Regulatory affairs is without a doubt a challenging function for all life sciences companies. In a recent survey of industry executives, 72% of them reported that regulatory affairs is one of their top 3 challenges. The pain is even more acute in the medical technology space. In the past few years medical device and in vitro diagnostic companies have had to contend with a host of new, more complex regulations for the European market (the new EU MDR/IVDR regime), as well as nascent medical device regulations in new markets around the world.
A significant additional challenge that medtech companies have to manage is that of continuity. Perhaps due to the challenges of the job, turnover among regulatory affairs (RA) professionals is surprisingly high. According to data from Zippia, RA professionals at all levels average less than 3 years in their jobs. This is echoed by the RAPS Global Compensation and Scope of Practice Report which showed that 63% of RA professionals have more than 7 years of regulatory experience, but 60% have been in their current jobs 3 years or less.
One of the most common ways that medtech companies attempt to address continuity challenges is by employing external consultants. Consulting firms provide needed expertise, and especially bandwidth to resource-constrained RA teams. A recent survey by Grand View Research found that large medtech companies regularly outsource 50% or more of their regulatory activities.
Consultants are undoubtedly helpful, but the general approach to consulting engagements makes them less than ideal for a broad set of regulatory activities. Consulting engagements are inherently project-based. They generally have a specific scope, and a set of associated deliverables. However, medtech regulatory affairs is inherently product-based. Activities revolve around the product’s lifecycle—from market introduction to maintenance to withdrawal. A consulting firm may help to complete market applications for a new device in Latvia, Japan, and Brazil, but the company still needs to maintain a full post market surveillance regime, track standards in associated essential principles tables, and keep UDI information up to date as packaging permutations change.
At some point there’s a transition from the consultants back to the internal RA team, and the same continuity problem re-asserts itself. How to capture and disseminate the information, applications, and country certificates associated with a consulting project so that the internal team can move forward while maintaining compliance and market clearance?
The lack of technology solutions designed specifically for medtech regulatory affairs is another driver of continuity issues. Regulatory activities necessitate the organization and management of large amounts of information. Detailed product specifications, performance and safety data, regulatory requirements, and relevant standards are just a few of the key pieces of information associated with each individual product and countries in which it’s sold. This is why RA professionals spend a huge amount of their time (up to 50%) simply looking for information.
Typically organizations manage regulatory information using spreadsheets or other general purpose tools. These tools, used to try and help manage information continuity, can actually create information silos. This happens for two reasons. One, the information that RA teams need for their activities is often broadly dispersed across the organization. Regulatory documents may be in a document management system (or just as often on individual employees’ computers), product and quality information is stored in PLM/QMS systems, and information about countries and selling status is contained within ERP systems. Spreadsheets don’t actually integrate with these sources, they just link. As information changes or is updated, it’s incumbent on employees to make manual updates to the spreadsheet.
Which brings us to the second problem. While there have been significant improvements in collaborative editing, documents like spreadsheets aren’t designed for the level of auditing and information management that regulatory teams need. Knowing whether an individual line item showing market status to be active, or a link to testing information in the QMS systems is up to date, still becomes “tribal knowledge” known only to the individual employees that make the update. If an employee leaves the company, all of that information goes with them.
The emergence of new technologies designed specifically for regulatory affairs activities has provided some new ways that medtech companies can tackle the continuity issue. Regulatory information management (RIM) systems provide a couple key capabilities that can increase the productivity of RA team members, and ensure that their work continues uninterrupted as team members come and go.
The first advantage of a RIM system is data association and integration. Rather than simply noting information, RIM systems can actively integrate with information sources, and automatically update as information changes. All of the information can be organized around individual products—the way that feels most intuitive to RA professionals. For any given product, an RA team member can quickly find country selling status, registrations, certificates, and expiration dates.
RIM systems can also eliminate a lot of the manual administrative work associated with regulatory activities. They can help streamline registrations with digitized authoring and publishing of regulatory submissions, and the creation and maintenance of digital essential principles tables. These capabilities are wrapped in a full set of project management tools, allowing teams to create workflows, approvals, timelines, etc. that match their internal processes and organizational goals. Individual records can be automatically updated such as the auto-population of UDI data when product details change, or bulk updates of essential principles tables when a standard is updated. These capabilities increase bandwidth across the RA team, and ensure that even new members can easily operate in accordance with the company’s processes.
RIM systems function as a “single source of truth” for RA teams. Because they work with all regulatory activities, they not only store information, but cross-link it in ways that make it instantly usable. RA team members can quickly pull regulatory information about products, product families, countries, regions, individual projects, eliminating the time spent searching for information. With enterprise integration capabilities, information can be pulled and shared with PLM, QMS, and ERP systems. This ensures that information is automatically updated, and key dependencies on regulatory activities are automatically linked. For example, clearance to enter a new market could automatically trigger a change in selling status in the ERP system. Having an organized, central source of regulatory data prevents information silos from forming, and ensures that nothing is lost when RA team members move on to other roles.
Medtech regulatory complexity isn’t likely to abate any time soon, but there are steps that companies can take to better manage RA team bandwidth and continuity. Traditional approaches like outsourcing, or general productivity/information tools like spreadsheets are helpful, but they have limitations that can exacerbate continuity challenges. Modernizing the regulatory affairs toolset can be a good starting point. RIM systems with the right capabilities have the potential to increase RA team productivity, and eliminate information silos.
Key RIM features include support for a broad set of regulatory activities. Some tools focus on one aspect of RA like product registrations. As a result, they’re unlikely to effectively centralize and organize a broad set of regulatory information. While helpful from a productivity perspective, they can still lead to information silos for activities that aren’t digitized within the tool. Other RIM systems are primarily designed for the pharmaceutical industry. While they appear similar, regulations, and processes for medical technologies are different across the board. Tools that aren’t designed for medtech won’t feel as intuitive for employees, and likely won’t do as good a job at automating regulatory activities.
Rimsys provides a full-featured RIM system that is designed specifically for medtech companies, and supports a full range of regulatory activities. To see if the Rimsys Platform can improve your RA continuity, request a custom demo today.