Collaborative Communities: An Opportunity To Contribute To Medical Device Industry Improvements

By Adam Atherton, PE, RAC, independent consultant

Collaborative communities are a global grassroots effort convened by interested public and private stakeholders who work to solve shared challenges and achieve common goals related to medical devices. Collaborative communities do not replace established regulatory mechanisms, are not federal advisory committees, and are not chaired or convened by the FDA, but FDA may participate. Additional information on collaborative communities is here.

The FDA is motivated to participate because collaborative communities are included in FDA’s strategic goals, and participation may help advance the agency’s goals of ensuring that patients in the U.S. ultimately have access to high-quality, safe, and effective medical devices. The FDA’s Center for Devices and Radiological Health (CDRH) currently participates as a member of 12 different collaborative communities, but it does not establish, manage, or control the collaborative communities. Collaborative communities can exist without FDA participation.

As a collaborative community is established, it is encouraged to cast a broad net across industry sectors to ensure a diverse perspective from potential members. Members of collaborative communities may be selected from:

• Patients or care-partner organizations
• Hospitals/hospital systems
• Public-private partnerships
• Trace associations
• Technology manufacturers
• Medical device distributors
• Professional societies/associations/organizations
• Payers
• Research institutions
• Academic institutions
• Other state and federal agencies
• International organizations
• Foundations and other non-profits

Here are the descriptions, goals, and contact information for each of the 12 collaborative communities that have FDA CDRH participation.

Collaborative Community on Ophthalmic Imaging (CCOI)

Founded: March 2019. FDA joined in September 2019.

Mission: Clarify challenges, best practices, strategies, and standards while advancing innovation in the ophthalmic imaging space.

Goal: Develop solutions to refine the diagnosis, management, and treatment of patients with eye diseases, along with other medical conditions.

Meetings: The latest conference was held in September 2020. The topic was The Future Of Artificial Intelligence-Enabled Ophthalmic Interpretation: Accelerating Innovation and Implementation Pathways. The recorded conference can be found here. The next CCOI virtual conference will be held Jan. 28, 2022.

How You Can Get Involved: Byers Eye Institute in Palo Alto, CA

National Evaluation System for health Technology Center (NEST)

Founded: July 2017. FDA joined in September 2019.

Mission: The NEST community is passionately committed to transforming the way medical device technologies are tested, approved, and monitored. 

Goals: (1) Coalesce diverse medical device stakeholders around initiatives that further the utilization and beneficial impact of real-world evidence (RWE) to find common paths forward on tough and broad questions and present leadership and consensus-driven guidance to the community. (2) Provide a forum for stakeholders to work proactively to speed innovation and enhance the safety and effectiveness of medical devices and health technology.

Meetings: The latest conference was held in October 2020. The topic was NEST Collaborative Community Unique Device Identifier (UDI) Initiative. The recorded conference can be found here. The next NESTcc meeting will be held on Nov. 18, 2021, and the topic is device identification and real-world data. Meetings are held semi-annually; sub-groups meet on an ad-hoc basis.

How You Can Get Involved: NESTcc in Arlington, VA. There are several open calls for people to join NEST. Additional information on NESTcc is here starting at minute 10. NESTcc is seeking medical device ecosystem experts for its Data Quality Subcommittee to update the Data Quality Framework; see https://nestcc.org/explore-open-calls/#toggle-id-1

Standardizing Laboratory Practices in Pharmacogenomics (STRIPE)

Founded: 2020. FDA joined in August 2020.

Mission: Accelerate the development of personalized medicine practices as a standard of care by uniting patients, providers, industry, regulators, payers, and other key stakeholders.

Goal: Harmonize and optimize standards practices and resources related to pharmacogenetics testing that will improve access to safe, accurate, and reliable information about a patient’s medication and drug-gene interactions and reduce adverse drug events.

Meetings: The latest conference was held in November 2020. STRIPE participated in Precision Medicine Leaders Summit, PMLS 2020. STRIPE began a short series of monthly webinars in September 2021 titled Partners in Precision Medicine, How to find a laboratory of excellence. Registration is free.

