The failure of the DePuy hip implant is probably due to not enough diversity in the testing population. Real world patients can vary widely in weight, height bone density and levels of physical activity can affect an implant’s effectiveness over…   Read more»

The best way to translate a qualitative user need into a quantitative and testable design specification is through thorough research of standards and peer-reviewed literature. You must begin by identifying the functional requirements that directly support the user need, then…   Read more»

Rebuilding a design history file for a legacy combination product can be hard especially when the original documentation isn’t finished or does not exist. Since a lot of these products were made before modern design controls, the best method is…   Read more»

A contract manufacturer plays a important role in process validation by giving documented evidence that the manufacturing equipment, processes, and controls are capable of consistently producing products that meet specifications. A contract manufacturer is expected to give detailed process documentation,…   Read more»

Even though verification and validation may seem similar, they do serve different purposes. Verification is focused on confirming that the design meets the technical and regulatory requirements. Validation makes sure that the product meets the user’s needs and performs efficiently…   Read more»

A good CM manufacturer should validate machines and have a maintenance plan, and also provide full documentation for proof that the process works the same way every time. The document should have test plans, results and checks if the equipment…   Read more»

I agree that multiple review meeting should be made during a medical device’s lifecycle. Deciding on how many meetings are happening should be governed by what goals must be met before being able to move on to the next step….   Read more»

@shreya This is a great set of ideas to build upon for the complexities of developing & reviewing a potential product, especially regarding living documents, progress traceability & structure. I want to add my thoughts on using these methods. When…   Read more»

I think that these four columns are enough, but one more should be added it should be about the manufacturing process and how easy it is to build the actual product on a mass scale. It should explain the review…   Read more»

I am a proponent for extra precautions being taken no matter how similar the steps may be because it is easy when as a company the goal is to simply meet deadlines to just miss a major flaw, so I…   Read more»

I think that unforeseen circumstances can always occur no matter how in-depth of a plan someone has, it is difficult to predict every possible outcome and even if you have the best scientists available it is easy to miss something….   Read more»

While it might be possible that not every real-world failure can be predicted or fixed with design controls, however in this case highlights how design controls are not effective unless there is a workplace culture willing to enforce integrity and…   Read more»

Design transfer and process validation are closely related processes that require careful management from the right personnel. The design transfer must be completed so that the manufacturing stage can start. To prevent any issues or limitations, a contract review should…   Read more»

To answer your question, I do not believe it possible to entirely predict all real world failures of medical devices. The core problem of design controls is that they are created with what the designers or creators anticipate to occur…   Read more»

I believe that the four columns (design inputs, specifications, verification, and validation) provide enough information for a design matrix. The purpose of the matrix is to serve as a tool for mapping and tracking the entire design control process, and…   Read more»

Verification and validation are both essential processes in medical device development, each serving a distinct and critical purpose. Verification ensures that the device has been designed correctly by confirming that design outputs meet the specified design inputs. In contrast, validation…   Read more»

Understanding customer needs and translating them into clear design inputs is a fundamental step in medical device development, typically documented in the Design Input Document (DID). Customer needs, gathered from clinicians, patients, and other end users, are analyzed and converted…   Read more»

Insufficient design controls in medical device development can lead to serious consequences affecting both patient safety and regulatory compliance. Without proper design verification and validation, devices may fail to meet intended performance standards, resulting in malfunction or harm to users….   Read more»

Both processes are necessary to ensure the product pleases two key stakeholders: the company itself and its customers. Maintaining this distinct difference between them enables specialized processes that cater to the target audience(s). Putting it together would unlikely be effective….   Read more»