Home hemodialysis device manufacturer, NxStage, used the MDIC Patient-Centered Benefit-Risk (PCBR) Framework as a guide in developing a patient preference survey to quantify the acceptable risk of hemodialysis home alone versus at a dialysis center. Data from that survey were taken into consideration in FDA CDRH’s decision to clear an expanded indication for NxStage’s home hemodialysis device – the first 510(k) clearance in which quantitative patient preference data played a role.
This document provides an updated Literature Review for the Medical Device Innovation Consortium (MDIC) Science of Patient Input (SPI) Working Group for submission as a deliverable under the MDIC BAA contract. This high-level review reflects a broad scan of publicly available information about relevant organizations, initiatives, materials and publications. While it is up to date as of March 2019, this summary is not exhaustive and should be viewed as a representative snapshot of activities and resources within the highly active and evolving field of patient engagement in clinical research. As new organizations, resources, and publications are being developed and launched continually, this work should be updated regularly to ensure its completeness and relevance over time.
MDIC received funding for this project from FDA BAA HHSF223201810116C “Framework for Patient Input in Medical Device Clinical Trials.”
MDIC surveyed 53 device and diagnostic industry stakeholders and separately surveyed 123 individuals identifying as patients. The goal of the complementary surveys was to inform future work to develop guidelines for industry on how to involve patients in the design of clinical trials.
Within our survey response populations, we discovered:
- Over 50% of industry respondents involved in protocol development never gained patient input to protocol development. A further 28% gained input less than 25% of the time.
- Figures were even greater for industry gaining patient input to operational study design after protocol finalization with over 80% involving patients never or less than 25% of the time.
- There were some disconnects in the perspective of industry vs patients with regards to the reasons patients might enroll in a clinical trial, particularly around the importance of doctor recommendation.
The lack of patient involvement by industry in study design, contrasted with some of the differences in perspective that this survey uncovered, supports the need for further work to enable medical
Surrogate samples, when properly used, can not only decrease the time needed for analytical testing, but also reduce the costs and time of sample collection for development and regulatory submission. But the lack of commonly agreed to terminology and a defined experimental framework for surrogate use reduces the predictability and efficiency of IVD development, translating into higher costs and reduced patient access to new and innovative medical devices.
The framework — created via a 22-month collaborative process between MDIC, FDA CDRH, AdvaMed, BD, Abbott, Hologic, Sysmex, Roche, and BARDA — aims to establish a foundation for the use of surrogate samples to support IVD product development and the regulatory process. The framework may be found here.
Harmonized educational materials were created for IVD test developers and FDA CDRH reviewers to facilitate a more predictable pathway for submissions. These educational materials include a Surrogate Sample Framework Training Module and five case studies.
Keynote Panel: Intersection of Quality and Cybersecurity
Intersection of Quality and Clinical Diagnostics: An opportunity for cross-collaboration at MDIC
Update from CDRH
MDIC CfQ VIP Update
Working Group Update – Leadership Engagement
Working Group Update – Quality as Career Option
Working Group Update – CAPA
Working Group Update – Analytics: NESTcc Test Case
What’s Next and Closing Remarks
We’ve published our first-ever annual report to share the impact of our work during the 2018 year. This report not only helps quantify and demonstrate the impact we’ve had but also helps us identify opportunities for growth and improvement. Some of the key highlights from the Annual Report include launching the Health Economics and Patient Access initiative, announcing NESTcc’s Real-World Evidence Test-Cases, and publishing a number of tools and resources for stakeholders. We developed and published a report on cybersecurity for medical devices. These accomplishments would not have been possible without the dedicated members of our public-private partnership who help us promote patient access to innovative medical technologies.
Below are downloadable files from the Case for Quality Forum.
- Welcome from ASQ | American Society for Quality
- MDIC Overview Presentation | Medical Device Innovation Consortium
- MDIC CfQ Presentation | MDIC Working Group
- Advancing Quality and Regulatory Science | CDRH: OIR / FDA
- Medical Device Discovery Appraisal Program | CMMI, CDRH/ FDA, Two Harbors Consulting
- Reflections on Illumina’s MDDAP/VIP Appraisal | Illumnia
- 501(k) Program Improvement Project | NSigma Solutions
- #MAKECAPACOOL | MDIC Working Group
Welcome and goals for the day – Beth Staub | Slides
Keynote: Building Digital Analytics Foundation for Autonomous Factories at Western Digital – Attila Lengyel | Slides
Results of the CDRH Voluntary Medical Device Manufacturing and Product Quality Pilot – George Zack, Kim Kaplan, Francisco Vicenty | Slides
What we learned from the pilot – Kim Kaplan | Slides
MDIC Governance Survey Results – George Serafin | Slides
What’s Next? – Francisco Vicenty | Slides
MDIC contracted with Deloitte & Touche, LLC to conduct research concerning the use of maturity models in other industries. Although there are explicit regulations globally for medical devices and diagnostics, there is no recognized quality system maturity model. The objective of this research was to gain an understanding of various maturity models and how they have been implemented and leveraged within other industries. This information will be helpful to devise a plan for the potential development of a maturity model for use by both industry partners and regulators in the Medical Device industry.
Released June 2015