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The response to increased regulatory rigour – what medical device suppliers can learn from pharma best practice

Pharma’s experience in honing the management of regulated product data and content presents some useful lessons for medical device suppliers as their own regulatory workloads increase.

A steady progression of health authority (HA) demands in pharma has triggered extensive investment over the last two decades in IT systems and optimised data and content management.

As medical device suppliers adapt to their own rising regulatory commitments, there are some useful best practices emerging from pharma that could serve this sector well as companies strive to maximise their resources.

A recent survey of Regulatory Affairs (RA) professionals across the life sciences industry as a whole confirms that time and bandwidth are now the primary challenge for these teams, followed by costs and budgetary pressures.

These concerns are particularly acute for medical device companies. While just over half (57%) of pharma RA teams feel under-resourced to meet their 2024 priorities, this rises to more than three-quarters (77%) of medical device RA teams.

Among the best practices being established in pharma is a distancing from the traditional document-centric, case-by-case approach to dossier creation – a highly repetitive and labour-intensive process with steps that add little value beyond the immediate purpose.

Modern regulatory information management (RIM) and enterprise information management (EIM) strategies, and supporting systems and processes, help tackle these inefficiencies – first by breaking down silos so that Regulatory, Safety and Quality teams can more readily share data and materials.

This means regulatory and safety teams can avoid creating new content from scratch for each respective set of submission or reporting requirements, and even leverage content prepared for one country for other markets.

A proactive approach to establishing systems and processes for content management and information exchange will also stand companies in good stead for compliance with requirements around electronic information exchange (e.g. under the FDA’s eSTAR; the EU’s EUDAMED; and STED, widely supported globally).

Medical device companies’ appetite to invest in process-enhancing technology is tangible. In the 2024 RA survey, the top three targets for planned investment specifically by device companies were system capabilities to cope with MDR compliance and MDR maintenance, as well as improvements to regulatory intelligence – to keep track of respective market requirements.

Currently most device companies track regulatory developments manually, and respond to changes reactively.

This is despite the survey finding that almost half of medical device suppliers indicated ‘knowledge of changing global regulatory landscapes’ as among their top three most critical compliance skillsets for the next 2-3 years.

In pharma, where RIM capabilities are more advanced, change management came out as a higher priority in the survey, signalling a capability that medical device suppliers are likely to need in the future too. All of this places an emphasis on being able to pinpoint where various data and content assets are, and where any cascading interdependencies exist between them.

Where companies have deployed advanced content management capabilities, they are seeing the benefit of transforming narrative/text-based content from existing documents into data-driven structured/tabular information.

Turning flowing text into data or content ‘extracts’ makes it possible for content to be reliably re-used.

This can be achieved via software featuring smart automation - to populate each new template, and fulfil the given set of regulatory submission or publishing requirements.

It can also support more efficient change management across the product life cycle, as part of compliance maintenance.

Taking a more structured approach to content creation also supports ‘lean authoring’, a more direct and to-the-point way of writing that focuses documents on key data – resulting in streamlined documents that are easier to digest; reduced review and quality control time; and increased quality.

For regulatory dossiers in the life sciences industry, lean authoring involves maximising the scope for reuse of sections of approved content (content modules or building blocks), while keeping the emphasis on what each respective HA ultimately wants.

In the survey, a large proportion of RA professionals highlighted increased consistency across submissions, and reduced time and effort as the two main benefits of automated submission preparation/reuse of content extracts.

The opportunity to harness artificial intelligence (including Generative AI or GenAI) is now coming into focus, pointing to something medical device regulatory professionals may want to provide for now, e.g. to enable rapid data extraction and information summarisation from documents and other sources, and compliance gap analysis, and more.

One of the overriding challenges the pharma industry has faced in fulfilling its RA obligations over the years has been the diversity of approaches, processes, systems and formats in use across global organisations and markets, which has hampered visibility, order and consistency.

This is among the strongest reasons for the medical device sector to be proactive in its approach to capturing, managing and sharing its information, and using this to build, submit and publish regulated content.

If medical device suppliers can capture information from the outset in a form that will be easily retrievable and reuseable in different forms for different purposes (from authority submissions to instructions for use), it follows that they will be setting themselves up for maximum process efficiency in future.

Although standards for regulatory content management in the medical device industry are still being formalised, pharma’s visible progress with smarter regulatory content management sets a good precedent that device suppliers can look to – both in fulfilling evolving regulatory requirements and in optimising operational efficiency.

Sonia A. Veluchamy is the CEO and co-founder of Celegence.
Go to celegence.com