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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…
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Negotiation: what needs to be done, who will do it, and by when
In any industry, effective negotiations play a pivotal role in ensuring tasks are completed on time and within budget, without compromising team dynamics. This stands doubly true for the medical device industry. Medical devices must meet strict safety and quality standards, and any mistakes or delays can be costly. On top of that, it involves multiple stakeholders, including manufacturers, suppliers, and healthcare professionals. This article takes a deep dive into the intricacies of negotiation, providing project leaders with a roadmap to navigate the complexities of team dynamics, diverse projects, and…
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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…
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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…
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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:…
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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…
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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…
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How Project Managers Can Effectively Scope and Plan a New Project.
How do you complete a new project on time and within budget while maintaining company goals and objectives? Simple. Work on the project scope and plan a new project effectively before executing it. Easier said than done, you say. I hear you. In medical device project management, it’s common to have modifications during the project’s lifetime. We just need a way to stay ahead of these possible changes and challenges to execute the project effectively. That’s what we’ll discuss below. The article includes: The steps to scope and plan a…
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