How You Can Get Involved: STRIPE is an initiative of the American Society of Pharmacovigilance (ASP) in Houston, TX. Registration for STRIPE is open and is here: https://twitter.com/cc_pgx

International Liquid Biopsy Standardization Alliance (ILSA)

Founded: June 2020. FDA joined in August 2020. FDA has been at all ILSA CC quarterly meetings.

Mission: ILSA brings together complementary efforts around liquid biopsy standardization, focused on circulating tumor DNA (ctDNA), to promote its use as a broadly functional biomarker in cancer. These efforts aim to provide guidance on the development of universally recognized reference samples and best practices, which will increase assurance that assay testing is executed appropriately and provide harmonized and accurate results.

Goal: Help harmonize the many disparate efforts that strive toward progress in achieving full clinical utility of liquid biopsy in the many contexts of use in which it is applicable. Progress in achieving harmonization of the field will be evaluated periodically by the group to assess effectiveness and additional needed efforts.

Eventually, ILSA would like to identify and develop a uniform end-to-end process from pre-analytic capture through technology and assay validation to clinical collection and analysis. The group would then hope to promote the use of this process to allow for standardized data capture for liquid biopsy to build the necessary level of evidence required to have multiple contexts of use qualified by regulatory agencies for clinical implementation.

Meetings: ILSA CC meets quarterly. Members are sent a link after joining the group.

How You Can Get Involved: Send an email of interest to Dana Connors at dconnors@fnih.org.

Xavier Artificial Intelligence (AI) World Consortium

Founded: FDA named Xavier a partner in AI in November 2020. This partnership included involvement in this collaborative community.

Mission: Inspire collaboration, lead innovation, and make a difference in all it does. Xavier Health Community is composed of FDA and industry leaders from pharmaceutical, medical device, and combination products industries.

Goal: Accelerate innovation through the use of AI and digital health advancements in healthcare.

Meetings: Summit workshops – Virtual sprints are scheduled for Nov. 4 and 5, 2021. Main Summit Sessions – Virtual sprints are scheduled for Nov. 9, 10, and 12, 2021.

How You Can Get Involved: Register at https://www.xavierhealth.org/ai-summit-registration

Case for Quality Collaborative Community (CfQcc)

Founded: FDA launched Case for Quality in 2011 to elevate the focus of all medical device stakeholders that advance medical device quality and safety to achieve better patient outcomes. In 2014, FDA enlisted the Medical Device Innovation Consortium (MDIC) to foster a new level of collaboration between FDA and the medical device industry in a far-reaching CfQ movement. FDA announced participation in MDIC’s CfQcc in October 2020.

Mission: Enhance medical device quality and patient safety.

Goals: Develop practices, tools, and metrics to promote product quality, from product design and manufacturing to product performance and support regulatory practices that promote these goals.

Meetings: Slides from the online Aug. 1, 2021, CfQcc meeting are here. This is a status update slide deck. Another presentation providing an update on three MDIC involved collaborative communities is here.

How You Can Get Involved: Fill out form at https://app.smartsheet.com/b/form/71049d08824e49e8ab750b06acd236c4

Heart Valve Collaboratory (HVC)

Founded: HVC was established in April 2020. FDA announced involvement in HVC in February 2021.

Mission: Create a dynamic, interactive collaborative community of stakeholders under a single umbrella for the purpose of catalyzing clinical research, advancing regulatory science, addressing gaps, and creating meaningful advances in our understanding of valvular heart disease.

Goal: Catalyze innovation in device development and revitalize clinical research to rapidly address the many knowledge and evidence gaps in valvular heart disease.

Meetings: Slides from Cardiovascular Pandemic Task Force: Webinar on Cardiovascular Research During the COVID-19 Pandemic held Aug. 20-21, 2020, are here. HVC hosts quarterly think tanks covering various topics. Videos of past meetings are here.

How You Can Get Involved: Send a note of interest to https://heartvalvecollaboratory.org/hvc/contact-us

Wound Care Collaborative Community (WCCC)

Founded: WCCC was one of the original five collaborative communities. The FDA became involved with WCCC during the summer of 2020. The WCCC was officially formed as a 501(c)3 nonprofit in February 2021.

