Kalypso director of life sciences Dave Hadfield gives his opinion on why regulatory information management systems are an important tool for medical device manufacturers. 


Both an opportunity and challenge to innovation, medical device companies are faced with complex and constantly changing regulations, growing product quality requirements, and an evolving landscape of digital technologies.

To navigate this environment, companies must find ways to maximise ROI (return on investment) by manufacturing products as efficiently and cost-effectively as possible.

To compete for business worldwide, medical device providers must deliver products in accordance with varying, strict global regulations and comply with each nation’s unique submission process, while accommodating evolving and increasingly sophisticated customer needs.

And all these efforts must be executed quicker and quicker with each coming year.

To thrive in this difficult landscape, medical device companies need a more streamlined and integrated approach to manage these processes. Regulatory Information Management (RIM) systems offer exactly that.

Dave Hadfield, director of life sciences at Kalypso (Credit: Kalypso)

Streamline processes and accelerate time to market with regulatory information management systems

Centralised and highly adaptable, RIM systems enable medical device providers to manage data for both upcoming and current devices before, during and after the product design and registration phases.

Organisations can manage all regulatory and compliance information in a single, consolidated system instead of relying on disparate, siloed systems.

This results in much greater operational agility that allows medical device companies to govern and track all of their regulatory data at once.

Combining and organising structured and unstructured data in one system dramatically streamlines cumbersome product registration, submission and tracking efforts, which helps accelerate time to market.

By leveraging RIM systems, businesses progress in their digital transformation journey, relying more on structured data and less on documents.

Ultimately, this allows them to move faster and more efficiently when completing regulatory duties.


The three generations of RIM

RIM systems have existed for decades. Over time, though, they have matured significantly, especially in recent years.

Over the course of three generations, RIM systems have increasingly leveraged cutting-edge, data-driven technologies to better connect data during a product’s lifecycle.

They have also grown to improve support for the changing global requirements of medical device companies.

The first generation collected documentation from different systems and consolidated it within one package.

This early iteration of RIM required manual data collection and lacked any capacity for integration or reciprocity.

The second generation incorporated broader data-management capabilities, enabling organisations to collect more information, such as market authorisation, manufacturer information, packaging information and clinical data – however, it only supported a regional scope.

The third and latest generation introduced an entirely comprehensive and fully connected system that operates globally and leverages the product lifecycle data throughout the value chain from early regulatory strategy to submission preparation, market registration and in market management.

The data integrates the product record, change record, international table of contents, DHF, product registration, UDI, GTIN, labelling and much more.

First and second-generation systems required users to pull this information from many point systems to get a complete picture of what’s going on.

In the third-generation system, this rich data set allows for deeper insights, including predictive analytics.

Providing a holistic view and single source of truth for data, the newest RIM systems dramatically simplify efforts to harvest rich data to deliver regulatory submissions.

Many medical device companies have adapted to new regulations with a first-or second-generation RIM system.

They often assume there is no need to go to the trouble to adopt a third-generation system – but that is a critical mistake.

Medical industry technology has changed and progressed considerably over recent years.

These evolutions are not limited only to medical devices: data systems have also evolved rapidly, ushering in a new era of connected data.

Systems are starting to provide real-time updates on market and regulation changes. By swiftly recognising and analysing these updates, companies can rapidly adjust their submission data.

These new technologies far surpass previous data-management system features and they are designed to be upgraded in the future as technology continues to advance.

Furthermore, C-level executives at medical device companies today are much more focused on regulatory concerns than they were in the past.

Most of these execs are eager to use cutting-edge technology to improve the registration process, boosting key business metrics.

Their best option to achieve this is through third-generation RIM systems.


The value of RIM

Adopting a new RIM system is a big undertaking that requires considerable effort across an organisation, although it can be done in phases with incremental benefits.

However, RIM systems provide enormous value that makes the commitment well worth it. Using the latest RIM technology, companies can:

  • Reduce product registration process time and expedite time to market
  • Prevent unsalable products due to delayed compliance renewals and changing country regulations
  • Expedite international sales and controlled distribution with connected data
  • Drive more informed decisions with updated data
  • Improve compliance and regulation tracking across the global economy

RIM systems can transform medical device companies. Adopting them will bring organisations closer to customers than ever before.

In turn, they will gain a massive leg-up in a complex and competitive industry that will yield massive ROI now and in the future.