Based on your experience, I have only seen and done three forms of communication: Microsoft Teams messages, email, and verbal dialogue. All three are extremely effective when used correctly and with the right people. I do not believe there are…   Read more»

Testing variability can significantly impact product risk in medical device project management. Inconsistent test results can lead to uncertainty about device performance and safety. This variability may stem from differences in testing environments, equipment calibration, or operator technique. When test…   Read more»

The most effective form of communication in medical device projects is a combination of structured and transparent communication channels. Clear documentation through written reports and meeting minutes ensures traceability, which is critical for regulatory compliance. Face-to-face or virtual meetings promote…   Read more»

Using Schedule Variance (SV) and Cost Variance (CV) in medical device project management presents several challenges. First, SV and CV are often based on planned values that may not account for regulatory delays unique to the medical device industry. Second,…   Read more»

In my opinion, time, risk, and cost are the three most important knowledge areas in project management. Time is crucial because managing the project schedule ensures that tasks are completed on time, avoiding delays and maintaining stakeholder satisfaction. Risk management…   Read more»

I think it would be more effective to use Bottom-Up estimations in most cases. Using analogous estimations can be extremely dangerous for a large, complex, and costly project. An incorrect estimation can sink a project, so it is best to…   Read more»

I agree that the top reason that smaller companies may lack a formal QMS is lack of resources.This can also be attributed to budget constraints and a company-wide focus on immediate deliverables over long-term process optimization. Without dedicated QM processes,…   Read more»

The Medtronic SynchroMed II example demonstrates an important principle: the lifecycle of a device does not end once it enters the market. Instead, it enters a phase where rigorous change control, robust quality systems, and continuous post-market surveillance become critical….   Read more»

I think that cases like these really highlight how project development errors can affect stakeholders so strongly. Many parties will suffer because of something like this. The stakeholders that suffer the most are the customers/patients that use these products. Errors…   Read more»

In the medical device industry, a primary challenge is to identify, investigate, and resolve deviations in a compliant manner while avoiding significant changes to major design controls. Deviation Management, as defined by the FDA, addresses unexpected or planned events that…   Read more»

Maintaining clear communication among team members in a development project is essential, yet choosing the best communication method can be challenging due to differing personalities and communication styles. Effective communication directly impacts project management success. Several factors can hinder effective…   Read more»

In medical device projects, where precision and clarity are paramount, combining formal and informal communication methods often proves most effective. A strategic mix of these methods can address the fast-paced and intricate demands of such projects. For instance, structured weekly…   Read more»

Risk transfer is commonly confused with risk shifting. To reiterate, risk transfer is passing on (“transferring”) risk to a third party. On the other hand, risk shifting involves changing (“shifting”) the distribution of risky outcomes rather than passing on the…   Read more»

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»