Ensuring content compliance as MedTech market booms
SummaryWith the global medical device market expected to hit USD 613 billion value by 2025, there will be an inevitable increase in associated regulatory requirements. That means MedTech manufacturers must adopt a more cohesive way of refining technical content, while integrating market feedback into product lifecycle and labelling management. Barbara Peralta, Director of Life Sciences Solutions at Amplexor, explores how this might happen.
- Author Company: Amplexor
- Author Name: Barbara Peralta, Director of Life Sciences Solutions
- Author Email: Barbara.firstname.lastname@example.org
- Author Website: http://www.amplexor.com
The EU Medical Device Regulation (MDR) is now in force across member states, and the equivalent In Vitro Diagnostic Regulation (IVDR) will follow in May 2022. Other major geographies are either well into their own initiatives or heading in a similar direction, as health authorities around the world seek to make devices more traceable and ensure more consistent monitoring of device safety, both pre-market and in deployment.
To understand the scale of what needs to be done, companies should start with with a gap analysis, allowing them to determine a realistic timescale and plan of action. Each MedTech company’s situation will be different, depending on their product portfolio, device classes, current 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. Regulatory experts will be able to help with these assessments and with regulatory planning.
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.
A centralized content strategy
Most companies will be starting from a point of holding very dispersed and fragmented information across different functions in the organisation. The Quality department, responsible for quality reporting, will hold a lot of the content in Microsoft Word documents. This will form the basis for much of what will need to be translated for local markets and included in labelling.
Regulatory Affairs will have its own systems for managing regulated information. And Marketing will have its own creative designs for content, and ways it wants to phrase things from a promotional perspective. Marketing will also want to make certain claims are aligned with clinical technical documents.
Up to now, each team has pursued its own agenda, without much thought to combined efficiency or consistency of content or its presentation. The MDR and IVDR regulations change all that. The focus on clinical evaluation and post market surveillance requires that MedTech manufacturers develop a coordinated content management and translation strategy that spans and consolidates common information sources, and drives 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 to capitalise on the wider benefits of holistic content management - including new scope for structured content authoring/automated publishing, dynamically calling up and re-using agreed fragments of content/topic-specific information to create content for Regulatory, Quality, or Product Labelling requirements.
The right tool for the requirements
With a good grasp of their starting point and where they need to get to, medical device manufacturers can begin their search for the right content management and authoring system for their particular circumstances. Some tools are more technically complex, requiring retraining, which might feel a step too far. Other systems look and feel more like Word, while still delivering the XML output needed to support dynamic search and structured authoring/automated publishing.
The right partner should be able to help with pilot projects and ROI forecasting to show the savings that will be possible from adopting a particular approach. As a rule of thumb, companies should allow 1-3 months for the assessment and pilot and another 3-6 months for the phased transition to the new way of managing content, labelling and document publishing. With the MDR/IVDR deadlines either past or looming – there is little time to make these necessary changes so MedTech companies are well advised to get moving.