@dev-doshi, I agree with your point that financial models are important, but they should not be the only factor when deciding whether to invest in medical technology. I believe companies should consider both short-term costs and the long-term benefits a…   Read more»

I agree that outsourcing can help companies reduce costs and focus on their main areas of expertise. However, I believe that in the medical device industry, cost should not be the only factor when making these decisions. Quality control, patient…   Read more»

@aysegultinas, I agree with your point that there should be a balance between protecting innovation and holding medical device companies accountable. I believe leaders in the medical device industry should have a higher level of responsibility because their decisions directly…   Read more»

From my experience working in a medical laboratory, I can see why the Cost of Quality is so important. In the lab, we perform quality control, instrument maintenance, calibrations, and specimen checks before releasing patient results. These processes require time,…   Read more»

Yes, it can. Too much quality can slow innovation, but in medical devices it is necessary. Quality control is a required part of compliance. A medical device exists to deliver or support patient care. Quality control acts as an evaluator…   Read more»

The QA professional should make the final decision. AI is a useful tool that speeds up analysis, but it is not fully reliable. AI in this scenario can lack data and context needed to reach a conclusion, and it can…   Read more»

@Ahmed-elmonier, good point about claims changing the pathway. It connects to what we talked about with the 510(k) process. To get cleared, a new device has to be shown to be similar to a device already on the market, and…   Read more»

The 2011 article “Medical Devices and the Public’s Health – The FDA 510(K) Clearance Process at 35 Years” raises two major concerns. First, there is doubt about whether the 510(k) process actually ensures that medical devices on the market are…   Read more»

To show compliance, companies keep a signed consulting agreement, a record of the business need, proof of the work done, and payment records. Fair market value means paying a fair rate for the real service, not for how much the…   Read more»

M.O.R.E. is a perspective PMI introduced in 2025 as a call to action for project professionals to take accountability beyond meeting success metrics and to deliver value to stakeholders (PMI, 2025). It is not a conflict-resolution method, but its principles…   Read more»

According to the PMBOK Guide, initiation is the process of formally recognizing that a new project exists or that an existing project should continue into its next phase. In practice, it answers the foundational questions of why the project is…   Read more»

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»