Data Science and Technology

DATA SCIENCE AND TECHNOLOGY

The Data Science and Technology initiative works to fulfill the promise of advances in data analysis by creating tools and methods to use advanced data analysis techniques and new technology to accelerate the collection of clinical data, remove barriers to patient access, and monitor product safety, quality, and effectiveness.

Programs:

• Case for Quality • Computational Modeling & Simulation • Cybersecurity • External Evidence Methods

2019 Data Science and Technology Year in Review:

The Data Science and Technology Advisory Committee was formed in November 2019 to gather input from government, industry, and non-profit stakeholders to identify high-value data science and technology initiatives and recommend strategic priorities and future directions for MDIC. The committee will focus on modeling and simulation, external evidence methods, cybersecurity, interoperability, artificial intelligence and machine learning, and other technology-based initiatives for devices and diagnostics. In 2020, the committee will develop a multi-year roadmap with recommended areas of focus required to advance regulatory science for patient benefit. The current committee will serve a two-year term.

CASE FOR QUALITY

MDIC’s Case for Quality (CfQ) is setting a cultural shift in motion to focus the medical device ecosystem on sustained product quality that enhances patient safety and outcomes and adds value to stakeholder organizations. Through the collaboration of ongoing working groups, representatives from FDA and medical device manufacturers of every size are developing practices, tools, and metrics to enhance product design and manufacturing processes and inform regulatory practices.

Case for Quality Voluntary Improvement Program Governance and Charter Established

A governing committee, charter, and initial membership were established. The number of active participants increased to 59 active sites across 27 companies. Of the active sites, 39 percent are located internationally (outside of the United States) and 7 percent are recognized by FDA as small businesses.

CfQ Governance by the Numbers

59 Sites

27 Companies

39% International

7% Small Business

New CfQ Working Groups Created

Seven new working groups were launched to address the following needs within the Voluntary Improvement Program:

Additional Regulatory Benefits Performance Measures Reappraisals Multi-Site Appraisals Medical Device Context Program Features EU Agencies

Communications and Training Activities

Program representatives convened a wide variety of events: three CfQ forums, a presentation at the MDIC Annual Public Forum, two CfQ webinars, bi-weekly VIP Alignment and VIP Appraiser calls, and monthly participant calls. The team trained an additional 35 industry staff and 16 FDA staff on internal appraisals.

#makeCAPAcool (CAPA Process Improvement) Program CAPA Framework Published

Stakeholders developed and aligned around a new framework to recast the Corrective and Preventive Action (CAPA) process as a Continuous Improvement process and to design a less burdensome process that drives higher product quality and improved patient safety. The Framework summarizes the team’s initial findings and recommendations, including a proposed framework for risk-based improvement.

Strategy for New CAPA Framework Designed

The strategy includes pilot site selection, a formal pilot playbook, standardized data collection systems, regulatory change management strategy, and an audit memo to communicate the Framework to regulators evaluating a site’s CAPA process.

Accelerated Sustainable Capability Pilot Study Program Launch Milestones Achieved

The Accelerated Sustainable Capability pilot study tests the expansion of the Case for Quality Voluntary Improvement Program to aid underperforming medical device manufacturing sites. Following the approval of a Broad Agency Award, a team consisting of MDIC, FDA, and industry was formed. Through a series of face-to-face meetings, they evaluated various elements of the pilot study in detail and aligned around strategy for a successful study. Site enrollment into the pilot study is expected to begin in summer 2020.

C-Suite Leadership Engagement

Leadership Engagement Workstream Developed

The Leadership Engagement Working Group focuses on promoting quality as a strategic priority for all parts of an organization through strong leadership, strategic alignment, and tone at the top. The working group identified and aggregated best practices across ten companies , including communications, behaviors, metrics, and strategy, and is in the process of developing a draft of the playbook to aid executive leaders in establishing a healthy and effective culture of quality within their organization.

Quality as a Career Mission Statement Developed

The mission of the Quality as a Career program is to accelerate the next generation of critical-thinking professionals grounded in the science of quality by immersing students in real-world

experiences, thus engaging students in “Quality as a Career.”

Pilot Program Initiated at Xavier University

Thirteen students enrolled in the webbased Global Regulatory and Legal Requirements of Quality course at Xavier University. More than 90 industry volunteers taught, graded homework and exams, and mentored the students. Students from 16 universities around the world enrolled in the January 2020 cohort. AstraZeneca and Merck signed on to teach the programs on campus at Xavier University and La Salle University, respectively.

