MDIC has a number of working groups and committees that actively work to further our mission to accelerate and improve patient access to innovative, high-quality, safe, and cost-effective medical technologies. Below is a list of our current working groups and their focus areas. For more information on joining a working group, please complete our membership interest form or send an email to our membership department.
Case for Quality
MDIC’s Case for Quality Collaborative Community elevates the focus of all medical device stakeholders from baseline regulatory compliance to sustained, predictive practices that advance medical device quality and safety to achieve better patient outcomes.
- CfQcc Steering Committee: With the assistance of the MDIC CfQcc Program Director, this committee manages the general course of the collaborative community operations, sets and decides on the strategy and priorities of the program, and opportunities for growth.
- CfQ VIP Governing Committee: The Governing Committee (GC) oversees and gives input to
the strategic activities of the CfQ VIP initiative. The GC reports updates regularly to the MDIC Board and CfQcc Steering Committee and sets the strategic plan for the CfQcc VIP initiative.
This group considers input from the Steering Committee and Advisors as appropriate while also collecting input and reviews updates regularly from the CfQ Working Groups. The GC assures appropriate input and engagement from industry representatives on the CfQ VIP.
- Voluntary Improvement Program Working Groups: These WGs focus on ways to continue to enhance the participation and benefit of the VIP, by leveraging a proven maturity model, the CMMI framework, by which medical device organizations may measure their capability to produce high-quality devices and increase patient safety.
- C Suite Engagement Working Group: This WG influences CEOs and senior leaders of medical device companies to participate in quality initiatives in a meaningful way that will effect change in their organizations and the industry. It promotes Quality as a “strategic priority” being integral to all parts of an organization through strong leadership, strategic alignment, and tone at the top.
- CAPA Working Group: This WG leverages cross-industry best practices and collaboration to fundamentally recast CAPA as a continuous improvement (CI) framework.
- Quality as Career Working Group: This WG establishes a Quality discipline at the College/ University level and educates students on the benefits of making Quality a foundational start to a successful career within the MedTech industry.
- Safe Space Working Group: This WG seeks to create a non-competitive, collaborative, and sanction-free environment enabling open discussions on a variety of critical improvement initiatives. This space would permit open dialogue concerning sensitive improvement subjects in a non-punitive environment and leverages well- established models for the environment (i.e., emulating Federal Aviation Administration (FAA)/ Department of Defense (DoD) Quality “Safe Space”). This space had the potential to help the industry and FDA gain a broader view of quality performance improvement from leading industries, their trusted traders, suppliers, and contractors and enables a significantly improved environment for identifying root causes for the most challenging improvement initiatives.
MDIC’s Clinical Diagnostics program is focused on fostering innovation and speeding patient access to new IVD tests by developing new tools and methods that will improve processes to assess safety, effectiveness, and the value proposition of diagnostic tests.
- CDx Steering Committee: This committee decides on the priorities of the program and assists the MDIC CDx Program Director with managing the general course of the program operations and areas of opportunities for growth.
- COVID Real-World Evidence Working Group: This WG is focused on applying MDIC’s IVD RWE framework to IVD development and regulatory submissions related to COVID-19.
- Fingerstick Capillary Blood Specimens Working Group: This WG is working on the Fingerstick blueprint to develop study designs for capillary whole blood collection using fingerstick. It will focus on precision and method comparison tests for analytical validity.
- Artificial Intelligence and Machine Learning (AIML) for IVDs Working Group: This WG is scoping a new project for the application of Artificial Intelligence and Machine Learning for in vitro diagnostics.
- Systemic Harmonization and Interoperability Enhancement for Laboratory Data (SHIELD) Working Group: This WG aims to reduce the burdens of laboratory data stewardship and enable access to understandable, high-quality, actionable Real-World Evidence (RWE) leveraged in clinical decisions and regulatory submissions. SHIELD has focused on harmonizing the adoption/ development and implementation of lab data standards to ensure that the same type of test is described the same way in electronic healthcare systems.
