All posts by Administrator

01Apr/19
68530 Connected Doctor

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.

 

 

26Mar/19
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New Whitepaper Series – Why MedTech Must Embrace Industry 4.0

Medical Device Companies Must Embrace Modern Manufacturing Execution System (MES) Strategies to Future-Proof Their Business

By: Sandra K. Rodriguez, Market Analyst

FDA’s upcoming guidance on Computer Software Assurance (CSA) paves the way for Digital transformation and Industry 4.0 in MedTech. The Agency recognizes that systems like MES provide manufacturers advantages for reducing or eliminating errors, increasing business value, optimizing resources, and reducing patient risk.

Need a roadmap to enable Industry 4.0 in MedTech?  Read this whitepaper series to discover:

  • How to use MES as the backbone to enable Industry 4.0
  • Why modern MES support the transition from compliance to excellence
  • How to enable a step change for your business and patient outcomes
  • Ways to utilize Industry 4.0 across your manufacturing network

Download the series here and start your digital manufacturing transformation.

This white paper series was sponsored by Critical Manufacturing.

22Mar/19
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FDA Shares Quality Considerations for Continuous Manufacturing

A Straight from the Source Webinar

 FDA is committed to supporting and enabling pharmaceutical innovation and modernization. The Agency recognizes that continuous manufacturing is an emerging technology that can enable pharmaceutical modernization and deliver potential benefits to both industry and patients.

Join FDA’s Thomas O’Connor, Ph.D. and Axendia’s Daniel R. Matlis for a live webinar.

Date and Time:  April 17th at 11:00 AM ET. 

We will discuss FDA’s perspective on pharmaceutical innovation and modernization including:

  • FDA’s draft guidance on Quality Considerations for Continuous Manufacturing
  • How continuous manufacturing can improve pharmaceutical manufacturing
  • Support of enhanced development approaches such as quality by design (QbD), process analytical technology (PAT) and models
  • Insights from dialogue with sponsors through the Emerging Technology Program, externally funded and internal research
  • Experiences from review and approval of five drug applications utilizing continuous manufacturing to date

Meet Your Trusted Sources

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Scheduling Conflict? Register and receive a link to view the on-demand recording after the event.

Participation is Limited!

register

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.

 

19Mar/19
Sparta CSA eBook Cover

eBook: Goodbye Computer System Validation…

Hello Computer System Assurance (CSA)!

By: Daniel R. Matlis, President and Ellyn McMullin, Research Associate

FDA supports and encourages the use of automation systems and digital technologies throughout the product lifecycle to improve patient outcomes and reduce the risk to patients. It is a common misconception that extensive testing and documentation is required to demonstrate the validation of computer software used in automation.

The FDA, recognizing industries CSV challenges, has announced new guidance on “Computer Software Assurance for Manufacturing, Operations and Quality System Software.” This guidance is on the Agency’s “A-list” and is planned for release in FY 2019.

The content is this eBook represents Axendia’s analysis and opinions on “Computer Software Assurance for Manufacturing, Operations, and Quality System Software” based on the following trusted sources:

  • Axendia’s interaction with FDA representatives on this topic
  • Content and material sourced from FDA
  • First-hand experience from Axendia’s clients on the implementation of CSA

Register to receive this eBook, sponsored by Sparta Systems, and learn:

  • Why Critical Thinking is the Foundation of CSA
  • How to Implement a Risk-Based Approach to CSA
  • The Objectives of CSA
  • What the CSA Landscape Looks Like
  • Acceptable Levels of Assurance

Webinar also now available on-demand:  Understanding the FDA’s New Approach to Computer System Validation.