For my capstone project, my team and I are currently developing a syringe mixer and pumper designed to evenly distribute microbubbles—specifically, mono-lipid bubbles containing treatment—within a saline solution. The primary challenge we have encountered has been related to motor issues,…   Read more»

I agree that device validation is crucial for ensuring that a product meets user needs and expectations. However, it’s important to recognize that there are several types of validation processes that play a vital role in overall product quality.  …   Read more»

People may choose to participate in clinical trials for a variety of reasons. Some may have a personal health condition that lacks effective treatment options, making them eager to try new therapies in the hope of improvement. Others may be…   Read more»

From a statistical perspective, ensuring diverse representation in clinical trials is crucial for enhancing the validity and generalizability of the results. One method to address potential biases in participant selection is blocking. Blocking is a technique used in the design…   Read more»

This SWOT analysis changes if the company was based outside of the US (taking a UK-based company for example).    Strengths: Innovative Product: The internal stent utilizes cutting-edge technology, potentially offering improved patient outcomes. Experienced Team: A skilled team with…   Read more»

A recent example of an external environment factor affecting companies is the CrowdStrike incident earlier this year. This was a major external event in the cybersecurity space, where several organizations were affected by a new strain of ransomware. This external…   Read more»

With the growing role of technology and engineering in medical device development, marketing strategies must evolve to effectively communicate value to both healthcare professionals and patients. A key adaptation is the increased use of online platforms like social media, company…   Read more»

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»