Overview

This Request for Proposal (RFP) is part of an ongoing collaboration between the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) and the National Evaluation System for health Technologies (NEST) Coordinating Center (NESTcc) and focuses on the Central Data Operations Hub for the Active Surveillance Program for medical devices.

NESTcc and FDA intend to develop and implement an active surveillance system of electronic health data to better understand the safety of medical devices as used within clinical practice. Once realized such a system will optimize data collection, quality, completeness, and analysis within a comprehensive framework to assess potential and ongoing safety signals in a timely manner. The active surveillance program is focused around achieving better data capture, detection of potential safety signals, and a timely assessment leading to actionable findings. In addition, the data structure developed for the active surveillance system will be viable for generation of real-world evidence fit for purpose for regulatory decisions.

NESTcc Background

NEST was established in 2016 by a cooperative agreement between the FDA’s CDRH and the Medical Device Innovation Consortium (MDIC), a 501(c)3, the first public-private partnership created with the sole objective of advancing regulatory science of medical devices for patient benefit. The purpose of NESTcc is to increase quality and efficiency in the development of real-world evidence (RWE) to inform medical device development and evaluation, as well as support clinical, patient, regulatory, and reimbursement decisions throughout the total product lifecycle (TPLC). NESTcc catalyzes RWE generation for medical device and health technology for all members of the device ecosystem. One of the specific aims of the agreement is to develop new systems of data collection and/or analysis to permit prospective active medical device post-market risk identification.

NESTcc Role

As described in the FDA’s Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health, NEST is intended, in part, to be an active surveillance and evaluation system that complements the passive surveillance approaches currently in use. FDA’s current reliance on more traditional surveillance studies can take a long time before we can characterize any risks and determine whether a signal represents a true safety concern. By driving standardization of data capture, quality, and completeness by electronic health information owners; by establishing agreements with those data owners for efficient data access; and by

providing for the linkage and aggregation of large data sets to which advanced methods and analytics can be applied prospectively, NEST will facilitate detection of potential safety risks that would not otherwise have been identified as quickly, or at all, as well as facilitate more timely assessment of potential safety signals. In doing so, NEST also will provide for data that better capture the safety and effectiveness of devices across diverse populations and across the range of clinical settings, allowing for better device evaluation pre- and post-market.

From 2019 – 2022, NESTcc and its stakeholders, including the FDA, collaborated closely to plan an active surveillance environment for medical device safety. During this period, NESTcc formed the Active Surveillance Task Force; established multiple Working Groups; completed the setup and testing of a pilot analysis (Phase I) within a cloud-based environment followed by the simulation, development, and testing of a pilot federated cloud environment along the issuance of a draft Active Surveillance Road Map. The decision has been made with the FDA to continue investment in building an Active Surveillance program and has resulted in the issuance of this RFP.

Project Concept

Background

This solicitation is for the contract to the develop and execute a minimally viable medical device active surveillance system. Key aspects of this medical device active surveillance system include:

•    Detection of potential signals without comparisons between devices

•    Notifying FDA of a potential signal, including the ability to share de-identified event- and patient-level information with the FDA, when requested by the FDA

•    Continued data accrual and monitoring of devices over time, including conduct of replicate analyses despite changes in source records (at least monthly)

Active Surveillance Infrastructure

Active surveillance utilizes extant electronic health data to assess the safety of medical products. It does not require collection of new data from patients or clinicians, nor does it require that separate safety reports be generated and sent to the monitoring entity.

Many active surveillance systems utilize distributed data networks in which multiple institutions retain individual patient health data behind their own firewalls, execute standardized assessments using a common data model, and share aggregated results. Governance and infrastructure vary across distributed data networks, however most use a federated data exchange to minimize data sharing and a common data model to maximize on efficiency and resources while conducting repetitive queries for safety monitoring. Such networks maintain patient privacy while utilizing infrastructure and information sharing to assess public health and medical product safety in a sustainable manner.

While many distributed data networks exist, there has been limited realization of utility for medical device surveillance. This may be due to the depth of procedural data needed to adequately identify device use and subsequent safety coupled with the breadth of data needed to assess the longevity of effects (e.g., implants remain in the body for decades). Additionally, differing data capture is needed across therapeutic areas to understand the safety of devices. A device-focused system is warranted to address these needs.

