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Episode 233  |  36:03 min  |  10.27.2021

Project Management for Product Development of Medical Devices

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This is a podcast episode titled, Project Management for Product Development of Medical Devices. The summary for this episode is: <p>What is the best way to approach project management (PM) for medical device product development? Don't settle for the trial and error method, turn to the experts with proven best practices for managing your product development project.</p><p>In this episode of the Global Medical Device Podcast, Jon Speer talks to Devon Campbell with Prodct and Christie Johnson with Kasota Engineering and Prodct partner about Greenlight Guru Academy’s new course offering, <em>Introduction to Project Management for Product Development of Medical Devices</em>.</p><h3><strong>Some of the highlights of this episode include:</strong></h3><ul><li>It’s assumed that engineers good at managing projects, getting things done, and working with different resources/team members make good project managers.</li><li>The gold standard is Gantt charts and waterfall methodologies. They have their place and have done a lot of good, but developers do not have to follow the waterfall method - it’s simply a project management practice and example.</li><li>There’s an appropriate time and place for PM practices and tools, including the Gantt chart. However, don’t blindly apply learned principles.</li><li>The wrong time to use a Gantt chart is managing how people do their work. Be vulnerable, open, and trust the professionals to know what they are doing and get their work done.</li><li>Project planning and management are not the same. Project planning does not equal project management.</li><li>Follow the Keep It Simple Stupid (KISS) philosophy. Rather than build complex and sophisticated tools, acknowledge that you won’t do it right the first time and put time in to react to what you learn and optimize.</li><li>Who’s running the show? There’s a lot of overlap and not enough room to redo, learn, and make a product better. Also, a lot of iteration happens between those steps. Give time and respect to making a product stronger.</li><li>Good project management is perpetual because there is a flow to it. It’s cyclical. Prototype and conduct testing early and often if the schedule allows to define and refine product details.</li></ul><h3><strong>Memorable quotes from this episode:</strong></h3><p><em>“Starting as an engineer and then moving into quality and approaching things with a 30,000-foot view, you kind of see the whole project and the impact of all the sub-tasks. It’s hard not to want to get involved and make sure that everything that needs to get done does.” </em>Christie Johnson</p><p><em>“It will ultimately deliver something. It might deliver it over budget. It might deliver it over time. It might deliver it with a bunch of disgruntled employees who hate going through product development because of the way that the project is being managed.” </em>Devon Campbell</p><p><em>“Potentially, too many bells and whistles that it makes it really easy for you to create something that looks really awesome, but it’s really hot garbage.” </em>Devon Campbell</p><p><em>“Critical path calculations and analyses through tools is generally meaningless. I don’t believe it whenever I see it because we build these really complex and sophisticated models.” </em>Devon Campbell</p><p><em>“There’s a lot of overlap and not enough...room to go back and redo and learn and make the product better. There’s a lot of iteration that happens between those steps.” </em>Christie Johnson</p><h3><strong>Links:</strong></h3><p><a href="https://academy.greenlight.guru/introduction-to-project-management-for-product-development-of-medical-devices" rel="noopener noreferrer" target="_blank">Introduction to Project Management for Product Development of Medical Devices</a></p><p><a href="https://medicaldevicehq.com/" rel="noopener noreferrer" target="_blank">Medical Device HQ</a></p><p><a href="https://www.prodct.dev/" rel="noopener noreferrer" target="_blank">Devon Campbell with Prodct</a></p><p><a href="https://kasotaconsult.com/about/our-team/" rel="noopener noreferrer" target="_blank">Christie Johnson with Kasota Engineering</a></p><p><a href="https://www.amazon.com/Critical-Chain-Eliyahu-M-Goldratt/dp/0884271536" rel="noopener noreferrer" target="_blank">The Critical Chain</a></p><p><a href="https://www.leanproduction.com/theory-of-constraints/" rel="noopener noreferrer" target="_blank">Theory of Constraints</a></p><p><a href="https://www.gantt.com/" rel="noopener noreferrer" target="_blank">What is a Gantt Chart?</a></p><p><a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/design-control-guidance-medical-device-manufacturers" rel="noopener noreferrer" target="_blank">FDA - Design Control Guidance for Medical Device Manufacturers (Waterfall Diagram)</a></p><p><a href="https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-system-qs-regulationmedical-device-good-manufacturing-practices" rel="noopener noreferrer" target="_blank">FDA - Quality System Regulation, Part 820</a></p><p><a href="https://www.greenlight.guru/blog/waterfall-agile-product-development-methodologies" rel="noopener noreferrer" target="_blank">Waterfall vs. Agile: Battle of the Product Development Methodologies</a></p><p><a href="https://www.amazon.com/X-teams-Build-Teams-Innovate-Succeed/dp/1591396921" rel="noopener noreferrer" target="_blank">X-teams: How to Build Teams That Lead, Innovate, and Succeed by Deborah Ancona</a></p><p><a href="https://dsmweb.org/" rel="noopener noreferrer" target="_blank">Design Structure Matrix (DSM)</a></p><p><a href="http://web.mit.edu/eppinger/www/SDE-MIT/Home.html" rel="noopener noreferrer" target="_blank">Steven D. Eppinger</a></p><p><a href="https://www.greenlight.guru/academy" rel="noopener noreferrer" target="_blank">Greenlight Guru Academy</a></p><p><a href="https://virtual-summit.greenlight.guru/" rel="noopener noreferrer" target="_blank">The Greenlight Guru True Quality Virtual Summit</a></p><p><a href="https://www.greenlight.guru/podcast-mtqs" rel="noopener noreferrer" target="_blank">MedTech True Quality Stories Podcast</a></p><p><a href="https://www.youtube.com/channel/UCYfQsPqHW8H8mZ4xpM4gn1Q" rel="noopener noreferrer" target="_blank">Greenlight Guru YouTube Channel</a></p><p><a href="https://www.greenlight.guru/" rel="noopener noreferrer" target="_blank">Greenlight Guru</a></p>