Harness MDIC's Collaborative Resources to Strengthen Clinical Trials and Patient Outcomes
By Joe Sapiente, chief science and technology officer, MDIC
From the first stages of development through post-commercialization, medical devices — across all classifications — must clear a complex series of hurdles throughout their total product life cycle. The role of the Medical Device Innovation Consortium (MDIC) is to convene the right stakeholders — manufacturers, regulators, regulatory experts, clinicians, patient advocates, and industry change agents — to turn obstacles into opportunities, developing and empowering them with tools that create efficiencies, illuminate and clarify complexities, and ultimately foster better outcomes for all patients through actionable, practical solutions.
Early-Phase Clinical Trial Support
One example of an initiative envisioned as a platform for enhanced collaboration is MDIC’s Clinical Site Alliance. For over a decade, the MDIC community has supported the FDA’s Early Feasibility Study (EFS) with the launch of the Clinical Site Alliance. The Alliance is designed to connect manufacturers with clinical trial sites that are prepared to navigate the unique challenges of early-stage trials. With access to resources such as standardized clinical trial agreements and investigator training guides, medical device companies participating in the Clinical Site Alliance can reduce logistical barriers in developing early-stage studies, ensuring trials can move forward efficiently and effectively.
Breakthroughs In Genomic Testing
As precision medicine continues to transform the landscape of healthcare, especially in the sector of cancer diagnostics, ensuring the accuracy and reliability of genomic testing has never been more critical. Effective collaboration across a network of contributors helps establish the trust and consistency needed to drive the adoption of these advancements.
MDIC’s Somatic Reference Samples (SRS) initiative exemplifies how partnerships with manufacturers, clinical laboratories, and regulators can drive progress. By developing high-quality reference materials, such as those created through the CRISPR Reference Sample project, the SRS initiative works to elevate the standard for next-generation sequencing (NGS) assays. These materials enhance the reliability of genomic tests, increasing trust in the clinicians using these diagnostics when presenting life-changing treatment decisions to their patients.
Incorporating Real-World Evidence Into Regulatory Submissions
The medtech industry is increasingly adopting real-world evidence (RWE) to support regulatory submissions by leveraging health data from EHRs, medical claims, and patient-generated data. Recent applications have focused on claims expansions and label modifications for existing products, demonstrating RWE’s ability to streamline regulatory processes and improve patient access. Realizing its full potential for both novel technologies and expanded use cases will require collaboration among stakeholders to ensure the reliability, quality, and acceptance of real-world data (RWD) across regulatory scenarios.
The National Evaluation System for health Technology (NEST), an MDIC initiative, exemplifies the power of collaboration in advancing RWE. By bringing together industry sponsors, regulators, regulatory experts, and data source and analysis partners, NEST provides sponsors with a pathway for incorporating RWE into pre-market submissions and post-market label expansion processes. Central to NEST’s efforts is the NEST Mark process, which certifies the reliability and relevance of RWD for pre-market regulatory submissions. By establishing consistent criteria for evaluating data quality, the NEST Mark helps sponsors ensure their data meets regulatory expectations and supports informed decision-making.
Intuitive Surgical’s engagement with NEST underscores how RWE can play a key role in regulatory strategies. In its FDA submission for updates to the labeling of the da Vinci Surgical System, Intuitive used RWD to address specific regulatory requirements. Through this process, the integration of data from clinical practice highlighted the potential of RWE to complement traditional clinical trials and provide additional context for evaluating device performance.
Addressing Evolving Digital Health And AI Needs
As the medtech industry evolves, new challenges such as algorithm transparency, device cybersecurity, and the ethical use of AI require forward-thinking solutions. These technologies hold immense potential to transform patient care, but their adoption depends on ensuring they meet the highest standards for safety, reliability, and trustworthiness.
MDIC is advancing solutions to these challenges through its digital health and AI initiatives by collaborating with stakeholders to establish frameworks that promote algorithm validation and transparency. For example, MDIC's Pre-determined Change Control project focuses on developing a library of examples that can be utilized with the Predetermined Change Control Plan (PCCP) across all software types. This initiative aims to provide structured approaches for managing software modifications, ensuring that changes maintain the safety and effectiveness of medical device software, including AI/ML algorithms.
Cybersecurity remains a top priority as the number of interconnected medical devices powering patient care grows. MDIC’s cybersecurity benchmarking surveys and shared learning initiatives equip stakeholders with the resources to address vulnerabilities, strengthen protections, and maintain trust in the safety and functionality of medical technologies. These efforts are critical in building a medtech ecosystem that balances innovation with robust safeguards for patients and providers.
Keeping Patients At The Center
Patient perspectives are vital to shaping meaningful innovation in medical technology. The Science of Patient Input (SPI) program aims to create resources to promote the integration of these perspectives throughout the total product life cycle, ensuring that medical devices are designed to address real-world challenges and elevate care in meaningful ways.
This commitment is put in action through SPI’s Patient-Centered Benefit-Risk Framework, which guides developers in incorporating patient input into evaluations of safety and effectiveness. By using tools like surveys and preference studies, the framework identifies what patients prioritize in their healthcare experiences and device use. These insights, such as preferences for ease of use or improved quality of life, help manufacturers design devices that can address the needs and expectations of those they aim to serve.
Building on this foundation, the Using Patient Preference Information in the Design of Clinical Trials framework highlights the importance of embedding patient input into trial designs. By addressing priorities like convenience and accessibility, this framework helps developers overcome barriers such as distance to trial sites and burdensome trial requirements. These efforts ensure trials are more inclusive and representative of the diverse populations medical devices aim to serve, advancing equity and trust across the healthcare landscape.
Shaping The Future Together
Collaboration proves to be the cornerstone of progress in medical technology. By uniting diverse stakeholders, MDIC transforms challenges into opportunities, creating practical tools and frameworks that drive innovation and deliver safe, effective technologies to patients who need them most. MDIC remains committed to empowering the medtech ecosystem with solutions that foster trust, improve access, and advance the future of patient care.
About The Author:
Joseph Sapiente is MDIC’s chief science and technology officer, bringing more than 38 years of experience in medical device quality, regulatory compliance, and innovation. Before joining MDIC, he held executive roles in quality, regulatory, and clinical affairs at Hologic, Medtronic, Covidien, Tyco Healthcare, and U.S. Surgical. At Covidien, he led the Quality Begins With Me initiative, later overseeing its enterprise-wide rollout at Medtronic. He also played a key role in industry-wide quality advancements, serving as industry chair for MDIC’s Case for Quality collaborative community and AdvaMed’s Case for Quality Working Group. With four years at MDIC, he continues to drive regulatory science and technology efforts, advancing patient safety and product innovation in the MedTech ecosystem.