Regulatory Information Management (RIM) systems provide a single platform for regulatory teams to manage submission and compliance data, reducing administrative overhead and increasing confidence in a company’s global regulatory data. RIM systems can digitize and automate a broad set of regulatory activities from new product submissions, to registration and standards management, to UDI data management. These capabilities can significantly improve RA efficiency and effectiveness - reducing workload for new releases by over 80% and maintenance time for technical files more than 90%. However, not all organizations can realize results like these immediately. When deciding to implement a RIM system, medical device companies need to consider many factors and ensure that they have the needed systems, processes, and personnel in place.
RIM systems are fundamentally about data. They first and foremost provide a system to collect (either directly within the system or through integrations) and centralize regulatory information, making it easily accessible across the organization. This means that in order for a RIM system to be useful, your data needs to be accessible to the system. Medtech companies without the following in place may not be ready for a RIM system:
- Digitized documentation: It is imperative that regulatory documentation, such as technical files and design history files, are in a digital format. If you still have older product documentation on paper in locked file cabinets - it’s time to get them digitized!
- Application infrastructure: RIM systems rely on data that is often stored in other applications, such as eQMS, PLM, or ERP systems. It is rare to implement a RIM system as the first application in a medtech company’s software stack. Medtech companies should have, at a minimum an eQMS system that is compliant with 21 CFR Part 820 and/or ISO 13485 and an ERP system in place before implementing RIM.
- No competing major IT initiatives: A RIM implementation is a major project that should be given dedicated resources and the attention of the management team. Consider the timing of a RIM implementation carefully if there are other majorIT projects, such as an ERP implementation or a major system upgrade.
It’s important to understand RIM projects as a true digital transformation. While it is primarily a technology implementation, the end result is a significant change in that way that regulatory affairs teams work. This change is very beneficial, but it’s still disruptive in the short term. Teams without the right leadership support and change management plans may struggle to realize value from their RIM investment.
- Digital transformation strategy: A RIM implementation is an integral part of a larger digital transformation strategy. Medtech companies that are most successful with RIM have a digital transformation initiative in place, and an understanding that they are driving organizational process change in addition to technology adoption.
- Recognized need: RIM implementations are significant projects that require resources and the attention of the management team. RIM projects are most successful when the management team recognizes that the status quo is not sustainable and places a priority on providing resources for the regulatory team.
Timing a RIM implementation
Medical device manufacturers who can benefit the most from a RIM system are those whose regulatory teams are, or will soon be, surpassing their ability to handle submission and product market data manually. For most medtech companies, the best time to start a RIM system implementation is about a year before they expect a significant increase in the demands on the regulatory team. While a RIM implementation rarely takes a year to complete, this will give you time to put in place the data and processes in time for them to be tested and accepted before the regulatory team is overwhelmed with other priorities. Consider:
- Expanding geographic reach: Expanding from one country or region into multiple markets creates significant complexity for regulatory teams. Manually maintained spreadsheets become insufficient for handling the ever-changing regulatory requirements in multiple countries.
- Growing product portfolio: Similarly to entering new markets, new products can exponentially increase the complexity of processes and data that regulatory teams need to manage.
- Greater product complexity or risk: Regulatory teams managing lower risk products, such as Class I products in the U.S., will not have as great of a need for a RIM system as those managing more complex products with greater regulatory requirements.
- Significant upcoming changes: Pending company acquisitions, changes to legal entities, major design updates, or other changes that would trigger re-registration activities mean significant increase in activity and risk for your regulatory team.
Teams and Personnel
A RIM system empowers regulatory teams, allowing them to save time on administrative tasks and spend more time making sure their company’s products are entering markets efficiently and staying in market effectively. This means that a RIM system will be of use to a seasoned (almost always overworked) regulatory team. It is rare to implement a RIM system before an internal regulatory team is in place. If your company doesn’t have the following, then you likely won’t get full use or value out of a RIM implementation:
- Dedicated regulatory personnel: One or more regulatory professionals responsible for obtaining and maintaining market clearance for your products, and interacting with government health authorities.
- Committed management team: A management and executive team that recognizes the importance of a strong regulatory system, and is willing to commit the resources necessary to make it successful.
Think your team is ready for RIM? Not sure? Download our RIM readiness checklist or talk to us today!