- Somatic Reference Samples Working Group: This WG is in the process of developing physical reference samples to be used in validating NGS based oncology tests for solid tumors.
- Surrogate Samples Harmonized Education Working Group: This WG created a framework for using surrogate samples along with case studies and educational materials to teach the audience how to use the framework.
Computational Modeling and Simulation
MDIC’s Computational Modeling and Simulation (CM&S) aims to achieve the delivery of medical product solutions in a responsible, patient sparing way that balances the desire for certainty in the device performance while limiting the delay in patient access associated with increased certainty through the use of computer modeling and simulation (CM&S) as valid scientific evidence.
- CM&S Steering Committee: The steering committee is working to scope, streamline and advise various projects led by multiple working groups—for example, blood damage modeling for generating regulatory grade data, code verification for software in medical device development, in silico clinical trials, and good simulation practices (GSP).
MDIC’s Cybersecurity program launched in 2018 to identifying cybersecurity priorities for the medical device industry to help ensure the safety and effectiveness of medical devices across the total product lifecycle.
- Cybersecurity Steering Committee: This committee decides on the priorities of the program and assists the MDIC Data Science and Technology Program Director with managing the general course of the current program areas such as Coordinated Vulnerability Disclosure Practices, Threat Modeling, MedTech Cybersecurity Benchmarking as well as on areas of opportunities for
- Medical Device Cybersecurity Benchmarking Working Group: This WG will provide a common method and rubric for the medical technology industry to measure cybersecurity maturity across the industry to drive common improvements that reduce overall cybersecurity It will establish the industry benchmark based on a collection of medical technology companies and stakeholders contributing their MedTech Joint Security Plan (JSP) Maturity Model metrics and share the aggregated data in report format. This will enable individual medical technology companies, HDOs, and other stakeholders to establish long-term strategic plans to increase their cybersecurity maturity and track their progress along the way.
MDIC’s Digital Pathology program is working to prioritize the areas of digital pathology and artificial intelligence where MDIC can bring industry, users, government, insurance companies, and patients together to collaborate on several new projects.
- Digital Pathology Steering Committee: This committee decides on the priorities of the program and assists the MDIC CDx and Data Science and Technology Program Directors with managing the general course of the program operations and areas of opportunities for growth.
- The Pathology Innovation Collaborative Community (PIcc): This group is not a standard working group, but a collaborative community focused on facilitating innovations in pathology as well as advance safety and effectiveness evaluation and harmonizing approaches to speed delivery to patients using collaborative, pre-competitive approaches. The collaborative community (PIcc) is open to all stakeholders, public or private, including, but not limited to, academia, industry, health care providers, patients, and advocacy groups.
Data Science and Technology
MDIC’s Data Science and Technology Initiative works on advancing 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.
- Data Science & Technology (DST) Advisory Committee: This group is comprised of senior-level SME/executives from MDIC member organizations who are working to gather input, discuss strategic priorities and recommend future direction for MDIC in areas such as Computational modeling & simulation (CM&S), External evidence methods (EEM), Cybersecurity, 5G-enabled health technologies, AI/ML, Cloud technologies, Digital health, and other DST based initiatives relevant to devices and diagnostics community.
- 5G Enabled Healthcare Technologies Working Group: This WG will work on a 5G implementation roadmap specifying open regulatory research questions and knowledge gaps that should be addressed to facilitate the integration of 5G technology in medical devices and accelerate 5G-enabled device availability to patients.
Early Feasibility Studies
MDIC’s Early Feasibility Studies Initiative is working to develop tools and best practices for EFS for sponsors and clinical researchers in order to drive overall EFS efficiency and support the continuous assessment of EFS efficiency and effectiveness for US patients.
- EFS Executive Committee: This committee decides on the priorities of the initiative, oversees the steering committees, and assists the MDIC Clinical Science Program Director with managing the general course of the initial operations and areas of opportunities for growth.
- Cardiovascular Steering Committee: This committee decides on the priorities of the program with regards to the cardiovascular space and assists in keeping the tools updated that have been previously developed in the EFS Initiative.
