How to Use Artificial Intelligence & Machine Learning to Produce Better, Smarter, Safer Devices

May 13, 2020


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 about how AI and ML can be utilized to produce better, safer, smarter, and faster medical devices.




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Some highlights of this episode include:

  • 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.



Prodct LLC

Devon Campbell’s Email

Devon Campbell on LinkedIn

Anthony Habayeb on LinkedIn

Anthony Habayeb on Twitter

FDA Digital Health

Software as a Medical Device (SaMD)

Artificial Intelligence and Machine Learning in Software as a Medical Device (SaMD)

FDA Artificial Intelligence and Machine Learning Discussion Paper

John Martin of Butterfly Network

John McCarthy

The Greenlight Guru True Quality Virtual Summit

MedTech True Quality Stories Podcast

Greenlight Guru YouTube Channel

Greenlight Guru


Memorable Quotes from this episode:

“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



The Global Medical Device Podcast powered by Greenlight Guru is 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.

Like this episode? Subscribe today on iTunes or Spotify.

Nick Tippmann is an experienced marketing professional lauded by colleagues, peers, and medical device professionals alike for his strategic contributions to Greenlight Guru from the time of the company’s inception. Previous to Greenlight Guru, he co-founded and led a media and event production company that was later...

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