A nice review of the @CMMI_Institute Capability Counts Conference. Hope to see you there in 2019. https://www.youtube.com/watch?v=RiEjb_4Bz1s

The latest webinar regarding the maturity model program as a part of the Case for Quality is available from MDIC.  https://lnkd.in/efXnq9N It was great that we had two different medical device manufacturer participants presenting on their experience in the program.  Contact us if you have any questions.  

“As part of efforts to combat opioid crisis, FDA launches innovation challenge to spur development of medical devices ‒ including digital health and diagnostics ‒ that target pain, addiction and diversion … ” https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm609188.htm

This is the second podcast from Medtech Insight covering the Medical Device Discovery Appraisal Program (#MDDAP).  The program leverages the CMMI framework so device manufacturers get  feedback regarding their capabilities.  In turn they also receive regulatory benefits from CDRH.   Give it a listen and let me know what you think.  https://soundcloud.com/pharmaintelligence/device-week-may-24-2018-medtechs-next-top-maturity-model-part-2 

Part 2 of the Medtech Insight articles on the Medical Device Discovery Appraisal Program.  https://bit.ly/2K6TWRV   In this article, Baxter speaks to their rationale for getting involved in the program, and how using the CMMI framework for process improvement is important to them.

Part 1 of the Medtech Insight series on the Medical Device Discovery Appraisal Program (#MDDAP) by Shawn Schmitt. Provides a good oversight on the basics of the program that has CDRH using the CMMI framework to asses and organization’s capabilities with the provision of regulatory benefits to medical device manufacturers. https://bit.ly/2jGPlL1.  Contact us at Two Harbors if interested or if you have any questions.

Overview in podcast form of FDA’s Medical Device Discovery Appraisal Program (#MDDAP) by Shawn Schmitt (@MedtechShawn). Contact us at Two Harbors if you are interested in leveraging the CMMI framework to assess your med device organization capabilities. https://lnkd.in/gNQbZvM 

The 2.0 version of the CMMI Model has been officially announced. Contact me or any of my colleagues at Two Harbors if you have questions about the model (e.g transition from 1.3 to 2.0, how to use the model for process improvement, how we are using the 2.0 version of the model in the Medical Device Discovery Appraisal Program (#MDDAP) with the FDA).  https://www.businesswire.com/news/home/20180328005267/en/CMMI%C2%AE-Institute-Announces-CMMI-Development-V2.0

@Innovize ‘s Mark Rutkiewicz talks about the Medical Device Discovery Appraisal Program (#MDDAP) and the @CMMI_Institute framework as part of @FDAcdrhIndustry Case for Quality: https://www.mddionline.com/qa-developing-maturity-model-assessment-device-makers “The MDDAP assessment asks people throughout the company how they do their job, but with a bent toward leading them toward better practices.”  Contact us at Two Harbors Consulting if you are interested or have questions.