There was significant M&A activity in the MedTech sector in 2024, and the industry is predicting another big year for mergers and acquisitions. As MedTech companies aim to expand their product lines, enter new markets, innovate faster, and remain competitive in a rapidly evolving space, mergers and acquisitions can be attractive and cost-efficient options. Additionally, some manufacturers are choosing to divest parts of their business to hone their focus, drive additional investment in other key areas, and optimize operations.  

For the regulatory affairs professional, M&A activities can be anything but efficient. An influx of new products, registrations, and regulatory information to maintain can wreak havoc on RA teams who are already struggling to effectively manage and maintain compliance amid a seemingly constant state of regulatory change.  

In an increasingly complex regulatory landscape, many MedTech teams are turning to RIM systems to help them centralize regulatory information across the business, automate time-consuming, manual processes, and strengthen global compliance. These benefits are even more palpable for companies undergoing mergers, acquisitions, and divestitures, giving them streamlined, fully visible regulatory information management that can scale with their evolving business needs and additional regulatory information to manage.  

Case Study: Large, Publicly Traded Device Manufacturer Navigates Product Line Divestiture with Ease

A large, publicly traded manufacturer of products for pain management, digestive health, and IV therapy was in the process of divesting one of its product lines to another company. As a result, some of their regulatory employees were transitioned to the company that purchased its product line. The customer leveraged Rimsys’ unique Linked Accounts feature, which allows users to grant external stakeholders controlled access to Rimsys, to give those impacted access to the 100+ registrations associated with the divested products. As a result, the transitioned employees lost no access to their respective products and are able to manage, review, and approve those registrations as they normally would.  

“Linked Accounts is a fantastic feature that I didn’t originally appreciate as much. Rimsys made it easy for us to identify the products impacted by the divestiture and provide access to those who need them. It has been a bright spot in the sea of headaches both teams are experiencing when trying to review and approve information in other systems.”

-Program Manager, Regulatory Information Management

When the transaction is complete, the customer will easily be able to export the list of registrations by product tag and archive the registrations in Rimsys for easy management and visibility. The transitioned employees will also still retain access to the information they need in Rimsys as they work to implement their own Rimsys solution to manage those registrations.

Navigating Business and Regulatory Changes with RIM Systems

As the MedTech industry prepares for additional mergers, acquisitions, and divestitures this year, getting a solid regulatory information foundation in place is critical for a successful transition and ongoing compliance. Yet, many MedTech RA teams are using manual processes and siloed systems to manage regulatory information.

One of Rimsys’ goals is to serve as a strategic partner to MedTech RA teams, helping them better understand their current RIM state and the steps they need to advance their processes. This includes the implementation of a RIM system such as Rimsys to centralize their regulatory information, enable easy collaboration with internal and external stakeholders, and automate time-consuming manual processes for strengthened global compliance.  

See our Guide to MedTech RIM Maturity, which provides our RIM Maturity Model Framework, for ways to better assess your organization’s current RIM state and incrementally reach new milestones.  

Rimsys has helped global MedTech leaders navigate business and regulatory change with unified RIM software that provides full visibility into their regulatory activities. If you’re looking to stay ahead of upcoming strategic activities or are simply looking for a better way to manage your information amid increasing complexity, contact us to learn how Rimsys can help you streamline and automate your processes for long-term success.

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