Two other benefits of software validation include: Enhanced Regulatory Compliance: In industries such as healthcare and aerospace, software validation ensures that the device software meets the strict regulatory standards throughout its lifecycle. By adhering to these regulations, companies can facilitate…   Read more»

In my experience, the validation processes of testing and verification are essential for enhancing the quality and success of product development across various industries. These processes help detect errors early, minimize the costs associated with fixing defects, and improve product…   Read more»

I think these four columns give a solid starting point, but adding a few more could definitely enhance the matrix. A ‘Timeline’ or ‘Deadlines’ column, for example, could help keep track of when each design phase is expected to be…   Read more»

My capstone project focused on using machine learning to detect defects in roll bearings. We trained models on a variety of datasets to identify early signs of bearing wear and tear. One challenge we faced was balancing model complexity with…   Read more»

Totally agree on how industry deadlines can limit the number of inputs! From my own experience in school projects, we had to prioritize essential features to keep on schedule. In a real industry setting, I imagine it’s even more pressing,…   Read more»

I think it is very possible for teams to log additional design inputs beyond the basic requirements, especially when trying to anticipate factors impacting long-term performance, regulatory shifts, or future iterations. Over-engineered design controls are meant to prepare a product…   Read more»

When creating test methods and protocols, key factors include ensuring that the tests accurately simulate the device’s real-world use, assessing risk to patient safety, regulatory compliance, and repeatability. Each test should align with critical design inputs, measure the appropriate performance…   Read more»

Design controls are critical to mitigating potential risks in product development. They guide the design process to make sure a medical device meets safety and performance requirements. By establishing clear design inputs, conducting risk assessments, and performing verification and validation…   Read more»

In my experience in the industry, I have seen the the importance and effects of both verification and validation. The first step in the journey of the product is that it is verified to match safety and functionality according to…   Read more»

In the world of medical devices, I would imagine that companies take corporate responsibilities pretty seriously because patient safety and following FDA regulations are highly crucial. How companies actually commit however, depends on the company itself. Some factors are the…   Read more»

It can be easily argued that a change notice is required for every proposed change to any document. It is a good practice for several reasons. It ensures that everyone is dealing with changes in the same way, and allows…   Read more»

I think that design controls “force” the company to be responsible for having a product that works and does not harm anyone. At the end of the day, biomedical device companies are businesses, so the main motivator is the monetary…   Read more»

Although AI has quite a lot of potential to benefit clinical trials, there are ethical questions it brings up as well. These include bia…[Read more]

My capstone project focuses on creating a chitosan based sulfated polysaccharide hydrogel for wound healing, specifically aimed at larger cutaneous wounds, including the potential for diabetic foot ulcers. There is a gap in the market regarding diabetic wound care, as…   Read more»

I agree with you that design controls are very important for ensuring the safety and efficacy in medical device development. They help in maintaining the structural approach that aligns with FDA requirements, especially for class II and III devices which…   Read more»

When it comes to medical device companies and “corporate responsibility”, they tend to the take the matter very serious due to ethical obligations and regulatory requirements. To start with regulatory accountability, medical device companies need to follow the stringent safety…   Read more»

While it is certainly worth arguing that a Design Matrix with the four columns listed above (inputs, specifications, validation, and verification) can provide enough critical information to complete a matrix, I believe that adding additional columns could enhance the matrix’s…   Read more»

For my capstone project, my team and I designed and developed a mechano-myography (MMG) armband that was able to track the mechanical vibrations of the upper arm while also measuring the changes in circumference during a muscle contraction. The armband…   Read more»