Balancing early client excitement with a product’s development readiness is tricky but crucial in medical device projects. While early interest is encouraging, rushing to share prototypes or skipping ...

In the pharmaceutical and medical device industries, risk transference is a commonly used strategy—especially in areas where a third party may be better equipped to handle a specific type of risk.A cl...

Closing a project without capturing lessons learned is a missed opportunity, especially in highly regulated and complex fields like medical device development. To make the most of these insights, the ...

In the fast-paced world of project management, staying on budget while keeping things on schedule can be tough—especially with so many moving parts. That’s where Earned Value Management (EVM) proves i...

Choosing the right organizational structure plays a huge role in how well medical device projects are managed. Functional organizations, with their clear departmental hierarchies, make it easy to allo...

I think the starting point has to be a deep understanding of the user needs, regulatory requirements, and the intended use of the device. From there, we can also pull information from previous product...

TMV is all about making sure that the test methods we use are accurate, reliable, and appropriate for what we’re trying to measure. In other words, before we use a test to verify or validate a design,...

1.The first step in any successful medical device project is creating a solid Design and Development Plan. This plan outlines the key activities, deliverables, and timelines for the project. It should...

That’s a great question and one that’s super important to understand in medical device development! The 510(k) pathway is generally used when a company can show that their new device is "substantially...

Some simple medical devices like tongue depressors, surgical gloves, and basic face masks really do have unusually long maturity phases. Because their design is already so effective and reliable for w...

You bring up a really important real-world challenge—balancing business pressures with regulatory expectations is never easy, especially in medical device projects. In my opinion, while it’s understan...

In the medical device world, procedures and standards for verification and validation (V&V) tests usually don’t need to be directly approved by the FDA before they’re used. However, the FDA defini...

You bring up such an important point—SV and CV are only as good as the assumptions they’re built on. I’ve definitely seen situations where the initial estimates were too optimistic, and even though th...

That’s a great point—design reviews are serious checkpoints, not just casual updates, especially in the medical device world. To ensure everything is ready on time, early preparation and clear ownersh...

That's a really good question, and honestly, both communication and technical skills are important—but if I had to pick one, excellent communication skills are more critical for a project manager. A p...