Category Archives: Regulatory

22May/18
EU MDR LSP Tile

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

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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04Apr/18
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Quality: STOP Working on Compliance

Excessive focus on compliance can create hurdles in cultivating quality and innovation

By: Daniel R. Matlis, President

What is the role of Quality in MedTech? 10% said the primary role of quality is to drive product / process improvement. In sharp contrast, 85% indicated the primary role of quality is ensuring compliance

No wonder, the industry has to overcome some many hurdles when cultivating a culture of quality and innovation.

To compete in today’s global markets, Med-Tech companies must change their approach to Quality, from meeting compliance requirements, to driving product and process improvements across the product life-cycle.

A closed loop approach can help MedTech organizations make this crucial shift by enabling better collaboration, visibility and product quality across the product life-cycle.

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Read my latest Soapbox column in MedTech Intelligence for key takeaways from Axendia’s research on this topic.

06Mar/18
MDIC_Logo_Tagline_3Color_webready

CDRH Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program

What’s In It For You?

By: Sandra K. Rodriguez, Market Analyst

On February 27th, the Medical Device Innovation Consortium (MDIC) provided a quarterly update on the CDRH Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program.  The program aims to build a culture of quality across the entire organization while producing measurable results including:

  • Reduce defects/re-work
  • Reduce costs
  • Accelerate time to market
  • Increase customer satisfaction

The pilot was announced in the Federal Register on December 28, 2017.  During the recent webinar, Kimberly Kaplan of CMMI Institute reviewed how the pilot program leverages the CMMI framework as the standard maturity model by which medical device organizations can measure their capability to produce high quality devices and improve patient safety.  To date, 13 organizations have enrolled in the pilot program.  She pointed out early indications show industry is having a hard time shifting from an inspection or audit mindset, to an appraisal approach – which is more conversational in nature. Continue reading

14Feb/18
thinking

What is FDA Thinking? We Asked, They Answered!

An Interview with Francisco (Cisco) Vicenty – US FDA

By: Daniel R. Matlis, President

That is a question I often hear from industry executives around the globe.

To answer this question, I sat down with FDA’s Francisco Vicenty, for over an hour, to discuss a wide range of topics and gain an understanding of FDA’s current thinking on these topics. Cisco Vicenty is the Case for Quality Program Manager at FDA’s Office of Compliance, CDRH.

FDA-Axendia-Webinar

Driving a Culture of Quality in Industry

The overarching drive at FDA is enabling high levels of product excellence and innovation across industry and to provide patients with access to high quality, safe, and effective medical devices.  The agency wants to incentivize industry to adopt quality best practices; to adopt product quality excellence that drives improved patient outcomes.


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