Medical Device Innovation Consortium (MDIC)

Jijo James

Patient-centric innovation – developing new ideas, technology and approaches to our work that put patients and their needs first – is of critical importance to those working in healthcare. Yet, despite the best of intentions, our healthcare system operates in siloes comprised of different stakeholders, systems and incentives that do not seamlessly connect. This reality requires interventions from all stakeholders to work together to better serve patients and provide them with the most optimal treatment for their condition and keep them as safe as possible. Therefore, it is imperative we create closed-loop systems to reduce inefficiencies, increase industry collaboration and create innovative techniques or methods to help improve patient safety and outcomes.

Since 2014, I have had the privilege to work alongside a talented team within Johnson & Johnson’s Office of the Chief Medical Officer that advocates for patient safety and develops innovative solutions, guided by principles of science, data, ethics and values that keep the best interests of patients at the center. Given its independent nature at the company, we can objectively view challenges and opportunities through an unbiased lens and frequently consult with industry regulators and other decision makers to apply our learnings and collaborate to come up with new best practices to advance patient safety and trust.

Promoting a culture of safety in the operating room (OR)

When we look at the greatest breakthroughs in healthcare over the last few decades, one common theme from these successes comes to mind, and that is collaboration – the community of ideas convened from productive discussion and knowledge sharing with organizations and individuals collectively. One example of collaboration is the development of a new tool to standardize safety measures in operating rooms through Johnson & Johnson’s partnership with Ariadne Labs, a joint center for healthcare innovation of Brigham & Women’s Hospital and the Harvard T.H. Chan School of Public Health.

To inform our approach for this new tool, we leveraged the World Health Organization (WHO) Surgical Safety Checklist, which was built on current evidence pointing to a link between high-functioning OR teams and significantly reduced rates of adverse events. Published in 2008, the checklist promotes effective communication and teamwork and can reduce mortality by nearly 25% and morbidity by over 40%. This checklist has spread to 70% of countries globally and is widely implemented in practice – according to a recent study published in the British Journal of Surgery, which surveyed facilities across 94 countries, 75% of them utilize the checklist.1,2,3 There are remaining opportunities to build upon the success of the checklist and continue to improve safety practices surrounding the use of surgical devices.

Using these insights, we developed the Device Briefing Tool (DBT), a simple, four-item communication tool designed for use in conjunction with the Surgical Safety Checklist. The DBT helps OR teams accurately and efficiently review a device’s instructions prior to a procedure, promoting better communication in the OR. Results published in the Journal of Surgical Research from our first study piloting DBT concluded high acceptability, adherence and feasibility of the multidisciplinary trainings and the DBT among representatives and clinicians, with most respondents rating the DBT as moderately useful to extremely useful.4 We continue to study the effectiveness of DBT in sites worldwide and just concluded a pilot study in Singapore’s largest hospital system to assess the effect of the DBT on Device Related Interruptions, which has revealed positive early results. In addition, we are commencing a pilot study in evaluating the effect of a digital DBT on clinical outcomes in patients undergoing colorectal procedures in Germany to add to the evidence in driving better outcomes for patients in the age of digital interventions.

Leveraging RWE to support clinical trial designs and inform regulatory decisions

Elevating patient safety continues to be improved by using Real-World Evidence (RWE) to support decision-making on medical device safety, effectiveness and innovation. RWE analyses can quickly analyze data from a wide range of patients (e.g., age, sex, ethnicity, and disease profile) and providers (e.g., experience levels, volume of procedures, hospital setting, etc.). In turn, this gives companies and regulators a more inclusive understanding of how devices work in different real-world settings so we can identify potential safety and effectiveness issues as soon as possible.

" When we look at the greatest breakthroughs in healthcare over the last few decades, one common theme from these successes comes to mind, and that is collaboration "

Leveraging RWE is also a priority topic at the Medical Device Innovation Consortium (MDIC), where I serve as chair of the Board of Directors. MDIC is the first public[1]private partnership that brings together representatives of government, academia, non-profits, patient groups, and industry, with a shared mission of advancing medical device regulatory and safety science for patient benefit. At MDIC, we launched the National Evaluation System for Health Technology Coordinating Center (NESTcc) – an initiative that supports the sustainable generation and use of timely, reliable, and cost-effective RWE throughout the medical device lifecycle. Our goal is to help build a platform for using RWE for label extensions, product approvals, and external controls in collaboration with leading academic centers, healthcare systems, and the FDA. Through sharing, collaborating and learning about how RWE can be used to inform regulatory decisions, and clinical practice, the medical community can.

Reflecting on closed-loop systems

As we consider a future built on the most optimal use of surgical devices for improved outcomes, it’s critical that we also consider the role of post-market surveillance and signal detection in the real-world environment. For example, our MedTech team recently heard from a health authority expressing concerns around reports of orthopedic nail product breakage incidences during surgery. Johnson & Johnson took these surveillance findings very seriously given its safety implications. To evaluate the safety of the product, we conducted a real-world comparative data study of more than 14,000 patients to assess different equivalent nails and breakage rates. By conducting this regulatory-grade study, we were able to demonstrate that our nail product carried no higher risk than other similar products in the market. Ultimately, through the findings from this study, we implemented additional improvements to product design, proposed labeling changes, additional trainings, and updated the surgical technique guide for this product. This example illustrates how when we take the learnings from the post-operative stage, we are able to apply those insights toward device development and improvement, creating a feedback loop that closes information gaps that may contribute to complications and errors in daily practice.

Throughout my career I’ve often reflected on how the many ways in which the whole is greater than the sum of its parts. The healthcare ecosystem is no different, and it is critical that we continue to do all we can to affect positive change to better serve all patients. We all have a role to play in determining the future to elevate safety and improve outcomes. As a community – and only together – can break down siloes and develop new, close-looped systems that rely on collaboration, emerging technology and data to get us there.