Erez Kaminski, an expert in validating machine learning systems for safety critical applications, discusses the regulatory burdens on ML teams in medical applications, the challenges of validating ML systems, and opportunities for automating overhead. He also shares insights into the excitement in the medical field for improving medical applications and highlights the benefits of using Ketryx for building medical software.
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Quick takeaways
Regulations in the medical field require robust validation and evidence to ensure software safety and compliance.
Machine learning has transformative potential in medical applications, improving diagnostics and reducing healthcare costs.
Collaboration and tools are essential for efficient and compliant software development in regulated industries.
Deep dives
The challenges of developing regulated software in the medical field
Developing regulated software in the medical field carries significant challenges, particularly in highly regulated industries. Regulations require robust validation and evidence that your system performs as intended. This includes demonstrating that the system does not pose harm to users and meets strict requirements. For highly regulated industries, such as medical applications, there are additional burdens of regulation and evidence. These burdens encompass product regulations, compliance with standards, and proper documentation of system functionality. Developing validated software in the medical field requires subject matter expertise, a sophisticated approach to risk management, and effective change management processes.
The impact of machine learning in the medical field
Machine learning has had a transformative impact on the medical field. The use of machine learning in medical image processing, such as radiology image classification, has been particularly innovative. Machine learning models aid in suggesting areas of focus for physicians by processing and classifying medical images. The ability to automate tasks and reduce the cognitive load on healthcare professionals is an area of great promise. Surgical robotics and other advancements in machine learning also aim to streamline procedures and improve patient outcomes. Machine learning shows immense potential for reducing healthcare costs and increasing access to advanced treatments, particularly in underserved areas.
The importance of regulatory compliance in software development
Regulatory compliance is crucial in software development for the medical field. Compliance with regulations ensures that medical software is safe and reliable for patients and healthcare professionals. The complexity of regulations necessitates subject matter expertise and a comprehensive understanding of the regulatory landscape. Regulatory requirements impact the entire software development lifecycle, from design to testing to deployment. Additionally, change management is vital to ensure that any updates or modifications are properly documented and evaluated for potential risks. With the increasing importance of machine learning in medical applications, regulatory agencies are addressing the unique challenges associated with validating and updating machine learning models.
The role of collaboration and tools in software development for regulated industries
Collaboration and effective tools play a critical role in software development for regulated industries. There is a need for improved collaboration options between different stakeholders in the software development process, especially in distributed environments or across organizations. Building a collaborative ecosystem that spans the entire supply chain is essential. Developing tools that facilitate collaboration and automate validation processes can significantly reduce the burdens associated with building regulated software. Such tools can streamline documentation, improve change management, and provide support for compliance with regulatory requirements. The goal is to make software development in regulated industries more efficient, cost-effective, and ultimately safer for patients.
Overcoming barriers to machine learning adoption in the medical field
The biggest barrier to machine learning adoption in the medical field is the need for subject matter expertise. Developing and implementing machine learning models in healthcare requires deep understanding and knowledge of both the medical domain and machine learning techniques. The shortage of experts who can confidently navigate the nuances of building and validating machine learning models for medical applications poses a significant challenge. Additionally, there is a need for educational resources and increased awareness of best practices in machine learning for healthcare. Bridging this expertise gap will be crucial in accelerating the adoption of machine learning in the medical field to improve patient outcomes and healthcare delivery.
Summary Software systems power much of the modern world. For applications that impact the safety and well-being of people there is an extra set of precautions that need to be addressed before deploying to production. If machine learning and AI are part of that application then there is a greater need to validate the proper functionality of the models. In this episode Erez Kaminski shares the work that he is doing at Ketryx to make that validation easier to implement and incorporate into the ongoing maintenance of software and machine learning products. Announcements
Hello and welcome to the Machine Learning Podcast, the podcast about machine learning and how to bring it from idea to delivery.
Your host is Tobias Macey and today I'm interviewing Erez Kaminski about using machine learning in safety critical and highly regulated medical applications
Interview
Introduction
How did you get involved in machine learning?
Can you start by describing some of the regulatory burdens placed on ML teams who are building solutions for medical applications?
How do these requirements impact the development and validation processes of model design and development?
What are some examples of the procedural and record-keeping aspects of the machine learning workflow that are required for FDA compliance?
What are the opportunities for automating pieces of that overhead?
Can you describe what you are doing at Ketryx to streamline the development/training/deployment of ML/AI applications for medical use cases?
What are the ideas/assumptions that you had at the start of Ketryx that have been challenged/updated as you work with customers?
What are the most interesting, innovative, or unexpected ways that you have seen ML used in medical applications?
What are the most interesting, unexpected, or challenging lessons that you have learned while working on Ketryx?
When is Ketryx the wrong choice?
What do you have planned for the future of Ketryx?
From your perspective, what is the biggest barrier to adoption of machine learning today?
Closing Announcements
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