Author: twoharbors

The FDA’s commissioner Scott Gottlieb made several large announcements this week that reflect a continued drive to reduce regulatory burden to industry to foster an environment for innovation and allowing greater speed to market for regulated products. Earlier in the week the Agency announced its intentions to publish a guidance to “modernize” the 510(k) process:  “FDA intends to publish a draft guidance, again in early 2018, setting forth factors that the agency may consider when assessing […]

Presentations from the latest CfQ forum are up on the MDIC site (https://lnkd.in/e3hvHsb). We strongly recommend reviewing Rob Becker’s presentation regarding his medical device organization’s experience going through a CMMI appraisal, what he found valuable and what were challenges: https://lnkd.in/ga4SHm7

Curious as to where FDA inspections have been the last 10 years? Checkout the inspections database: https://www.fda.gov/ICECI/Inspections/ucm222557.htm

Two Harbors Consulting has been working closely with partners in industry, the Medical Device Innovation Consortium, the Food & Drug Agency, and the CMMI Institute to further the Case for Quality program leveraging the CMMI Maturity Model as a framework to assess and drive quality improvements in medical device firms. As background, please review FDA Director of CDRH, Dr. Jeff Shuren describes the Case for Quality here. The CMMI Institute has provided a comprehensive FAQ […]

A good set of background information related to the Case for Quality and the voluntary maturity model program … really reflecting how the FDA is taking a different approach: https://www.youtube.com/watch?v=JCZcxaTf1pQ

written by George Zack: I’d like to share with you a story comparing some of the experiences our daughter had in her college search. I think the different experiences with some of her “top choice” universities provide possible learning opportunities for business organizations. Our daughter had done well in high school and determined she wanted to continue her education after graduating. Like millions of kids each year, she started the search for a school that would be […]

Wanted: Several healthcare departments or organizations to participate in research leveraging a lean assessment technique evaluating how value flows through their services organization. You will receive: An electronic copy of the value stream map A common understanding of actual current state Prioritized target areas; and Clear, quantifiable metrics for demonstrating impact The market value of this work is $10,000. This workshop is provided free of charge. Asking for 2-4 hrs. phone time with executive sponsor […]

Authored by George Zack, President Two Harbors Consulting – As we have set for the question, “can the frameworks you utilize for business process improvement be leveraged for your personal life,” we will now start to explore that in detail.  In this series of posts, I will work through each of the elements of a what the Capability Maturity Model (CMMI) considers a managed or defined process.  The goal of this series is to provoke thought […]

Dave Grohl once said, “I love being a drummer. Everyone thinks you’re dumb. What they don’t realize is that if it weren’t for you, their band would suck.” Contrary to what Dave believes the rhythmically-challenged think, I have great admiration for percussionists. The things some drummers can do with a drum kit seems, frankly, impossible to me. The speed of their hands…the fact that they are often doing four separate things with their hands and feet (five if you count […]

Authored by George Zack, President Two Harbors Consulting – As we have set for the question, “can the frameworks you utilize for business process improvement be leveraged for your personal life,” we will now start to explore that in detail.  In this series of posts, I will work through each of the elements of a what the Capability Maturity Model (CMMI) considers a managed or defined process.  The goal of this series is to provoke thought […]