Mission: Assure that patients and healthcare professionals have access to safe, effective, and high-quality medical device and drugs to treat chronic wounds.

Goal: Accelerate the development of science-based patient-centered solutions and address public policy challenges related to assuring patients receive early access to innovative treatment options.

Meetings: Charter Member, Work Group, Steering Committee, and Board Member meetings occur every 6-8 weeks. Meetings are presently closed.

How You Can Get Involved: Contact WCCC at info@woundcarecc.org or 312-201-6771 for additional information.

Pathology Innovation Collaborative Community (PICC)

Founded: PICC is a newly formed collaborative community. FDA announced its participation in PICC in January 2021.

Mission: Accelerate the development and delivery of regulatory science initiatives in the precompetitive space that modernize the clinical practice of pathology.

Goals: Unlock the potential of digital pathology using regulatory science approaches to help as many patients as possible, train and educate each other in an interdisciplinary fashion with a focus on precompetitive regulatory science, and create an environment that motivates and encourages all stakeholders to move the field of pathology forward.

Meetings: All meetings are open to the public. There is at least one annual meeting. Additional information on PICC is here starting at minute 30.

How You Can Get Involved: Membership is open. Fill out the form at https://mdic.org/program/picc/

RESCUE (REducing SuiCide Rates Amongst IndividUals with DiabEtes) Collaborative Community

Founded: FDA has been involved with RESCUE since it was formed in early 2021.

Mission: Reduce rates of intended self-injury (ISI) and suicidal acts by people with diabetes through improved understanding of the risk factors and implementing strategies to address them.

Goal: Goals are tied to each of four work packages. Goals include conducting surveys, improving coding in electronic health records, developing assessment tools, and developing screening tools.

Meetings: On Nov. 11, 2021, the results of a survey of healthcare professionals’ perspectives on depression and suicide among people with diabetes will be presented. Register here. More info is here.

How You Can Get Involved: Send a note of interest here.

MedTech Color Collaborative Community

Founded: MedTech Color CC was founded in May 2021. FDA has been involved since its founding.

Mission: Create a forum where medtech professionals and other stakeholders can address minority health issues in medical device product development and clinical research.

Goals: Increase clinical trial enrollment participation to represent diverse patient populations served. Create awareness of different disease states, prevalence rates in people of color, and symptom recognition among minority populations. Develop solutions to recruit and retain minority physicians, researchers, and other stakeholders in research and product development. Identify unmet needs and advance research on health issues unique to minorities.

Meetings: A MedTech Color CC webinar on learning how to engage patients and communities of color in clinical research is scheduled for Nov. 9, 2021. Register here.

How You Can Get Involved: Fill out form here.

Digital Health Measurement Collaborative Community (DATAcc)

Founded: DATAcc was founded in May 2021. FDA has been involved since its founding.

Mission: Hosted by Digital Medicine Society (diMe), DATAcc will use interdisciplinary expertise, data, and use cases to develop and demonstrate best practices and advance harmonized approaches to speed the use of digital health measurement to improve health outcomes, health economics, and health equity.

Goal: Convene the many stakeholders necessary to establish and implement a shared vision of high-quality digital health measurement such that it is equally accessible to and effective for every person.

Meetings: Recent meeting minutes are here. The most recent Steering Committee meeting was held on Oct. 26, 2021.

How You Can Get Involved: Fill out the form here.

About The Author:

Adam Atherton, PE, RAC, is an independent consultant to medical device and combination product manufacturers. He develops strategies to address technical feasibility, new product development, remediation, regulatory, clinical, manufacturing, and post-market surveillance for Fortune 200 medical device and pharmaceutical companies as well as startup ventures. He manages key aspects of design control, risk management, product architecture, and quality systems. He graduated from Naval Postgraduate School with his MSEE degree and from California State University, Fresno with his BSEE degree. He can be reached at www.keb-llc.com or info@keb-llc.com.