The FDA Center for Devices and Radiological Health (CDRH) published a Sources Sought document on February 15th, 2023, in which they are conducting market research to identify industry members who are interested in providing services for a future Medical Device Active Surveillance System. CDRH is interested in responses from businesses of all sizes on GSA MAS Schedule 54151HEAL Health Information Technology Services who can fully answer the necessary questions in this document. Businesses not on GSA schedule may also send a response. It is noted that Small Businesses are encouraged to submit.
FDA will use results of this market research to determine if there are sources capable of meeting requirements set out by the agency. While FDA anticipates the establishment of a contract with vendors/contractors in the future, currently they are seeking information on a voluntary basis for planning purposes only.
The FDA is using this Sources Sought to inform the advancement of medical device active surveillance system. As stated in the document, the “FDA is committed to development and implementation of an active surveillance system of electronic health data to better understand the safety of medical devices as used within clinical practice”. FDA is aiming to create a system that optimizes data collection, quality, completeness and analysis. The active surveillance system is based around achieving “better data capture, detection of potential safety signals, and a timely assessment leading to actionable findings”.
Background on Active Surveillance Systems
Active surveillance systems use existing electronic health data to assess the safety of medical products. Many active surveillance systems use distributed data networks where multiple institutions retain individual patient data and use common data models to do standardized assessments which then are shared as aggregated results.
While many distributed data networks have been previously established, the application to medical device surveillance has been limited due to breadth & depth of the health data in relation to device safety and along with the wide span of therapeutic areas that need to be captured. Another challenge is that many distributed data networks focus on signal refinement, which uses known signals and characterizes the potential impact of a safety signal. For medical device applications, the primary need for an active surveillance system is signal detection, which identifies new signals for potential risks or changes in known risks.
In order to address the unmet need for an active medical device surveillance system, FDA invested in a cooperative agreement with the National Evaluation System for health Technology coordinating center (NESTcc) in April 2019. The purpose of this agreement was to lay the groundwork for an active system that could meet the needs for application to medical devices. This NESTcc project included simulation, development and testing of a cloud environment and ended by producing a Draft Active Surveillance Roadmap (which can be read here). This document, along with the outcomes of the pilot program, will be leveraged for future active medical device surveillance system projects.
The goal of the next contract will be to establish a Medical Device Active Surveillance System comprised of distributed data networks with data partners to capture all medical encounters over at least 1 year for U.S. patients. Selected contractors who fit the criteria will serve as coordinating centers and will design and run the active surveillance system.
FDA is requesting that interested parties answer the questions listed on the Sources Sought document. Answers to these questions must demonstrate the organization’s capability to provide the requested services. Questions are grouped under the following topics:
- General Business Information – which requests information such as company name, structure, contact information, GSA contract, etc.
- Structure, governance and workflow – which requests a description of how your company would provide a medical device active surveillance system & what considerations would be most critical for your organization’s system
- Data sources & common data models – which asks what data sources would be included by your organization in order to maximize availability of detailed device data
- IT & Privacy – which requests a description of how your organization would develop and maintain an IT cloud environment and how your organization would link patients across multiple data sources
- Analysis – which requests information related to your organization’s capability to incorporate machine learning and artificial intelligence to identify adverse events and potential device safety signals & your organizations capacity for conducting surveillance in a variety of categories
- Cost Modeling – which requests cost modeling recommendations based on assumptions listed in the document
The full list of questions can be found in the Sources Sought document.
In the future, FDA plans to partner with a coordinating center that will agree to organize an active surveillance system and provide vision and leadership, contribute adequate governance to guide development and utilization, develop and maintain a culture of patient privacy, and increase workflow effectiveness. FDA is also considering a “network of data networks” which would include multiple partners.
Key aspects for the system include signal detection identification, identification of signals without comparison of two products/therapies, notification to FDA of potential signal, continued monitoring of devices over time and baseline capability to surveil specific endpoints. FDA is interested in a variety of device types for monitoring, including implanted devices, reusable equipment/surgical medical devices, single use devices used as primary component, and devices for ongoing patient use.
Call to Action: How to Submit a Response
Interested parties may submit responses to this Sources Sought up until March 20th, 2023 @10:00 AM EST. Submissions must be made through email to Michelle Dacanay (firstname.lastname@example.org) and need to include the Sources Sought number (FDA-SS-75F40123Q00084) and description in the email subject line. Submissions should not exceed 25 pages in length and must fully answer all questions in the document. It is noted that responses must demonstrate capability, not merely affirm your organizations capability.
Danielle Short – Associate Medical Device Consultant