Category Archives: Regulatory

09Aug/18
EU MDR LSP Tile

Industry Call for EU MDR Freeze

Stop The Clock

By: Sandra K. Rodriguez, Market Analyst

MedTech Europe has issued a position paper asking the EU for a “stop the clock mechanism, that freezes the remaining transition time for both regulations until full readiness of the system has been achieved.”  This will create opportunities for Med-Tech companies to take a long view on EU MDR and enable Digital Transformation as a Journey to Support EU MDR and Beyond.

See:  Implementing the New MD and IVD Regulations: Industry Calls for Solutions to Ensure Continuity of Care of Patients. 

EU MDR LSP TileOur Infographic offers you a road map to sustainable, positive disruption.  We’ve also identified some road hazards and areas of interest along the way.

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”

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

Briefing requests can be directed to: info@axendia.com

02Aug/18
Outcome based Medicine-Low-Res

FDA: Simulation is Digital Evidence, Not Made Up Stuff

Digital Evidence is Already Being Used at FDA to Support Regulatory Submissions

By: Daniel R. Matlis, President

Tina Morrison PicFDA is leading the way in the use of simulation and modeling in the medical device industry. “Simulation is digital evidence, not made up stuff,” said Tina Morrison Ph.D., Deputy Director, Division of Applied Mechanics, OSEL, CDRH, U.S. FDA, during her keynote address on Day 2 of the Siemens PLM Industry event, hosted by Medtronic at their operational HQ in Minneapolis, MN.

For details on Day 1 of the event see At 21, Computer System Validation Comes of Age.

Day 2 also included presentations from Medtronic, Atrium Health, Siemens Healthineers, and Agilent Technologies on their use of simulation and modeling across the product lifecycle and the environment of care.

“Access to safe and effective medical device technology calls for Regulatory Grade computer models & simulations,” said Morrison.

“Many companies aim for the Digital Twin and end up getting a Digital Mutant” commented Brent Roberts, Vice President of Medical Supply Chain Strategy at WL Gore.  “I think one of the keys to ensuring you don’t end up with a digital mutant is to stick with partners who understand the journey and rely on them helping you translate your internal view to a rest of the world outlook,” Roberts added.

To receive a copy of this brief, please register here.

We also welcome you to Register for FDA Grand Rounds “Advancing Regulatory Science with Modeling and Simulation at FDA” on August 9, 2018 from 12 – 1pm EST.

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
Lucky 13-700x400

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
483-6Sigma

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