Tag Archives: MDIC

06Sep/18
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The Value of Analytics in Value-Based Healthcare

Perspectives from Key Stakeholders in the Healthcare Ecosystem

By: Daniel R. Matlis, President

The primary drivers for Healthcare today are improving the quality of patient outcomes, enhancing patient-centered care and adopting initiatives that control costs while maximizing patient benefit.

Healthcare ecosystem stakeholders, including physicians, clinicians and supply chain professionals utilize data to make value-based procurement decisions for medical devices to ensure and improve patient access to high quality devices.  The integrity of these decisions depends upon the accuracy and completeness of unbiased analysis of underlying data to support patient care decisions.

To gain insights from key stakeholders on the use of analytics to support the transition to value based healthcare, Axendia interviewed a group of thought-leaders representing the Medical Device Innovation Consortium (MDIC) Case for Quality Product Quality Outcomes Analytics (PQOA) working group.

Each stakeholder offered their unique perspective on the value proposition for the PQOA Dashboard.

These thought-leaders are (in alphabetical order):

Stephanie Christopher – Program Director at Medical Device Innovation Consortium (MDIC).

Garth Conrad VP Quality at BD Peripheral Intervention.

Michael Ruhlen – MD, MHCM, FAAP, VP Division of Medical Education, Atrium Health

Michael Schiller – CMRP, Senior Director at the Association for Healthcare Resource & Materials Management (AHRMM)

Nathan Soderborg PhD, Principal Scientist, Statistical and Data Sciences, Exponent.

Francisco (Cisco) Vicenty Program Manager for Case for Quality, Office of Compliance, CDRH, FDA (OPEQ Pilot: Immediate Office, Strategic Initiatives Staff)

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16Jun/17
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10 FDA Answers on ‘Driving a Culture of Quality for Devicemakers’

By: Daniel R. Matlis, President

The Case for Quality: Why Does It Matter?

Last month, I had the privilege to moderate a discussion with Capt. Sean Boyd, deputy director for regulatory affairs in CDRH’s Office of Compliance, and Francisco (Cisco) Vicenty, acting program manager of Case for Quality in CDRH’s Office of Compliance.

During the webinar hosted by FDAnews, we discussed topics including:

  • The Case for Quality – Why does it matter?
  • Are we playing regulatory whack-a-mole?
  • How is the role of FDA evolving to encourage a culture of quality for device makers?
  • Have “Compliance First” regulatory approaches slowed innovation?
  • Who benefits from a focus on quality?
  • Are there appropriate substitutes for routine FDA inspections or pre-approval inspections?
  • What are the quality outcomes metrics FDA will collect and monitor?
  • How will FDA operate as we shift from documents to data/metrics as a result of using quality tools?

In addition, Capt. Boyd and Mr. Vicenty addressed the following audience questions:

Q1: How is the CfQ program different than Quality by Design?

A1: Quality by Design (QbD) is the systematic approach used in the pharmaceutical space for development that focuses on risk management and predefined objectives for product and process control. QbD is more analogous to Design Controls in Quality System Regulation. Case for Quality is an effort to work together with a community of stakeholders to incentivize performance and product quality. This collaboration will allow for faster and better data to drive purchasing decisions and FDA activity.

Fore more Q&A, read the article in its entirety in FDANews Device Daily Bulletin.