Tag Archives: Case for Quality

01Apr/19
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The Value of Analytics in Healthcare

Perspectives from Key Stakeholders in the Healthcare Ecosystem

By: Daniel R. Matlis, President

Healthcare is shifting to a value-based model focused on improving the quality of patient outcomes, enhancing patient-centered care and adopting initiatives that control costs.

The transition to value-based healthcare hinges on the availability of unbiased quality and outcomes 7-Metrics-Value-Based-Care_1data. Furthermore, the integrity of these decisions depends upon the accurate and objective analysis of these data to support patient care decisions.

We interviewed the following thought leaders representing key stakeholders from the CfQ PQOA working group to gain their unique perspective on the value of analytics in value-based healthcare.

  • Stephanie Christopher, Program Director at MDIC
  • Garth Conrad, VP Quality at BD Peripheral Intervention
  • Michael Ruhlen M.D., 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, Ph.D., Principal Scientist, Statistical and Data Sciences, Exponent.
  • Francisco (Cisco) Vicenty, Program Manager for Case for Quality, OC, CDRH, FDA

Continue reading the full article in MedTech Intelligence.

Related

NBC News Reports – Device-Safety Experts to FDA: Make Data Public.

Download the full report and read our interview with CfQ PQOA stakeholders.

 

 

26Nov/18
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FDA’s Medical Device Enforcement and Quality Report

FDA Issues a Report on Increased Medical Device Inspections and Improved Compliance

The Report highlights:

  • Annual device inspections have increased 46% since 2007
  • The annual number of foreign device inspections have increased 243%  since 2007
  • The Agency is taking a targeted, risk-based enforcement approach to address specific device areas of concern.  Case studies mentioned in the report are:
    • Infusion Pumps
    • Automated External Defibrillators
    • Radiation Therapy Devices
  • From 2008 to 2007, 82% of firms corrected observed violations on follow-up inspections.
  • The FDA is also continuing to promote device quality through the Case for Quality initiative.

For related reading based on our involvement with the Case for Quality, please see:

FDA Driving Industry “Beyond Compliance” to Promote Manufacturing Quality

Is Compliance an Obstacle to Quality?

What is FDA Thinking? We Asked, They Answered!

The Case for Quality Voluntary Pilot Program

 Quality Metrics Program Update

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)

Register to Receive this Report.

13Jul/18
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Lucky 13! What’s in a Number?

At Axendia, We Consider 13 More Than a Lucky Number!

We are quickly approaching our 13 Year Anniversary!  Since 2005, we have been providing trusted advice to Life-Science Industry Executives on Business, Regulatory and Technology Matters. It’s more than just luck, our analysts help a diverse set of clients achieve positive disruption through primary research and deep industry experience in a complex and highly regulated Industry.  Not only is our staff passionate about what they do, they average 20 years of Life-Science industry experience.

As a result, Axendia has proudly built long-term relationships across a broad industry ecosystem including:

Life-Science and Healthcare Organizations 68530 Connected Doctor

We provide strategic advice on key initiatives and understand the issues and priorities facing Industry Executives. We architect strategic road-maps to support positive disruption.

Examples include:

Continue reading

06Mar/18
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CDRH Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program

What’s In It For You?

By: Sandra K. Rodriguez, Market Analyst

On February 27th, the Medical Device Innovation Consortium (MDIC) provided a quarterly update on the CDRH Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program.  The program aims to build a culture of quality across the entire organization while producing measurable results including:

  • Reduce defects/re-work
  • Reduce costs
  • Accelerate time to market
  • Increase customer satisfaction

The pilot was announced in the Federal Register on December 28, 2017.  During the recent webinar, Kimberly Kaplan of CMMI Institute reviewed how the pilot program leverages the CMMI framework as the standard maturity model by which medical device organizations can measure their capability to produce high quality devices and improve patient safety.  To date, 13 organizations have enrolled in the pilot program.  She pointed out early indications show industry is having a hard time shifting from an inspection or audit mindset, to an appraisal approach – which is more conversational in nature. Continue reading