Quality Assurance (QA) and Quality Control (QC) are fundamentally different, leading to distinct career paths and training. QA is preventive and process-oriented, focusing on creating and managing the overall system to ensure quality is built in from the start 1;…   Read more»

You’ve perfectly captured the essential difference between the two roles. While both QA and QC are absolutely critical, I believe the biggest impact on patient safety comes from prioritizing resources in Quality Assurance (QA). The slides define QA as “Preventive…   Read more»

To keep QA efficient with new technologies like AI, we should enhance foundational principles rather than replace them. By applying adaptive frameworks like the “Plan, Do, Check, Act” (PDCA) cycle, new technologies become powerful tools within the existing quality system….   Read more»

Regulations can both hinder and drive innovation, depending on how they’re structured and applied. On one hand, overly rigid or outdated rules can slow progress by imposing high compliance costs, limiting experimentation, or discouraging startups from scaling. This is especially…   Read more»

You’ve raised a thoughtful point about the importance of top-down quality system design and the challenges that arise when companies grow, merge, or restructure. I agree that starting with a clear mission statement and cascading through the quality policy, manual,…   Read more»

Corporate teams often have structured roles and hierarchies that make them more productive by keeping goals clear and responsibilities organized, as shown in the slides for this week on how corporations operate with defined leadership roles like CEO or CFO….   Read more»

I think both improving patient care delivery and innovating with new technology are equally important for physicians who want to start their own practice. Telehealth and clinics help expand access to care and make treatment more convenient, while new devices…   Read more»

If I had the chance to build my own business, I would start by identifying a problem I’m passionate about solving and then create a plan around that. The biggest considerations would be understanding my target audience, managing finances carefully,…   Read more»

I agree that the strategic use of color is one of the most fascinating aspects of Branding in marketing. When I look at companies, I notice they are masterfully leveraging color psychology to instantly communicate their values and influence my…   Read more»

Based on the scenario of an engineer transitioning to a commercial role, I would choose to go into Upstream Marketing after my engineering role. My reason for this choice is rooted in the fact that Upstream Marketing, or Product Management,…   Read more»

I fully agree that biotech and medical device companies are extremely strategic, using a targeted approach to advertising based on demographics and necessity. This is driven by two main factors: efficiency and target audience. Since ad space is costly and…   Read more»

You can make medical device marketing more ethical and accurate by doing a human-factors testing, something similar to testing that’s done during device design. Before releasing ads about the product to the public, companies could first show them to a…   Read more»

I think one way to keep medical device marketing effective while still being ethical is implementing something similar to a traceability matrix into the marketing process. This would require every statement used in marketing to be required to be connected…   Read more»

For marketing products in general, knowing who your audience is can determine how to optimize your marketing strategy towards that audience. For medical devices specifically, that audience would typically be the hospital’s internal evaluation group rather than just physicians. Most…   Read more»

Two companies, Kimberly-Clark and Halyard Health, were found guilty of fraud eight years ago for the medical gowns they sold. The gowns were marketed for disease protection and claimed they met AAMI level 4 standards. However, the defendants concealed data…   Read more»

The transition from an Engineering role to Sales or Marketing in medical device development is a highly valuable career pivot that leverages technical expertise for commercial success. An engineer’s intimate knowledge of a device’s features and design inputs is an…   Read more»

The medical device market demonstrates a consistently robust market growth rate, fueled by global demographic and technological trends. The global market size is typically valued in the hundreds of billions of U.S. dollars and is projected to expand at a…   Read more»

Differentiation in the highly regulated and competitive medical device market is paramount for achieving sustainable market share. The primary strategy involves establishing clinical superiority, which requires demonstrating significantly better patient outcomes, reduced complication rates, or enhanced procedural efficiency through robust…   Read…[Read more]

I think the best mode of selling for this would be physicians and dentists themselves because they are the ones using it and they will be able to help spread the word because there are definitely connections. It helps if…   Read more»

I think for a medical device it is best to highlight what the other brands are lacking and then exploiting that to sell your own product. It sounds harsh, but the products are going to be different in some way…   Read more»