Compliance woes? Take a leaf out of pharma’s eClinical book

Ricky Lakhani, director of product management, Pharmaseal, explains how medical device companies can learn from biopharma firms to stay ahead of the regulatory curve.

Advances in technology are stretching the definition and utility of medical devices to ever new lengths – and the regulations are following suit. Since May 2021, organisations working in the space have been expected to comply with the new EU MDD, which subjects devices to similar clinical trial standards to their biopharmaceutical cousins. The need for CE marks and greater pre- and post-marketing scrutiny is fundamentally changing the way companies operate. Luckily, there is no need to start from scratch. Adopting the processes and technologies that biopharma has been using – and refining – for years will allow medical device businesses to stay ahead of the curve, and ensure products are safe, effective, and compliant, both now and in the future.

Traditionally, medical device companies have operated with a lower level of regulation around clinical trials than their biopharmaceutical counterparts. The introduction of the EU MDD changed all that, placing greater scrutiny on pre- and post-marketing procedures, and fundamentally changing the way companies operate.

Far from being an insurmountable challenge, however, this paradigm shift could be a huge opportunity to future proof business. 

Medical device organisations are in the perfect position to learn from their drug developer counterparts and embrace the advanced clinical trial technologies biotech and pharma have been using and refining for years. 

With their ability to unify disparate systems to provide global data oversight, modern SaaS technologies provide a tried and tested, cost-effective approach to compliant trial management.

In short, it's time for the medical device industry to be bold. Because by taking the leap and adopting these technologies, companies can get ahead of current regulatory requirements and equip themselves for a future in which data will be central to everything they do.

According to the European Commission, the EU MDR brings EU legislation into line with “technical advances, changes in medical science, and progress in law making” and places “more emphasis on a life-cycle approach to safety, backed up by clinical data.”

As well as changing the classification of many devices, it significantly alters the obligations of manufacturers in their quest for a CE mark. For example, it stipulates manufacturers have systems for risk and quality management, that they conduct clinical evaluations, compile technical documentation, and apply conformity assessment procedures. 

It also makes manufacturers responsible for their devices after release, meaning post-marketing monitoring becomes essential, and states each organisation have a named person responsible for regulatory compliance. 

The regulation significantly increases pre-market scrutiny. It requires all applicable devices to undergo additional assessment and validation from notified bodies before being awarded a CE mark and eliminates “grandfathering” meaning all existing devices reaching a certification renewal date must be compliant with the new rules.

While these changes may appear daunting at first glance but in many cases, they simply bring device regulations into line with those applied to biopharmaceutical companies in their own journeys towards market approval – journeys that have been expedited and simplified using eClinical solutions.

Adapt and thrive 

For medical device companies, complying with these new rules requires more pre- and post-market surveillance and active monitoring of device performance than ever before, increasing the time to market for many products.

Attempting to make that move using traditional processes, or legacy, standalone technologies will put organisations behind the curve. Luckily, there is no need to reinvent the wheel, as businesses can follow the lessons of their biopharmaceutical cousins, who fully understand this additional focus on safety measures, risk management, post-market surveillance, and data collection and exchange. 

The drug development sector has been refining the processes and technologies needed to run safe and effective clinical trials for years. In that time, they have learnt that data is king, and that deploying single-use technologies to solve singular problems only leads to a tangle of disparate systems that require complex and costly integrations.

The result is today’s advanced clinical trial technology, which provides flexible solutions that simplify workflows and unify processes, boosting productivity and reducing the overheads associated with using multiple platforms. 

Medical device organisations stand to benefit from this learning curve. But to do so they need to take a more structured approach – they need to plan, secure management buy-in, and provide the training required to ensure the right skills and budget are in place to automate processes to embrace digital transformation.

Technological solutions 

As the biopharma industry now knows, consolidating Clinical Trial Management Systems (CTMS) and electronic Trial Master File (eTMF) offers a range of benefits – benefits that, under the EU MDD, are just as pertinent to the medical device sector. 

The approach eliminates the need to invest in multiple systems, while reducing the risks associated with information fragmentation, and the cost and complexity of integrating disparate platforms. 

Allowing for interoperability across eClinical applications unifies information and processes, streamlining study management processes into one, end-to-end, compliant, collaborative technology. 

And by increasing the visibility and transparency of information across studies and devices, it can provide actionable insights to drive proactive decision making. This global view of operations creates a closed-loop process that improves strategic planning, and is vital for the faster, safer, more efficient conduct of compliant studies. 

This approach consolidates key data within one system. It provides a single source for master data, providing fully compliant access to the entire audit history, without the risk of data loss, or the burden of reconciliation.

Sharing best practice

To date, the medical device sector has been underserved by eClinical solutions that have been designed specifically for biopharmaceutical organisations. But today’s SaaS systems are easily adapted to the space, come with low overhead and maintenance costs, and relieve the pressures of running trials.

Importantly, embracing digital transformation and striving for more connected trials – from initial safety studies to post-marketing real-world data collection – will give companies access to the data they need to stay compliant in this new landscape.

While the processes and terminology are slightly different in the medical device and pharmaceutical arenas, they share the same goals – to bring novel innovations that improve people's lives to market as quickly and as safely as possible – and integrated eClinical solutions are key to doing just that.