Prioritizing Your Medical Devices for MDD to MDR conversion
When you are creating a priority list for your Class II and III Medical Devices, you need to take many things into consideration. Most people look for the simple answer: How much revenue and profit is generated in Europe by my list of products? This can be a good litmus test, and might even be the right one for you. But we encourage you to take a step back and look at the bigger picture. You should ask yourself what the impact is of each of your products going off…
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Introduction to European Medical Device Regulation (MDR)
The European Union (EU) is set to shift the regulatory structure of medical devices from MDD to MDR compliance. Simply put, Class II, Class III, and other high-risk medical devices are going to require recertification under a new set of rules to remain on the market. The EU will not allow any devices to be grandfathered in. When your existing certification ends, you will be required to make sure you are in compliance. If this is not taken care of, your products may go off the market in Europe. If your…
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Micromanaging: Neither Good nor Evil
To micromanage or not to micromanage: that is not the question. Rather you should ask yourself how each member of your project needs to be managed. And to answer that question, you need to be very aware of the strengths, weaknesses, and personalities of each member of your team. Engaging with members of your team Some people need constant attention and are only effective when they are micromanaged. They need the daily check-in with the positive (or negative) reinforcement that comes with that. Their ability to focus requires they feel…
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How do you know when a Project Manager is not managing a project well?
In previous blog posts we talked about how projects can go off the rails and also how to prevent them from going off the rails. But those only apply if you are actively involved in the project. If you have Project Managers who report to you, what should you be looking for to know when their / your project is having trouble. Key Indicators The big “E” on any Project Management eye chart is always whether the project is on time and on budget. The other issues tend to revolve…
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Superstars: Sometimes you love them, sometimes you hate them
When you are in the medical device space, there is a level of competence and intelligence that you expect from every member of your team. The fact that your team has the ability to design, manufacture, and put a product through FDA testing means they are above average intelligence and capability. With that said, we also know there are some people who excel even among this rarified air. These are people who are smarter and more clever than the rest of us. They see through to a solution immediately while…
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Know your appetite: Avoid overly optimistic expectations
We all know that person who thinks everything will be smooth sailing and there won’t be any problems on a project. The great thing about these team members is that they are positive about the project and bring upbeat energy. However, balancing a team out with people who recognize there will be hurdles and obstacles to overcome is useful. These realists should help hold the team accountable. Identifying your project teams As a project manager, you need to identify which team members are optimistic and pessimistic. If someone is predicting…
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Why do Start Ups Need Project Management?
Waddell Group consultants have worked with all sizes of companies. One of the questions asked quite often is “why would a small company hire an outsourced project manager?” The question of hiring a Project Manager is driven by balancing the needs of investors, the experience and talent of the CEO and staff, and the market opportunity of the product. Project managers aren’t just for the big companies Project Managers are often seen as only useful in big companies. In our experience that isn’t the case at all. An effective PM…
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How to Scope a Project Successfully
In an earlier blog post we discussed how a project can go off the rails. A key cause is failing to scope a project properly. So this begs the question – how DO you scope a project properly? What belongs in your Project Scope: There are two key ways to look at this: Scope is set by defining what you are going to do Scope is set by defining what you will NOT do – this is critical When crafting a project plan draw a firm line around your product…
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Is Your Project Going Off the Rails?
Updated on June 2022. You know the scene. The team has tried to get back on the plan but everything in the medical device project seems to be running disastrously off the rails and no one quite knows why. The budget is shot, the team is disorganized and the finger-pointing has begun. Senior executives meet in a fact-finding effort to identify the problem and hope to find a solution. If this were a movie, this is when a stranger walks in with sage advice that cuts through the fog and…
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How Can an Outsourced Project Manager Deliver?
One of the most frequent questions we are asked is how we, as outsourced project managers, can expect to deliver superior results for our clients over internal project managers. The perceived challenges we supposedly face include having to adapt to a culture, learn a product, meeting the people, and work within a new team. Concerns with Project Management Some of these concerns are standard questions to outsourcing anything, but when it comes to project management, often these perceived obstacles to success are actually accelerators. We often step into an…
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