefit for each group or discipline in the company. In the new white paper “Traceability as Opportunity: Medical Device Manufacturers Must Proactively Re-Frame Compliance Needs” we include 10 disciplines that can benefit. Some are areas that might never need the eDHR, but can use accurate and detailed production data.

So traceability can be seamless across many disciplines in the enterprise, and it can deliver them all benefits. Taken in aggregate, this becomes a company-wide effectiveness and profitability opportunity. Will you seize it?

To learn more about traceability requirements, and the role of integrated manufacturing software in eDHR and UDI compliance, please view Dassalt Systèmes’ webinar: Making Traceability Work for the Business: Effective eDHR and UDI, hosted by MedTechWorld. For more information on how Dassault Systèmes is helping is helping medical device companies take control of quality across their global operations by fostering compliance and improving operational performance, visit our , please visit our Made to Cure for Medical Device information centers. 

Julie Fraser
With 30 years of passion and experience as a manufacturing systems industry advisor and researcher, Julie Fraser is Founder and Principal of Iyno Advisors Inc. Fraser believes manufacturing matters and work is life, not something you balance with it.
Julie Fraser

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