Category Archives: Quality

21Mar/19
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Unstructured Tools Are Not A Good Fit For A Structured Process

Jama Software Brief

By: Sandra K. Rodriguez, Market Analyst

The Jama Software executive team recently briefed Axendia on its product development platform that is comprised of its flagship product – Jama Connect – and newly developed Jama Analyze.  Headquartered in Portland, Oregon, the company aims to help medical device companies modernize, digitize and transform an increasingly complex product development process.

Jama Connect allows companies to focus on quality from the standpoint of requirements, risk management and testing and brings it all together in a modern, collaborative and centralized way.  “Customers are coming to us to really drive innovation and quality in an accelerated time frame as they face competitive pressures,” said Joel Hutchinson, Product Manager at Jama Software.

Companies ranging from Merck to Boston-Scientific are managing requirements, risk, test and project volatility through the use of Jama Connect.

Please register to receive your complimentary copy of this Brief.

 

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.

22Aug/18
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Do You Want Less FDA Inspections? Here is FDA’s RX

Quality Metrics Program Update: We Asked and FDA Answered

By: Sandra K. Rodriguez, Market Analyst

The Quality Metrics program is a key step in the Agency’s objective to encourage industry to implement state-of-the-art, innovative quality management systems that drive industry to focus on improving product quality, rather than simply ensuring compliance to regulatory requirements.  

FDA recently published two announcements on the Quality Metrics program in the Federal Register: 

  • CDER intends to further develop a Quality Metrics Program through formal meeting requests and a pilot study to gain feedback from those establishments for which meeting requests do not apply 
  • CDER and CBER are initiating a 2018 Quality Metrics Site Visit Program to assist the Agency in understanding existing programsii 

These announcements prompted a number of industry executive to reach out to Axendia to understand FDA’s current thinking on Quality Metrics. 

For a first-hand account, we reached out to FDA with a few questions – we asked and they answered. [1]

AXENDIA: What drove the delays in the program?

FDA: There were many comments submitted to the docket after the revised draft 2016 guidance was published.  The comments generally indicated that additional feedback and a pilot would be useful.  Further, we took time to listen to additional comments and feedback from industry and industry trade organizations provided at conferences and presentations.  We determined that our next steps should be a Feedback Program and Site Visit Program which would allow individual companies an opportunity to discuss their approaches from different sub-sectors of the industry.  Continue reading

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

29May/18
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FDA: Consumers and Patients Deserve Six Sigma Quality Products

Compliance vs. Quality – Interphex Edition

By: Daniel R. Matlis, President

Last month, I had the privilege to heaYU-Interphex-2018r Lawrence Yu, PhD, FDA Deputy Director of CDER’s Office of Pharmaceutical Quality (OPQ) at INTERPHEX 2018.

The theme of his presentation “The Future of Pharmaceutical Quality and the Path to Get There,” was that consumers and patients deserve six sigma quality products.

To encourage this effort, the Agency began the drive to modernize its regulation of the pharmaceutical industry to emphasize Quality more than a decade ago with the 21st Century Initiative.

Continue reading