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 »
Why you should know your regulatory requirements before starting a medical device project
When you build(or buy!) a house, you make sure the foundations are in place before starting anything else. The same goes for starting a new medical device project. And one of the major foundational pieces for starting a new medical device project is to know your regulatory requirements. Ignoring or misunderstanding these requirements can lead to significant setbacks, financial penalties, and even project failure. Here’s why knowing your regulatory requirements at the beginning of a project is important Knowing your regulatory requirements helps you avoid market entry barriers Ignoring regulatory…
Read More »
How not to screw up getting your medical device to market on time.
Our clients have shared with us the most important questions they have regarding project management. The first one is, how do we make sure we get the medical device to market on time? That’s clearly our client’s number one priority, as medical device development (for products to sell) drives a medical device company’s top line in years to come. When a project is delayed, it can remove the product from the market completely as it may already be obsolete due to evolving market needs and advancements by competitors. When writing…
Read More »
How to become a top-level medical device project manager
A project manager can make or break your medical device project. They are responsible for ensuring that the project is completed on time and within budget while meeting all the necessary quality and regulatory requirements. Without a top-level medical device project manager, the project can quickly get off track. At Waddell Group, excellence is not just a standard; it’s a necessity. We only work with top-level project managers. Here’s what sets them apart from others in their field: A track record of at least five successful projects under their belt. …
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 »
What to Do When Your Medical Device Project Falls Behind Schedule
Looming deadlines, anxious stakeholders, high pressure. Even if the project is going well, a medical device project manager is familiar with this. So what happens when that project falls behind schedule? What if, despite everything you have done to avoid project delay, your medical device shows no signs of reaching the market on time? What do you do then? We have two words for you: Proactive action. Let’s explore the steps you can take when your medical device project falls behind schedule. 1. Start by conducting a GAP Analysis To…
Read More »
Why is it better to have a project manager with experience in medical device development
When you have a GI tract issue, do you go to a gastroenterologist or a general practitioner? If you want to handle a property dispute, would you go to a real estate attorney or a general practice attorney? Now, think about your medical device project. If you want a project manager for it, would you prefer a typical project manager or a project manager with experience in the medical device industry? The math is simple. If you want the best service, you need to go to people who specialize in…
Read More »
Cost-Effective Strategies for Developing Medical Devices
Many companies make this mistake when it comes to cost-effective strategies for developing medical devices. The mistake; thinking cost-effective strategies equal cost-cutting. Or at least include cost-cutting. This is not necessarily the case. Sometimes, cost-cutting is the last thing you should do when it comes to medical device development. This article discusses some cost-effective development strategies that may seem counterintuitive. However, we have spent 20 years trying and testing these strategies in the medical device industry with great success. We can assure you they work. Cost-Effective Strategies for Developing Medical…
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 »