Pharma's Data Secret That Medical Device Companies Should Adopt
By Sonia Veluchamy, Celegence
In pharma, a steady progression of health authority (HA) demands has triggered extensive investment over the last two decades in IT systems and optimized data and content management. As the medical device sector adapts to its own rising commitments, there are some useful best practices emerging from pharma that could serve this industry well as companies look to maximize their resources.
New research among regulatory affairs (RA) professionals across the life sciences industry as a whole1 confirms that time and bandwidth are the primary challenge, followed by costs and budgetary pressures. These concerns are particularly acute for device suppliers. 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.
Prioritizing Smarter Content Creation
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 labor-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 can even leverage content prepared for one country for other markets.
A proactive approach to establishing systems and processes for content management and information exchange also 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, widely supported globally).
Medical device companies’ appetite to invest in supporting technology is tangible. In the 2024 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 two to three years.
In pharma, where RIM capabilities are more advanced, change management came out as a higher priority in the survey, signaling a capability that medical device suppliers are likely to need in the future, too. All 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 reused. This can be achieved via software featuring smart automation to populate each new template and fulfill the given set of regulatory submission or publishing requirements. It also can 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 and have reduced review and quality control time and increased quality.2
For regulatory dossiers in the life sciences industry, lean authoring involves maximizing 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.
AI-enabled Efficiencies
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, e.g., to enable rapid data extraction and information summarization from documents and other sources, to perform 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 organizations 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 regulatory 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 the future.
While exact standards for regulatory content management in the medical device industry are still being set down and harmonized across the world, the pharma industry’s progress maps out a route that the medical device sector is very likely to travel. So why not prepare for the journey now?
References
- Medical Devices Industry Regulatory Readiness & Resources: 2024 Survey Report (Celgence/Qdossier research conducted with almost 700 members of the Regulatory Affairs Professionals Society (RAPS) and reflecting differences between pharma and medical device RA teams)
- Medical writing: regulatory matters – lean authoring, European Medical Writers Association, 2024: https://journal.emwa.org/social-media/regulatory-matters/
About The Author:
Sonia A. Veluchamy is the CEO and cofounder of Celegence, a company dedicated to improving patient outcomes through intelligent regulatory compliance. Previously managing director and a board member at ArisGlobal, and with 15 years of industry experience, Veluchamy founded Celegence in 2017 with COO Punya Abbhi. Veluchamy can be reached by email at sveluchamy@celegence.com.