Balancing early client excitement with a product’s development readiness is tricky but crucial in medical device projects. While early interest is enc...

In the pharmaceutical and medical device industries, risk transference is a commonly used strategy—especially in areas where a third party may be bett...

Closing a project without capturing lessons learned is a missed opportunity, especially in highly regulated and complex fields like medical device dev...

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. T...

Choosing the right organizational structure plays a huge role in how well medical device projects are managed. Functional organizations, with their cl...

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, ...

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, be...

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

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 compan...

Some simple medical devices like tongue depressors, surgical gloves, and basic face masks really do have unusually long maturity phases. Because their...

You bring up a really important real-world challenge—balancing business pressures with regulatory expectations is never easy, especially in medical de...

In the medical device world, procedures and standards for verification and validation (V&V) tests usually don’t need to be directly approved by th...

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...

That’s a great point—design reviews are serious checkpoints, not just casual updates, especially in the medical device world. To ensure everything is ...

That's a really good question, and honestly, both communication and technical skills are important—but if I had to pick one, excellent communication s...