March 17, 2021
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 Broad Agency Agreement (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 December 2020, 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.
March 8, 2021
The Medical Device Innovation Consortium (MDIC) Virtual Patient Engagement Forum held on November 18, 2020, engaged approximately 100 participants, including patients, patient advocates, medical device leaders, regulators, healthcare providers, payers, and experts in communication and shared decision-making. Participants joined in a day-long, interactive meeting focused on communicating benefit-risk and uncertainty for medical devices. Content for […]
February 17, 2021
Emerging HealthTech Series: Case for Quality
Learn more about Case for Quality through Emerging HealthTech’s six-part series covering the following topics:
- Clip 1: The Genesis of Case for Quality
- What Case for Quality is and what it aims to accomplish as a collaborative community
- Clip 2: Quality as a Journey for the Patient
- A widening of perspective – from product quality to the broader quality for the patient
- Clip 3: The Culture of Quality
- What is a Culture of Quality, why it is important and what it means to the medical device industry and, ultimately, patients
- Clip 4: Why Should Companies (Large & Small) Engage in Case for Quality
- These are just some of the unique benefits of participating in Case for Quality, especially for smaller companies and emerging technologies
- Clip 5: Can Corrective and Preventive Action (CAPA) Be Cool?
- Yes it can! Learn about Case for Quality’s “Make CAPA Cool Pilot Study” and how it can improve how your company performs CAPA.
- Clip 6: The Digitalization of an Expanding Medical Device Industry
- A new direction in the medical device industry toward using advanced technologies, including digital predictive methods and models, and algorithmic approaches to quality management systems and product quality to drive better patient outcomes.
January 19, 2021
A culture of quality in life sciences organizations transcends compliance and serves as a clear, competitive differentiator. In an industry facing increasing competition, regulations, and customer demands, and a mandate for innovation, today’s life sciences leaders are committed to cultivating a culture of quality.
Driven by payers (including the Centers for Medicare and Medicaid Services), the life sciences industry is moving from a reactive to a proactive approach to quality. This requires, in part, a commitment to measuring quality investments. Life sciences organizations, more and more, are being measured and paid based upon clinical outcomes and the quality of their products and services.
This playbook, developed by the Case for Quality Collaborative Community, describes 10 best practices for moving from a culture of compliance to a culture of quality:
- Facilitate a Culture of Quality
- Develop a Quality Strategy
- Make Quality a Priority
- Measure the Value of Quality
- Be Proactive, Not Reactive
- Clearly Define Quality at the Individual Level
- Encourage Quality Behaviors
- Use Quality Benchmarking
- Use Quality Metrics
- Recognize and Reward Quality
Current as of January 19, 2021
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