Regulations around medical device monitoring and reporting are on the cusp of a big shake-up. The PIP breast implant scandal is just one of a number of alarming public scares that have contributed directly to calls for greater tracking and reporting rigor.
The developments have clear echoes of those that began rolling out across the pharmaceutical industry some 14 years ago—as authorities around the world sought to enforce stricter safety controls. Since then, drugs companies have come a long way—culminating in their current preparations for standards set under Identification of Medicinal Products (IDMP) .
So what can device manufacturers learn from their journey? Until now, this sector has been largely exempt from after-sale monitoring controls; quality/safety considerations have been largely confined to the manufacturing shop floor. But all that will need to change in the run-up to the European Commission’s new medical device regulation (MDR), applicable from May 2020, and the equivalent in vitro diagnostic medical device regulation (IVDR), due for introduction in May 2022.
Once the new regulations are applicable, it will be incumbent on device manufacturers to formally monitor the long-term safety of their products, and provide evidence of their follow-up findings in periodic safety update reports.
Measure, then Manage
First, companies will need a means of capturing postmarket safety data. MDR demands a detailed summary of safety and clinical performance information, which must be updated and reported at regular intervals with post-market clinic follow-up findings—a combination of formal studies, incoming feedback from patients and physicians, and potentially commentary captured via public online patient forums and social media platforms.
This rigorous postmarket surveillance will apply to every category of medical device, too, creating a lot of work for manufacturers. Failure to play ball could lead to multimillion-dollar fines, products being taken off the market and lasting reputational damage.
The requirements could have global implications as well. Late last year the International Consortium of Investigative Journalists reported that, over the past 10 years, more than 1.7 million injuries and almost 83,000 deaths were linked to medical devices. In addition, the International Medical Device Regulators Forum (IMDRF) has taken an interest in MDR and IVDR, which could lead to the adoption of variations of these requirements in Asia, North America and South America in the future.
So what plans do manufacturers need to put in place, and what lessons can they learn from the experiences of pharmaceutical companies that improve their efficiency and impact?
The first recommendation is not to see compliance as a single event that manufacturers can plan for with a finite, all-encompassing project or definitive software solution. As pharma organizations have found, the global regulatory climate is continuously evolving, so there is no silver bullet in delivering compliance. Many pharma companies ended up with 20 or more different systems from different vendors by taking a best-of-breed systems approach. When they subsequently ran into integration and data-exchange problems, they then largely had to fall back on manual processes and spreadsheets for pulling together all of the required information.
Over time, pharma firms have recognized the value in establishing an end-to-end information management capability that can be adapted to a range of different needs. This would ideally involve a single, complete master set of data about products and their evolving status right across the drug lifecycle, which can be applied as needed for each different use case.
Medical device manufacturers would benefit from this end-to-end product tracking from the outset in their own regulatory reporting preparations. It would enable them to develop a clearer line of sight across product lifecycles, including postmarketing stages, which, as well as covering current and future regulatory reporting obligations, could be used to feed back into future product development, for example.
Taking a comprehensive “master data” approach, rather than trying to apply a single-fix software solution, offers multiple operational and strategic advantages. In addition to maximizing cost efficiency and leaving options open for the future, it brings opportunities to reduce repetitive data re-entry or document creation, and scope to develop a fuller picture of what happens with products beyond the factory floor.
Developing a structured way of managing product data, meanwhile, presents opportunities to automate and expedite processes such as routine document compilation and initial content checks. Opportunities here include applying artificial intelligence/machine learning and workflow rules to collate what is needed, and detect and flag any omissions or concerns with content.
Looking Laterally for Added Business Benefits
Pursuing broader efficiency gains from reporting compliance initiatives will also help medical device manufacturers with other requirements, such as providing better information directly to patients. As part of new regulatory measures, they will be expected to provide more easily accessible advice to patients online (i.e., pacemaker users would be able to quickly look up the implications of air travel). Meanwhile, simply being able to look up a product’s market and regulatory status with just a couple of clicks could be transformational in ensuring that marketing licenses don’t lapse, because all the latest information about a product can be found in one place.
If medical device companies want to maximize the business benefits of their regulatory compliance measures, however, they will need to formulate clear plans right now. As many pharma firms learned the hard way, leaving compliance investments until too late can limit the kind of big-picture thinking that leads to extended benefit cases. Too often, when deadlines are bearing down, the response is to take shortcuts to achieve the immediate compliance goals. In so doing, manufacturers risk not only having to spend again each time regulatory specifications are updated, but also limiting what else they can do with the data they are collecting.
For now, there is still time to build out a broader vision. But only just.