Resources Archive - Page 4 of 12

MDIC Patient Engagement Forum Lessons Learned

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 […]

March 8, 2021/by MDIC Communications

Clinical Science

Patient Engagement in Clinical Trials: Patient, Industry, and Clinical Investigator Perspectives

March 2, 2021

March 2, 2021/by MDIC Communications

Case for Quality

Case for Quality Video Series

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.

February 17, 2021/by MDIC Communications

Case for Quality

Frequently Asked Questions about the ASC Pilot Study

February 9, 2021

February 9, 2021/by MDIC Communications

Case for Quality

Leadership Engagement Playbook

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 19, 2021/by MDIC Communications

Case for Quality

Accelerate Sustainable Capability Pilot Study: Pilot Site Playbook

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.

FAQs