April 4, 2024
Understanding the complexities of successfully navigating the reimbursement and coverage processes to commercialize disruptive medical technologies can often be a complicated endeavor for organizations. MDIC has partnered with leading industry experts to review key components of developing a successful reimbursement strategy in a new series of informational videos. These videos highlight how to achieve commercial product success by securing favorable payer coverage, coding, and payment for new technologies.
The series of videos cover reimbursement and coverage best practices for the following key topics:
Navigating the US Public Payer Reimbursement and Coverage Landscape
Navigating the reimbursement and coverage landscape is critical to the short and long-term commercial success of medical technologies. Securing favorable reimbursement with public payers is often a complex and highly specialized process. Understanding the payer coverage pathway will assist organizations in developing a realistic timeline and planning for success.
Hosted by: Joel Brill, MD, FACP, Chief Medical Officer, Predictive Health
Reimbursement Professionals: Keely Scamperle, FACHE, CPC, CCS-P, CHC and Tamara Rook, MBA
Navigating the US Coding Processes
The reimbursement elements of coding, coverage, payment, and health policy are dynamic and should be considered early and often throughout the product life cycle. The coding process and pathway can often seem complicated but are critical for organizations to understand as a key component of a successful commercialization and adoption strategy. Learn about some of the ins-and-outs of the AMA CPT® and RUC processes as well as stakeholder considerations relative to navigating the process here.
Hosted by: Joel Brill, MD, FACP. Chief Medical Officer, Predictive Health
Reimbursement Professionals: Keely Scamperle, FACHE, CPC, CCS-P, CHC and Tamara Rook, MBA
Developing a Dynamic US Reimbursement and Coverage Strategy
A successful reimbursement and coverage strategy requires ongoing assessment and adjustment to the dynamic environment and its key stakeholder requirements. It also requires an understanding of benefit categories and the role of pricing and fee schedules. Learn from subject matter experts on how to develop a successful market access strategy for new technologies.
Hosted by: Joel Brill, MD, FACP, Chief Medical Officer, Predictive Health, former Payer Medical Director
Reimbursement Professionals: Liesl Oldstone, MBA, PhD, RPh, Mark Domyahn, MBA
April 17, 2023
Senior health care executive moves to advance the role of real-world evidence in medical device ecosystem
April 17, 2023
FOR IMMEDIATE RELEASE
[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.
Contact
Todd West
twest@mdic.org
January 31, 2023
ARLINGTON, Va., January 31, 2022 — The Medical Device Innovation Consortium (MDIC) released the “Landscape Report & Industry Survey on the Use of Computational modeling and Simulation (CM&S) in Medical Device Development”. This new report from MDIC discusses the potential of CM&S to reduce product development costs, speed up time to market, and better serve patients with safe and effective medical devices. Case studies included in this report demonstrate tangible evidence of the value of CM&S to both industry and regulatory bodies such as the US Food and Drug Administration (FDA). The report also discusses current barriers to more widespread adoption and offers recommendations for future actions.
“The use of CM&S, or in silico methods, is well-established and rapidly increasing in the medical product development process, but still lags behind compared to other sectors like aviation or automotive industries. One of the goals for the MDIC CM&S program is to increase confidence in the use of CM&S in regulatory submissions. MDIC aims to generate more discussion on this topic using this report and survey results included in it,” said Jithesh Veetil, Senior Director for Digital & Health Technology portfolio at MDIC.
Featuring insights from experts from industry and regulatory agencies, the report explores the evolution of the use of CM&S in the design and development of medical devices. The report is informed by comparing the results of two surveys that MDIC conducted nearly a decade apart – each of which had input from about 40 small, medium, and large medical device manufacturers, both domestic and international.
“This report validates the broad applicability—and true value—of computational modeling and simulation as a critical engineering discipline. Tangible cost, quality and performance improvements are being realized by the early adopters,” said Randall Schiestl, vice president, Research & Development, Global Technology, Boston Scientific and Chair of MDIC CM&S steering committee. “The report also highlights the need for continued work to increase both design and regulatory use across small, medium and large device developers.” The CM&S steering committee includes representatives from the FDA, National Institute of Health (NIH), and the medical device and diagnostics industry.
Case studies in this report represent areas such as orthopedics, cardiology, and digital twins, among others, and highlight the benefits of applying these methods in medical device design. Combined with the analysis of the MDIC survey results, these examples help organizations justify utilization of computational modeling and simulation in product development.
Steven Levin, Sr. Director, Virtual Human Modeling, Executive Director, Living Heart Project agrees. “The MDIC survey shows the business impact of modeling and simulation is now well established and the FDA is recognized as a strong supporter. The landscape report adds important context and is a call to action for companies holding onto old R&D processes, highlighting MDIC’s important role as we enter the era of digital health.”
In addition to this landscape report on CM&S, MDIC’s CM&S program focuses on topics such as (1) Augmenting clinical trials with virtual patients and external evidence methods to reduce the burden on human subjects; (2) Translational research to bridge the gap between NIH and other publicly funded academic research human models – like blood damaging model, orthopedic models – with the aim to assess the credibility of simulation models for industry contexts of use and develop models with sufficient credibility into a Medical Device Development Tool (MDDT); and (3) Bootcamps specifically focusing on medical device CM&S for device manufacturers and regulatory professionals. 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 MDIC 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.
Contact:
Todd West
twest@mdic.org
202-684-8371
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.
Contact
Todd West
twest@mdic.org
202-684-8371
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.
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Contact
Todd West
twest@mdic.org
202-684-8371
Current as of November 17, 2022
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