Question 1

What is Spectrum?

Accepted Answer

Spectrum is an innovative app designed to automate the post-market surveillance (PMS) process for medical device manufacturers. It uses smart algorithms, machine learning, and large language models (LLMs) to streamline the traditionally manual tasks of monitoring scientific databases, adverse event registers, and social media platforms.

Question 2

Who is Spectrum designed for?

Accepted Answer

Spectrum is tailored for employees and decision-makers in medical device manufacturing, particularly those with backgrounds in regulatory affairs or medicine. It is ideal for users who are overwhelmed by regulatory requirements and are seeking efficient, cost-effective solutions to meet compliance standards.

Question 3

How does Spectrum address market perception tracking?

Accepted Answer

Spectrum provides comprehensive insights into how your products and competitors are perceived in the market. It tracks data from social media, scientific literature, and adverse event registers, presenting this information through intuitive dashboards and AI-generated reports.

Question 4

What makes Spectrum different from other PMS solutions?

Accepted Answer

Unlike other solutions, Spectrum not only automates PMS processes but also offers a central location to manage devices, variants, studies, surveys, literature, indications, and more. It generates visually appealing, compliant reports that can be easily modified in Microsoft Word.

Question 5

How does Spectrum handle duplicate literature in scientific databases?

Accepted Answer

Spectrum automatically merges duplicate literature entries from multiple scientific databases, reducing evaluation time and eliminating potential errors caused by duplicate evaluations.

Question 6

Is Spectrum easy to use?

Accepted Answer

Yes, Spectrum is designed to be user-friendly with minimal training required. It features extensive in-app tutorials, tooltips, and detailed end-user documentation to help users get up to speed quickly and efficiently.

Question 7

What are the key benefits of using Spectrum?

Accepted Answer

Time Efficiency: Reduces PMS report preparation time by 80%.
Compliance: Ensures adherence to regulatory requirements.
Market Insights: Provides detailed insights into market perception.
Comprehensive Management: Centralizes management of devices and related data.
User-Friendly: Requires minimal training with built-in support features.
Error Reduction: Automatically handles duplicate literature entries.

Question 8

What is the vision behind Spectrum?

Accepted Answer

Our vision is to make medical device development affordable again, helping to restore the innovation and growth of start-ups that have been challenged by tightening regulatory requirements in the EU.

Question 9

How can I see Spectrum in action?

Accepted Answer

If you're ready to see how Spectrum can enhance your post-market surveillance processes, we invite you to request a personalized demo tailored to your specific needs.

Question 10

How does Spectrum help me gather PMS data on my devices?

Accepted Answer

Spectrum streamlines the collection of PMS data through federated searches across multiple platforms, including literature databases like PubMed and Livivo, adverse event databases such as MAUDE and BfArM, and social media channels like Reddit and Instagram. The system enhances efficiency by automatically merging duplicate entries, providing an AI-driven second opinion on the relevance of the data, AI summaries, and automatically finding and downloading full texts. Additionally, Spectrum generates comprehensive reports that are fully compliant with EU MDR standards, ensuring that your surveillance activities meet regulatory requirements efficiently and effectively.

Question 11

How can I manage my devices in Spectrum?

Accepted Answer

You may use Spectrum’s Device Manager as central location for variant, accessory, indication, contraindication, side-effect, study, survey, warning & precaution and claim management. A powerful search engine allows users to quickly find any information they desire about your product portfolio without having to browse excel or PDF files.

Question 12

Does Spectrum integrate into my system?

Accepted Answer

Absolutely! Spectrum seamlessly integrates with SharePoint and Google Drive. Additionally, we provide customized solutions for local storage systems to meet your specific needs.

Question 13

What insights can Spectrum provide?

Accepted Answer

Spectrum is designed to empower your business and product design decisions by providing comprehensive insights into various market dynamics. Here’s how Spectrum can help you gain a competitive edge:
Query analytics: Extract high value keywords and authors (KOLs) from queries for your product. Improve your query performance with each PMS cycle, further reducing the time it takes to screen literature.
Trend statistics: Improve patient safety through detailed graphs on adverse events and receive automated warnings in case trends are monitored.
Market insights: Gain an in-depth understanding of how your products perform against the competition. Identify trending topics in social media that relate to your product group or indications.

Question 14

What reports does Spectrum provide?

Accepted Answer

Spectrum provides a robust suite of reports tailored for Post-Market Surveillance of medical devices under the Medical Device Regulation. Our platform ensures that your compliance requirements are met with precision and ease.
Literature Search Protocol: This report includes all raw data from searches performed, documenting your thorough research process in accordance with regulatory standards.
Literature Search Report: This summarizes the relevant search results, providing critical evaluations necessary for regulatory and compliance purposes.
Market Analysis Report: Delivers a detailed comparison of your product against competitors and connected technologies. This report is key to both product design and strategic market positioning and will be introduced in Q4 2024.
Post-Market Clinical Follow-Up (PMCF) Plan: Outlines your strategy for ongoing clinical assessment post-launch, ensuring continuous monitoring of your product's safety and effectiveness in real-world use.
PMCF Report: Provides comprehensive findings from the PMCF activities, critical for ongoing regulatory compliance and product optimization.
By utilizing Spectrum for your PMS needs, you are equipped with all necessary tools to remain compliant with the MDR, ensuring that your medical devices meet the highest standards of safety, quality, and efficacy throughout their market lifecycle.

Question 15

Which databases, registers and social media can I screen using Spectrum?

Accepted Answer

Spectrum provides access to a broad range of sources, currently supporting ten key databases and social media platforms across Europe and the USA. We are dedicated to continually expanding this list to include additional databases from other regions like Asia and South America. Among the databases and platforms Spectrum can access are notable examples such as PubMed, Livivo, MAUDE, BfArM, MHRA, Reddit, Instagram, and several others.

Question 16

What does Spectrum cost?

Accepted Answer

Spectrum offers flexible subscription plans tailored to your business needs, whether for individual users or product groups. Contact us for a personalized quote that fits your requirements.

Frequently Asked Questions