The global medical device – or MedTech – market is growing sharply, and is expected to be worth $613 billion by 2025. As the market continues to grow, the associated regulated information that needs to be managed will swell to many times its current scope.
From late May, the EU Medical Device Regulation (MDR) will be in force across member states, and the equivalent In Vitro Diagnostic Regulation (IVDR) will follow in May 2022.
Other major international regions are either well into their own initiatives or heading in a similar direction too, as major health authorities around the world seek to make devices more traceable and enforce more consistent monitoring of device safety, both before products enter the market and once they are deployed in the real world.
Although a transition period will follow once the new EU regulations are in play, companies will need to develop a clear content strategy if they are to make the most of the requirements and deliver their own business benefits from increased information and process rigour. Small and medium-sized manufacturers, in particular, will need to think carefully about how they will optimise their processes, manage their resources and fill any gaps in current skill sets.
Overcoming functional content silos
Up to now, many device companies have typically taken a very siloed approach to managing content, and a relatively ‘loose’ approach to change management – for example amending labelling, quality and marketing content in a siloed manner rather than scheduling the updates centrally – as part of planned change management cycles.
To stay 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 co- ordinated means of refining technical content. This should involve looping market feedback back into product life cycle and labelling management, and a holistic and systematic approach to planning and scheduling content updates.
As well as establishing good practice for immediate requirements, this will also set them in good stead for increased regulatory measures in other major regions around the world as these evolve.
Performing a gap analysis
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 its 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.
Establishing a centralised 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 a lot 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 so that they sound better 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.
Matching the right tool to the requirements
Once they have 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.
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. As a rule of thumb, companies should allow one to three months for the assessment and pilot and another three to six months for the phased transition to the new way of managing content, labelling and document publishing. 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.
The rise of combination products
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.
The evolving role of combination treatments in diabetes care highlights the more embedded role MedTech is playing in patients’ everyday lives. First, home kits were used simply to test for glucose levels following a pin-prick blood test.
This scenario progressed to continuous monitoring using patches or implants, and now the latest MedTech innovation goes one step further – automatically administering glucose once a lower threshold has been crossed. The more invasive and safety-critical the role of the devices, the more important regulatory rigour – close monitoring and reporting of their efficacy, safety and reliability – becomes.
Often the hardest part of embracing change is accepting that it is needed and taking the time to scope what’s required. The best thing MedTech manufacturers can do to help themselves in the long run is to climb that hill sooner rather than later.
Barbara Peralta is director of Life Sciences Solutions at Amplexor
