Maximizing Patient Outcomes Through Quantified Benefit-Risk in the Medical Device Sector with Jijo James, M.D., Chief Medical Officer at Johnson & Johnson [Speaker Spotlight]

Could you kindly introduce yourself, with your role and responsibilities as the Chief Medical Officer, MedTech and Interventional Oncology, at Johnson & Johnson?

My name is Jijo James, and I joined Johnson & Johnson’s Office of the Chief Medical Officer (OCMO) in 2014, where we advance healthcare innovation that patients, families, and providers trust. 

Since stepping into my current role as the Chief Medical Officer (CMO) for Johnson & Johnson MedTech & Interventional Oncology (INTO) in 2017, I’ve been responsible for driving robust safety governance and risk management across the product lifecycle, with the goal of advancing safety science and promoting safe and effective patient outcomes.

Could you tell us about your career journey within the medical device space and what brought you here today?

Throughout my career, I’ve worked with exceptional teams to drive innovative research through the use of real-world evidence and analytics and advance medical safety excellence with the goal of improving patient health and care across the consumer, medtech, and pharmaceutical segments of the healthcare industry.

At Johnson & Johnson, I’ve had the unique opportunity to lead and collaborate across both Innovative Medicine and MedTech segments. While my background was primarily in therapeutics, stepping into the role of Chief Medical Officer for MedTech allowed me to broaden my perspective and apply those insights to the medical device space. It’s been a deeply rewarding experience, shaped by working in concert with a world-class team of experts, and our cross-segment collaboration truly makes Johnson & Johnson unique in our industry.

I have also been involved with the Medical Device Innovation Consortium (MDIC), most recently serving as Chair of the Board of Directors for several years. MDIC is a pioneering public-private partnership dedicated to advancing regulatory and safety science in medical devices for the benefit of patients. These experiences have reinforced the importance of collaboration and information exchange. Similarly, forums like the European Medical Device Summit play a key role in bringing our community together to share best practices and accelerate innovation and safety in the field.

At this year’s Summit, there’s a shared sense of urgency around accelerating innovation and delivering solutions that truly center on patients. One question I encourage all of us to keep asking is: “Does this make a meaningful difference to patient care?”

This simple question challenges us to rethink conventional approaches and ensures that the patient experience remains central to everything we do. At Johnson & Johnson Office of the Chief Medical Officer (OCMO), this mindset guides our work every day as we aim to support patients and those who use our products to reduce avoidable harm.  

In today’s complex healthcare environment, understanding the true benefit and risk of our innovations is more important than ever. Rigorous, quantified benefit-risk assessments help us clearly demonstrate the value of our medical devices and make informed decisions that prioritize patient safety and outcomes. Ultimately, I hope attendees leave with a renewed commitment to embedding patient-centric thinking into every stage of innovation and with a deeper appreciation for how structured benefit-risk frameworks can drive better, more meaningful solutions for the communities we serve.

"In today’s complex healthcare environment, understanding the true benefit and risk of our innovations is more important than ever. Rigorous, quantified benefit-risk assessments help us clearly demonstrate the value of our medical devices and make informed decisions that prioritize patient safety and outcomes."

Given the global nature of regulatory landscapes, how do you harmonize benefit-risk quantification approaches to meet divergent requirements across regions like the EU, US, and APAC?

Each region brings its own regulatory framework, guidelines, and expectations for benefit-risk assessments. On top of that, patient populations across the EU, US, and APAC have distinct needs and perspectives, which have been instrumental in shaping our benefit-risk framework. 

To harmonize our approach, we focus on building a deeper understanding of regional nuances, both from a regulatory and a patient perspective. Open dialogue and collaboration with regulatory bodies are critical. These conversations help us align on expectations and refine our methodologies to meet diverse requirements without compromising scientific rigor or patient focus.

For example, through Project BeRMuDa, we’ve made meaningful progress by actively engaging with regulators, including the FDA and key EU notified bodies. Their feedback has been instrumental in strengthening our methodology and ensuring it remains robust, adaptable, and aligned with evolving global standards. Ultimately, harmonization isn’t about one-size-fits-all, but about creating a flexible, evidence-based framework that can be tailored to meet regional needs.

Looking ahead, how do you see AI and machine learning further transforming benefit-risk analysis, especially in adapting to dynamic patient populations or personalized therapies?

Artificial intelligence (AI) and machine learning (ML) have been part of the healthcare landscape for some time, but their role in benefit-risk is rapidly evolving. These technologies are helping us move beyond traditional methods by enabling faster, more precise, and more scalable approaches to data analysis. 

In benefit-risk analysis, AI and ML play an increasingly important role in data collection and analysis. For example, these tools can help us process large volumes of data quickly and automate data analysis faster. This allows us to identify patterns, predict outcomes, and adapt benefit-risk assessments in near real time. By automating routine data processing, we can reallocate expert resources toward deeper analysis and decision-making. This not only improves efficiency but also enhances the quality and relevance of our insights—ultimately supporting more informed, patient-centered innovation.

These forums are a wonderful opportunity to connect with peers and colleagues across the medtech industry. Through collaboration and sharing key learnings across various panels and talks at the Summit, we are collectively moving the needle forward to advance innovation for patients.