Rising regulatory demands: are medical device suppliers ready?
The global medical devices market is set to reach $886.80 billion in value by 2032[1]. As devices become more critical to patient outcomes, regulators’ quality and safety expectations and associated controls are increasing. It’s why medical device sector representatives now account for some 50-70% of attendees at meetings of RAPS, the Regulatory Affairs Professionals Society.
So how well are device manufacturers and suppliers adapting to rising regulatory demands? We recently commissioned independent new research to find out.
The 2024 study, conducted with 202 regulatory professionals at Class 2 and 3 medical device companies in the EU (Germany) and North America (the US), assesses device suppliers’ current state of regulatory readiness.
E-labeling
E-labeling is high on the medical device regulation agenda on both sides of the Atlantic, and currently just under two-thirds (62%) of medical device companies are involved in associated initiatives. EU companies are more likely to be actively involved in e-labeling than those in the US (71% vs 53%, respectively).
FHIR
Fast Healthcare Interoperability Resources (FHIR), a proposed new global standard, is set to streamline data exchange and facilitate real-time information access for healthcare providers. 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
Although approached slightly differently, a unique device identification (UDI) system is advocated by both EMA and the FDA as an efficient and effective means of tracking and identifying medical devices globally. 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 strategies
Medical device companies are dealing with the impact of increasing regulations via 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.
The difficulty of finding and appointing qualified professionals to alleviate growing regulatory workloads is a particular issue on both sides of the Atlantic. Over a third (34%) of respondents cited this as the greatest challenge facing their company currently, while almost a quarter (23%) said that staff retention was their biggest issue.
Technology, then, is an important facilitator. Device companies plan to use a range of IT solutions to support upcoming projects, most notably electronic document management (EDM); content management; proofreading/content comparison; labeling management; and product lifecycle management solutions.
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 in rise and regulations expand.
Packaging & labeling challenges
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 requirement elicited 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 maximize its impact. Looking to the future, respondents also pointed to the need for greater investment in company culture (cited by 35%, rising to 43% of German/EU respondents); increased resources/recruitment (34%); greater emphasis on wellbeing (33%); and increased focus on education and training (32%).
Technology could offer a powerful solution here, although enhancements to processes will also be important to maximize its impact. Looking to the future, respondents also pointed to the need for greater investment in company culture (cited by 35%, rising to 43% of German/EU respondents); increased resources/recruitment (34%); greater emphasis on wellbeing (33%); and increased focus on education and training (32%).
The rising emphasis on such factors further highlights the new pressure that regulatory functions are under, and the criticality of making teams – and the way they work – part of the solution.