COMPUTATIONAL MODELING & SIMULATION The ENRICHMENT in silico Clinical Trial Project Launched

MDIC is now a part of the ENRICHMENT in silico Clinical Trial Project—a shared mission among leading cardiovascular researchers, educators, medical device developers, regulatory agencies, and practicing cardiologists to develop and validate highly accurate personalized digital human heart models. This is a proof of concept project to further evaluate the use of MDIC Virtual Patients derived using computational modeling and simulation (CM&S).

Good Simulation Practices in Health Technologies

MDIC in partnership with FDA and Avicenna Alliance is promoting a discussion around modeling and simulation practices by industry and the development of a framework for evaluating and assessing the utility of computational modeling and simulation in health technologies. A joint workshop is being planned with the key focus on the role of computational modeling and simulation in the regulatory evaluation of health technologies and current simulation practices, as well as gathering input to inform the development of good simulation practice recommendations for the community.

CYBERSECURITY

MDIC recognizes that cybersecurity is critical infrastructure for the United States. Cybersecurity threats can have a debilitating effect on security, national economic security, and national public health and safety. As such, MDIC is focused on making meaningful contributions to advance cybersecurity as it relates to medical devices.

MDIC Awarded FDA Grant for New Cybersecurity Resources

In Sept 2019, FDA awarded a grant to MDIC for a project that will focus on threat modeling for medical devices and diagnostics. MDIC, in collaboration with FDA, will work with cybersecurity experts from the medical device industry, other industries, academia, and non-profit organizations to develop a threat modeling playbook and a bootcamp series for healthcare stakeholders.

Threat modeling expert Adam Shostack leads a training at MDIC headquarters to prepare subject matter experts to lead cybersecurity threat modeling bootcamps that will be hosted by MDIC in 2020.

Communications Activities

Representatives from the Cybersecurity initiative led or participated in panel sessions at the MedTech Conference, Health Sector Coordinating Council Joint Cybersecurity Working Group meeting, and FDA/CMS Summit.

EXTERNAL EVIDENCE METHODS

The External Evidence Methods (EEM) initiative aims to establish a more predictable pathway for use of external evidence methods, such as innovative (Frequentist/Bayesian) methods, and to catalog existing methods for evidence fusion from data external to a clinical trial. These external data include but are not limited to real-world data, Real-World Evidence (RWE), engineering modeling and simulation, and similar device clinical trial data that support regulatory medical device decisions and other stakeholder decisions .

The EEM program builds and expands on the success of MDIC Virtual Patient project and FDA Mock Submission using the Virtual Patient model.

EEM Executives and Fellows Meeting Held

In April 2019, the EEM program convened more than 70 subject matter experts from FDA, industry, and non-profit organizations to discuss existing methods and identify gaps for the use of external data. A working group of industry and FDA experts is now developing the MDIC External Evidence Methods Framework, scheduled for release in Spring 2021.

Living Heart Project Launched

MDIC is now a part of the Living Heart Project—a shared mission among leading

cardiovascular researchers, educators, medical device developers, regulatory agencies, and practicing cardiologists to develop and validate highly accurate personalized digital human heart models. This is a proof of concept project to further evaluate the use of MDIC Virtual Patient initiative derived using computational modeling and simulation (CM&S).

ALLIANCE FOR DIGITAL PATHOLOGY

MDIC, as a part of a broader alliance in digital pathology including FDA and the Digital Pathology Association, is working to prioritize the areas of digital pathology and artificial intelligence in which MDIC can bring industry, government, insurance companies, and patients together to collaborate on several new projects. This alliance is a voluntary and temporary collaboration to identify and create concrete, practical deliverables and relevant strategic aims that are of shared interest to the whole field of digital pathology.

Program Updates

MDIC participated in initial discussions with FDA in July 2019 and contributed to additional discussions held at the International Digital Pathology Conference (PathVisions) in October 2019. In November 2019, MDIC convened an executives and fellows meeting with more than 60 digital pathology/AI experts from industry, FDA, the National Institutes of Health (NIH), the National Cancer Institute, academia, and patient-advocacy and non-profit organizations including the American College of Radiology, Friends of Cancer Research, and PCORI, to brainstorm strategies for advancing regulatory science for digital pathology.