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Randal Schulhauser, Former Senior Manager of Research, Technology & Business Development at Medtronic, Shares His Perspectives on AI/ML and the Future of Medical Device Manufacturing


Q: Can you provide a brief overview of your role and responsibilities at Medtronic? 

A: For the last decade or so, my role was loosely described as envisioning how medicine is going to be practiced 5 to 10 years from now and helping to guide investment decisions accordingly. This got me involved in fundamental strategy development – identifying portfolios and gaps and strategies to fill them. I worked for the Cardiac Implantable Technology Development Center (TDC). Medtronic operates several of these TDCs, each designed to become a center of excellence that acts as a go-to resource for the enterprise to help integrate capabilities and technologies that create additional value. 


I also managed an internal venture fund that has this philosophy – “think like a startup.” This is how you convert conversations and ideas into something tangible that you can put into somebody's hands. That is how you start to mature; taking ideas and translating into something that is real and tangible.  


Q: Can you describe your experience working with ecosystem partners at Medtronic? What were some of the key projects or collaborations you were involved in?

A: One example is Arizona State University. Tempe’s campus has microelectronics technologies that are relevant in the cardiac implantable TDC. I have been involved in implantable cardiac monitoring since its inception in the mid-1980s through today. This technology can be applied to neuroscience, particularly to the concept of neuromonitoring, which is exciting. 


We have also partnered with the WearTech Center and GCU on biochemical sensor development beyond glucose sensing. This wearable monitor will provide measurements of Glucose, Potassium and Creatinine for patients at the risk of acute kidney injury (AKI) and chronic heart failure (CHF). 


I've been working with the Fogarty Institute in the Bay Area. Fogarty specializes in taking entrepreneurs’ ideas and helping shape them into investable opportunities for VCs. Our collaboration involved intentionally spinning out a project by applying our cryoablation technology to chronic obstructive pulmonary disease (COPD) therapy through targeted lung denervation. I facilitated strategy development, aligning Medtronic’s business areas with the institute’s innovation capabilities. I see this as a potential model for MDM2 to explore in Arizona.


Q: How do you see the medical device industry evolving over the next 5-10 years? What are some emerging trends or technologies that you believe will significantly impact the industry? 

A: In the next 5 to 10 years, some of the biggest emerging trends or technology that will have a significant impact on the industry are the concept of AI and machine learning (ML). From my perspective, this isn't anything new; it's just that it has become very efficient in recent times. AI/ML has the potential of really reshaping the entire industry. This is one of the reasons why I'm actively participating in MDM2 – because what I would really like the federal government to do is make their investment through the CHIPS Act in the semiconductor industry. This type of investment could proliferate into the MedTech sector. I think AI/ML capabilities would be a game changer. 


Today, MedTech devices sense and detect, and I believe AI/ML can start to sense precursor events and predict and prevent serious conditions from happening. One example is what causes cardiac death in one manifestation, it's an electrical storm in the heart. The heart starts beating in a very uncoordinated fashion which leads to sudden cardiac death. Today’s implantable defibrillators detect the electrical storm, and they deliver this defibrillation pulse to go and break up that storm. AI/ML can analyze patterns and events that occur before an electrical storm begins, identifying repetitive signals. By recognizing these patterns, it may be possible to implement interventions to prevent the electrical storm from occurring.


Q: In your opinion, what are the biggest opportunities and challenges facing the healthcare industry today? How can companies better prepare for the future of healthcare and the increasing role of technology? we're facing their future.

A: Looking at the technology component 80/20, the technology lies in the 20%. There are a lot of things in the 80% that still need to be addressed. To be able to leverage AI/ML technology, we need data. But fundamentally, that data doesn’t exist. I don't think that we are addressing 80% of the problem and that is a big challenge. How do you leverage it, integrate it, and use it? There's more to the puzzle than technology per say and many people have said that data is the currency of the future. I’m of the opinion that no one knows how to exchange that currency. We need to work on those fundamental problems.


My understanding of “Consortiums 101” is that you start to identify the common problems as a collective when the individuals don't have a good solution. If you can come up with a common solution, that's when a consortium will be successful. I think MDM2 can have true utilization and create value to leverage these nascent technologies.


How do you envision the medical device manufacturing landscape evolving over the coming decades, and what role will MDM2 play in that evolution? 

A:  I worked 39 years for Medtronic. When I started working, the world was a very simple place. All I had to do was work with a physician that had an unmet need, satisfy that unmet need, they would use it, and you were in business. Today, there are all these barriers, and the bars raised significantly higher. The physician might use your solution once for a study but then there's the question of what happens after that? That’s one bar but then the next bar is reimbursement. Healthcare is always increasing as a percentage of gross national product, but is there a way to stabilize it? Time is money and any opportunity just becomes more and more expensive to go and satisfy those requirements.


This leads to a direct opportunity with MDM2 and leveraging the CHIPS Act. A significant number of MedTech products are what I call “dumb” products, and by that I'm saying that they lack electronics. Electronics are the brains of the product. The opportunity is that we can go and take a generation of “dumb” products and make them smart. Once you enable smart devices, next-gen microelectronics facilitate reduction in size, with greater capabilities and longevity. I think that one of the opportunities within the MDM2 environment is strategizing about how we can go and create a world where there’s no such thing as a dumb medical product, they're all smart.  


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