Despite the high number of academic centers and research clinics, identifying sites suited to your medical device study can be challenging. There are a lot of misconceptions that site effectiveness relies upon a thought leader as an investigator or a study coordinator with eons of experience. Well-versed teams are important, but these foundational requirements fit within a broader set of parameters that make your study a success. Learn about barriers to site selection for medical device studies, developing partnerships in your organization to speed site identification, the importance of engagement and motivation, and the impact of patients’ experiences with the study.

Clinical study protocol development has become much more complicated, particularly with the notion of Decentralized Clinical Trials. Additional considerations, such as the use of apps, telemedicine and other digital tools such as eConsent add complexity. This session will discuss some of the recent trends and provide perspectives on considerations for protocol writing, and then study implementation.

Using a Clinical Trial Management System (CTMS) provides companies many advantages by organizing and streamlining the planning and tracking of key study and site level attributes and activities.  Abbott has been managing clinical studies through integrated customized CTMS platforms to allow study execution, site management, and site operations teams to collaborate and drive clinical studies to completion.  We recently re-designed the CTMS into a modern and intuitive enterprise-level application, merging key clinical study services into a single platform, providing new features to track and reconcile requirements and documents real-time, improving efficiencies and increasing productivity, and achieving audit readiness.

A clinical evaluation is a methodological method used to collect, appraise and analyze clinical data to support the safety and performance of a medical device when used as intended, and clinical investigations provide the highest level of clinical data of safety and performance for a medical device. While one may connect the two, how much of a benefit is this connection and how does one maximize it?

Understanding risk is a necessity to bring and keep a medical device on the market. Medical device manufacturers are required to make risk-based decisions and conduct risk management activities as a part of the design, manufacture, and production of medical devices or in general as part of the quality system. In addition, the regulation of medical devices incorporates risk-based decisions to assure devices are safe and effective. FDA provided updated training material on this topic late in 2022. This session will provide an overview of the application of risk management principles and review of risk information for medical devices, and links to the recently updated FDA training materials on this topic.

Kids are not small adults. Developing a medical device or a mobile health app for children requires not only originality and creativity, but also extensive knowledge of developmental psychology and child behavior. It is particularly important to create age-appropriate medical content and attractive graphic illustrations in an effort to keep children engaged throughout the clinical trial journey. Gamification is a key element for implementing incentivised strategies combined with accessible technology to ensure protocol adherence and retention of trial participants. The child's mental well being is often not receiving enough attention at the protocol design stage. There is so much more we can do to improve the clinical trial experience, making it more friendly for both parents and children. This may include the use of (a) Video animation in eConsent materials; (b) Virtual awards based on the child's preferences; (c) Gamed-based clinical trial software platform; and (d) Augmented reality to alleviate stress and anxiety before complex medical exams such as MRI, muscle biopsy, and Phlebotomy.

As relatively new entrants to the regulatory landscape, DTx products, many of which are classified as software as medical device (SAMD), are learning more from FDA about what types of study design features are needed to earn clearance. This talk will provide an overview of key design considerations for SAMD trials, including endpoints, safety considerations, and endpoint collection, with a deeper dive on choice and design of comparison group.

The FDA draft guidance Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Subgroups in Clinical Trials outlines new requirements for inclusion in IDE submissions. This talk will discuss how decentralized models can help expand geographic reach by leveraging technologies and local infrastructure to gain access to intended and underrepresented populations; and how innovative patient-centered trial approaches help broaden participation among underserved populations by improving awareness and decreasing patient burden

The barrage of technology has taken clinical trial execution and operations by storm.  This does not only apply to sponsors.  While dealing with pandemic exacerbated stressors, clinical trial sites are being inundated with requests to adopt new technologies.  Not all sites meet technology-related requests with a smile. What are the major pain points sites experience when dealing with new technologies? How can sponsors help ease sites’ implementation and ongoing use of clinical systems?  What is the value proposition for the sites? This presentation will provide some pointers on dealing with these questions and others in pursuit of reducing barriers and achieving a better site technology experience.

There are multiple types of real-world data (RWD). This presentation will review requirements by study type and share how real-world data and experience (RWD/RWE) could be used in both the pre- and post-market settings. This presentation will highlight a case study in embedding post-market studies in a national registry.

The landscape is changing in the development of novel diagnostics. Many organizations developing advanced tests are leveraging large data sets to create more personalized tools in in vitro diagnostics. Such data sets require large studies, multi-center participation, inclusive study populations, and commitment to curation and maintenance of data in a platform that fosters research while protecting security and privacy. Driving innovation in diagnostics requires also becoming a data science company.

Building evidence strategies for AI-enabled devices can be a complex process however, with the right understanding of the requirements, the process goes from complex to more straightforward. In this talk, we'll go over what to consider when building a data collection strategy, review what the FDA expects, and how to design studies that balance AI development needs, regulatory requirements, and company objectives.