Overview of Electronic Data Capture for Advanced Medical Device Design and Development

For centuries, record-keeping productivity depended on the number of humans writing down data at any given time. Clay tablets in museums and huge archive rooms filled with aging paper folders show us the limits of pre-electronic data storage.

When computers and the internet began to go mainstream in the 1980s, one of the promises of emerging technology was that it would simplify our lives. What we see today, especially where research and regulation meet, is that innovation, technology, and complexity have a scaling effect on each other.

Technology enables more complex innovation, creating a demand for efficient systems to manage the complexity that manual human labor can no longer feasibly support. In the late 1980s, medical device manufacturers began using early versions of Electronic Data Capture (EDC) systems to capture and record research data electronically. Today, a robust EDC is essential to satisfying FDA reporting and winning approval for going to market. Share on X Read on for an overview of EDC and its place in the advanced medical device development lifecycle.

What is Electronic Data Capture for Advanced Medical Device Development?

Electronic data capture is a computer-based system used primarily in medical device design and development. EDC’s benefits are streamlining the data collection process, reducing costs, simplifying data reporting compliance, and improving data quality.

As you might expect, EDC systems use technology to capture, collect, input, store, and manage clinical trial data. In the context of medical device companies, The Chief Information Officer (CIO), is the senior executive responsible for the information technology and computer systems supporting an organization’s operations and goals. CIOs and their staff oversee data collected electronically from multiple sources, such as patient questionnaires, clinical study documents, lab results, and other sources of raw medical data.

EDC aims to maximize security and efficiency while collecting accurate trial data from any location on any device. EDC also simplifies usability for working with data in various formats, including text files and digital images, allowing for rapid access to critical information required for research.

In the past, human data collection and copying errors often compromised data quality. EDC reduces errors by providing an automated validation process that checks all values for accuracy before storing them in the system. Additionally, various tools help maintain quality control over the submitted data throughout the process, eliminating potential human error issues when manually transferring or entering data into the system.

EDC also assists with regulatory compliance measures by allowing managers to track progress efficiently. Full accountability audits verify the accuracy and completeness of trial information throughout its lifespan. EDC creates greater confidence in submitting accurate reports to regulatory authorities during product development cycles, helping to reduce time to market.

What Are the Critical Components of an Effective EDC Solution?

Regardless of how complex a project is, the key components of an effective EDC solution remain the same. They include:

1. Automation

Teams should set up EDC systems to automate as many processes as possible, including data collection, storage, and analysis. Automation helps ensure data transparency, consistency, and timeliness.

2. Secure Storage

The EDC system must securely store data to protect patient privacy and comply with relevant regulations. This includes ensuring that information is stored on secure servers or in the cloud and using encryption protocols to protect confidential information from unauthorized access or manipulation.

For example, in June, Galen Data achieved HITRUST Risk-based, 2-year (r2) Certified status. This means Galen Data’s Cloud hosted on Amazon Web Services meets key regulations and stringent industry-defined requirements for appropriately managing risk. The HITRUST Assurance Program helps organizations address security and data protection challenges through a comprehensive and flexible framework of prescriptive and scalable security controls. HITRUST is not a rubber stamp certification, Galen devoted significant time and resources in meeting the requirements. Galen is now among an elite group of organizations worldwide that have earned this status.

3. Quality Control & Monitoring

An EDC system should have built-in quality control measures, such as rigorous validation checks on entered data and continual monitoring of collected data for discrepancies or errors. These measures are essential for maintaining accurate data over time and revealing any potential issues with the study design or implementation early in the process.

4. Reporting & Analytics

A vital component of an effective EDC system is its ability to generate reports that offer insight into individual records and more significant trends across studies or subject populations. The system should also enable real-time analytics, allowing CIOs and researchers to quickly identify any issues or trends related to their medical device development efforts.

5. User Experience & Usability

The EDC interface should be intuitive and straightforward. The initial inputting and validating stages need easy-to-use forms for collecting patient information (or other baseline data sets) to help users quickly enter accurate data with minimal effort. The EDC should also provide smart tools for reporting and analytics. From the start, managers should provide training to ensure all users understand how to use the system correctly and follow best practices when entering data.

The Rise of Artificial Intelligence (AI) in EDC

Artificial intelligence doesn’t exist without data, so it makes sense that AI will significantly impact EDC, both in data collection and digital data flow. For example, 76% of Deloitte’s life sciences digital innovation survey respondents report investing in AI for clinical development. Below are some ways AI can benefit EDC:

• AI can leverage data collected from wearable devices to increase the number and diversity of participants.
• Wearables also remove data collection friction by automating data collection, which boosts participant retention.
• AI algorithms can interpret individual patient behaviors or needs, resulting in more patient-centric interactions and better retention.
• AI accelerates smart automation and efficiency to produce faster trials at a lower cost.
• AI technologies help teams and organizations intelligently repurpose existing data based on standards and metadata instead of replicating initial data collection for multiple trials.

How Does EDC Help Ensure Compliance with FDA Regulations?

Compliance with FDA regulations plays a significant role in the EDC process. EDC simplifies collecting and managing data to support medical device design and development and testing, manufacturing, and post-market surveillance activities.

Through EDC, medical device companies can streamline their processes for documenting and managing the design history files, test data, and other FDA-required documentation needed to get approval for new medical devices.

EDC enables improved quality control by increasing data consistency, accuracy, and security throughout the product life cycle. During manufacturing, the EDC automates tracking of each device throughout the production process, providing detailed information on who made what changes to the product at any given time. This records management feature helps compliance with FDA regulations related to Good Manufacturing Practices (GMPs), which require that manufacturers properly document every step in their processes to ensure the safety and efficacy of their products.

EDC automates record-keeping requirements such as change orders, incident reports, corrective action plans, design controls, and device history records (DHRs). In this way, EDC ensures compliance with all applicable regulatory standards while reducing the paperwork burden.

With an integrated approach to capturing audit trails on any changes made during product development, EDC helps simplify review cycles for a potential product or process changes to ensure compliance with FDA regulations. Additionally, it can facilitate long-term storage capabilities for DHRs while allowing for quick access when needed.

Overall, EDC helps ensure regulatory compliance regarding medical device design and development. By automating record-keeping processes and providing detailed information on changes at any given time during production efforts, EDC saves medical device companies time and money while helping devices pass the stringent inspection standards set by the FDA before market launch.

Moving Ahead

At the most basic level, we could think of medical device design, development, approval, manufacture, and post-market monitoring as one huge data management process. As technology accelerates, so does the complexity and regulatory scrutiny.

At Galen Data, we have years of experience and the partner relationships to help clients with this mission-critical role. Contact us today to learn more.