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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How to get the most out of your remote teams as a project manager
According to Upwork, by 2025, an estimated 32.6 million Americans will be working remotely, which equates to about 22% of the workforce. This continuous shift towards remote work and remote teams presents unique challenges and opportunities for medical device companies and their project managers. In this article, we discuss actionable strategies for getting the most out of your remote teams, drawn from our interview with Courtney Jones, a seasoned project manager at Rebiotix, a Ferring Company. Let’s dive in. Strategy #1 to get the most out of your remote teams:…
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How to foster cross-departmental communication in medical device companies
If you have ever worked in a medium or large size company, you know how the communication process can sometimes resemble a high-stakes game of ‘telephone’ where the message gets lost in translation. Different departments often continue in silo mode and don’t have very open communication with other departments. It doesn’t take a project management expert to realize how damaging that is for your projects and the company as a whole. So what do you do to break down these silos and foster cross-departmental communication? To complete a project on…
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Leveraging ChatGPT for Risk Management in Medical Device companies.
The second in our AI for risk management–beginners series, this article will talk about leveraging ChatGPT for Risk Management in Medical Device companies in conjunction with traditional risk management tools. Allow me to preface this by saying our focus with these articles is on making risk management slightly easier for project managers and medical device companies. That’s why we will only touch upon AI techniques that don’t require expert-level ChatGPT skills. The best and simplest AI technique is to ask questions. In all of our experiments with GPT4, our first…
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How Artificial Intelligence(AI) can help you with risk identification
We know that risk management ensures project success by identifying and mitigating potential risks before they escalate. We also know why it can be time-consuming. With AI making progress in leaps and bounds, we decided to see how it can ease the burden on project managers for risk management. Because the topic is so vast, we decided to start with step one of risk management and talk about how Artificial Intelligence(AI) can help project managers with risk identification. If project managers in small companies go in and actually do a…
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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…
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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. …
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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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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…
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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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