The shift to remote work during the COVID-19 pandemic had a massive impact on leadership behaviors and organizational structures, forcing leaders to rethink how they manage, communicate, and drive productivity. Leadership across functional, project-based, and matrix organizations faced challenges unique…   Read more»

Organizational change and development extend beyond structural adjustments or operational shifts; they encompass creating a foundation for sustainable growth, resilience, and alignment with overarching organizational goals. A critical, often underemphasized, aspect of this process is the integration of adaptive strategies…   Read more»

Organizational development (OD) serves as a critical enabler for medical device manufacturing companies to successfully integrate advanced technologies such as AI and IoT. Beyond fostering adaptability and skill development, OD plays a strategic role in aligning the introduction of these…   Read more»

I’ve personally been involved in a CAPA after a few audit findings. First of all, audits are grueling! Any and all paperwork that has ever been documented has the chance to be scrutinized and picked apart and any processes that…   Read more»

I agree that risk avoidance is a foundational strategy in the manufacturing process, but it must also be complemented by mitigation efforts and risk acceptance to ensure a balanced approach. Manufacturing involves certain complexities, and while avoidance is always the…   Read more»

Risk management is an evolving process that extends beyond compliance with ISO 14971 and encompasses a broader integration of proactive methodologies through a device’s lifecycle. One important area not mentioned above is the incorporation of human factors engineering (HFE) in…   Read more»

Coordinating risk evaluations with design verification and validation results to assess potential risks throughout the development process is incredibly important. Failure Modes and Effects Analysis (FMEAs) and Hazard Analysis are two commonly used techniques that help with assessing these risks….   Read more»

Great question Samiha! In my opinion, when transferring design control and standards to any contract manufacturer, especially in medical device production, companies must consider several critical issues or limitations to ensure compliance and quality. First, quality control consistency is critical….   Read more»

The Design Transfer team ensures that all relevant design information is provided to production teams. They consolidate every critical detail, from material requirements to assembly instructions, and act as a single source of information for production teams to refer to….   Read more»

There are many factors that go into deciding how to interpret these guidelines. A few that I can think of include Regulatory Strategy and Risk Tolerance, and Experience with Regulatory Audits. In terms of regulatory strategy and risk tolerance, some…   Read more»

I think that the steps taken to define success criteria have been more or less clearly represented by previous responses in this discussion thread. I’d like to expand more on the disadvantages of moving target success criteria. For one thing, moving…   Read more»

A few more benefits of software validation include but are not limited to:Extended Device Longevity and Lower Maintenance Costs: Validated software is typically more stable and less prone to bugs or malfunctions, reducing the need for frequent updates and repairs….   Read more»

Participating in a clinical trial is a meaningful way to contribute to the development of new treatments potentially shaping the future of medicine. Modern tools make it much easier to search for trials near your location, learn about the study…   Read more»

While clinical trials are critical for evaluating the safety and efficacy of a product, they often lack in participant diversity and the real-world complexity required to paint a full picture of product performance. Some specific issues or trends not seen…   Read more»

Effective coordination and communication are essential when adverse events occur in clinical trials. Maintaining clarity between investigators, sponsors, IRBs and CROs is essential. In my opinion, using a hybrid approach would be effective. Combining standardized protocols with some flexibility for…   Read more»

Contingency plans are certainly important for companies to avoid being affected by external factors. Specifically in terms of weather, it is important for companies to maintain a diversified supply chain. Sourcing materials from multiple locations helps to mitigate the risk…   Read more»

I certainly agree that it depends on the type of person you are. To be successful in sales, there has to be some sort of extroverted nature that you can bring out when speaking with customers. I would argue, however,…   Read more»

I think the answer to this question is really based on where you want your career to end up. I have always been interested in people management. Before starting my graduate studies, I was torn between trying to attain my…   Read more»

When deciding between going with an S-Corp or C-Corp structure, one must carefully weigh the benefits of tax savings against broader opportunities such as raising capital and attracting investors. As mentioned, S-Corps have flow-through taxation. Basically, their income is only…   Read more»

Regulatory agencies such as the FDA and EMA, while governmental agencies, tend to operate similarly to non-profit organizations. They do not generate their own profit. Instead, they focus on providing the public service of ensuring that medical products are safe…   Read more»