Handling MedTech regulatory requirements during industry growth

Life Sciences

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The MedTech market is expected to be worth USD 613 billion by 2025. As the value of the market grows, so does the volume and complexity of the associated regulated information that needs to be managed.  

In May 2021, the EU Medical Device Regulation (MDR) came into force across EU member states, and the equivalent In Vitro Diagnostic Regulation (IVDR) will follow in May 2022. The aim is to make devices more traceable and enforce more consistent monitoring of device safety prior to products entering the market and once they are in use.  

Organizations must define and implement a clear and robust content strategy to meet global requirements and to reap their own business benefits from them. Although regulatory compliance can feel onerous, increased information and process rigor can positively affect any MedTech business.  

How to eliminate content siloes through centralization 

It’s not unusual for businesses to store content across different repositories. This approach includes amending labeling, quality, and marketing content in a siloed manner rather than scheduling the updates centrally. 

To stay on the right side of the new regulations, to maintain the highest level of patient safety, and to take advantage of economies of scale, manufacturers need to adopt a more joined-up and coordinated means of refining technical content. This should involve looping market feedback into the product lifecycle and labeling management as well as creating a holistic and systematic approach to planning and scheduling content updates.  

This establishes good practice for any immediate requirements and readies them for increased regulatory measures in other major regions worldwide as they evolve. 

Set sensible goals 

MedTech firms should begin with a gap analysis to prioritize and plan much more effectively. Each company's situation will differ depending on their product portfolio, device classes, current clinical evidence (CE) marks and their time to expiry, and what it will take to make each product compliant with the new requirements under MDR or IVDR.  

The next logical step is to assess what it will take to bring content into a compliant state and how to do this efficiently and economically, aligned with other change requirements – especially if there are high volumes of technical and quality documents or labels to update. There are no shortcuts to doing this properly, so a long-term plan will be required. 

Manage content centrally 

MedTech manufacturers should develop a coordinated content management and translation strategy that spans and consolidates common information sources. It will drive higher quality, greater content control and streamlined change management across the board – serving the needs of Quality and Marketing as well as regulatory compliance from a single, master source of truth. 

Being strategic about all of this will enable companies to start capitalizing on the wider benefits of holistic content management. These include new scope for structured content authoring/automated publishing, dynamically calling up and re-using agreed-upon fragments of content/topic-specific information to create content for Regulatory, Quality, or Product Labelling requirements. 

Pick the right solution 

Some tools are more technically complex, requiring retraining, which might feel a step too far. Other systems look and feel more like Microsoft Word while still delivering the XML output needed to support dynamic search and structured authoring/automated publishing.  

A good partner will be able to help with a pilot project and ROI modelling to show the savings that will be possible from adopting a particular approach and system. So while the MDR/IVDR deadlines are looming – there is still time to make this strategic change and reap the long term benefits from it post-deadline. 

Retain content control 

As combination products – those combining devices and drugs - continue to multiply, and as these products become smarter and more sophisticated, maintaining high levels of content control will become more important too.  

Content is one of the most important assets any MedTech firm has at its disposal. But it needs to be managed effectively in order for organizations to reap the most benefit from it. This is true now and will be even truer in the future when regulatory compliance requirements become even greater. 

Are you on the right track with MDR? Reach out to us to find out. 

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