Regulatory scrutiny of medical devices is increasing across developed economies to keep patients safe and maintain public confidence.
Published in Medical Product Outsourcing
With the medical device industry on target to reach a value of $886.80 billion by 2032, it is a natural progression that representatives from the sector now constitute a swelling proportion of attendees at Regulatory Affairs Professionals Society (RAPS) meetings. As ever-smarter devices evolve and become integral to patient outcomes, it follows that industry authorities in the major economies are driving up safety controls including device identification and traceability requirements.
But just how well are medical device manufacturers and suppliers adapting to the requirements, and how well-resourced are they to keep pace with the changes and checks now needed? This is the subject of a timely new international research report. The 2024 study was conducted with 202 regulatory professionals at Class II and III device companies in the EU (Germany) and North America (the US).
Escalating Requirements
The regulatory affairs survey began by probing medical device companies’ awareness of and existing involvement with many increasingly prominent regulatory initiatives. These included:
E-labeling/eIFU
E-labeling is high on the medical device regulation agenda on both sides of the Atlantic. Electronic information provision and management promotes standardization and consistency (e.g. format and terminology), making it easier to manage and process the contents in any market. It also plays a key role in product traceability, a critical safety lever.
Providing critical product information digitally (e.g. under expectations associated with electronic instructions for use, or eIFU) makes it easier to issue prompt updates, too. It also simplifies international content and translation management and, in the case of user advice or safety information, facilitates spontaneous online or mobile lookup by clinicians or patients. Crucially, e-labeling allows device manufacturers to provide more detail than can fit on a physical label.
Currently, just under two-thirds (62%) of medical device companies are involved in e-labeling initiatives. EU companies are more likely to be actively involved in e-labeling than those in the US (71% vs 53%, respectively). This makes sense as the EU is ahead of the US with the practice; companies here are also less likely to outsource labeling as a service.
FHIR/Standardized Data Exchange
Fast Healthcare Interoperability Resources is a proposed new global standard, designed to streamline data exchange and facilitate real-time information access for healthcare providers. It will shift the emphasis of content creation and management to ‘publishing’ rather than ‘printing’, promoting the digitization of the production and management of regulated medical device information and content.
In the survey, three in five respondents (60%) were involved with the standard, rising to 67% for EU (German) respondents; in the US, only just over half were occupied with FHIR (FHIR is not as high profile in the US), though the FDA is encouraging manufacturers to adopt interoperability standards.
UDI/Device Identification
Unique device identification (UDI) employs a unique numeric or alphanumeric code to identify individual devices across the healthcare supply chain. Although approached slightly differently, a UDI system is advocated by both EMA and the FDA. Benefits include expedited and more targeted product recalls, a reduction in product counterfeiting, and a better, safer experience for patients.
In the survey, two-thirds (66%) of respondents (rising to 74% of EU survey participants, but accounting for a much lower proportion in the US at 57%) express involvement in UDI activity.
Regulatory Readiness: How are Compliance Approaches Evolving?
In the medical device sector, the use of regulatory information management (RIM) systems is currently less prominent compared to the pharmaceutical industry, indicated as already implemented by only 29% of respondents. Structured authoring/creation tools were almost as likely to be present, but again cited by only just over a quarter (27%) of respondents as being in use today.
The penetration of formal systems in the medical device sector is likely to grow as ambitions rise and regulations expand. Respondents indicated that as they continued to invest in existing devices, as well as projects linked to emerging healthcare trends, and new materials and technologies, they would look to a range of technology solutions for support – most notably electronic document management (EDM); content management; proofreading/content comparison; labeling management; and product lifecycle management solutions – each cited by a third of respondents.
To cope with increased regulatory submissions, more than a third (36%) of medical device companies use software to accelerate the proofreading and content review process for regulatory documents, labeling materials, and promotional content; while a slightly smaller proportion (29%) still do this manually in house – rising to 37% of medical device companies in the US. In the EU, more respondents (41%) use software to help them review content quality. A third (34%) of all respondents outsource content proofreading, which could be as part of a broader arrangement with an external partner.
As tracking and supply chain transparency requirements rise, the challenges of producing compliant and correct device packaging and labeling for each respective market intensify. In the research, this pain point saw particularly strong responses. Just under two-thirds (65%) of respondents said they find translations challenging to manage; 61% find barcodes challenging to manage; 60% struggle with graphics including symbols (shorthand guidance on device sterilization, for instance); and 59% have difficulty with tables. This is on top of any issues getting the text right (cited as a challenge by 54% of respondents).
Technology could offer a powerful solution here, although enhancements to processes will also be needed to ensure ROI.
A Plan of Action: Survey Takeaways
The medical device sector regulatory study (the full report is available here) concluded with companies’ top takeaways that will inform their next regulatory actions.
These most commonly included greater investment in company culture (cited by 35%, rising to 43% of German/EU respondents); increased resources/recruitment (34%); greater emphasis on wellbeing (33%); more investment in technology (33% – rising to 42% of US respondents); and increased focus on education and training (32%).
The emphasis on cultural considerations, in addition to matters of employee well-being factors, underlines the rising pressures that regulatory functions now face. It also reinforces the importance of making regulatory teams and their everyday processes an integral part of any emerging strategies and remedial efforts.