- Neurovascular Steering Committee: This new committee is working on transferring materials previously made under the EFS Cardiovascular committee to the neurovascular space.
External Evidence Methods
MDIC’s External Evidence Methods (EEM) program is establishing a more predictable pathway for use of EEM, such as new, innovative (Frequentist/Bayesian) methods and the cataloging of existing methods, including computational modeling & simulation (CM&S), for
evidence fusion from data external to a clinical trial.
- External Evidence Methods Steering Committee: This committee comprises of RWE/biostatistics SMEs who decides on the priorities of the program and assists the EEM working groups and MDIC
Data Science and Technology Program Director with managing the general course of the program operations and areas of opportunities for growth.
- Virtual Patient Model Working Group: MDIC championed the development of the Virtual Patient Model for advancing regulatory science for medical devices. The WG now focuses on the expansion of tools and resources available (such as new case studies and mock submissions for demonstrating how to implement this framework in atrial design and IDE submission) for wider adoption of the virtual patient model.
Science of Patient Input
MDIC’s Science of Patient Input (SPI) Initiative works on advancing the science of patient input and improve our ability to include patient perspectives in the development, pre-market approval and post-market evaluation of medical devices.
- Science of Patient Input Steering Committee: This committee decides on the priorities of the program and assists the MDIC Clinical Science Program Director with managing the general course of the program operations and areas of opportunities for growth.
- PI Statistics and Patient-Centered Outcomes Working Group: This WG is developing a Report on the lessons learned from the MDIC Patient-Centered Clinical Trial Design project in Parkinson’s Disease, including guidelines to integrate patient preferences into the statistical design of clinical trials.
- Advance and Promote SPI Working Group: The purpose of this working group is to generate awareness within Industry and support adoption of the work SPI has produced that will help prioritize patient input throughout the medical device lifecycle.
- SPI Digital Health: Exploratory Working Group: The goal of this working group is to research and develop SPI’s portfolio expansion. The working group has both short term and long-term projects identified. The short-term project is to understand how Digital Health tools have been implemented or adopted during COVID-19 with the goal of creating a white paper of “lessons learned” and create digital health “best practices” for the medical device industry using the lens of SPI. The long-term project focuses on understanding the challenges, successes, and opportunities of Digital Health in SPI to help identify the next chapter of SPI.
- SPI Heart Failure Patient Preference Working Group: The objective of this project is to advance the science of regulatory patient preference assessment by giving medical device industry sponsors, regulatory agencies, and preference assessment experts another example of a disease-specific patient preference study. This study builds on the MDIC Patient-Centered Clinical Trial Design project in Parkinson’s Disease by building a coalition of medical device manufacturers, heart failure patients, regulators, and patient preference experts to conduct a preference study across heart failure patients.
Health Economics and Patient Value
MDIC’s Health Economics and Patient Value Initiative is focused on promoting predictability of evidentiary processes, improving pathways for coverage to speed patient access, and ensuring patient perspectives are considered.
- Health Economics and Patient Value Steering Committee: This committee decides on the priorities of the program and assists the MDIC CEO with managing the general course of the program operations and areas of opportunities for growth.
- Patient Preference Research Working Group: This WG is exploring methods to provide a more scientific and rigorous way to incorporate what’s important to patients that will better inform the health care decision-making process. The working group is focusing on CMS first then will explore the broader payer community.
- Real-World Evidence Working Group: This WG is focused on RWE approaches that are scientific and have methodological rigor for use with payers; Payer acceptance and adoption of RWE into coverage and health technology assessment (HTA) evidence standards; and manufacturer awareness of RWE and capacity to develop RWE for coverage, reimbursement, and HTA purposes.
Clinical Science and Medical Officers
The Clinical Science and Medical Officer Forum is a group of senior scientific and medical executives from medical device and diagnostics companies, government, and non-profit organizations, that provides advice to MDIC’s Board on issues regarding clinical and
regulatory science and patient safety to maximize clinical and medical value.