If I were the owner of a company, I would absolutely see value in having a documented contingency plan for legal and operational decisions in case I became temporarily unavailable. In the medical device industry especially—where contracts, regulatory deadlines, and…   Read more»

Balancing legal protection with collaboration is one of the biggest challenges when drafting agreements in the medical device industry. NDAs, confidentiality agreements, and consulting contracts are meant to safeguard intellectual property and clarify responsibilities, but they can also become restrictive…   Read more»

In the medical device industry, written contracts are the standard because they protect all parties, clarify responsibilities, and support compliance with FDA and ISO requirements. Still, verbal agreements do happen, especially during early negotiations or quick operational decisions. Since verbal…   Read more»

As healthcare systems continue shifting toward value-based care, medical device companies need to adapt their operations, product strategies, and support services to align with outcomes rather than just product sales. Several organizational development strategies can help meet these new expectations.One…   Read more»

From a project manager’s perspective, both matrix and project-based organizations offer advantages—but they also come with very different types of challenges.In a project-based organization, the project manager typically has high authority. Team members are assigned full-time to the project, decision-making…   Read more»

A Gantt chart and a network diagram are both useful tools for visualizing a project timeline, but they serve slightly different purposes within the design development plan. A Gantt chart is task-oriented and time-focused—it lays out each activity along a…   Read more»

In past projects, I’ve primarily used Failure Mode and Effects Analysis (FMEA) because it provides a structured and quantitative way to assess potential risks. By breaking down each step of a process or component function, FMEA helps identify possible failure…   Read more»

I agree with your explanation — distinguishing between hazards and hazardous situations is essential because it helps clarify when and how a potential danger actually becomes a risk. A hazard on its own may not always lead to harm unless…   Read more»

I agree with your stance that risk avoidance tends to be the most favored approach in manufacturing, particularly because it directly supports safety, efficiency, and regulatory compliance. In manufacturing, risk management is deeply integrated into process design and quality control…   Read more»

You’re absolutely right — design control provides structure and accountability throughout the medical device development process, but when it’s implemented poorly or insufficiently, several issues can arise. One major problem is traceability gaps. If design inputs, outputs, or verification activities…   Read more»

That’s a great point — keeping “living documents” like the DDP continuously updated is essential, but it can easily become overwhelming if not managed well. One effective approach organizations use is controlled versioning and scheduled updates rather than real-time edits…   Read more»

Yes, typically when an error is discovered in formal design documents like a DID (Design Input Document) or DSD (Design Specification Document), a change request is issued. This is part of the document control and quality management process to ensure…   Read more»

That’s a really thoughtful point — and one that a lot of people in medical device design struggle with. Design controls can definitely feel like barriers when you’re trying to move quickly or experiment with new ideas. Having to document…   Read more»

That’s a great question—and one that every real-world engineering team faces. In practice, it’s all about finding a balance between user-centered design and business feasibility. Engineers should absolutely advocate for the ideal design that best meets user needs, because that’s…   Read more»

That’s a great question — it’s true that design verification and validation (V&V) can seem redundant at times, especially when tests or documentation overlap. However, they serve distinct purposes that complement each other. Verification ensures the device meets its design…   Read more»

I agree that Good Clinical Practice (GCP) is essential for maintaining ethical standards and protecting patients, but I also see how it can sometimes feel overly focused on documentation rather than the people participating in the studies. The guidelines are…   Read more»

You raise a really good point — it does seem at first that a single-blind study, where only the patient doesn’t know what they’re receiving, should be enough. However, the reason double-blind studies are preferred is to remove investigator bias…   Read more»

The placebo effect is a fascinating and challenging aspect of clinical research because it highlights how powerful the mind-body connection can be. When patients receiving a sham or inactive treatment (placebo) report improvements similar to those receiving the actual drug,…   Read more»

If I were to transition from an engineering role, I would likely choose marketing over sales, particularly in an upstream capacity. Marketing allows for a more strategic approach, where I could use my technical background to better understand the product,…   Read more»

Storytelling is a powerful marketing strategy because it helps brands connect with customers on an emotional level and stand out in competitive markets. When done effectively, it allows companies to express their values and create meaningful connections that build long-term…   Read more»