April 17, 2023

Senior health care executive moves to advance the role of real-world evidence in medical device ecosystem

April 17, 2023


[Arlington, VA.] – The National Evaluation System for health Technology Coordinating Center (NESTcc), an initiative of the Medical Device Innovation Consortium (MDIC), has named Simon Mason as its new President. In his new role, Mr. Mason will lead strategy and operations for NESTcc to serve its stakeholders, including patients, providers, payers, medical device manufacturers, regulators, and others.

With a thirty-year career spanning roles in executive management as well as product and business development, Mr. Mason joins NESTcc from Pharmaspectra, a business acquired by IQVIA, where he most recently served as Chief Operating Officer. At Pharmaspectra, he led development and commercialization of a data lake of scientific and medical affairs information utilized by pharmaceutical and medical device companies.

“I’m honored to join the great team at NESTcc and work with this unique organization’s network collaborators, partners, customers, and other stakeholders to change the paradigm of clinical research through the appropriate use of real-world evidence,” said Mr. Mason. “Together, we will drive continued innovation for the benefit of patients and all medical device stakeholders.”

NESTcc is focused on advancing the use of medical device real-world evidence (RWE), and Mr. Mason’s experience in building healthcare data businesses positions him strongly to advance NESTcc’s mission. As President, he will lead NESTcc’s continued development of a trusted not-for-profit platform for the timely generation of RWE and its collaborative work on advancing RWE methodologies to address pre- and post-market challenges in the medical technology space.

“We’re thrilled to welcome Simon to NESTcc to build on the organization’s strong foundation and accelerate its development to support medical device innovation,” said Andrew Fish, JD, President & CEO of MDIC. “Simon’s operational and commercialization expertise make him an excellent candidate to lead NESTcc’s work in advancing the use of real-world evidence for the benefit of patients and all medical device stakeholders.”

“Simon is an innovator and accomplished leader in building healthcare data companies, and I’m excited to collaborate with him to guide NESTcc’s strategic priorities and deliver ever greater value for stakeholders across the medical device ecosystem,” said Diane Wurzburger, Chair of the NESTcc Governing Committee and Executive of Regulatory Affairs & Quality for GE Healthcare.

“CDRH congratulates Simon in his new role as the President of NESTcc,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health (CDRH). “We look forward to working with Simon and leveraging his expertise to support our shared goal of advancing medical device safety and innovation.”

NESTcc is delighted to welcome Simon Mason as its new President and looks forward to working with him to continue advancing the use of real-world evidence across the medical device ecosystem.

About the National Evaluation System for health Technology Coordinating Center

In 2016, the U.S. Food and Drug Administration (FDA) awarded the Medical Device Innovation Consortium (MDIC) funding to establish the National Evaluation System for health Technology Coordinating Center (NESTcc). NESTcc is advancing the use of real-world evidence (RWE) in medical devices for regulatory decision-making and committed to transforming the way medical device technologies are tested, approved, and monitored. The Coordinating Center combines RWE system infrastructure with the unparalleled expertise of its network collaborators to accelerate patients’ access to safe and effective medical technology and provide Quality Evidence by Design™. For more information, visit http://www.nestcc.org.

About the Medical Device Innovation Consortium

Founded in 2012, the Medical Device Innovation Consortium (MDIC) is the first public-private partnership created with the sole objective of advancing medical device regulatory science throughout the total product life cycle. MDIC’s mission is to break down barriers in the medical technology life cycle to accelerate innovation and adoption of safe, effective, and high-quality medical technologies. The consortium brings together medical technology manufacturers, researchers, regulators, payers, patients, and health care providers as trusted collaborators to solve complex challenges in the scientific and technical disciplines that propel medical technology development, approval, adoption, and access. MDIC’s work improves regulatory pathways, advances medical device quality, enhances patient safety and access, and facilitates the development of better evidence for approval, coverage, and utilization decisions. For more information, visit http://www.mdic.org.

