-
gg382 replied to the topic "Device Companies Org Development" – 4 months, 1 week ago
Organizational change isn’t just about adjusting structures; it’s about building a culture of collaboration and adaptability. Clear communication is key—employees need to know what’s changing, why it’s happening, and how it supports the company’s goals. This creates trust and a… Read more»
-
gg382 replied to the topic "AI & IoT in medical device industries." – 4 months, 1 week ago
Organizational development plays a vital role in helping medical device companies adopt advanced technologies like AI and IoT. It provides a structured approach to change, making it easier for teams to adapt their skills, processes, and mindsets to support innovation…. Read more»
-
gg382 replied to the topic "Value-based healthcare: "Dos and Don'ts"" – 4 months, 1 week ago
Medical device companies need to adapt to the shift toward value-based healthcare by focusing on strategies that emphasize better patient outcomes and cost efficiency. One key approach is investing in data and analytics to clearly show how their products improve… Read more»
-
gg382 replied to the topic "Evaluating in the RM process" – 4 months, 2 weeks ago
Potential risks associated with AEDs include improper electrode placement, device malfunction, and environmental hazards. Improper placement often occurs due to user error, with the probability depending on the quality of training, and the severity being high as it could delay… Read more»
-
gg382 replied to the topic "Risk Management in the Manufacturing Process" – 4 months, 2 weeks ago
I agree that risk avoidance is a critical aspect of the manufacturing process, but I think mitigation and acceptance also have their place, depending on the situation. For example, while avoidance is ideal, it’s not always feasible, especially when dealing… Read more»
-
gg382 replied to the topic "Risk Free Analysis" – 4 months, 2 weeks ago
Advancements in data analytics and AI can significantly improve post-market surveillance by enabling real-time monitoring and early detection of risks. For example, AI can analyze data from wearables or connected devices to predict failures before they occur, enhancing patient safety…. Read more»
-
gg382 replied to the topic "Design Input Requirement Categories" – 5 months ago
I’ll discuss an insulin pump as an example device: Functional – A functional requirement for an insulin pump is to deliver precise doses of insulin at regular intervals, as well as provide on-demand doses to manage blood sugar levels based… Read more»
-
gg382 replied to the topic "Validation Study Success Defined" – 5 months ago
Defining clear success criteria is fundamental to a robust validation process. To establish these criteria, a cross-functional team including representatives from engineering, quality, regulatory, and sometimes end-user stakeholders should align on key performance metrics and regulatory requirements early on. This… Read more»
-
gg382 replied to the topic "Details needed in a DHF for complex devices" – 5 months ago
To keep a DHF organized and manageable, break it down into modular sections that align with key design phases like concept, development, and testing. Within each section, group documents by type to make it easy to follow the development process…. Read more»
-
gg382 replied to the topic "Double Blind Experiment for Fibroids" – 5 months, 1 week ago
Another benefit of blinded studies, especially double- or triple-blind designs, is the reduction of the placebo effect. In cases where participants know they’re receiving a treatment, there’s a psychological tendency to perceive improvement due to expectations, regardless of actual effectiveness…. Read more»
-
gg382 replied to the topic "Tests and treatments involved in clinical trials" – 5 months, 1 week ago
Another essential testing process in clinical research for the medical device industry is the Investigational Device Exemption (IDE). This exemption allows a medical device that’s still under investigation to be used in clinical studies to collect safety and efficacy data… Read more»
-
gg382 replied to the topic "Handling Adverse Events in Trials" – 5 months, 1 week ago
When addressing unexpected adverse events in clinical trials, I think a combination of predefined protocols and event-specific flexibility is essential. Standardized guidelines set a clear baseline for accountability and efficiency, ensuring everyone knows their roles and responsibilities in routine scenarios…. Read more»
-
gg382 replied to the topic "marketing strategies and technology" – 5 months, 2 weeks ago
I completely agree with what’s been said, and I’d like to emphasize the importance of post-purchase support as a crucial aspect of medical device marketing. Especially in healthcare, ongoing education and customer service after the sale can significantly impact how… Read more»
-
gg382 replied to the topic "Long-term customer relationships in the face of increasing competition" – 5 months, 2 weeks ago
I completely agree with the points made so far. Personalization, backed by effective CRM systems, is key to maintaining customer loyalty. Another strategy to consider is creating loyalty programs that reward customers for their continued business. These programs not only… Read more»
-
gg382 replied to the topic "Importance of brand storytelling in sales and marketing strategies" – 5 months, 2 weeks ago
I agree—storytelling builds a strong emotional connection between brands and customers. Nike’s “Just Do It” campaign is a great example, using stories of perseverance and empowerment to build loyalty beyond just their products. But as companies grow, staying authentic is… Read more»
-
gg382 replied to the topic "For New Business Builders" – 5 months, 3 weeks ago
I agree that building a business requires careful planning and a solid foundation in both finances and marketing. One thing to keep in mind, though, is that while understanding accounting and financial statements is crucial, many first-time business owners underestimate… Read more»
-
gg382 replied to the topic "Differences in team dynamics and leadership styles between corporations and research labs" – 5 months, 3 weeks ago
In corporate teams, clear roles and hierarchies streamline productivity, but they can sometimes limit creativity by restricting how people think and collaborate. In contrast, research labs offer more academic freedom and interdisciplinary collaboration, which can fuel creativity but may slow… Read more»
-
gg382 replied to the topic "Business in Regulatory Agencies" – 5 months, 3 weeks ago
Regulatory agencies like the FDA and EMA operate similarly to non-profits, focusing on public safety rather than profit. They are funded through government budgets and user fees from companies seeking product approval. While these fees help expedite reviews, they can… Read more»
-
gg382 replied to the topic "Quality Assurance Job Example" – 6 months ago
I agree with the idea of involving clients or end-users in the development process, especially for medical devices. Gathering feedback early on can help ensure that the final product meets the real needs of the people who will actually use… Read more»
-
gg382 replied to the topic "Quality To The Rescue" – 6 months ago
I completely agree with everyone’s points about the importance of quality assurance and control, as well as the role of regulatory affairs and continuous improvement. One thing I’d like to add is the significance of employee training in all of… Read more»
- Load More