Artificial intelligence (AI) in healthcare was a hot topic of conversation at the recent MichBio Medical Device Summit in Ann Arbor last week. The conversation centered on AI’s transformative potential, particularly in medical devices, and it was moderated by MichBio President and CEO Stephen Rapundalo.

Speakers at the summit shared insights on how AI is reshaping healthcare, offering deeper data analysis, improved patient care, and helping physicians make better-informed decisions. 

AI is causing a paradigm shift in healthcare 

Jim Mault, CEO of BioIntelliSense, likened AI’s role in healthcare to the Hubble Telescope. Just as the Hubble allowed scientists to see the universe beyond our galaxy, AI is enabling healthcare providers to look beyond the immediate data, he shared. The potential of AI to sift through massive datasets and identify patterns beyond human capabilities is revolutionizing how medical professionals diagnose and treat patients. 

Mark Salamango, CTO of Fifth Eye, added to this, emphasizing that cardiologists currently only see about six seconds of data at a time. This, he says, limits their ability to proactively care for patients. AI, through machine learning, can process extensive data points in real-time, providing a broader and more holistic view of patient health. This can allow for earlier interventions and more precise care, ultimately improving patient outcomes. 

However, there are still significant challenges when it comes to the adoption of AI in healthcare at large. Salamango noted that many hospitals are still based on outdated electronic health record (EHR) systems and are not networked, making it difficult to fully implement AI solutions. This is also the case for many processes in the clinical trial space where manual effort is still preferred.  

At TrialAssure, we see the need to keep humans-in-the-loop, ensuring that AI is not left alone and neither are humans. This allows the human expertise to combine with the unmatched speed and power of AI to make end products that are effective and scalable. And, this is exactly what LINK AI is doing for medical writing and ANONYMIZE is doing for data and document sharing.  

Trust and Regulatory Challenges 

One of the major concerns raised during the summit was the fear and reluctance among industry professionals regarding AI adoption. According to Mault, this fear stems from concerns about job security, the complexity of AI, and trust in the technology itself. There is a natural hesitation, as some may feel threatened by the introduction of AI systems that seemingly replace certain tasks. 

Education plays a key role in overcoming this reluctance. As Salamango pointed out, when clinicians understand that AI tools can make their jobs easier—rather than more complex—adoption increases.  

Mault highlighted the parallels to autopilot systems in aviation. Before autopilot, crashes occurred once every million flights. After its implementation in the 1990s, that rate drastically dropped to one in every 25 million flights. Similarly, AI can drastically improve patient safety and care if properly integrated into healthcare systems. 

However, regulatory hurdles remain a significant barrier. Mault discussed the challenges of working with the FDA, particularly regarding “self-learning” algorithms. While the FDA has been collaborative, he shared, they are wary of continuously adaptive AI, requiring that each algorithm change undergo new rounds of approval. This has slowed the adoption of AI in healthcare compared to other industries. 

Two discussion papers released by the FDA on AI and machine learning in drug development can be reviewed here.  

MichBio medical device summit
Pictured (l to r): Rapundalo, Mault, and Salamango.

The Road Ahead for AI in Healthcare 

Despite these challenges, the outlook for AI in healthcare is optimistic. Salamango predicted that while AI adoption in medical devices will bring about “amazing, insane things” in the future, it will likely take twice as long as in other industries due to regulatory oversight and the complex nature of healthcare. 

One recent study from PwC on AI in pharma aligns with these perspectives. According to PwC, pharmaceutical companies that fully embrace and industrialize AI across their organizations have the potential to double today’s operating profits by 2030, primarily by boosting revenues and reducing operational costs.  

This will be achieved through the widespread integration of AI technologies, which enable better decision-making, faster drug discovery, and enhanced supply chain management. The process, however, requires a concerted effort to prioritize AI and develop systems that can scale across the organization​. 

Building an AI partnership: Better than developing?  

Doubling an organization’s revenues by 100 percent sounds appetizing, but developing AI technologies internally can be difficult without the right team, processes, and support in place. TrialAssure executives have experienced this recently, offering a tailored starting point for companies looking to adopt AI technology without the burden of building from scratch. 

Our commercial AI product experience extends back years before generative AI became a household name, and current products that the team has built can be easily adapted and customized to fit the specific systems, workflows, and processes unique to each organization. 

This approach not only accelerates AI implementation but also ensures that companies can fine-tune these technologies to optimize for their distinct needs. Leveraging pre-existing, customizable AI frameworks from TrialAssure eliminates the high costs and complexities of developing proprietary solutions, making the adoption of AI much more accessible and efficient across both healthcare and other industries. 

View more on our AI partner programs here.  

While the MichBio Medical Device Summit delved into much more than AI, the topic’s presence was felt beyond the few discussions. There are still AI challenges like adoption and regulatory hurdles, but the consensus is that AI’s full potential is just beginning to be realized. By 2030, as the healthcare and pharmaceutical industries continue to embrace and industrialize AI, we can expect a major shift in how care is delivered and companies operate. 

For any questions regarding AI, email info@trialassure.com.  

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