“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.
The full video of the MDICx (@MDIConline) quarterly webinar regarding the Medical Device Discovery Appraisal Program that leverages the CMMI Framework (@CMMI_Institute) is now on line: https://www.youtube.com/watch?v=9vjEtJ62DBs Great overview of program and success stories from industry. Contact us at Two Harbors if you have any questions.
“Edwards Lifesciences is among the companies participating in the pilot program, and Rob Becker, director of quality at Edwards, said the MDDA audit that the company went through in 2017 ended up costing Edwards about $74,000 compared to a traditional compliance audit that would have cost closer to $140,000. What’s more, Becker said the process involved minimal business interruption compared to what the company was used to dealing with in the compliance audit process.” https://www.mddionline.com/what-if-fda-and-medtech-worked-together-quality […]