Funding for NESTcc was made possible, in part, by the Food and Drug Administration through grant (U01 FD 006292). Views expressed in written materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services; nor does any mention of trade names, commercial practices, or organization imply endorsement by the United States Government.


Todd West

March 17, 2023

December 15, 2022

MDIC’s new report surveys the role of 5G connectivity in current and future states of the healthcare continuum of care. The report highlights key challenges and knowledge gaps to help deliver the benefits of 5G in healthcare more safely to patients.


ARLINGTON, Va. – The Medical Device Innovation Consortium (MDIC), has released the Landscape Analysis of 5G in Healthcare report. This report, accompanied by a one-page overview on 5G Security Enhancements, details the role of 5G connectivity in the future state of medical devices utilizing the technology that will contribute to the continuity of care.

The report developed by MDIC’s 5G–Enabled Health Technologies Working Group highlights key challenges and knowledge gaps to deliver the benefits of 5G in healthcare more safely to patients. This report was championed by MDIC 5G Working Group members Dr. Omar Al-Kalaa, PhD, Staff Fellow FDA; Inhel Rekik, MS, CISM, Sr. Director, Product Security, Bracco Medical Technologies; and Mark Wehde, Chair, Mayo Clinic Engineering, Mayo Clinic, with contributions from experts in the sector.

The MDIC 5G–Enabled Health Technologies Working Group is comprised of leading experts from the FDA, United States Department of Veterans Affairs, academia, medical device industry, telecommunications sector, standards development organizations, and chipset and network equipment manufacturers. For this report, they convened to develop a better understanding of how 5G can improve patient safety across the entire continuum of care – from prevention through diagnosis, treatment, post-treatment monitoring, and beyond.

Key topics covered in the report include:

  • 5G-enabled simulation with extended reality (XR)
  • 5G-enabled robotics, remote surgical robots
  • Mobile units, remote care, and telemedicine
  • Supply chain and cost
  • Network coverage
  • Ongoing QoS monitoring
  • Communication Key Performance Indicators (KPIs)
  • Lack of evaluation methods for device functions enabled by 5G
  • Roles, responsibilities and service level agreements
  • Electromagnetic environment and wireless coexistence
  • 5G cybersecurity and privacy considerations.

“MDIC convened over 150 global subject matter experts from various stakeholder groups to establish the common understandings of the technical and operational requirements for
5G-enabled devices, which in turn contribute to the safety and effectiveness of the device as well as accelerating patient access to this technology,” said Jithesh Veetil, PhD, Senior Program Director, Digital Health & Technology, MDIC.

Advances in wireless technologies can contribute to continued technical advancements in healthcare delivery.  In this rapidly evolving environment, technology moves quickly, especially with a healthcare model moving to more remote, virtual care of patients. 5G plays a significant role in this care evolution.

“It was a truly rewarding experience to work with subject matter experts from around the globe through MDIC on the 5G landscape analysis.  5G technology will enable advanced home healthcare as well as allow hospitals including those in rural areas to provide cutting edge procedures and therefore narrowing health disparities among less favored communities while allowing them access to their highest level of care,” said Inhel Rekik.

“5G in healthcare advancements are accelerating device innovation and will allow us to treat, diagnose, and track patient health anywhere the patient is. Health management solutions that aren’t tied to a physical location such as a hospital, clinic, or home will fundamentally change how we provide healthcare, who provides healthcare, and most importantly, it will democratize who has access to healthcare. The two publications from MDIC will be excellent resources for anyone interested to learn more about 5G in healthcare,” said Mark Wehde.

In addition to Landscape Analysis of 5G in Healthcare and MDIC 5G Working Group released “5G Communication in Healthcare: Background, Landscape, and Use Cases Webinar” in August 2022.  A collection of MDIC resources across the total product lifecycle of medical devices that highlights the dynamic and evolving technology advancements in healthcare is available in the online Resource Library.


