Archives
The dos and don’ts of preparing for FDA submissions in the medical device industry
Preparing for FDA submissions isn’t new to us. As project management consultants for the medical device industry, prepping for these(among other project management activities) is what we do well. Currently, one of our clients is in the middle of an FDA submission, responding to a round of questions. The lessons from this, and from many other submission prep efforts, are very top of mind right now, so I thought I’d share them with you. The dos of preparing for FDA submissions in the medical device industry 1. Understand your Project…
Read More »
Managing up as a project manager: The what, the how and the why
As project managers, we’re the glue that holds timelines, teams, and (often) the collective sanity of an organization together. Whether it’s a large company with specialized project managers for each project or a smaller company where the project manager handles everything project related, managing your team is only half the battle. Effective project management also involves the often-overlooked skill of “managing up”—proactively keeping leadership informed, aligned, and engaged. Knowing how to manage up effectively can make all the difference between a well-oiled medical device project and one that clanks along,…
Read More »
Employee vs. consulting project manager: Which one’s right for you?
If you’re trying to decide between hiring an employee project manager for your medical device company or bringing in a consulting project manager, you’re not alone. As the CEO of a company that provides world-class medical device project managers, I have talked to people struggling to decide between the two. While most people lean towards hiring an employee project manager, it’s important to consider both sides of the equation. There are a lot of factors to consider, and both options have their own set of pros and cons. Let’s break…
Read More »
Our New Year Gift To You
As we approach 2024, we want to take a moment to express our gratitude for your continued support and readership. It has been an incredible journey, and we are thrilled to have you as a part of it. As a token of our appreciation, we wanted to offer you a special gift – a year-end wrap-up blog post that highlights our top ten blog posts from the previous year. We hope that this compilation will help you gain predictable success will all your medical device projects. Top 10 blog posts…
Read More »
Five Tips to Making Project Management Easier for Medical Device Companies
Project management for medical devices can often feel like an episode of “Survivor,” where teams face tough challenges (product complexity, changing market and safety regulations), compete for resources, and face critical decisions at Tribal Council(project meetings). It’s an intense, high-stakes game that requires strong leadership, technical expertise, and adaptability. With these five tips, you can make medical device project management easier and make sure everyone is playing fair. Five Tips to Making Project Management Easier for Medical Device Companies – The Survivor Edition 1. Review and improve your new product…
Read More »
Hiring a medical device project consultant: What you need to know
According to a survey conducted by the Project Management Institute (PMI), 97% of organizations believe that project management is critical to business performance and organizational success. The same survey found that 80% of high-performing organizations attribute their success to the use of standardized project management practices. Now that we have established the importance of hiring a project management consultant for your medical device company let’s move on to exactly how you can do that. Hiring a medical device project consultant: What you need to know, will go into detail about:…
Read More »
How to turn a failing project around
Medical device project teams are usually multidisciplinary. The team members often include a mix of project managers, engineers, regulatory experts, and clinical researchers, to name a few. These teams are also often cross-functional, with each team member having additional roles and responsibilities beyond a particular medical device project. As a result, the project is often influenced by: If not managed well, these may lead to project failure down the line. When that happens, your best bet is to leverage the expertise and collaborative skills of these diverse team members to…
Read More »
An Insider’s Approach to medical device vendor selection + Resources
The first step to selecting the right fit vendor for your medical device project is to determine exactly what you need from your vendor. The next step — gather information on potential medical device vendors from the market to select the best vendor from the lot. Doing this research will not only help you come up with a list of potential vendors that closely match your requirements but also help you: Recently we talked about establishing a networking tree to gather current industry feedback on medical device vendors. Here are…
Read More »
What are some signs that a project isn’t going well?
Imagine this scenario with me. You have planned your medical device project down to the tee. You have sufficient budget and resources to take it to completion. You have risk mitigation in place, and you think your project is going along swimmingly. And then suddenly…boom! Despite everything you have done to avoid project failure, your medical device doesn’t reach the market. Or if it does, there are significant time and budget issues. You wonder what you could have done differently. Don’t let that happen to you. Here are the top…
Read More »
Why Can’t You Find A Qualified Medical Device Software Project Manager?
Waddell Group has seen increased demand for Software Project Managers for Medical Devices over the past several months. In our searches, these people are hard to find and extremely valuable when it comes to projects. Because they are scarce, there is a significant demand for their time, adversely impacting many medical device projects. Let’s understand why finding a good Medical Device Software Project Manager is difficult and potential solutions to combat it. The Importance Of A Medical Device Software Project Manager Information technology is advancing in leaps and bounds, and…
Read More »