In the rapidly evolving world of medical technology, staying ahead of regulatory changes, understanding product performance in the real world, and ensuring patient safety are top priorities for every product license holder. To help MedTech companies meet these demands, we are excited to introduce Redica Systems’ latest product: Postmarket Intelligence.

We are launching Postmarket Intelligence because we saw that:

Quality and Regulatory teams at life sciences companies were spending far too much time on laborious data collection and structuring in order to perform their analysis.
The quality of that data could be much better, leading to more powerful analysis that positively impacts the business.

Why Postmarket Intelligence Matters

Medical devices and technologies do not stop evolving after they receive regulatory approval. Once a product hits the market, it faces real-world usage, compliance challenges, and an array of regulatory scrutiny. Managing these postmarket dynamics is critical to a product’s long-term success and patient safety. However, many companies struggle to keep track of relevant events across a product’s markets, from adverse event reports to changing regulations.

Postmarket Intelligence from Redica Systems is here to solve that problem. It empowers MedTech companies to efficiently monitor, assess, and act on postmarket data—saving time, improving decision-making, and ensuring compliance with industry standards.

Anyone who is used to trying to get the data they need from the various FDA, and other regulatory agency websites, knows that collecting, cleaning, and structuring that data takes hours. And that’s before any analysis can get done.

You can now free up your time to focus only on the high-value analysis and subsequent recommendations to leadership, rather than wrangling the data.

Top 3 Use Cases:

Early risk detection and trending for Quality Unit/Management Review
Automation of data for Postmarket Regulatory Records
Deep analytics for Design Control/Change Control

Learn more about these 3 use cases here.

How Postmarket Intelligence Fits In

Quality professionals are already familiar with the Learning Management System (LMS), Quality Management System (QMS), and the Regulatory Information Management System (RIMS). So how does Postmarket Intelligence (and Quality and Regulatory Intelligence more broadly) fit into that ecosystem and your team’s existing workflows?

QRI LMS RIMS QMS landscape updated Sept 2024

All three of those categories (LMS, QMS, and RIMS) are well-established, but they all share a common problem: they aren’t fed by timely, well-structured regulatory compliance and enforcement data. That compromises the value any life science customer can extract from those systems.

With a modern Quality and Regulatory Intelligence (QRI) solution, like Redica Systems, in the middle of that ecosystem, you can:

Feed your QMS information on Postmarket events, updated Rules/Regulations/Guidance, Vigilance, Adverse Events, Recalls, etc.
Feed your RIMS with updated regulatory guidance, and examples of recent comparables
Feed your LMS with current enforcement action cases, Rules/Regulations/Guidance, Inspection Enforcement Actions, etc.

Key Features of Redica’s Postmarket Intelligence

1. Custom Dashboards

Postmarket Intelligence lets you save dashboards that show you at-a-glance data and trends specific to your product or business unit. No more sifting through data from irrelevant product types or geographies. If you are only interested in defibrillators in the U.S., for example, you can limit your data to that product category and geography. This enables far more accurate and powerful analysis.

2. Adverse Event Monitoring

Monitoring adverse events related to medical devices is critical for product safety and continuous improvement. Our platform aggregates data from various regulatory bodies and industry sources, providing clear insights into how your devices are performing post-launch. This allows you to quickly address issues, improve patient outcomes, and maintain a competitive edge.

3. Competitor and Market Surveillance

In a competitive MedTech environment, understanding how your product stacks up against others in the market is invaluable. Postmarket Intelligence helps you monitor competitor performance, spot emerging trends, and assess how market dynamics are shifting. With this data, you can refine strategies and innovate faster.

4. Custom Alerts and Notifications

Never miss an important update again. With Postmarket Intelligence, you can set up custom alerts tailored to your products, competitors, and markets of interest. Whether it’s a regulatory change, safety concern, or market trend, you’ll get instant notifications that enable timely and strategic action.

5. Data-Driven Decision Making

From adverse event trends to regulatory changes, Postmarket Intelligence empowers you to turn data into action. Postmarket Intelligence integrates various data streams into easy-to-understand dashboards, making it more straightforward for your team to make informed decisions and reduce risks. Perhaps most importantly, it allows the Quality team to show the value of Quality to senior leadership.

How Postmarket Intelligence Benefits MedTech Companies

By integrating Redica’s Postmarket Intelligence into your workflow, you gain access to a wealth of actionable insights that drive better decision-making and more efficient product compliance management. Here are just a few ways the platform can benefit your organization:

Proactive Risk Detection and Management: Identify and address potential issues before they become major problems by keeping an eye on global regulatory updates and adverse event trends.
Reduced Compliance Risk: Stay ahead of evolving regulations, ensuring that your products remain compliant in all the markets where you operate.
Improved Product Quality: Utilize real-world data to refine your products, ensure they meet safety standards, and perform optimally in real-world conditions.
Increased Competitive Advantage: Gain a clearer understanding of market dynamics and how your products compare to those of competitors, helping you stay ahead of the curve.

Ready to Learn More?

Redica’s Postmarket Intelligence is designed to meet the unique needs of modern MedTech companies looking to streamline their postmarket surveillance, compliance, and market monitoring efforts. By providing real-time data and customizable insights, we help you navigate the complexities of the postmarket landscape with confidence.

Stay ahead of the competition, manage risks effectively, and ensure patient safety with Redica’s Postmarket Intelligence.

To learn more or request a demo, reach out to our team today!