What is artificial intelligence (AI) and machine learning (ML) and how do the two differ in the medical device industry? How can companies leverage AI and ML in their medical devices to improve the quality of life?
In this episode of the Global Medical Device Podcast Jon Speer talks to Devon Campbell, founder of Prodct LLC, and Anthony Habayeb, co-founder and CEO of Monitaur.ai about how AI and ML can be utilized to produce better, safer, smarter, and faster medical devices.
What is AI? John McCarthy, Father of AI, defined it as: “The science and engineering of making intelligent machines.” Basically, it’s Independent robots thinking and acting like humans, completely autonomously.
ML is a technique within AI that focuses on algorithms and models in software to reach real-time conclusions and decisions based on a foundation of learning, training, and rules.
What’s the reality of AI adoption in major industries? It’s challenging to get large, regulated, medical device companies to implement ML due to safety risks. Yet, it can be transformational.
Machine Learning Assurance: Guidance on how to perform audits of ML models to create assurances that build trust and confidence in a quality management system (QMS) and development process.
Culture of Quality Control: Mistakes can and will be made. Is AI and ML behaving within certain bounds and rendering good results in the medical device industry?
FDA encourages collaboration for companies to demonstrate ML assurance, mitigate risks, prove quality control mindset, understand Algorithmic Change Protocol (ACT), and provide post-market surveillance.
Lean in and Lead: Focus on safety and effectiveness to meet the needs of patients and caregivers by using AI in some way with medical devices.
“ML really is one of those techniques within that AI umbrella that you can use to produce intelligent behavior.” Devon Campbell
“It gives us a new tool and an ability for us to try to produce better, smarter, faster medical devices, especially in the SaMD space.” Devon Campbell
“How do we know that it is behaving within certain bounds and that it’s rendering good results?” Devon Campbell
“The FDA is working really hard to create safety around artificial intelligence. They believe there’s great potential to improve healthcare.” Anthony Habayeb
“The FDA is really looking for companies and partners to help them demonstrate great examples of how you can have good assurance on your machine learning.” Anthony Habayeb
ABOUT THE GLOBAL MEDICAL DEVICE PODCAST:
The Global Medical Device Podcast powered byGreenlight Guruis where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.
Nick Tippmann is the Chief Marketing Officer for Greenlight Guru, a MedTech Lifecycle Excellence Platform (MLE) that provides an industry-specific solution to help medical technology innovators around the world use quality as an accelerator to move beyond baseline compliance and achieve True Quality. Tippmann is...