While there’s no universal metric defining the exact degree of deviation warranting a rollback, the overarching principle is that any deviation posing a risk to safety, efficacy, or compliance is taken seriously. Implementing robust design controls and risk management practices,…   Read more»

In my experience, I’ve used weekly in person meetings in order to make actual progress in a project I’m working and discuss with coworkers. Then I use Slack and some of my free time in order to conduct more research…   Read more»

To build confidence in testing outcomes, companies often create a standardized test kit that includes the product sample, and instructions for handling, storage, and testing. This kit could include things like labeled materials, checklist for covering compound ratios, incubation time,…   Read more»

When facing a late-stage development issue, one method to consider is using the “5 Why’s” Method, where you’re keeping asking why the failure is happening up to 5 times to determine whether the root of the problem is due to…   Read more»

In medical device development, it’s critical to make sure your results are generalizable and repeatable. One way to do this may be to implement standards that all labs should use when conducting their experiments. A good demonstration of how this…   Read more»

This is a topic I was interested in discussing as well, especially after getting started on this week’s simulation. In the context of the simulation, it seems as though there were some disclosure issues: the client fully implemented the product…   Read more»

As the last post mentions, FMEA is a great and effective decision-making framework to use in such a scenario. It is extremely effective because it presents data to help calculate a risk priority number (RPN). This is an easy way…   Read more»

I agree that this would be quite a significant change, particularly because it affects a critical process that could alter the device’s biocompatibility, functionality, or performance. To implement the change without interrupting current production, I would second that the company…   Read more»

This topic is explored in Simulation 3, as a problem with cytotoxicity will force a return to the verification phase. This is costly and generally avoided unless absolutely necessary. Thus, such a step is warranted only when critical errors or…   Read more»

To build confidence in testing outcomes, teams should proactively engage in interlaboratory comparisons early in development to identify variability across labs and adjust accordingly. Establishing internal benchmarks using worst-case or most stringent test conditions can help ensure robustness against methodological…   Read more»

Adaptive project management is how projects are executed in today’s environment. Unlike traditional methodologies, this approach embraces flexibility and adaptability, continually allowing teams to learn and improve throughout the project’s lifecycle. A defining feature of adaptive project management is its…   Read more»

@benjaminrofail Hi Ben! You’ve made a good point— change fatigue is indeed a reality, particularly in regulated settings such as medical device development, where alterations in documentation and design are frequently unavoidable. I experienced this myself firsthand when I was…   Read more»

@ms3548 In my experience, working in the medical device industry, one of the biggest challenges was ensuring that data from labs outside our immediate workplace aligned with our internal expectations. This is especially true during verification and biocompatibility testing. We…   Read more»

I think the aspect of sharing unfinished designs can be improved. Even though sharing a successful idea can boost the morale of the team, it can be just as devastating if one small thing goes wrong. Therefore, I think it…   Read more»

Project teams can implement a phased approach to client interactions to manage early-stage client engagement while maintaining the integrity of the development process. This could include establishing clear milestones and decision gates where client feedback is solicited and integrated in…   Read more»

To build confidence in testing outcomes, teams can implement a robust quality assurance program that includes regular interlaboratory comparisons and proficiency testing. By engaging multiple labs early in the development cycle, discrepancies can be identified and addressed before they impact…   Read more»

A structured decision-making framework like Failure Mode and Effects Analysis (FMEA) can be invaluable when late-stage development issues arise. FMEA helps identify potential failure points and assess their impact on the project, allowing teams to prioritize actions based on risk…   Read more»