MDICx Series

MDICx Series2MDIC presents an informative series of online teleconference workshops featuring emerging trends in medical technology regulatory science, MDIC projects and subject matter experts sharing perspectives, progress and opportunities.

Click on the + to read program details. Scroll below for past MDICx recordings.

 


MDICx: Draft Framework for Surrogate Sample Use in Clinical Diagnostic Test Development and Product Submission – from the MDIC Clinical Diagnostics Surrogate Samples Working Group: Public comment period open April 5 through June 30

Wednesday, April 5, 12:00 p.m. Eastern / 11:00 a.m. Central / 9 a.m. Pacific

Register here

The speed at which innovative and improved diagnostics are developed can be hampered by the difficulty in obtaining or retaining clinical specimens. This may be due to a variety of reasons, such as rare markers, specimens with markers at the high or low end of the range, specimen stability, the difficulty in obtaining certain specimens due to clinical practice, or patient care takes precedence over the ability to collect specimens under defined conditions. The use of surrogate or simulated samples can foster innovation when clinical specimens are difficult to obtain or retain.

 The goal of this MDIC Clinical Dx initiative is to establish a foundation under which the use of surrogate samples can support product development with an initial focus on studies to support product submissions.

The Surrogate Samples Work Group will present its draft framework describing how surrogate samples may be used to simulate clinical specimens to conduct validation studies during the development of in vitro diagnostic tests. The draft is open for public comment through June 30, 2017. The scope of the document will cover in vitro diagnostic validation studies. The Framework defines surrogate sample, promotes the use and adoption of common terminology and describes a hierarchy to aid in surrogate sample selection.

Key topics include:

  • Why surrogate samples are used
  • Factors to consider when using surrogate samples
  • Surrogate sample use in diagnostic validations by study type

Speakers:

  • Suzanne B. Schwartz, MD, MBA, Associate Director for Science and Strategic Partnerships, Office of Center Director, FDA | CDRH | OCD
  • Alberto Gutierrez, PhD, Director of Office of In Vitro Diagnostics and Radiological Health, FDA | CDRH | OIR
  • April Veoukas, JD, Director of Regulatory, Abbott | MDIC, Working Group Chair

Register here

Register here


MDICx – Quality Metrics: Best Practices, Cases Examples and How Metrics Factor into the Case for Quality

Thursday, April 6, 12:00 p.m. Eastern / 11:00 a.m. Central / 9 a.m. Pacific

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The Case for Quality continues to be a strategic priority for CDRH. One of the key questions continues to be how to measure quality. In this webinar, key contributors to the MDIC Case for Quality will discuss quality metrics and how those metrics can be used to assess sustained performance.

Topics include:

  • FDA 2017 – 2018 action plans regarding the Case for Quality
  • How to use the MDIC quality metrics in a meaningful way throughout the Total Product Lifecycle
  • A case example of a company’s experience implementing quality metrics and lessons learned – from early phase development forward.
  • How quality metrics inform other components of the Case for Quality initiative, including Maturity Assessments and Outcome Analytics

Speakers

  • Francisco Vicenty, Program Manager – Case for Quality (Acting), US Food and Drug Administration, Center for Devices and Radiological Health
  • Beth Staub, Group Compliance Officer, Global Quality and Operations, Stryker; Board Champion, MDIC Case for Quality
  • Marla Philips, PhD, Director, Xavier Health, Xavier University

In addition to the April 6 webinar, you can learn more about MDIC’s quality metrics work at the Case for Quality Metrics Workshop May 2 at Xavier University. Details at http://xavierhealth.org/caseforqualitymetricsworkshop/

Register here

Register here


MDICx – Leveraging Existing Information for Future Studies: The Case for Bayesian Methods

Monday, April 17, 9:00 a.m. Eastern / 8:00 a.m. Central / 6 a.m. Pacific

Register here

Medical device clinical trial growth in both size and complexity are well-documented burdens to clinical research conduct, regulatory review, and ultimately access to new medical technologies. The Medical Device Innovation Consortium (MDIC), a non-profit public-private partnership created to advance medical device regulatory science, has proposed a pathway to support industry and regulatory agencies in the transformation towards greater efficiency of clinical trials driven by innovation in design, operations, and the regulatory process.  Leveraging FDA guidance for the use of Bayesian statistics in medical device clinical trials, MDIC has created a statistical model which augments prospective clinical trial enrollment with virtual patients.  The model creates potential for smaller, faster and more cost-efficient clinical trials.  Incorporation of prior knowledge in clinical trial design benefits patients by reducing burden; decreasing study size and trial length; and maintains scientific rigor.  Shifting clinical trial culture to more efficient and effective practices improves innovative technology access for providers and patients alike.