About MDIC

The Medical Device Innovation Consortium (MDIC) is a public-private partnership that brings together representatives of the FDA, NIH, CMS, NIST, and other agencies, industry, non-profits, and patient advocacy organizations to improve the processes for development, assessment, and review of new medical technologies.

MDIC coordinates the development of methods, tools, and resources used in managing the total product life cycle of a medical device to improve patient access to cutting-edge medical technology.

We are driving faster, safer, and more cost-effective innovation for patient benefit.



Todd West

December 6, 2022

ARLINGTON, VA (BUSINESS WIRE)—The Health Economics and Patient Value (HEPV) initiative at the Medical Device Innovation Consortium (MDIC) has released the white paper, How Can Patient Preference Information Be Used in Payer Coverage Decisions and Health Technology Assessment?

As patients become more engaged with their care, healthcare stakeholders want to understand how to better incorporate patients’ wants and needs into their own processes. In the development of this technical paper, MDIC set out to understand how to incorporate patient preference information (PPI) in coverage decision making by payers and health technology assessment (HTA) organizations. It is the first MDIC resource focused specifically on awareness of patient preference and methods as a tool for payers and the medical device industry.

This MDIC initiative seeks to encourage the use of patient preference information by clarifying the standards and role of generating this data and presenting it in a more consistent, systematic format. “This report can serve as a resource for payers and health technology assessment organizations’ decision-making process. This is especially true for patients with diseases associated with shortened lifespans, high-cost impact, serious complications, and those with unmet medical needs,” said Harry Kotlarz, Assistant Vice President of Health Economics and Patient Value at MDIC.

MDIC sponsored a series of interviews with representatives from seven organizations including the Centers for Medicare and Medicaid Services (CMS), commercial payers, integrated delivery networks, and health technology assessment organizations. A Working Group comprised of 18 members from the medical device industry, patient organizations, and regulatory agencies provided input for the interview questions.

“This report confirms that payers want to hear a diverse and representative patient perspective. Quantitative analyses of patients’ preferences, when done right, can fill an important evidence gap for payers.” Barry Liden, Director of Public Policy at USC Schaeffer Center, and former Working Group leader.

The report highlighted how patient preferences and conventional clinical outcomes assessment must be integrated to provide robust means of evaluating what will be more acceptable to patients and increase the likelihood of favorable outcomes. This white paper helps guide firms to benchmark, select, and structure a roadmap aligned with their company’s business and technical priorities.

About MDIC
The Medical Device Innovation Consortium (MDIC) is a public-private partnership that brings together representatives of the FDA, NIH, CMS, NIST, and other agencies, industry, non-profits, and patient advocacy organizations to improve the processes for development, assessment, and review of new medical technologies.

MDIC coordinates the development of methods, tools, and resources used in managing the total product life cycle of a medical device to improve patient access to cutting-edge medical technology.

We are driving faster, safer, and more cost-effective innovation for patient benefit.


Todd West

August 30, 2022

The CfQ Program is a dynamic collaborative exchange and engagement of diverse experiences and professional insights in advancing innovation to the forefront of patient safety and accessibility. Below are some examples of current work groups moving the dial forward in that quest.  

Volunteer Improvement Program (VIP) 

The CfQ VIP Program involves working groups engaged in strategic adoption and sustaining initiatives for exploring potential regulatory flexibilities that provide incentives for industry participation, enable quality improvement, and streamline processes. These working groups also ideate possible new regulatory flexibilities that encourage expanded VIP adoption, while providing least burdensome oversight that maintains FDA regulatory standards for safe and effective products while affording continual quality improvement. 

Leadership Engagement 

 The Leadership Engagement program was developed to understand the impact of leadership engagement on company performance and the quality and safety of its products. While the focus of the program is to advance the medical device industry, the principles apply to all industries.  