Many distributed data networks focus on signal refinement – characterizing the potential impact of a safety signal. For medical devices, a primary need for an active surveillance system is signal detection – identifying new potential risks or changes in known risks that may affect the benefit-risk profile. The methodologies and applications for signal detection differ from signal refinement, and a device-focused system is needed for identification of potential signals.

FDA made an initial investment in active surveillance in a cooperative agreement with the National Evaluation System for health Technology coordinating center (NESTcc) in April 2019 to develop an active surveillance system capable of detecting potential safety “signals” for death, reintervention, or rehospitalization associated with medical devices. This initial work included simulation, development, and testing of a pilot federated cloud environment and issuance of a draft Active Surveillance Roadmap. Lessons learned from the initial investments will be leveraged to provide continued monitoring of electronic health data to quickly identify new potential signals and changes in frequency for known potential signals for marketed medical devices.

Objective

Expanding on previous work, this solicitation is to establish the central “hub” and analytic core of a medical device active surveillance system distributed data network. The central hub will work with data partners (identified by NEST, though proposals including ongoing data partnerships will be considered) with sufficiently linked medical claims and electronic health records (EHR) and other electronic health data to capture all medical encounters over a period of at least 1 year for U.S. patients and with sufficient granularity to capture brand and version (ideally via Unique Device Identifier [UDI]). The selected vendor will serve as the hub and will be responsible for designing the initial version of the active surveillance system, developing the system, and providing day-to-day system operations.

The active surveillance system should use privacy-preserving and (horizontal) federated learning techniques in a cloud-based environment to monitor (primarily) for signal detection using containerized analytic modules distributed to data partners for execution against data in a common data model (or alternatively, using FHIR-based interoperability between data sources). In addition to facilitating governance and day-to-day operation for standardized data curation and analytics, the central hub will contribute to establishing best practices and prioritizing enhancements for data architecture, IT systems and infrastructure, patient privacy and ethics, and active surveillance methodologies.

Scope

The work required for this requirement can be broken down into three areas:

•    Designing and developing an active surveillance system;

•    Maintaining the active surveillance platform infrastructure, security, and data privacy; and

•    The implementation and day-to-day operations to conduct active surveillance within the system.

The design and development of a system may depend on the types of devices being monitored. NESTcc and FDA are interested in someday including implanted devices, capital equipment, single use devices, and ongoing use of durable medical equipment within the active surveillance system. The two proof of concept use cases will be finalized at the time of contract. For the purposes of this solicitation, the following two cases will be considered:

•    Duodenoscopes (including fully disposable, disposable components, and reprocessed duodenoscopes)

•    Devices used in cholecystectomy procedures

• High-priority – laparoscopes, robotically assisted surgical devices (RASD), energy systems
• If available – trocars, closure devices, suction/irrigation devices, insufflation devices, hand access instruments)

Organizational Configuration

NESTcc anticipates an active surveillance system organized by a vendor that must:

•    Ensure adequate governance to guide development and utilization of the system;

•    Develop and maintain a culture of protecting patient privacy while obtaining actionable evidence for device safety; and

•    Increase workflow efficiencies through continual data, architecture, and process improvements.

Eligibility

This opportunity is open to private-sector, nonprofit, and for-profit organizations, especially those with experience in surveillance methodologies as well as implementation of a federated health data system (e.g., governance and infrastructure, IT and security, development of containerized modules deployed from a single central hub to multiple data holders, allowance for identification and sharing of encrypted data for individuals across data sources, using interoperability [via FHIR or CDM] to enhance collaboration and automation, retrieval of output from behind data holder firewalls, and aggregation and deployment of synthesized results via application program interface [API]).

Indication of Interest

As a preliminary step in the application submission process, please indicate your interest in submitting a proposal by contacting NESTcc@mdic.org by 5p.m. EST on July 26, 2023. NESTcc will provide interested parties with any additional supplemental material to prepare the proposals no later than July 31, 2023.

Timeline

• Posting Date: July 17, 2023
• Indication of Interest: July 26, 2023
• Due Date: August 28, 2023
• Presentation Date (by invitation): September 11-12, 2023
• Notification Date: September 18, 2023
• Contract Executed: October 15, 2023