Topics include:

What is Beyond Poolability? Exchangeability:  Roseann White; Director Pragmatic Clinical Trial Statistics – Duke Clinical Research Institute

The Use of Prior Data in a Clinical Trial; FDA Perspectives:  Laura Thompson, PhD; Statistician – Division of Biostatistics, Center for Devices and Radiological Health, Food and Drug Administration

Introduction to MDIC Virtual Patient Projects:  Dawn Bardot, PhD; Vice President, Technology Innovation – Medical Device Innovation Consortium

Retrospective Industry Examples Assuming Exchangeability:

  • Tarek Haddad; Sr. Principal Statistician – Medtronic
  • Tyson Rogers; Principal Medical Research Biostatistician at NAMSA

Lessons Learned from the MDIC Mock SubmissionRajesh Nair, PhD; Team Lead Therapeutic Statistics Branch II, Division of Biostatistics, Center for Devices and Radiological Health, Food and Drug Administration

Presenting Bayesian Design to an Advisory PanelChris Mullin; 3D Communications

 

Register here

 Register here


 

Past MDICx Series Events

March 23, 2017 – Survey of Surrogate Sample Use in Clinical Diagnostic Test Development and Product Submission – Report from the MDIC Clinical Diagnostics Surrogate Samples Working Group
The goal of this MDIC Clinical Dx initiative is to establish a foundation under which the use of surrogate samples can support product development with an initial focus on studies to support product submissions. One of the deliverables is to deliver an analysis of the use of surrogate samples to clearly understand and document under what circumstances such samples might be needed to verify or validate the safety and effectiveness of an IVD medical device. This included a survey of individuals that use or develop surrogate samples and analysis of publicly available IVD submission data via FDA’s Premarket Notification and Premarket Approval databases (e.g., 510(k) summaries, SSEs).

 

March 23, 2017 – Clinical Diagnostic Surrogate Sample Survey Report

 

February 14, 2017 – Making the Business Case for Quality – Reports from the MDIC Case for Quality Competencies Working group
The Case for Quality has been an FDA priority since 2011 with a goal to elevate 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. The Value of Quality was identified as a key component in driving executive understanding and building the business case for quality improvement. Speakers Pat Shafer and Pat Baird present this webinar on the Value of Quality whitepaper, a Cost of Poor Quality dashboard and a whitepaper on Management Review Guidance.
MDICx Making the Business Case for Quality

 

August 10, 2016 – Clinical Trial Quality by Design: Factors Critical to Quality
In 2015, the Clinical Trials Transformation Initiative’s Quality by Design Project published their CTTI Quality by Design Project intended to “support proactive, cross-functional discussions and decision making at the time of trial development.” In addition to CTTI’s comprehensive set of recommendations, the MDIC Clinical Trial Design working group has created with some additional considerations for quality and efficient medical device clinical trials. This joint webinar provided an overview of both groups’ effort to promote clinical trial quality by design.
MDICx August 16, 2016 – Clinical Trial Quality By Design

May 10, 2016 – The Case for Quality Open Forum
The Case for Quality Open Forum welcomed the device industry, FDA, and healthcare providers to hear how our Case for Quality Working groups are driving predictable medical device metrics, maturity model analysis of quality systems and competency and product quality outcomes analytics for hospital value analysis teams. Our goal is to drive the medical technology community to focus beyond compliance to the drivers of product quality.
MDICx Series: Case for Quality Open Forum 5/10/2016

March 15, 2016 – Practical considerations for measuring and integrating patient preference information into your regulatory submission
MDIC Patient Centered Benefit-Risk Steering Committee members Bennett Levitan, John Bridges, and Brett Hauber discuss the practical implications of the MDIC Patient Preference Framework and the CDRH draft guidance on patient preference as well as case studies of patient preference studies and the impact of those studies on product development.
March 15 MDICx Practical considerations for measuring and integrating patient preference information

