The global medical devices market is expected to grow from $542.21 billion in 2024 to $886.80 billion by 2032[1]. As devices become more critical to patient outcomes, regulators around the world are increasing their controls around their manufacturing, distribution, and monitoring – bringing suppliers of these products more closely into line with requirements around pharmaceutical goods.

New research[2] has assessed how well manufacturers and their regional or national partners are adapting to the rising regulatory demands. The 2024 study, with 202 regulatory professionals at Class 2 and 3 medical device companies in the EU (Germany) and North America (the US), highlights the number of challenges currently vying for attention and investment and assesses device companies’ current state of regulatory readiness.

Medical devices: the rise of regulatory requirements

The study started by surveying medical device suppliers’ involvement with a number of regulatory initiatives.

E-labeling/eIFU

Currently, just under two-thirds (62%) of medical device companies are involved in e-labeling initiatives, and up to a third of these (30%) are ‘very’ involved. EU companies are more likely to be actively involved in e-labeling than those in the US (71% vs 53%). 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 (FHIR) is a proposed global standard, designed to streamline data exchange and facilitate real-time information access for healthcare providers. It will make many regulatory professionals’ lives easier by shifting the emphasis of content creation and management to ‘publishing’ rather than ‘printing’, helping to drive process digitization in the production and management of regulated medical device information and content.

In the survey, three in five respondents (60%) claimed to be 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) makes it possible to track individual devices across the healthcare supply chain internationally. 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.

Anti-counterfeiting

Taking proactive measures to mitigate the threat to product quality and patient safety posed by counterfeit products is a further expectation and robust product identification and traceability are a cornerstone of this practice, along with vigilant supply chain monitoring. In the survey, over half (55%) of respondents indicate at least some involvement with anti-counterfeiting.

Navigating regulatory demands

Medical device companies are dealing with the impact of increasing regulations in a number of ways, including the implementation of key standards (e.g. ISO); process digitization and automation; greater use of outsourcing or third-party collaboration; and hiring of more regulatory people – all cited by more than a third of companies.

The difficulty of finding and appointing qualified professionals to alleviate soaring regulatory workloads is a challenge on both sides of the Atlantic, while almost a quarter (23%) said that staff retention was their biggest issue.

IT’s role in supporting strategic initiatives

Over the next 2-3 years, respondents foresaw projects linked to existing devices (cited by 32%, rising to 35% among US respondents); emerging healthcare trends (28%, rising to 34% of German/EU respondents); and new materials & technologies (27%). They planned to draw on a range of technology solutions to support these initiatives, most notably electronic document management (EDM); content management; proofreading/content comparison; labeling management; and product lifecycle management solutions, each cited by around a third of respondents.

Compared to the pharmaceutical market, the use of regulatory information management (RIM) systems is currently less prominent in medical device companies, featuring for just 29% of respondents, followed by structured authoring/creation tools (27%). The penetration of formal systems in the medical device sector is likely to grow as ambitions rise and regulations expand.

Keeping pace with Regulatory & Safety content production

To keep pace with rising workloads, more than a third (36%) of medical device companies already use software for the proofreading and content review process for regulatory documents, labeling materials, and promotional content, while 29% still resort to manual proofreading in house, rising to 37% in the US. In the EU, more respondents (41%) use software to help them review content quality.

A third (34%) of all respondents currently outsource their content proofreading, which could be as part of a broader arrangement with an external partner.

Packaging & labeling – a particular challenge

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, the subject yielded 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 important to get the most from any investment.

Revised priorities

Finally, the study (the full report is available here) surveyed device companies’ top five takeaways from the last year that would inform their next regulatory actions. They cited the need for greater investment in company culture (mentioned by 35%, rising to 43% of German/EU respondents); bolstered resources/recruitment (34%); more emphasis on wellbeing (33%); more investment in technology (33% – rising to 42% of US respondents); and increased focus on education and training (32%).

The prioritization of company culture and employee wellbeing is further evidence of the growing pressure that regulatory functions are under, and the criticality of making teams – and the way they work – part of the solution.

[1][1] Medical Devices Market, Fortune Business Insights, June 17, 2024: https://www.fortunebusinessinsights.com/industry-reports/medical-devices-market-100085

[2] The independent Census-wide survey, commissioned by Schlafender Hase, was conducted in late May/early June 2024, among 202 regulatory professionals at Class 2 and 3 medical device companies (those deemed of intermediate to high risk in the event of a malfunction or quality/safety issue). The samples were split 50/50 between respondents in the EU (Germany) and North America (the US). Link to full report: https://www.schlafenderhase.com/ebooks/medical-device-report-how-are-compliance-strategies-evolving