During the June CfQ the Leadership Engagement team presented the benchmarking quality metrics survey results conducted earlier this summer which was open to companies representing all industries with a goal to:  

  • Determine the level of use of metrics in managing businesses 
  • Identify companies’ objective for using metrics 
  • Understand the effectiveness of the metrics 
  • Understand what metrics are being used
  • Benchmark and analyze the most effective use of metrics 

Please feel free to reach out to cfqcc@mdic.org if you are interested in volunteering for these workgroups or would like information on some of the numerous projects within the CfQ Program. 


August 23, 2022

August 8, 2022

Congratulations to Jithesh Veetil, PhD, awarded The CDRH Regulatory Science Excellence Award for for the External Evidence Methods (EEM) Framework Project. MDIC EEM Framework is a document intended to help stakeholders navigate their way through the nuts and bolts of leveraging external data. Informed by a number of public forums and a survey of medical device manufacturers, the document catalogs different sources of external data and some of the traditional and novel statistical methods (Frequentist and Bayesian) applicable to the design and analysis of a clinical study in which external data play a role. Join Dr. Veetil at the JSM 2022 Conference for “Advancing Regulatory Science for Medical Devices and Medical Software Through Collaboration”, August 10, 2022 at 10:30 AM.

Learn more

August 8, 2022

Stakeholders seek tweaks to FDA’s voluntary improvement program guidance

Regulatory NewsRegulatory News
| 08 July 2022 | By Jeff Craven 3044 The US Food and Drug Administration (FDA) has received comments on its draft guidance on engaging with the Voluntary Improvement Program (VIP) through the Medical Device Innovation Consortium (MDIC), and device companies want to know more about how manufacturers can benefit from participating as well as how the program fits into existing regulatory programs.

FDA’s participation in the VIP means device manufacturers can be assessed by third party appraisers that provide feedback on strengths and areas for improvement as measured by a modified version of the best practices in the Information Systems Audit and Control Association (ISACA) Capability Maturity Model Integration (CMMI) system for the medical device industry across 11 practice areas. Data can then be de-identified and shared with FDA following an appraisal. (RELATED: FDA drafts guidance on medical device voluntary improvement program, Regulatory Focus 9 May 2022)

Site visits and analyses under the VIP are not regulatory inspections or audits, the agency said in the draft guidance, and the appraisers don’t collect evidence of regulatory findings or provide regulatory observations, including a rating or certification.

“Participating manufacturing sites who demonstrate sustained capability and performance, or improvements in the appraisal results, may benefit from several opportunities that the VIP offers, following FDA’s review of the site’s appraisal,” the agency wrote in the draft guidance.

The VIP is a permanent version of the Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program, which FDA launched with MDIC in 2018 and was well received by a majority of participants in the pilot. (RELATED: FDA Details New Manufacturing Quality Pilot Program, Regulatory Focus 15 January 2018)

In their comments to the FDA, medical device company Medtronic proposed changing the wording in the description of the Medical Device Discovery Appraisal Program (MDDAP) to include “Governance, Implementation Infrastructure and Managing Performance and Measurement” rather than FDA’s proposed practice areas of “Estimating, Planning, and Configuration Management” because the former are three core practice areas, while the latter “may or may not be included in future appraisals.”

Medtronic also suggested FDA change how it describes the ISACA CMMI “to include that firms are encouraged to identify an appraisal scope that applies CMMI best practices to proactively identify opportunities for continuous improvement.”

“We recommend VIP continues the focus on proactive identification of opportunities for improvement. Focusing on an increasing score year over year, could disincentivize firms who, today, are encouraging transparency during appraisals, and who are continuously looking at new areas to find additional opportunities for improvement,” they wrote. “This active search for improvement opportunities could temporarily result in a dip in scores.”

The device manufacturer suggested that a copy of any de-identified, aggregate information sent to the FDA should also be sent to the participating site. Medtronic recommended FDA make it clear that the appraisers don’t retain objective evidence collected during the site visit and remove terms like “rich dataset” that might imply quantitative data are being collected.

