March 2, 2021
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
January 14, 2021
The objective of this pilot study is to leverage a quality system maturity and integration approach to provide manufacturers with systemic insight that may improve the effectiveness of the quality system; focus and accelerate improvement efforts to reach a state of sustainable compliance faster; structure systems for continuous improvement; identify objective performance metrics, and develop reports that may provide the agency with the information it needs to oversee product safety throughout the pilot process.
To encourage manufacturers to enroll and participate, this pilot study will cover the costs of the activities listed and defined in this playbook.
September 11, 2020
Appropriate communication of benefits, risks, and uncertainty is essential at every stage of the medical device
life cycle. Products can be designed, and studies conducted, based on the risk, benefit, and uncertainty
preferences of the target patient population. During review, approval, and subsequent use of a device,
manufacturers and regulators have an obligation to ensure that benefits, risks, and uncertainty associated with
the device are communicated in an understandable way. Similarly, in the clinical setting, patient-centered care
requires effective communication of benefits, risks, and uncertainty between patients and providers. There
is increasing awareness surrounding the importance of patient engagement during the treatment decisionmaking
process, as well as across the medical technology product development cycle by industry
and regulators.
The intent of this report, developed by the Science of Patient Input Communication Working Group of
the Medical Device Innovation Consortium, is to familiarize all medical device stakeholders with evidence-based
practices for communicating the benefits, risks, and uncertainty of medical technology to patients
and providers.
An informational webinar was held on this report on October 2, 2020. View a recording of the webinar here.
Current as of January 5, 2021
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