Hi Jacob, you’ve provided a great definition of what makes an effective design input. There’s actually a mechanism that Dr. Simon discussed this week in the lecture. To turn a qualitative design goal into a quantitative result, you need to…   Read more»

A recent (2024) example of insufficient design controls is Tandem Diabetes Care’s t:slim X2 insulin pump mobile app recall. The iOS version of the app had a software glitch that rapidly drained the battery for the pump, which caused it…   Read more»

To put it another way, verification is typically carried out during development through inspections, testing, and analyses—such as comparing dimensions, materials, or performance metrics to design specifications. On the other hand, validation frequently entails clinical assessments or real-world testing to…   Read more»

In medical device development, design control offers structure and traceability, but if the procedure is not strictly adhered to, problems might undoubtedly occur. One significant issue is inadequate documentation, which makes it nearly impossible to prove compliance during an FDA…   Read more»

As a kind of predictive planning, engineering teams frequently decide to record extra inputs in order to foresee future design modifications, regulatory comments, or new user requirements. This proactive approach can facilitate verification and validation, but if too many non-essential…   Read more»

Ok so I think this could go both ways. I think over validation can be strategically beneficial at times as a proactive measure in case of any future regulations that need to be addressed. however, the other side of it…   Read more»

I think the biggest issue is that the device would fail in the market. If a product is poorly designed or has insufficient design controls, the product wouldn’t really meet client needs. i think it would also have insufficient risk…   Read more»

I am currently taking another Medical Devices class and we actually covered this in the first lecture. Validation is the process where there is objective evidence that client needs are met. It’s basically me asking, did I make the right…   Read more»

Customer feedback plays a crucial role in shaping the design inputs of medical device development, as it provides valuable insights into user needs, preferences, and potential challenges. By incorporating feedback from healthcare professionals, patients, and other stakeholders, developers can ensure…   Read more»

Design control and risk management are integral components of medical device development, ensuring that devices are both safe and effective for use. Design control refers to the structured process that guides the development of a medical device, from concept through…   Read more»

In medical device development, verification and validation are two critical processes that ensure the safety, efficacy, and quality of a product. Verification refers to the process of checking whether the device meets its specified design requirements, ensuring that it was…   Read more»

Verification is the process of confirming that design outputs meet the specified design inputs. This typically involves documentation in the Design Verification Plan (DVP) and summarized in Design Verification Reports. These might include mechanical testing data, electrical safety testing, software…   Read more»

Teams can establish when they have done enough reviews by following the framework they initially created at the beginning of their design process. To ensure success, teams should plan to have a design review at each major milestone during the…   Read more»

I think that the number of design reviews should depend on the complexity of the device. Although the FDA requires only one formal review, a single review is not sufficient for most devices and may raise concerns during regulatory evaluation….   Read more»

I think that design controls ultimately help innovation because they make the design process more sustainable and efficient in the long run. Checkpoints such as design reviews allows the creator to ensure that the device is working as intended and…   Read more»

I believe that design controls actually support innovation rather than hinder it, because they require clearly defined user needs and plan for each stage of the design process. Creating a medical device without a genuine user need or large enough…   Read more»

I believe it is more common for verification and validation activities to remain separate processes. Verification ensures that a device has been designed correctly, while validation confirms that the correct device has been designed to meet user needs. Verification can…   Read more»

Verification and validation sound similar, but they mean different things. Verification checks if the product was made right based on the design and requirements. Validation checks if the final product actually meets the user’s or customer’s needs. For example, verification…   Read more»