MDICx Series

MDICx Series2MDIC presents an informative series of online teleconference workshops featuring emerging trends in medical technology regulatory science, MDIC projects and subject

 


Upcoming Webinars

Q3 Quarterly update on the CDRH Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program

September 12, 2018, 12 p.m. Eastern, 11 a.m. Central, 9 a.m. Pacific

More information

In 2017, CDRH, in partnership with the Medical Device Innovation Consortium and the CMMI Institute, launched a pilot project designed to incentivize medical device manufacturers to demonstrate mature quality practices by reducing certain regulatory requirements for those who demonstrate quality maturity (http://mdic.org/cfq/enroll/). CDRH expects the pilot to continue through 2018.

Representatives from CDRH and CMMI will provide updates on pilot progress, lessons learned from manufacturers, CDRH and CMMI, and changes made to the program through this quarterly MDICx webinar series.

Register at: https://www.eventbrite.com/e/mdicx-q3-quarterly-update-on-the-cdrh-case-for-quality-voluntary-medical-device-manufacturing-and-tickets-47266689942

 

Past MDICx Series Events

 

August 15, 2018 – Designing patient-centered clinical trials: Results of the MDIC project to use patient preference information to design clinical trials

For chronic debilitating and terminal illnesses with no effective treatments, the standard statistical threshold for determining therapeutic effectiveness in clinical trials may be too conservative and may not reflect patients’ perspectives on the potential benefits and risks of a therapy. This webinar will present the results of an MDIC collaborative project to test a novel method for incorporating patient preference information as an explicit means to set significance levels in clinical trial designs, developed as part of a collaboration with MIT, RTI Health Solutions, FDA CDRH and The Michael J. Fox Foundation for Parkinson’s Research. The primary outcome of the project is a method to determine an appropriate p-value threshold and trial size using patient input. This method may help remove barriers to access by giving patients a pathway to breakthrough, lifesaving technologies based on their risk tolerance and the resulting potential for reduced clinical trial size.

In this MDICx, speakers shared the results from the first three aims of the project:

  • Aim 1 – Understanding what matters to patients
  • Aim 2 – Designing and Conducting the Patient Preference Study
  • Aim 3 – Designing methods for clinical trials based explicitly on patient input

For more information on the MDIC project, go to http://mdic.org/spi/pcor

Slides to this webinar are available here.


Check back for the link to the video!
August 1, 2018 – CDRH Critical to Quality Initiative

On September 12, 2017, CDRH announced the Premarket Approval Application Critical to Quality (PMA CtQ) pilot program which is part of the FDA’s ongoing Case for Quality effort to apply innovative strategies that promote medical device quality. Participation in the PMA CtQ pilot program is voluntary. The pilot program aims to engage qualifying PMA applicants early in the PMA review cycle with a focus on what the applicant has established as the Critical-to-Quality (CtQ) attributes, characteristics, and controls for the PMA device. FDA would provide feedback on the identified CtQ characteristics and controls for their device and forego the standard PMA preapproval inspection. FDA would, in turn, focus on the PMA applicant’s implementation of the CtQ controls during a postmarket inspection.

Representatives from CDRH and industry will discuss the pilot, clarify key concepts and terminology, address some of the learnings to date, as well as provide examples of device-related CtQ characteristics and controls. Additionally, FDA would like to discuss additional options to leverage value and impact from this pilot. Slides available here.

MDICx CDRH Critical to Quality Initiative

June 5, 2018 – Q2 Quarterly update on the CDRH Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program

In 2017, CDRH, in partnership with the Medical Device Innovation Consortium and the CMMI Institute, launched a pilot project designed to incentivize medical device manufacturers to demonstrate mature quality practices by reducing certain regulatory requirements for those who demonstrate quality maturity (http://mdic.org/cfq/enroll/). CDRH expects the pilot to continue through 2018.

Representatives from CDRH and CMMI provide updates on pilot progress, lessons learned from manufacturers, CDRH and CMMI, and changes made to the program through this quarterly MDICx webinar series. This Q2 webinar features speakers from Baxter and Medtronic speaking to their experience in the pilot. Slides are available here.

MDICx Quarterly update on the CDRH Quality Pilot

May 31, 2018 – Update on CDRH Patient-Centered Initiatives

CDRH has made partnering with patients an ongoing strategic priority and since 2012 has advanced a number of initiatives to make that strategic vision a reality. This webinar provided an update CDRH’s patient-centered initiatives being undertaken under MDUFA IV, including the Patient Preference Initiative, the Patient Engagement Advisory Committee, and patient-reported outcomes. We also learned about the AWAKE Sleep Apnea initiative, a patient-focused medical product development meeting and survey that will bring patients and caregivers affected by sleep apnea together with representatives from CDRH, the FDA’s Center for Drug Evaluation and Research, and life science companies (both pharmaceutical and medical devices). Slides are available here.

MDICx Update on CDRH Patient Centered Initiatives

April 19, 2018 – From stories to evidence: Quantitative patient-preference information to inform product-development and regulatory reviews – Data Analysis
The third in our three part series “From stories to evidence: Quantitative patient-preference information to inform product-development and regulatory reviews.”
The topic for this session: Example applications and lessons learned—Data analysis
Slides are available for download here.

MDICx Patient Preference series – Data Analysis

March 15, 2018 – From stories to evidence: Quantitative patient-preference information to inform product-development and regulatory reviews – Instrument Development
The second in our three part series “From stories to evidence: Quantitative patient-preference information to inform product-development and regulatory reviews.”
The topic for this session: Example applications and lessons learned—instrument development
Slides are available for download here.

