I think it’s important first to define what quality assurance and quality control’s main roles are within the field of medical device development. Quality assurance (QA) is a proactive, process-focused system used to ensure that medical devices are consistently safe,…   Read more»

One critical stage in the medical device concept-to-market process that is often overlooked and treated as an afterthought is proper documentation of the design control process. The Design History File (DHF) is meant to tell the complete story of how…   Read more»

AI has been evolving in healthcare since the 1970s, beginning with expert systems such as MYCIN, which helped diagnose bacterial infections using “if-then” rules. By the 1990s, neural networks were being introduced into medical imaging and signal processing. Between 2012…   Read more»

My professional and academic journey has taken several unexpected turns, but each experience has helped me better understand my interests and goals. I initially studied Bilingual Education, however, I eventually realized that I did not feel the passion or sense…   Read more»

* The ultimate question is are the devices that are being approved are they safe and have all the steps been taken to assure this? Six years have passed since the outbreak of the COVID-19 pandemic, and during this period…   Read more»

* Would some of you perhaps prefer a combination of industry/academia? Or maybe foresee a transition to one or the other later in your career? From my professional experience, I believe that combining industry and academia can be very beneficial….   Read more»

Human Resources Management primarily focuses on creating and maintaining a positive environment within the organization to drive its goals and align with its objectives. The PMBOK guide presents various motivation theories, all of which relate to Abraham Maslow’s comprehensive theory….   Read more»

Uncertainty is an inherent part of many projects, which can lead to discouragement among team members. It is important to address this uncertainty within the project’s performance domain. There are several strategies for responding to uncertainty: Gathering Information: In clinical…   Read more»

In BoneFix’s scenario, uncertainty arises in the performance domain, leading to a lack of understanding and awareness of issues, events, paths to follow, and solutions to pursue. This unpredictability brings the risk of not knowing future events, which can contribute…   Read more»

I have observed a lack of communication at different stages of projects, with this issue being most prevalent during the execution phase. In the planning phase, team members are usually excited about the new project and eager to contribute based…   Read more»

Monitoring and controlling are important aspects from both project management (PM) and clinical research perspectives. In project management, the goal is to ensure that the project stays on schedule, remains within budget, and adheres to its defined scope. Conversely, in…   Read more»

Understanding the clinical trials process involves delivering results through a service that fosters progressive collaboration, relying on clear communication. Underperformance becomes evident when it disrupts project workflow, leading to missed deadlines, compromised quality control, and increased costs, all of which…   Read more»

In the medical device industry, a primary challenge is to identify, investigate, and resolve deviations in a compliant manner while avoiding significant changes to major design controls. Deviation Management, as defined by the FDA, addresses unexpected or planned events that…   Read more»

Maintaining clear communication among team members in a development project is essential, yet choosing the best communication method can be challenging due to differing personalities and communication styles. Effective communication directly impacts project management success. Several factors can hinder effective…   Read more»

Changes are a normal part of any project, often arising from shifts in the project environment or risks associated with design controls. These modifications to the control process can significantly impact various aspects of project development, and it is essential…   Read more»

The success of a project largely depends on the closing phase. This phase is critical for generating insights that can lead to new ideas for improving or evolving the final product. Future project teams should gather insights from past projects…   Read more»

Validation is crucial in assessing test results. In a fast-paced world where immediate answers are required, there is a temptation to prioritize technological innovation to deliver rapid results, often bypassing essential protocols for quality control, verification, and validation. I work…   Read more»

The work breakdown structure (WBS) should be developed alongside scope verification. Together, these two processes enhance the effectiveness of delivering inputs and outputs before moving on to quality assurance. In creating a work breakdown structure, the scope statement serves as…   Read more»