This is the fourth blog post in a series on the changing European regulations in Europe. The previous three outlined what MDR is and why it is a concern, how to prioritize your devices in prep for the new regulations, and what to be thinking about as you perform a gap analysis.
Building A Plan of Action
This blog post concentrates on how to build a plan of action. If you need a refresher, please see the other posts or reach out to us and we can discuss how these apply to you. They are important as you must prioritize each device as well as understand the gap between where you are and where you need to be before you can create a plan to get on track to compliance.
Elements to focus on
There are four key elements to getting a plan completed: You need good planning, accurate budgeting, smart resource management and someone who will captain the ship (or Program Leadership).
Your plan must be sufficiently detailed to cover what your resources are going to be doing, with clear milestones along the way to measure progress and to create predictability to complete the project on time and on budget. This presents a great place for a strong project manager to meet/exceed your expectations. When you have done the gap analysis, you should identify how long it will take for this project to be completed.
If it is a six-month project, you may wish to outsource the project to a team like Waddell Group. If it is a multi-year project, you may wish to use in house talent or permanent employees.
You must also review your budget for this project. Where will the money come from? Odds are that you might be putting other projects on hold so that you can make sure your products stay on the market in Europe. In an earlier blog post, we discussed prioritizing your devices to get through MDR (and/or IVDR). Something similar might take place here where you weigh prioritization of products on the market vs. those you are working to get to market. What makes some projects a higher priority than others?
Management on the Project
Resource management is going to be key. As with any project, you have to know who you need (required skill set), when you need them, and how long you can keep them. Managing human capital along a timeline will be critical to getting your products compliant with MDR for your Notified Bodies.
Finally, you need strong project management. Because of the stakes for your company– your plan has to be credible, the plan must be executed on time and within budget, and you need experts who can manage all of your talented staff to this necessary end.
Contact The Waddell Group
If you’re in need of help on your medical device project contact or call the Waddell Group at 952.221.3333 We provide strategic level project leaders for the medical device industry. From start-ups to Fortune 100 companies, we go above and beyond to lead teams, manage in times of crisis, and influence change. We offer expertise, intellectual property, and proven methodology, our highly experienced consultants can help get your project across the finish line.