 

February 23, 2016 – The Emerging Case for Medical Device Interoperability Toward a Future of Patient Centered Care
MDIC invites FDA Associate Center Director for Digital Health, Bakul Patel, to present the agency’s current thinking on interoperability. Intersections with health care provider interests and device applications are presented by Julian M. Goldman, MD and Ed Cantwell. On January 26, 2016, FDA released draft guidance on medical device interoperability, and many medical device companies are considering how and why they might design their products to meet interoperability guidelines and standards. The draft guidance defines interoperability as “the ability of two or more products, technologies or systems to exchange information and to use the information that has been exchanged.”
Slides and links: Bakul Patel and Julian M. Goldman, MD

MDICx Series: The emerging case for medical device interoperability

 

November 17, 2015 – Advancing US Early Feasibility Studies – CDRH and MDIC Initiatives
This webinar discussed the CDRH Early Feasibility guidance, the MDIC Blueprint and experiences from sponsors who have submitted Early Feasibility Studies to CDRH. Speakers include: Owen Faris and Carla Wiese, CDRH; Angela Mallery, NAMSA; Vicki Pearson, Medtronic; and Karim Benali, Abiomed
MDICx webinar: Advancing U.S. Early Feasibility Studies – CDRH and MDIC Initiatives

 

August 12, 2015 – Advancing the Use of Central IRBs
We were pleased to host the Clinical Trials Transformation Initiative (CTTI) through a MDICx Series presentation. This session, moderated by MDIC President & CEO, Bill Murray, describes the work CTTI has been doing to advance the use of central IRBs for multi-center clinical trials. Featured speakers included: Cynthia Hahn, Chief Operating Officer, The Feinstein Institute for Medical Research and
Soo Bang, Sr. Director, Global Alliances & Business Development, Celgene Corporation
MDICx Series: August 12, 2015 – Advancing the Use of Central IRBs for Multi-site clinical trials

 

July 30, 2015 – Patient Preference Framework & CDRH Draft Guidance
This series session of the MDICx Series starts with MDIC Board Member and Project Board Champion, Ross Jaffe, giving an overview of the newly released Framework report for incorporating patient preferences into the development and submission of new medical technologies. Following Ross’ presentation, Annie Saha from FDA’s CDRH gives an overview of the draft guidance released on May 13, 2015.
MDICx Series: July 30th: Patient Preference Framework & CDRH Guidance

 

June 24, 2015 – Case for Quality Open Forum
In this first MDICx Open Forum on the Case for Quality, understand what MDIC’s CfQ program entails and what projects the MDIC CfQ Forum are initiating. Also, hear an update from representatives from the Food & Drug Administration on the FDA’s Case for Quality Journey and learn about the research on Maturity Models that Deloitte & Touche LLP conducted and hear their findings on applicability in the Medical Technology sector.
MDICx Series- Case for Quality Open Forum 6/24/15

March 10, 2015 – CM&S: Heart & Vasculature Working Group
This session was presented by Wei Gan, Marc Horner, Thierry Marchal, Richard Gray & Pras Pathmanthan from MDIC’s Heart & Vasculature Working Group. The presentation gives an overview of the work and then dives deeper into in silico clinical trials, physiologically realistic simulation and the history, need, and difficulty of verifying and validating whole heart models.
MDICx Series: Heart & Vasculature

January 22, 2015 – Patient Centered Benefit-Risk Assessment
This session was presented by Stephanie Christopher, Brett Hauber and Ross Jaffe from the MDIC Patient Centered Benefit-Risk Assessment Project. The presentation gives an overview of the project and details the Catalog and Framework documents the group has been working on.
MDICx Series- Patient Centered Benefit-Risk Assessment 1/22/15

December 4, 2014 – Computational Modeling & Simulation
Our first MDICx Series teleconference was presented by Dawn Bardot, Kyle Myers and Tarek Haddad from the MDIC Computational Modeling & Simulation Project. The presentation begins with an overview of the project, a presentation on mock submissions to FDA/CDRH and the incorporation of virtual patients into clinical trials.
MDICx Series- Computational Modeling & Simulation 12/4/14