Erik Heuer describes his experiences accelerating medical device software development by bridging the gap between regulatory compliance and modern software development methods: incorporating DevOps concepts, leveraging documentation automation, and establishing the two wheels for innovation vs. development and deployment.
A post-mortem or retrospective is a valuable opportunity to make long-term improvements in a product development organization. Understanding the goals of a post-mortem and avoiding the 4 common pitfalls will ensure a successful and valuable outcome of the post-mortem.
Product teams that skip Phase Zero and jump straight into development appear to be on a faster path to market. But the consequences of a lack of Phase Zero will become painfully apparent late in product development, when problems are much more expensive to fix.
Proven ideas to be able to catch problems earlier in complex product development, rather than wait for the finale of a big integration. Break the large stretches of work into small micro projects. When possible, build prototypes in these micro projects and demonstrate to customers to get early feedback.
The right product development team is much greater than the sum of its individual team members. Forming teams for complex product development involves effective leadership, cross-functional contributions and optimized team structure for the project.
Some product teams assume invention can be tackled during the “development" phase. This is a serious mistake. Trying to unravel difficult technical problems during development or even later after the product is released can be very expensive.
Phase Zero is a period of understanding your customer needs, then defining your product pathway and completing the invention, exploration, and discovery that outlines the parameters of your product. These three concepts are key to setting the stage for successful product development.
https://vimeo.com/333499493 This webinar describes how to support rapid design iterations of medical devices while still maintaining systematic, rigorous V&V testing. Traditional approaches to V&V are often slow, inefficient, and break down with repeated testing. Learn how to configure modern SW tools to manage testing of a large number of requirements [...]
Available Now This webinar describes how to support rapid design iterations of medical devices while still maintaining systematic, rigorous V&V testing. Traditional approaches to V&V are often slow, inefficient, and break down with repeated testing. Learn how to configure modern SW tools to manage testing of a large number of [...]
https://vimeo.com/326954860 Agile Design Controls Part 2 Webinar: Dynamic Risk Management for SW-Intensive Medical Devices This webinar describes a dynamic approach to managing risk analysis and risk controls to keep up with fast moving product development teams. Learn the nuts and bolts of how to integrate risk management into the overall [...]