Challenges and Barriers to the Adoption of Advanced Manufacturing in MedTech

MDIC Studio Panel: Challenges to Adopting Advanced Manufacturing in MedTech

Join industry leaders Domhnall Caroll, CEO of Digital Manufacturing Ireland, Garth Conrad, Vice President of Quality at Flex Health Solutions, Daniel Matlis, CEO and Founder of Axendia, and Francisco Vicenty, Case for Quality Program Manager at the FDA CDRH in a compelling discussion on the adoption of advanced manufacturing in the medical device field. Discover how companies are tackling barriers such as ROI and internal expertise, common fears and misconceptions industry has on advanced manufacturing, and how regulatory agencies are evolving their approach. Watch the panel and discover how participating in the Advanced Manufacturing Clearing House can improve overall quality and product safety.

The purpose of Advanced Manufacturing Clearing House is to encourage Medical Device Industry to adopt advanced technology across the total product life cycle. Objectives include improving design, supply, production, distribution, tracking, device reliability, overall quality, and safety across the product life cycle. Examples of advanced technologies include but not limited to additive and generative part design, digital twins, and digital threads (e.g., modeling and simulation for virtual design verification, validation and design transfer), and data-driven closed-loop quality.

Application open now for AMCH project funding!
Learn more or reach out to us at AMCH@MDIC.org

Cover Image Provided Courtesy of FLEX Health Solutions

 

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AMCH: Advancing Manufacturing Through Changing Perceptions

An Invitation to Join the Advanced Manufacturing Clearing House Evolution

Are you ready to share your story of digital transformation? Join Joe Sapiente, Vice President of Clinical Science and Technology at MDIC, and Fransisco Vicenty, Program Manager for Case for Quality at the FDA, as they discuss the evolution of the Advanced Manufacturing Clearing House initiative at MDIC.

Watch the Interview: Advancing Manufacturing Through Changing Perceptions

The purpose of Advanced Manufacturing Clearing House is to encourage Medical Device Industry to adopt advanced technology across the total product life cycle. Objectives include improving design, supply, production, distribution, tracking, device reliability, overall quality, and safety across the product life cycle. Examples of advanced technologies include but not limited to additive and generative part design, digital twins, and digital threads (e.g., modeling and simulation for virtual design verification, validation and design transfer), and data-driven closed-loop quality.

Application open now for AMCH project funding!
Learn more or reach out to us at AMCH@MDIC.org

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Video Series: Navigating the US Public Payer Reimbursement Landscape

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

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Medical Device Innovation Consortium Selects Simon Mason to Lead National Evaluation System for health Technology Coordinating Center

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

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Use of Bayesian Decision Analysis to Maximize Value in Patient- Centered Randomized Clinical Trials in Parkinson’s Disease Released

March 17, 2023

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MDIC Releases Landscape Report on Medical Device Computational Modeling and Simulation

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

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