Category Archives: Quality

08Jul/19
Jumping

Webinar: Digital Transformation Enables Review by Exception at FDI – A Case Study

A Straight from the Source Webinar

Review by Exception is the ultimate goal of Electronic Batch Records (EBR) and Manufacturing Execution System (MES) implementations at Life-Science organizations. Yet few industry companies have achieved this goal.

Fujirebio Diagnostics Inc., (FDI) is undergoing Digital Transformation, starting with MES / EBR implementation, resulting in a Review by Exception approach for manufacturing batch records.

Join FDI’s Samantha Schloth and Axendia’s Daniel R. Matlis for a live webinar on August 6 at 11:00 AM ET to learn how Digital Transformation is enabling Review by Exception and reducing manufacturing cycle times.

We will discuss:

  • Undergoing Digital Transformation
  • Leveraging FDA’s Risk Based Computer System Assurance Approach
  • An Implementation Strategy for success
  • Moving from Paper to Digital Records
  • The Value of Review by Exception
  • Lessons learned, challenges and opportunities

Meet Your Trusted Sources

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Can’t attend the live webinar? Register to receive a link to the on-demand recording after the event.

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01May/19
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Axendia to Provide Life-Science Analyst Keynote at 3DEXPERIENCE FORUM 2019

Harnessing Positive Disruption in Life Sciences to Achieve Patient-Centric Care

By: Daniel R. Matlis, President

Life-Science organizations must transform or be disrupted! They must harness positive disruption to achieve patient-centric care that supports prevention, improves outcomes as well as providing a holistic patient experience that drives value.

However, to achieve patient-centric care, Life-Science organizations must undergo digital transformation that enables closed loop visibility across the product lifecycle. This transformation requires core paradigm shifts in corporate culture, incentives, strategic planning, regulatory frameworks as well as technological solutions for industry stakeholders.

Male-Anatomy-Background-composite-cropped-low-resNew technologies like modeling and simulation, artificial intelligence and the Internet of Medical Things (IoMT) are enabling patient-centric models to serve more people around the world. The foundation of patient-centric care is the ability to connect the real and digital worlds through multi-discipline, multi-scale modeling and simulation, IoMT connected devices, visibility to data for decision support and greater collaboration. Continue reading

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.

 

 

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
68530 Connected Doctor

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.