MDIC’s VIP Expansion Working Group
The working group responsible for modifying MDIC’s VIP Reappraisal Guidelines also provided a comment to FDA and suggested changes to align with the goals of the working group. They noted the “intent of the program is to shift from a compliance mindset and towards continuous improvement.”

To that end, they suggested adding language to the draft guidance that would allow manufacturers to participate in alternate engagement activities such as focused scope appraisal, continuous improvement event, or a capability benchmark appraisal instead of a standard appraisal when appropriate.

“The intent of this objective is to maintain the requirement for all sites to regularly engage with the program while balancing a core program feature allowing flexibility for individual participant need,” they wrote.

Becton Dickinson
Medical technology company Becton Dickinson asked FDA in their comment to clarify how the program affects surveillance inspections and pre-market inspections.

“The guidance explains how participating in VIP can offer ‘risk-based inspection planning’ and potentially reduce the cadence of inspection. However, it is unclear specifically how it could potentially spare a manufacturer from a surveillance and/or premarket inspection,” they wrote. “Removing the need for surveillance and/or premarket inspections could be major incentives of participating in VIP, thus, how these inspection types are specifically impacted by VIP participation should be explained.”

W. L. Gore & Associates
Manufacturing company W. L. Gore & Associates used their comment to FDA to ask for clarity on what the agency expects in terms of “sustained capability and performance” and whether a manufacturer needs to achieve a certain maturity level to qualify for risk-based inspection planning.

Gore also requested that Office of Health Technology (OHT) officers within CDRH’s Office of Product Evaluation and Quality (OPEQ) receive training on the VIP program and features, particularly the 30-Day Change Notice submission template. They cited their experience with inconsistencies in the program.

“For example, one OHT reviewer would not accept the template during the Pilot Program because the submission included biocompatibility data. They asked that the manufacturer instead submit as a ‘traditional 30-day Notice.’ Another OHT reviewer accepted the format under the program for a similar change,” they wrote.

Boston Scientific
Medical device manufacturer Boston Scientific provided a brief comment to FDA about the VIP, asking the agency to “avoid specifying that appraisals be required annually, but instead at least leave it open to possibility that the frequency be tailored as companies/sites remain active in the program year-on-year.”

Bringing Real-world Insight for Device Governance and Evaluation (BRIDGE) Coalition
The BRIDGE Coalition emphasized in their comment that the permanent program should be as flexible and responsive as the pilot program. “We support quality measures and believe VIP can prove to be beneficial for some products and manufacturers,” they wrote.

However, they questioned how the program would apply to participants with multiple sites. “The program, as currently structured, works well for small entities with one facility, or large manufacturers who only designate one or two sites for certification. The biggest gain for large manufacturers with multiple sites would be an enterprise program that could simultaneously cover more than one designated site,” they said.

The coalition also expressed concerns about third-party auditors. “It must be clear that this program exists outside of MDIC. Stated differently, participation in this program must be permitted outside of any specific third party. The benefits should be applicable to assessments done outside of the MDIC system,” they said. “Likewise, FDA should be open to assessments system similar to CMMI. FDA should not endorse one entity or one system for the VIP program.”

They also raised concerns about legal liability for products in the program, and the discoverability of information within the program in litigation. They suggested protections be built into the program that state submissions are not admissions of liability as well as limiting discovery of information from the program in third-party litigation. “Including similar protections in this pilot program will encourage participation and avoid disadvantaging companies that do partake in the pilot,” the group said.

The Coalition also suggested a “re-scoping” of the program to include pre-market incentives for 510(k) manufacturers in addition to pre-market approval (PMA) devices. “This program will have limited effect if it is limited to PMA devices. In many ways, this program may better fit into the Class II/special controls approach. We believe that FDA should seek public input on including Class II/special control in this program,” they wrote.

Draft guidance

© 2022 Regulatory Affairs Professionals Society.

This story was originally published by RAPS.