The Benefits of Structured Data Use

 
Regulatory Affairs teams face impossible demands on their time, compounded by rising health authority expectations. The challenge is particularly acute in the medical device sector. Today, more than three-quarters (77%) of medical device RA professionals admit they are under-resourced even to meet immediate obligations. That’s according to new research conducted this year among members of the Regulatory Affairs Professionals Society, which highlighted the particular challenges of medical device providers¹.

Targeted use of the latest technology promises to alleviate the growing pressure, especially where it could simplify the process of capturing, organizing, and reusing critical product and manufacturing data, and the way this is reported to each market’s respective regulatory authorities. Examples of recommended practice include “lean authoring”. This refers to a modular approach to content generation, capable of fulfilling both current and unknown future regulatory needs. Supported by smart automation, lean authoring paves the way for higher-quality regulatory submissions, correct labeling, and instructions for use – produced and reviewed swiftly and cost-efficiently, in line with the relevant market requirements. 

This is the ultimate scenario that medical device suppliers can aspire to, assuming the right infrastructure – and culture – exists to support technology-enabled regulatory process optimization.

Maintaining Patient Safety as Device Innovation Accelerates

Worldwide, the medical device market is expected to achieve a value of $886.80 billion by 2032; it was worth $518.46 billion last year². As increasingly sophisticated devices – from surgical robots to implantable defibrillators – come to play an increasingly prominent and critical role in everyday patient care, industry regulators are steadily introducing new safety and traceability requirements to ensure their safety. 

As device suppliers strive to fulfill growing regulatory expectations, including those set out under the EU’s trailblazing Medical Device Regulations (EU MDR)³, there is an opportunity for these companies to start as they mean to go on, making strategic use of technology to capture, manage and repurpose critical product and manufacturing data.

Bridging Gaps in Resources: Technology’s Role

Modern regulatory information management (RIM) and enterprise information management (EIM) strategies, and supporting systems and processes, are a good first port of call to avoid departmental silos. Regulatory, Safety, and Quality teams can then share data and materials reliably and efficiently, rather than create new content from scratch for each respective set of requirements.

A proactive approach to establishing systems and processes for content management and information exchange will help companies keep pace as health authorities move forward with plans around electronic information exchange (e.g. under the FDA’s eSTAR; the EU’s EUDAMED; and STED, supported by many countries globally). More strategically, companies then have an opportunity to leverage content prepared for one country for other markets. They could save a lot of time by reusing existing content components to submit to other countries.

In the 2024 survey of Regulatory professionals’ priorities and concerns, the top three targets for planned investment specifically by medical 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, a large proportion of 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 two to three years.

Cultivating Reusable Data Assets

Content/regulatory change management is a further challenge that technology can support, by helping to pinpoint where various data and content assets are, and where any cascading interdependencies exist between them. 

This is about being able to “unlock” and “structure” the content of documents, turning this into a series of searchable data assets with their own descriptors to help identify and link them in a meaningful way.

There are many advantages to transforming narrative/text-based content from existing documents into tabular information, not least allowing content to be reliably re-used. Smart automation can be used to populate each new template and fulfill the given set of regulatory submission or publishing requirements – adding just what is needed, and no more. It can also support more efficient change management across the product lifecycle, as part of compliance maintenance.

A more structured approach to content creation also supports lean authoring, alluded to above. This is a more direct way of writing, focusing on key facts, resulting in streamlined documents that are easier to digest; reduced review and quality control time; and increased quality.⁴

Treating more content and company knowledge as ‘data’ rather than free-flowing descriptions captured in narrative form makes sense strategically then – both being more efficient to manage now while supporting the way regulators are moving in the long term.
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, it follows that they will be setting themselves up for maximum process efficiency in the future.

Fostering a Collaborative Mindset Around Regulated Content Management

While exact standards for regulatory content management in the medical device industry are still being defined and harmonized internationally, process efficiency potential ranging from eCTD dossier compliance to AI-supported structured content authoring is worth preparing for today. This is especially true given how diverse the medical device sector is, making it incumbent on suppliers to bring order, efficiency, and sustainability to the way their product and manufacture data and content are managed, for the benefit of their own productivity and ultimately for the benefit and safety of patients.

Finally, and as with any strategic deployment of systems, technology alone does not guarantee that data will be maximized, content will be re-used, or processes streamlined. Step-changes in productivity also require an adaptation in mindset within the company – toward a more collaborative attitude across functional boundaries that fosters data/content re-use; toward building regulated content assets in a granular and structured way from the outset, which is able to fulfill a range of purposes right across the product lifecycle.

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