See It Coming: Using CMMI to Predict & Prevent Quality Failures in MedTech

In the medical device industry, quality failures carry serious consequences—product recalls, regulatory penalties, and risks to patient safety. But what if organizations could detect the warning signs early?

This talk explores how Capability Maturity Model Integration (CMMI), a framework familiar to the SEA community, can be used not just for process improvement, but also as a preventive system for identifying and addressing quality risks before they lead to non-compliance.

By aligning CMMI practices with FDA and ISO requirements, medical device companies can build more resilient quality management systems—reducing variability, improving traceability, and surfacing issues earlier in the lifecycle. The result: safer products, stronger compliance, and fewer surprises.

Whether you’re working in medtech or applying these principles elsewhere, this session offers a compelling look at how capability enables foresight—and how foresight protects lives.

About the Presenter

As President of Performance and Methods (P&M) Consulting, LLC, Lynn Penn consults with organizations, focusing on enhancement, institutionalization, and optimization of business operations.

As a Director at Lockheed Martin Corporation, Information Systems & Global Solutions (IS&GS), Lynn oversaw policies and process command media, process compliance via audits, and process improvement activities. She developed and managed compliance to multiple process methodologies including CMMI DEV, CMMI SVC, RMM, Lean Six Sigma, Agile, ISO 9001/AS9100, ISO 20000 and ISO 27001.

Capability Maturity Model (CMM) involvement began with SW CMM and progressed to the current CMMI version 3.0. She has participated in multiple formal SPAs, CBA IPIs, Assessments using the Acquisition Model, Risk Evaluations and supported multiple Software Capability Evaluations per versions 1, 2, and 3. She has supported multiple assessments using People CMM, RMM, previous versions of CMMI DEV, CMMI SVC, DMM and current CMMI V3.0. She was a member of the CMMI V2.0 Core Team and continues to lead CMMI reviews and pilots. She is currently a Lead Appraiser with the Medical Device Discovery Appraisal Program.

Lynn has a BS in Mathematics from Villanova University, she has done graduate studies in Computer Science and Management Information Systems. She is a certified ISO 9000 internal auditor at Lockheed Martin. She is also a Certified Greenbelt and Blackbelt in Six Sigma and Lean Techniques.

She has published the book CMMI and Six Sigma: Partners in Process Improvement.