The booming medical device sector: How well are suppliers adapting to new regulatory demands?

Reviewing new international research, Peter Muller and Mike Baird of Schlafender Hase explore how Class 2 and 3 device manufacturers in Europe and the US are coping with rising Agency controls.

As medical devices become more critical to patient outcomes (the global market could reach a value of $886.80 billion by 2032¹), regulators around the world are increasing quality and safety controls, to bring device suppliers more in line with providers of pharmaceutical goods.

Now, new research² has assessed how well manufacturers and their regional or national partners are adapting.

Medical devices: The rise of regulatory requirements

The 2024 study, of 202 regulatory professionals at Class 2 and 3 medical device companies in the EU (Germany) and North America (the US), started by reviewing medical device suppliers’ involvement with a number of regulatory initiatives.

E-labelling/eIFU

Currently, just under two-thirds (62%) of medical device companies are involved in e-labelling initiatives, and up to a third of these (30%) are ‘very’ involved. EU companies are more likely to be actively involved in e-labelling 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 labelling as a service.

FHIR/standardised data exchange

Fast Healthcare Interoperability Resources (FHIR) is a proposed new 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 digitisation 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.

Navigating the new 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 digitisation 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.

Supporting technology

Over the next two to three 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; labelling 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.

Regulatory & safety content management

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, labelling 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 & labelling challenges

As tracking and supply chain transparency requirements rise, the challenges of producing compliant and correct device packaging and labelling 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 sterilisation, 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.

Takeaways

Finally, the study 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 prioritisation 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.

About the authors

Peter Muller is director of the Americas at Schlafender Hase. For more than two decades, he has worked on software and process improvement projects with Fortune 500 companies from life sciences and other regulated industries.

Mike Baird is director of product management at Schlafender Hase in Europe. He is a specialist in business/process transformation, optimisation, and quality, in particular linked to packaging and print, artwork, and labelling, particularly in life sciences.