Verification protocols matter deeply in a medical device’s journey to market because they ensure that the device meets all design, regulatory, and safety considerations in advance of validation. A well defined protocol can help teams to detect issues early which…   Read more»

Modifications are expected in the development of medical devices, albeit the extent and procedure for these modifications vary with respect to the impact on design, adherence to regulations, and project deadlines. These changes can be classified as minimal, such as…   Read more»

In order to be successful, medical device projects integrate many PMI defined Project Management Knowledge Areas, as it is crucial for every member of a team to manage scope, time, cost, quality, and risk in addition to regulatory aspects. In…   Read more»

In the development of medical devices, determining the critical path of a project is necessary for keeping the project on target. The critical path is described as the longest series of dependent tasks that determines the minimum time necessary to…   Read more»

Gantt charts are very helpful for visualizing timelines, dependencies and progress in medical device projects. They serve as a helpful tool for R&D and testing and even manufacturing while ensuring that cross-functional teams devise a cohesive plan ahead of time….   Read more»

Risk management is particularly important for medical devices since regulatory, technical, and market risks can jeopardize timelines or even result in complete failure. If a team doesn’t assess risk early on, they might be compelled to undergo additional testing, experience…   Read more»

Setting the initiation phase of a medical device project can lay the groundwork for its success. Projects can face unclear objectives, unrealistic goals, increased costs, problems with regulations, and ultimately delays or failure if there is no appropriate proposal and…   Read more»

Maintaining stakeholder expectations together with managing the project scope is critical to the success of a medical device project. A look at the company structure will confirm that the key decision makers consistently track the scope. However, there still exists…   Read more»

Verification testing is one of the most critical steps in the medical device development process. It is supposed to ensure that the product meets the design requirements, is compliant, and would work as expected. Unfortunately, many issues tend to arise…   Read more»

Managing problem-solving in different teams means that collaboration, flexible thinking, and structure will be required in the decision making process. Teams with different specialties are able to provide a wider range of ideas which leads to better solutions for the…   Read more»

I consider that the most complex aspect of managing a project for a medical device is the interplay between challenges in compliance and technology. These two factors tend to reinforce and aggravate each other, presenting major problems for project managers….   Read more»

Managing the competing needs of different stakeholders and the market for a medical device is one of the biggest and most important difficulties that has to be addressed. Investors, regulatory agencies, and top managers in the businesses, for example, focus…   Read more»

Focusing on time, cost, and scope during the design and development life cycles of a medical device is one of the challenges of project management commonly known as the ‘Project Management Triangle.’ The focus on these aspects is very crucial…   Read more»

Medtech project managers could argue that managing compliance while pursuing innovation in the design and engineering of medical devices is a delicate balancing act. While innovation is an important component for medical improvement, which could lead to improved patient care…   Read more»

Each stage of medical device development invariably results in a conflict amongst team members due to the vast areas of expertise required. Engineers, regulatory affairs, quality engineers, marketing staff, and clinical researchers all have completely different needs and priorities during…   Read more»

Establishing a clear regulatory strategy is key in medical device project management since it affects time to market, product effectiveness, and cost efficiency. In the absence of a defined route to receive regulatory approval, even the finest medical devices are…   Read more»

Design change requests (DCRs) are bound to happen in the development of a medical device either through user suggestions or feedback, risk analysis, adherence to regulations, or incorporation of new technologies. Nevertheless, unmanaged changes that are made later in the…   Read more»

Design reviews are critical in the development of medical devices to manage risks, gain compliance, and improve the product before failures that are costly in nature arise. Medical products are unlike any other product. While other products can be tested…   Read more»

Design verification is one of the phases in medical device development that serves the purpose of ensuring that the device has achieved all of the design specifications, performance capabilities, and regulatory expectations set for it prior to moving forward with…   Read more»