The AI Experts Focus Sessions cover frequently-requested topics to enhance knowledge and insights into AI.

Advancing the Pharmaceutical and Medical Device Industries

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​In February of 2022, the efforts of Xavier Health were assumed by the AFDO/RAPS Healthcare Products Collaborative. Because of the important work done before this transition, the Collaborative has chosen to retain documents that have Xavier branding and continue to provide them to the communities through this website.  If you have questions, please contact us at

August 4, 2023: Algorithms: apex predators of the software eating the world!

As algorithms (decision support, feedback control) eat their way into medical products, what can and should we learn from other industries which have been disrupted by algorithms?  

Cyberphysical systems: software is a harmless mental abstraction until it is instantiated in the physical world.

    Data:  good experimental designs yield good experiments, which yield good data, which yield good models, which yield good predictions, which yield good algorithms, which yield good outcomes. 

    Human factors: algorithms change the tasks and roles of humans; people go from being “in the loop” to being “on the loop” or “out of the loop”.  

    Using an automated insulin delivery system case study, we’ll discuss why and how to tame these apex predators, ensuring safe and effective algorithm development and deployment.

    Featuring Lane Desborough, CEO, Nudge BG

    June 30, 2023: XAI & usefulness in Healthcare

    As AI becomes more mainstream, companies and regulatory agencies are racing to understand AI best practices. Historically many of these models have been “black boxes,” but advances in areas like XAI have aimed to make many of these models’ outputs and inputs more understandable.

    Featuring Mike Salem, Associate Data Science, Gilead Sciences

    April 21, 2023: Large Language Models, Tools, Automation and Future Applications in HealthTech

    Large Language Models, Tools, Automation and Future Applications in HealthTech

    The rapid rise of Large Language Models (LLMs) such as ChatGPT and GPT-4 in recent months has sparked an unprecedented surge in new research, models, frameworks, and industry applications. This talk will provide a concise overview of the historical development of LLMs and examine current models, frameworks, and applications. We will conclude with a forward-looking discussion of future applications, including LLM tool integration (e.g., LangChain), multimodal processing (e.g., JARVIS, HuggingGPT), automation frameworks (e.g., AutoGPT), and potential integration with Distributed Autonomous Organizations (DAOs)/Blockchain. Special emphasis will be placed on the unique challenges and opportunities associated with incorporating LLMs and related technologies within the healthcare and HealthTech startups.

    Featuring Professor Jon Chun,

    March 31, 2023: Best Practices When building AI-based Medical Devices at Scale

    An inherent part of building data-driven software is the constant need for change, but existing lifecycle management tools and processes for medical systems create significant resistance to change management. These less flexible operations stand in contrast to the tech industry, where change management is a sought-after, routine process.

    This talk will cover the best practices for building cloud-based, AI-driven medical software and the challenges of building at scale: the lack of software tooling, high attrition rates, and the difficulties of executing in a regulated, ever-changing environment. Along with best practices, real-world case studies of building validated software will be used to illustrate how to move fast, and break nothing.

    Featuring Erez Kaminski, Owner & CEO, Ketryx

    February 24, 2023: Explainable and Interpretable AI for medical devices certification

    Featuring Akhilesh Mishra, Sr. Medical Devices Industry Manager, MathWorks

    December 3, 2021: Issues in Reference Standard Determination for Performance Evaluation Studies of AI/ML-based Medical Devices

    Featuring Alexej Gossmann, Staff Fellow at the Division of Imaging, Diagnostics, and Software Reliability, FDA-CDRH

    Evaluation of an AI/ML-based medical device is typically performed by comparing the system output to a reference standard. A poorly chosen reference standard that is a poor proxy to the targeted real-world clinical task may result in the measurement and reporting of misleading performance results for the AI/ML algorithm, which do not adequately represent the real-world performance or utility of this algorithm. This is particularly concerning when it applies only to specific socio-economically disadvantaged groups or racial minorities.

    A more appropriately chosen reference standard can still be subject to several distinct types of bias that can lead to systematic flaws in algorithm training and testing. This includes, for instance, verification bias, measurement bias, and imperfect reference bias, which need to be assessed and accounted for when evaluating the performance of medical AI/ML algorithms. In addition, the reference standard can be partially missing, which can be accounted for with appropriate statistical analysis methods in some settings. This presentation provides a discussion of these and other reference standard issues in the assessment of AI/ML-based medical devices.

    October 8, 2021: Incorporating AI Techniques for Medical Imaging

    Featuring Lars Bielak, a researcher at the University Medical Center in Freiburg, Germany

    Tumor segmentation, or segmentation using CNNs in general, is a well-developed field in AI research. Unfortunately, the data acquisition and the data post-processing are often two completely separate topics, leaving computer scientists to refine their models based only on large, publicly available, and fixed datasets. In this session, Lars Bielak presents a strategy for prospective input data optimization for CNN head and neck tumor segmentation based on seven unique MRI channels.

    August 6, 2021: Pharma Manufacturing – When Complexity Cannot be Linearly Managed or Solved via a Singular AI Model

    Featuring Toni Manzano, Co-Founder and CSO, Aizon

    Toni Manzano presents two use cases, one of AI application in biopharmaceutical operations and one of biotech research in which Xavier AI was involved, to explain the hard reality behind amazing AI outputs.

    June 25, 2021: Developing AI-Enabled Smart Medical Devices Using Model-Based Design

    Featuring Kirthi Devleker, Mathworks, and Akhilesh Mishra, Mathworks

    In this talk, Kirthi Devleker and Akhilesh Mishra provide an overview of how AI algorithms can be developed and deployed in Medical Devices using Model Based Design approach – an approach adopted by large medical device organizations globally to develop next generation medical devices.

    April 16, 2021: GxP AI Workflow: An NLP Case Study

    Featuring Erez Kaminski, Researcher/Graduate Student, MIT

    In this second AI Learning Session covering the topics most frequently requested by our AI Experts Network, Erez Kaminski provides an overview of a systematic way to develop GxP artificial intelligence applications focused on code reusability and streamlined development operations. The talk includes a case study on the development of a Natural Language Processing application for adverse event detection, which is used to reduce processing costs and intake error rates.

    February 5, 2021: Cybersecurity Compliance and AI

    Featuring Emily Luvison, Cybersecurity Compliance Lead for Digital Health Technologies, Genentech

    In this inaugural AI Learning Session, Emily Luvison (Genentech) will be providing an overview of cybersecurity considerations as they apply to AI.