Regulatory Support to New Product Development Project

Background

ECI was engaged by a global device firm with a business roadmap to drive medical device connectivity and interoperability solutions to meet patient needs. This evolution is visible across all areas of medicine, as communicated by the Food and Drug Administration (FDA) and specifically by the Center for Devices and Radiological Health (CDRH) strategic priority for advancing health equity, making access to in-home therapy possible. By launching numerous projects, the business intends to deliver a complete solution providing patient therapy via medical device connectivity to a centralized cloud-based platform for data management, remote care monitoring, clinical decision support and other telehealth capabilities.

Objective

The objective of the engagement was to provide technical support for cross-functional activities for product development and identify regulatory considerations applicable to the project, with major deliverables to include:

• a comprehensive description of the cloud solutions and each specific software for data management, remote monitoring and other capabilities. This description defines all interaction mechanisms with its medical devices and other connected systems to clearly describe data information flow.
• a proposed regulatory strategy and compilation of a pre-submission to introduce and engage CDRH to obtain FDA feedback on the strategy.

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ECI Engagement

The consultation involved primarily a Principal Regulatory Consultant, a former FDA reviewer with a strong scientific background in software. ECI contributed to generating several essential elements of the Quality Management System (QMS) documentation such as:

• Product description
• Project plan
• Risk management file
• Use cases specifications
• Stakeholder needs
• Discovery phase activities
• Supplier request for proposal
• Supplier evaluation

ECI also provided training to the product development team on Good Machine Learning Practice Principles.

The regulatory strategy included a comprehensive analysis of the competitive landscape and status of major players in the field of electronic health or medical record systems.  It also identified existing device manufacturers currently marketing or manufacturing similar products with connectivity and interoperability capabilities. Device classification and proposed product predicates were identified when applicable.  Additionally, a thorough list of applicable regulatory requirements, standards, guidance from FDA and the National Institute of Standards and Technologies (NIST) were proposed.

A pre-submission meeting request was drafted to introduce the product to FDA and further confirm specific regulatory assumptions including proposed submission deliverables.

Results

ECI provided both regulatory and technical expertise, contributing to the product development team’s ability to generate a complete set of quality documentation supporting design controls. Numerous quality management system documents were reviewed and guidance provided on a variety of topics such as,secure by design and privacy. Another example, a strategy to proactively introduce artificial intelligence capabilities at a later phase of the post market product lifecycle was discussed. A product description, regulatory strategy and pre-submission meeting request were produced per the company’s defined timeline.