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 steps like design verification can lead to big problems—missed deadlines, failed tests,…   Read more»

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 clear example of transference is outsourcing clinical trials to…   Read more»

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 key is to document them in a format that is…   Read more»

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 its worth. It’s a helpful tool that brings together scope,…   Read more»

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 allocate resources and develop deep expertise, but they can also create silos…   Read more»

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 data, industry standards, feasibility studies, and…   Read more»

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, we need to…   Read more»

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 clearly map out how the team will manage design…   Read more»

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 equivalent” to an already legally marketed device (called…   Read more»

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 what they need to do, there’s little motivation—or even need—for…   Read more»

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 understandable that teams look for ways to streamline the submission process, “cutting corners” should…   Read more»

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 definitely expects that your V&V methods are based on solid,…   Read more»

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 the metrics looked fine on paper, the…   Read more»

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 ownership are essential. Teams should start by creating a design review…   Read more»

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 project manager’s main role is to coordinate people, manage…   Read more»

That’s a thoughtful question, and honestly, it hits on a real tension that project managers often face, especially in the high-stakes world of medical device development. To make an informed decision between crashing and fast tracking, project managers need to…   Read more»

Absolutely—your summary really captures the heart of effective project management. When scope, time, and cost are actively controlled, everything else tends to fall into place more smoothly. One thing I’d add is that constant communication across the team is just…   Read more»

That’s a great breakdown of how organizational planning plays a role in human resource management. For safety-critical projects—especially in medical device development where lives may be at stake—it’s essential to use tools and techniques that catch potential issues early and…   Read more»

That’s such a relevant question because finding that balance with the WBS can really make or break a project. To make sure a WBS is detailed enough but still manageable, I think the key is to focus on deliverables, not…   Read more»

That’s a really important question, especially in a field as dynamic and high-stakes as biomedical devices. To keep the project scope manageable and focused, one of the most effective strategies is to implement a strong change control process right from…   Read more»