MDICx Patient Preference Series – Instrument Development

February, 27, 2018 – Quarterly update on the CDRH Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot program
In 2017, CDRH launched a pilot project designed to incentivize medical device manufacturers to demonstrate mature quality practices by reducing certain regulatory requirements for those who demonstrate quality maturity (http://mdic.org/cfq/enroll/). CDRH expects the pilot to continue through 2018 and MDIC will provide updates on pilot progress, lessons learned, and changes made to the program through this quarterly MDICx webinar series.
This first update webinar featured George Zack from Two Harbors Consulting, Kimberly Kaplan from CMMI, Joe Friedrich from Boston Scientific and Cisco Vicenty from FDA Center for Devices and Radiological Health.
Slides are available here

MDICx – Quarterly update on the CDRH Case for Quality Pilot Program

February 15, 2018 – From stories to evidence: Quantitative patient-preference information to inform product-development and regulatory reviews
The first in our three part series “From stories to evidence: Quantitative patient-preference information to inform product-development and regulatory reviews.”
Reed Johnson, Shelby Reed and Juan Marcos Gonzales present: When is a patient-centered case needed for regulatory decisions and how can you build it?
Slides are available here.
Webinar summary and references are available here
MDICx When is a patient-centered case needed for regulatory decisions?

December 12, 2017 – Framework for Surrogate Sample Use in Clinical Diagnostic Test Development and Product Submission – from the MDIC Clinical Diagnostics Surrogate Samples Working Group
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 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 scope of the document covers 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.
 

MDICx: Clinical Diagnostics Surrogate Sample Framework December 12, 2017

December 4, 2017 – A Case Study in How Patient Preference Information Contributes to Regulatory Decisions for Medical Devices
In 2016, CDRH issued its final guidance for the submission of patient preference information as part of a sponsor’s regulatory submission. As part of its commitment to partner with patients, CDRH has indicated willingness to work directly with medical device companies considering including patient preferences as part of their submission and encourages device companies to come to CDRH early to discuss their goals. NxStage, a medical device company that develops, manufactures and markets systems for the treatment of end-stage renal disease and acute kidney failure, submitted information from a patient preference study for a label expansion for their home hemodialysis (HHD) unit. The unit had been previously cleared for home use with a care partner, but patients expressed a desire for solo use of the device. A patient preference study measured patients’ maximum acceptable risk for HHD without a partner instead of in-center dialysis. On this webinar, NxStage shared their experience in working with CDRH on the development of this patient preference survey. Representatives from CDRH shared their perspectives on what they were looking for, as well as the Center’s commitment to partner with patients.

MDICx Series – A Case Study in How Patient Preference Informs Regulatory Decisions

November 17, 2017 – Patient values and P-Values: Exploring a new method for developing patient-centered clinical trials
Using patient preference information to set the significance level and power of a clinical trial can maximize the value of a clinical trial based on the relative importance of benefit and risk outcomes to a specific patient population. The explicit incorporation of patient preferences into clinical trial design will address the longstanding conundrum that, in an enterprise devoted to easing the burden of disease, the afflicted currently have no input into the process. By designing clinical trials that reflect patients’ urgency and risk tolerance, scarce resources can be allocated more efficiently, bringing more therapies to more patients faster and more efficiently.
The webinar speakers recently published an article on using the CDRH obesity patient preference study to set the statistical design for a hypothetical clinical trial. This retrospective analysis informs the ongoing MDIC project to use patient preferences to inform the design of Parkinson’s Disease clinical trials.

MDICx – Patient Values and P Values

May 18, 2017 – Virtual Patient R Code Access and Use
The Virtual Patient (VP) model demonstrates utility for integrating historical information into prospective studies; reducing clinical trial timelines and costs, reducing clinical trial subject burden, and increasing medical technology access to provider and patient teams. This MDICx discusses VP R Code access via CRAN with demonstrations applying the model to various study types.

MDICx Series: Virtual Patient – R Code Access and Use 5/18/2017

April 17, 2017 – Leveraging Existing Information for Future Studies: The Case for Bayesian Methods
 Medical device clinical trial growth in size and complexity are well-documented burdens to clinical research conduct, regulatory review, and access to new medical technologies. The Medical Device Innovation Consortium (MDIC) has proposed a pathway to support industry and regulatory agencies in the transformation towards greater clinical trial efficiency.  Leveraging FDA guidance for the use of Bayesian statistics in medical device clinical trials, MDIC has created the Virtual Patient statistical model, which forward leverages historical information into prospective clinical trials.  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.

MDICx Series: Virtual Patient – CRT17 Encore Presentation 4/172017

April 6, 2017 – MDICx – Quality Metrics: Best Practices, Cases Examples and How Metrics Factor into the Case for Quality
 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 discuss quality metrics and how those metrics can be used to assess sustained quality performance.

 

MDICx Case for Quality Metrics 20170406 1545 1

April 5, 2017 – MDICx: Draft Framework for Surrogate Sample Use in Clinical Diagnostic Test Development and Product Submission – from the MDIC Clinical Diagnostics Surrogate Samples Working Group
  • Why surrogate samples are used
  • Factors to consider when using surrogate samples
  • Surrogate sample use in diagnostic validations by study type

MDICx Clinical Diagnostics Surrogate Samples Draft Framework 4/5/17

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<a, 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