The two U.S.-based companies I reviewed are Zimmer Biomet Holdings, Inc. and Integra LifeSciences Corporation. They both supply surgical medical devices for spine and orthopedic conditions on the market but differ in corporate structure, size, and finances. They have similar…   Read more»

Another key component of building a business is creating a strong marketing strategy. Knowing your target audience and understanding the demographics you are selling to is critical for positioning your product or service effectively. By identifying the needs, preferences, and…   Read more»

One key element of a quality system that directly impacts the safety and efficacy of medical devices is the inspections conducted during the production process, particularly the final inspection. Inspections are critical for identifying defects, deviations, or inconsistencies before the…   Read more»

Building on this discussion, it’s essential to recognize that quality assurance (QA) has to prepare for both internal and external audits.  The primary purpose of internal audits is to assess whether internal processes, including those within the QA and QC…   Read more»

Finding a way to harmonize submissions in the biopharmaceutical industry is a challenge due to the varying requirements of regulatory agencies. In my experience, companies typically build a general template or “core dossier” that includes comprehensive data about the biologic….   Read more»

EUDAMED (European Database on Medical Devices) is an IT system created by the European Commission under the Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Device Regulation (IVDR). Its primary function is to improve transparency and strengthen the…   Read more»

In response to your question, the FDA’s approach to minor errors in compliance during an audit depends on the severity and potential risk to public health. When reviewing an audit, the FDA categorizes findings into three categories: No Action Indicated,…   Read more»

I agree that the complex and rigorous regulatory process of medical device development is difficult for companies to navigate. This is where regulatory consultants can play a crucial role in navigating the intricate requirements for FDA approval and other compliance…   Read more»

As many mentioned, it’s clear that there are significant differences between academia and industry research, particularly in terms of how they use their skills in each field. However, I also think the skills themselves are similar. For further/higher education, in…   Read more»

In fields like biomedical engineering, while deep technical expertise may not be mandatory, having foundational knowledge is crucial for understanding the complexities of projects and managing teams effectively.For a PM in biomedical engineering, the basics should include a working knowledge…   Read more»

I agree with many of the points made about the role of project managers and their need for strong communication and social skills. In my view, effective project management hinges on a few key abilities: listening, clear communication, and leadership….   Read more»

In the medical device industry, beginning certain aspects of execution during the initiation phase can be crucial, particularly for preliminary testing and development. In the medical device industry, the initiation phase often involves assessing feasibility and defining initial project scopes….   Read more»

I agree with the perspective that there is no “golden ratio” for the balance between practical and academic courses, as it truly depends on each student’s career goals. For instance, a student pursuing research may benefit more from a higher…   Read more»

While the question asks for an example of a corporation not complying with FDA regulations, I feel it’s important to highlight a broader issue—how the FDA has historically been reactive in its regulatory role, often evolving in response to public…   Read more»