Time for action: Practical advice on regulatory updates

David Gwyn, global solutions architect, Amplexor provides practical advice on regulatory updates, as Gwyn believes there are still many lessons to be learned.

While the medical device industry often looks to distance itself from big pharma, it could learn a thing or two from across the divide when it comes to rigorous reporting standards. With Medical Device Regulations (MDR) and equivalent international standards now being introduced, to increase traceability and improve patient safety, device producers have got a steep learning curve ahead.

The regulatory climate for medical device manufacturers is on the brink of a major shift, intended to raise patient safety and make companies more accountable for tracking the impact of their products in the real world. The high-profile PIP breast implant scandal is among the cases that have led to the formal steps being taken, first in Europe then globally in the coming years.

The new regulatory requirements pose some fundamental challenges with echoes of where pharmaceutical companies were some 14 years ago – when European Medicines Agency (EMA) and other regional authorities around the world began to usher through new information submission standards.

History repeating itself

After a huge amount of pain and cost, drugs companies have come a long way – their most recent effort being to create a more definitive, consistent and reliable picture of their products from a regulatory perspective, in anticipation of new ISO IDMP requirements. Here, through an internationally harmonised approach to identifying and describing medicinal products, the industry aims to bolster pharmacovigilance activities, make it easier to locate and exchange product and substance information globally; promote reuse of data across different procedures and regulators; and generally streamline regulatory processes.

Until now, medical device manufacturers have been mere observers of the developments. While quality and safety have always ranked highly for reputable players, efforts have largely been concentrated on the manufacturing shop floor in terms of product lifecycle information management.

But this will need to change in the run-up to the European Commission’s new MDR, applicable from May 2020, and the equivalent in vitro diagnostic medical device regulation (IVDR), due for introduction in May 2022.

One of the most critical areas of focus of these new regulations is post-marketing surveillance. Once the new regulations are active, device manufacturers will be expected to formally monitor the long-term safety of their products and provide evidence of their follow-up findings in periodic safety update reports.

Gathering evidence

So, first off, companies need to be able to capture post-market 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 GPs, and potentially commentary captured via public online patient forums and social media platforms.

The new post-market surveillance requirements will apply to every category of medical device, too, creating a lot of work for manufacturers. The implications of falling short of authorities’ expectations could be significant, ranging from multi-million-dollar fines and products being taken off the market, to lasting reputational damage.

The increased rigour won’t be confined to Europe, either. In the US, more than 1.7 million injuries and almost 83,000 deaths may have been linked to medical devices, based on reports to the FDA over a 10-year period. The International Medical Device Regulators Forum (IMDRF) has a keen interest in MDR and IVDR, too, which could result in countries in Asia and South as well as North America adopting their own variations on the requirements in the coming years.

Insights from big pharma

With little more than a year to go until the first new requirements come into force in Europe, there is a growing sense of urgency for medical device manufacturers to put in place strategies, processes and systems for managing all of their new reporting responsibilities. So what can they learn from their counterparts in the pharmaceutical sector, to save them from repeating early mistakes?

The first takeaway is not to see the coming changes as a single event that manufacturers can plan for with a definitive, one-stop project. If pharma has learnt one lesson above all, it is that the global regulatory climate is continuously evolving, so trying to pin down all requirements up front, or waiting until all the final variables are known before getting going, is not a practical approach.

Similarly, regulators’ hunger for information is seemingly insatiable, so selecting a series of best-of-breed applications that each handle a finite set of parameters, has been found to be be a false economy. When pharma companies did this, many ended up with 20 or more different systems from different vendors, all of which needed to be supported and updated, and many of which did not integrate and share data very easily with each other. This caused firms to fall back on manual processes and spreadsheets for managing all of the contributing information, reintroducing inefficiency, potentially introducing errors and undermining their considerable investments.

Laying futureproof foundations

Through more than a little pain, pharma companies have learnt that it is far more practical to create a more fluid, end-to-end information management capability which can be adapted to a range of different needs. The ideal many firms are now working towards is the creation of a single, complete, master set of data about their products and their evolving status – one that spans R&D, approvals, and post-marketing follow-up, and which can be applied as needed for each different use case.

Having a clear line of sight across a definitive single set of complete information offers companies all sorts of advantages, not least the scope to reduce repetitive data re-entry or document creation, and the opportunity to automate preliminary information checking and content building processes. In pharma, companies have been able to do away with huge teams of temporary staff who had been drafted in to review and edit regulatory documents ad infinitum. With strong, authenticated master data to draw on in support of multiple use cases, they were able to automate much of this work.

Staying prepared

Looking for broader efficiency gains will also serve medical device manufacturers well as they are required to provide better information directly to patients – for instance, online advice about the lifespan of a product, or guidelines about airport safety for users of pacemakers. That’s in addition to the immediate benefits of being able to call up a product’s status information in a couple of clicks, to verify where it is currently approved, or what has been the latest correspondence with a particular authority.

Working towards a comprehensive, global master resource of product regulatory data offers medical device manufacturers a host of potential advantages, and a chance to skip to the point that many pharmaceutical companies are only just getting to now.

With the first deadlines for the new regulatory compliance bearing down, medical device manufacturers now need to press ahead with their plans. One of the first discussions may need to be about moving extended product data management off the shop floor into a regulatory lifecycle/regulatory information management (RIM) environment, overseen by those tasked with matters of safety and compliance.

Certainly, as post-marketing surveillance activities grow in prominence, the role of regulatory affairs teams will become more critical in the medical device sector, with a likelihood that relevant skills will be in high demand. It’s a further reason why manufacturers should start acting now.