Artificial Intelligence (AI) Implementation in the Medical Device Market

A man in a suit and tie with a plus sign on his chest.

Course Director

A dollar sign in a circle on a white background.

Course Fee

$2150.00 Regular Registration

$1950.00 Early Bird Pricing (Register 30 Days in Advance)

A black and white icon of a calendar on a white background.

Course Description

This continually updated course covers current regulatory requirements, national and regional laws and standards which support the development and deployment of novel devices. Among the topics to be discussed will be:

  • AI Definitions and Model Understanding in the Medical Device
  • FDA and other health authority guidance
  • Intersection of key concepts to these products – Cybersecurity, Data Privacy, AI, etc.
  • Design Concepts and their implications: single threaded vs foundational models
  • WW data access, data management systems
  • Device Validation strategies: performance vs clinical product testing
  • Establishing the Novelty of the Device to Support Breakthrough Application
  • Reimbursement concepts and the impact to commercialization of these devices
  • Case Studies and Lessons Learned

Who Should Attend

This comprehensive 15-hour course will be valuable to personnel establishing new device strategy in the Artificial Intelligence (AI) Medical Device Market with a focus on development to revenue. The course will cover the intersection of AI ML models, Data Management, Validations and acceleration of revenue opportunities using the US FDA Breakthrough Designation and CMS NTAP/TCET (US Market Reimbursement programs) as key elements in bringing novel products to market. Course coverage includes the focus on an entrepreneurial approach to driving product market adoption using existing programs.


The course will benefit worldwide development of AI ML models for devices with foundational understanding of the different techniques and their inclusion: Machine Learning, GenAI, LLMs and Agentic; and where they fit within the worldwide regulatory context; how to use the Breakthrough Designation (US FDA) for novel devices to establish program acceleration and provide access to immediate opportunities for reimbursement to drive market adoption of your device.


This course will be of great benefit to the Entrepreneurs, Business Officers, Regulatory, Data Managers, Product Managers, and Reimbursement Strategists and those establishing early research and development programs with novel applications. This includes those with both technology, regulatory and reimbursement professionals.

Register for Live Stream Request On-Site Details

  • Learning Objectives

    Providing an understanding of the US Agencies and programs available to support the launch of novel technologies into the US Market (with Worldwide impact). The development of a proven process-based approach from the development through reimbursement of these devices. While US Agency focused, this course is not limited to US companies or groups and provides a well-rounded approach to understanding of the worldwide AI adoption of medical devices including cross-cutting common understandings of devices in the CAD space and the level of complexity of validation for different types of products. The course will cover the applied requirements/regulations of AI, Data, and Cybersecurity of these devices and their intersection of each of the areas and how to integrate them into the development process to deliver novel products; how to transition your product design into a Breakthrough Designated Product garnering accelerated access and deployment of the devices; and establishing a pathway to initial reimbursement in the US.


    By the end of the course, attendees will gain an over-arching understanding of the skill set necessary to pragmatically think through the AI development to market strategies and how they 

    may be tailored to your product development and business strategies.


  • Agenda

    Welcome

    • General overview
    • Understanding the Pathway of Success for New AI Product Adoption Through Existing Programs
    1. Section 1: Establishing the Framework of Novelty in Clinical and Technical Differentiation
    2. Section 2: The Breakthrough Application Process and intersection with Reimbursement

    Key Elements – Understanding the Process of Design to Commercialization


    Framework and Process Overview

    • Laws, Regulations, Standards, and Guidances,
    • US vs International Considerations – how to balance
    • Identifying the Opportunities based on device novelty

    Identifying the Opportunities

    • Establishing Device Novelty
    1. Searching for Opportunity for your concept
    2. Understanding how predicates work with the concept of Novelty
    • Establishing Clinical vs Technical Differentiation
    1. Pilot Data vs Peer Reviewed Journals as support
    2. Levels of differentiation required in the clinical scope

    Inclusion of the Key Ancillary Elements (WW Considerations)

    • WW Novelty and Special Considerations for innovative solutions
    • AI Law and Regulation
    • Cybersecurity of SaMD
    • Data and Data Management for the development/validation
    • Data Privacy

    The Design Process


    • AI is different from traditional coding – SDLC Considerations
    • Initial process to support Novelty in Clinical Indication
    • Validation Tools to support key elements of design: Examples

    The Breakthrough Application

    • Understanding the overall framework of Breakthrough Device Applications
    1. Administrative
    2. Clinical
    3. Technical
    • The Q-Submission Process for Breakthrough

    Meeting the Initial Criteria

    • Criterion I:
    1. Severity Criterion
    2. Effectiveness Criterion
    • Criterion II:
    1. Device Novelty
    2. No Comparable Devices
    3. Significant Advantage
    4. Best interest of patient(s)

    Establishing Reasonable Clinical Performance

    • Design Documentation for Application vs SDLC
    • Types of Testing Evidence (Pilot)
    • Alternative/Additional Support

    The Commercialization Opportunity

    • Overall considerations in tying the FDA and CMS processes together
    • Strategic Considerations and Timelines
    • Direct to Commercialization vs Effectiveness Study

    The Reimbursement Opportunity

    • General Reimbursement Structure
    • Special Programs for Breakthrough
    1. TCET
    2. NTAP

    Resources and Recommended Reading

    • Regulatory guidance documents
    • Web Sources
    • Utilization of AI to aid the process

Registrant Information:

Each person attending a course will be asked to set up an Attendee Profile Account during the registration process. Creating an Account helps you view your order history and manage your training programs. If you are registering for others, please set up an Account in the Attendee’s name. If you are registering more than one person, you’ll need to set up a separate account for each Attendee.