Like all products, time-to-market is a critical success factor for medical technology (medtech). Product research and development ties up capital investment that can only be recouped when products start selling. For start-up and early stage companies, time-to-market can be the difference between success and failure. With a limited capital runway, they must demonstrate market success to access additional funding and growth opportunities. Unlike other products, however, medical devices have an added hurdle of regulatory clearance that must be obtained before products can be marketed and sold.
Underestimating the regulatory burden
It’s easy to underestimate the amount of time and effort required for regulatory activities related to New Product Introductions (NPI), especially during the development process. Policies, procedures, and submission processes can vary significantly between countries and regions, and almost all of them require government clearance before devices can be marketed. For larger companies it’s not unusual to operate in 100+ countries, creating an enormous array of standards and applications that must be manually managed.
These challenges are exacerbated by unclear lines of communication and siloed information across systems. Product development and testing information is stored within Product Lifecycle Management (PLM) and Quality Management System (QMS) solutions. Sales forecasting, marketing, and production information is stored within Enterprise Resource Planning (ERP) and Customer Relationship Management (CRM) systems. And regulatory, standards information, and compliance documents are stored across various file systems.
Regulatory submissions must synthesize information from R&D, QA, and go-to-market teams, and data from across all of these systems. Any mis-steps, or missing information can result in significant go-to-market delays, and even rejections from regulatory bodies. Coordinating regulatory status between go-to-market regulatory affairs teams can be a particularly vexing challenge. Without clarity about what markets have been cleared/approved, companies run the risk of moving too quickly ahead of the regulatory process, or unnecessarily delaying market entry.
What is a RIM system?
Despite all of the complexity associated with regulatory submissions, many teams rely on rudimentary approaches to coordinate and manage them. Submissions and associated data are managed via individual documents or complex color-coded spreadsheets, with no central repository of submission records or status.
Regulatory Information Management (RIM) systems are software solutions designed specifically to help companies streamline the submission, authorization, and maintenance process. They provide a digitized central repository for all regulatory information and content, allowing companies to automate and maintain compliance in the global market.
Using a RIM system to manage regulatory submissions and compliance can improve efficiency and productivity, reduce the risk of rejected submissions and noncompliance, and provide greater visibility into ongoing registration processes and status across the organization. While RIM systems provide specific benefits to regulatory affairs teams, they also provide company-wide benefits—specifically when it comes to accelerating time-to-market for new products.
5 ways a RIM system can accelerate time-to-market for new products
Full-featured RIM systems (like Rimsys) provide a number of capabilities that MedTech companies can take advantage of to get new products to market more quickly—and keep them there.
- Regulatory intelligence. Medical device registration requirements and standards vary across regions and countries. Understanding market entry requirements and timelines for regulatory submissions are necessary for any go-to-market planning, but finding and keeping track of this information can be challenging—especially for early-stage companies. RIM systems can provide up-to-date information about regulatory requirements without a lot of manual research and document management. Go-to-market teams can leverage the breadth of regulatory information in the system to develop rollout strategies for different markets, and identify the most attractive markets based on size and regulatory complexity.
- Digital forms and templates. Each regulatory submission requires multiple templates and forms, many of which aren’t available digitally. Finding the correct, current form, and manually filling it for each country/region can add significant time to the regulatory submission process. RIM systems can take the guesswork out of finding forms, by providing a library of digital templates for different markets that companies can easily access and fill. Even offline forms can be loaded into the system for digital filing and storage. With a modern RIM system, regulatory teams can easily access, fill, and track progress for submission forms in all the markets they’re looking to enter.
- Centralized visibility and information storage. RIM systems can function as a “digital hub” and single source of truth for all of the information associated with the regulatory process. Submissions require detailed product information, testing results, labeling, and other information that is often stored in other systems. Rather than sourcing this information over and over again, RIM systems provide regulatory teams with an organized repository that they can reuse across global applications. RIM access can be extended to other teams, and even external partners (like in-country distributors) to provide visibility into regulatory information and the status of submissions, making it easier to drive alignment around the process and coordinate go-to-market plans.
- Process integration across systems. Market authorization is one of the most critical pieces of information that go-to-market teams need. Maintaining that information across multiple products and multiple markets, and keeping it visible to go-to-market teams is a consistent challenge. RIM systems can integrate directly with ERP or CRM systems to feed authorization information directly into sales and distribution processes. Automating the in-country authorizations across systems can prevent noncompliance, and ensure that go-to-market teams are able to launch as soon as authorization is obtained. The same integration capabilities can be used to automatically retrieve product information from PLM and QMS systems, further speeding the application process.
- Automated regulation and standards tracking. This doesn’t necessarily directly impact time-to-market for new products, but it can definitely impact time in the market. Regulations and standards aren’t static, and regulatory affairs teams must keep on top of pending changes to ensure that products remain compliant and retain selling authorization. RIM systems can help to track changes, and flag products for potential compliance issues or that are at risk of losing authorization.In addition to regulatory changes, RIM systems can track authorization expirations, and other important events, helping companies maximize the revenue potential of their products by avoiding regulatory disruptions.
Accelerating regulatory approval and product go-to-market
MedTech companies are keenly aware of the role regulation plays in getting new products to market, but they aren’t always aware of the time and effort required to reach all of their target markets. Manual processes, disjointed information, and lack of coordination and visibility across teams can make it hard to obtain marketing authorization in a timely manner. This can significantly impact time-to-market—delaying return on investment, and even putting companies, themselves at risk.
RIM systems can eliminate a lot of the inefficiencies that slow down regulatory processes. By providing insight into regulatory requirements, access to digital templates, and integration across tools, they make it easier for companies to complete timely, successful regulatory submissions, and accelerate time-to-market.
RIM software from Rimsys
Rimsys is the only holistic RIM software designed specifically for medical technology companies. It helps companies digitize regulatory management by bringing together global UDI requirements, Essential Principles/GSPR, and regulatory registrations while monitoring products at the SKU level.
To learn more about RIM software from Rimsys, read our benefits datasheet.
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