The Design and Development Plan is a foundational blueprint that guides the medical device engineering process. By first setting clear objectives, the plan ensures alignment across each phase of devel...

Design verification and design validation, though both integral parts of the PDCA cycle, serve distinct roles in medical device development. Verification confirms that the product has been built accor...

Transitioning into project management in the medical device industry blends technical acumen with strong organizational skills. A typical day involves monitoring timelines with Gantt charts, coordinat...

A project manager’s ability to adapt goals while preventing scope creep also hinges on understanding the personal challenges team members may face. Imagine a scenario where a key contributor stops att...

Balancing value between stakeholders and customers often hinges on project context, timelines, and long-term strategic goals. On one hand, prioritizing customers can foster loyalty and market expansio...

Regulatory risk is indeed a significant challenge in medical device project management. Even when the team has meticulously planned for FDA approvals, shifts in regulatory standards can occur unexpect...

Project managers can cope with external risks, such as supplier delays or supply chain disruptions, by implementing proactive strategies and maintaining flexibility within the project plan. Tools like...

Incorporating new technologies into a project depends significantly on the stage of the project and requires careful evaluation to balance potential benefits with risks. Early in the project, adopting...

When verification tests fail, the first step would be to distinguish between a test design issue and a device design issue. For example, a medical device might be designed to operate within specific t...

I’ve never experienced being a ring-fenced employee after a company was sold off, but it sounds like a bad situation. From what I understand, an advantage for the company that buys the business is tha...

Consulting and legal services are critical to the success of medical device companies, especially when navigating regulatory submissions. Regulatory compliance is a complex and ever-evolving landscape...

International contract law plays a critical role for medical device companies seeking to expand into foreign markets. These companies must navigate a complex landscape of varying regulations, standard...

The sudden move to remote work during the COVID-19 pandemic introduced unique challenges and benefits that affected each organizational structure differently. Functional organizations faced hurdles in...

Organizational change in the context of functional, project-based, and matrix structures offers a range of benefits and challenges. Each structure has unique strengths: functional structures promote s...

It seems that our project has naturally evolved into a matrix organizational structure, which brings a lot of flexibility and collaboration to our workflow. While each of us is part of a dedicated pro...