Getting Started with the New FDA Cybersecurity Guidance
New FDA cybersecurity guidance raises the bar due to the alarming increase in cyber attacks on hospitals and healthcare technology in recent years.
Medical Device Development
Using Design Controls to Undermine Medical Device Development – Part 2
Nobody sets out to write design control procedures that undermine product development but unfortunately that’s the situation I’ve observed at many medical device companies. In this blog post I continue the list of ways that your quality system can undermine your product teams (part 2 of 2)
Using Design Controls to Undermine Medical Device Development – Part 1
Nobody sets out to write design control procedures that undermine product development but unfortunately that’s the situation I’ve observed at many medical device companies. In this blog post I describe some common ways that your quality system can undermine your product teams (part 1 of 2).
What Are Medical Device Design Controls?
Medical device design controls are the regulations that govern the development of medical devices. The FDA established design controls in 1997 because they found that manufacturing controls alone were not sufficient. The FDA recognized that many patient injuries and deaths were the result of medical devices with fundamental design flaws (i.e. no matter how carefully …
Rules Are Changing for FDA Submissions for Software
Big news! After 16 years the FDA is changing its guidance on the software documentation needed in regulatory submissions.
Documentation for Medical Device Software
The documentation needed for medical device software is lengthy and complex. This article provides a list of needed documentation and tips on the best way to manage it.
Post-Mortem Pre-Celebration
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.
Successful Product Development: A Tale of Two Companies
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.
Micro Projects and Other Practices
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.
Forming the Right Product Development Team
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.