When a product fails verification, the immediate reaction is often to assume a fundamental flaw in the design or materials. However, in many cases, the testing conditions themselves may need reevaluat...

A key way to strengthen verification strategies after a failure is to establish a structured feedback loop where testing outcomes directly inform future design and risk management processes. When a fa...

Keeping the Design Input Document (DID) and Design Specification Document (DSD) separate helps ensure a smooth development process by allowing flexibility and better organization. The DID acts as a fo...

A key strategy for managing stakeholder expectations while staying within the project’s scope is to establish clear project boundaries from the beginning. When verification failures occur, it’s crucia...

One of the biggest challenges in medical device development is ensuring that design flaws are caught early enough to prevent costly rework or safety risks. When design reviews are conducted too infreq...

One of the biggest challenges in medical device development is handling design change requests without causing delays, confusion, or regulatory issues. Design changes can come from new regulatory requ...

One major challenge with the Humanitarian Device Exemption (HDE) is the balance between access and safety. Since these devices don’t have to meet the same level of clinical effectiveness as other Clas...

A common challenge in medical device development is creating a Design Development Plan (DDP) that is both comprehensive and flexible. The DDP serves as the foundation for the entire project, outlining...

A major challenge in medical device development is ensuring that all design decisions, changes, and testing results are well-documented to meet regulatory requirements. The Design History File (DHF) s...

Organizations can make PDCA an ongoing process by making small, frequent improvements instead of treating it as a one-time checklist. One way to do this is by incorporating PDCA into regular team meet...

Organizations can balance regulatory compliance and innovation by embedding Design Controls into their everyday workflow rather than treating them as a separate burden. Instead of waiting until the fi...

Developing combination products—such as drug-eluting stents, growth factor-releasing bone void fillers, or cell-seeded scaffolds—poses unique challenges because these products involve both medical dev...

In medical device project management, balancing time, cost, and scope is a constant challenge. While all three are interconnected, I believe time is the hardest to control. Delays can happen due to re...

A good regulatory strategy is important in medical device project management because it helps companies follow the rules, avoid delays, and get their products approved faster. Planning for regulations...

Avoiding PMA in medical device development can slow down innovation. Since PMA takes a long time and costs a lot, many companies choose to improve existing devices instead of creating entirely new one...