Naysayers are everywhere and if you’re not careful they can ultimately keep your medical device company from spreading its wings. Below are just a few myths and misconceptions I’ve heard by people who claim Regulatory Information Management (RIM) platforms used to manage MedTech regulatory workflows require beefed up involvement by stakeholders (not true), cause chaos for medical device regulatory teams (not true), and are too expensive (not true), among others.

Myth No. 1:

A RIM platform is a massive cost that requires heavy stakeholder involvement from multiple teams…

But in reality, the cost is nominal and will fit your specific needs. A modern RIM platform like Essenvia’s can be implemented in fewer than 90 days, and companies will realize the benefits and see returns within the first few weeks of use.

Following a staggered implementation prioritized by business value allows you to efficiently use resources and make progressive investments in time and effort. This also optimizes your overall cost of RIM transformation justified by your return on investment, or ROI. It’s not difficult to justify the ROI if you prioritize use cases tied to business value that drive the implementation roadmap. Completing the first implementation on time allows you to start realizing benefits faster, impacting the efficiency of your regulatory work and generating measurable returns that translate into a solid ROI indicator.

Myth No. 2:

A RIM platform will disrupt my regulatory team and how it currently works and functions…

But in reality, a good RIM platform, particularly those designed for MedTech regulatory teams such as Essenvia’s, adapts to your existing workflows. It makes your regulatory processes more organized, faster, and efficient without any disruptive changes. Implementing modern solutions is key to making sure your company is always in compliance with regulators.

Beyond that, RIM platforms can be adopted by local teams or departments and doesn’t require global implementation if that is the approach your company wants to take. Localized adoption of platforms allows you to validate the business case, realize company-specific value, and incorporate best practices before scaling the solution to the entire company. In other words, you can scale at your own pace.

For MedTech companies that already have a document management system (DMS), a product lifecycle management (PLM) platform, an electronic quality management system (eQMS), or other type of “solution,” adding a RIM platform to the mix is still extremely beneficial. After all, a robust RIM is designed to address the regulatory workflows for a manufacturer’s products and the markets they are in – or want to enter. Unlike a traditional DMS, RIM platforms streamline those workflows and related decision-making, providing unmatched accuracy for RA teams. Modern RIM solutions also integrate seamlessly with your existing DMS, PLM, or eQMS systems, enhancing their value by delivering a cohesive and efficient end-to-end regulatory experience.

Myth No. 3:

It takes years to start using the solution and realizing the benefits…

But in reality, this is not true for a RIM solution like Essenvia’s that is built with a modular and flexible architecture specifically for medical device regulatory teams. By prioritizing specific use cases in your RIM implementation schedule, you can address critical pain points immediately and gradually add more modules to achieve a comprehensive RIM solution – so get the ball rolling today with a new RIM platform.

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Founded in 2018, Essenvia is a MedTech RIM platform that gives you the tools you need to manage regulatory workflows across the total product lifecycle, accelerate global market access, and generate exponential business value. Discover more about what Essenvia can do for your company at Essenvia.com.