Category Archives: Regulatory

19Jul/18
Validation - original (1)

At 21, Computer System Validation Comes of Age

Stop Validating Computer Systems to Death!

By: Daniel R. Matlis, President

“FDA emphasizes that manufacturers are responsible for the adequacy of the software used in their devices and activities used to produce devices.  When manufacturers purchase “off-the- shelf” software, they must ensure that it will perform as intended in its chosen application.

FDA has amended the requirement to state, “When computers or automated data processing systems are used as part of production or the quality system,” for clarification. Software used in production or the quality system, whether it be in the designing, manufacturing, distributing, or tracing, must be validated.”[1]

According to FDA’s Francisco (Cisco) Vicenty, Program Manager, Case for Quality, FDA CDRH, the MedTech industry’s high focus on meeting regulatory requirements versus adopting best quality practices has the potential to increase risk to patients.  This compliance-centric approach has resulted in quality issues and has hampered innovation in manufacturing and product development practices.  Additionally this single-mindedness has led to low rates of investment in automation and digital technologies. 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:

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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.

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22May/18
EU MDR LSP Tile

INFOGRAPHIC: Digital Transformation is a Journey to Support EU MDR and Beyond

Achieve Sustainable, Positive Disruption

By: Sandra K. Rodriguez, Market Analyst

Compliance with Medical Device Regulation 2017/745/EU also commonly referred to as EU MDR, is presenting a significant challenge for the medical device industry. Executives we’ve talked to have stated:

  • “Older products will present a real challenge for us. 20 and 30 years ago, there weren’t many requirements for human factors, clinical trials and risk data”
  • “We are trying to get our business units to think about the systems as a platform….to execute against business processes which can be shared across organizations”

Are you lost? Access our Infographic for a road map to sustainable, positive disruption and see for yourself why Digital Transformation is a journey to EU MDR and beyond.  We’ve identified some road hazards and areas of interest along the way.Digital Transformation EU MDR

With the right platform, meeting the next regulatory requirement becomes an issue of formatting the data… not chasing it down.

Register to receive the Infographic today and keep an eye out for additional information.

27Apr/18
Patient

Lot Size: YOU – When YOU are the RAW MATERIAL and the FINISHED PRODUCT

Managing the Chain of Custody and Identity for Regenerative Medicine Products.

By: Daniel R. Matlis, President

According to FDA Commissioner Scott Gottlieb, M.D.  “We’re at the beginning of a paradigm change in medicine with the promise of being able to facilitate regeneration of parts of the human body, where cells and tissues can be engineered to grow healthy, functional organs to replace diseased ones; new genes can be introduced into the body to combat disease; and adult stem cells can generate replacements for cells that are lost to injury or disease. This is no longer the stuff of science fiction. This is the practical promise of modern applications of regenerative medicine.”

The promise of individualized therapies is why the FDA is encouraging and supporting innovation in this field. To this end, the Agency has released a framework outlining how it intends to apply existing laws and regulations to oversee these products. FDA’s stated goal is to ensure that it is nimble and creative to foster innovation, while taking steps to protect the safety of patients.

In individualized patient-derived cellular gene therapy products, the patient is the raw material, product, and the treatment.  In gene therapy products, cells removed from the patient become the raw material.  They are then genetically modified and returned to the patient as the “finished product”.

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