My team and I created a 3D-printed lattice cushioning system for construction helmets in order to lower the risk of traumatic brain injury for our capstone project. The idea was to replace conventional foam liners with a multi-layer lattice that…   Read more»

I think the four columns in the Design Matrix, inputs, specifications, validation, and verification, provide a strong foundation, but they might not be enough to capture the full scope of the design process. I would recommend adding columns for risk…   Read more»

I think our current design control systems have definitely come a long way since the Therac-25 incident, but I’m not sure they’re strong enough to completely prevent a modern “Therac moment,” especially with the rise of AI-driven devices. Standards like…   Read more»

I agree that product development is an evolutionary process that requires careful control and documentation to maintain quality. From my perspective, design control plays a critical role in ensuring that any modifications made to a device are intentional and traceable….   Read more»

I believe that many businesses, particularly smaller ones that are under pressure to launch a product quickly, first view design controls as merely another regulatory box to check. It’s simple to think of them as more paperwork rather than anything…   Read more»

I think it really depends on the company and how much they value quality in their process. Some teams tend to see design controls as just another set of documents to complete for FDA or ISO compliance, especially when project…   Read more»

A contract manufacturer has a lot of responsibility when it comes to process validation. Besides qualifying multiple machines and setting up preventive maintenance, they should also provide clear IQ, OQ, and PQ documentation that shows each step of the process…   Read more»

Similarly, as everyone has mentioned, I also believe that this incident (Therac-25) caused a fundamental rethinking and reshaping of how the industry approaches both software safety and design. With that said, it isn’t only just verification that is changing, but…   Read more»

I think a good contract manufacturer should do more than just produce the parts they should also thoroughly record every stage of the process, including operator training, equipment qualifications, and standard operating procedures. In order to show that the procedure…   Read more»

I think you brought up a great point about validating alternative equipment, in case of equipment failure. I think that in addition to validating alternative equipment, alternative materials should also be validated. Otherwise, disruptions in the supply chains can result…   Read more»

I agree that design controls are more than a regulatory requirement in the sense that they are frameworks for quality and long-term communication. To answer Krish’s question, I think that smaller startups can gain a strategic advantage if they integrate…   Read more»

Yes, a smaller startup can benefit from efficiently using design controls. The advantage can start as early as the design planning and scope management phases. A smaller startup may be more likely to develop and execute a more custom project…   Read more»

Alot of great points were already brought up in this thread. Trying to keep balance between maintaining up-to-date documentation and balancing inefficiencies, has some challenges. I agree with the approach of using controlled versions and schedules updates rather than real-time…   Read more»

I think everyone made great points regarding documentation, calibration, and clear communication between the Original Equipment Manufacturers and the Contract Manufacturer. Something that hasn’t been discussed yet, however, is ownership of data and traceability in validation. Modern validation is about…   Read more»

Controlled change really is what keeps product development from turning into chaos. Some common examples of device changes that need to be controlled include modifications to the materials used, updates to software or firmware, and adjustments to component dimensions or…   Read more»

My senior project was a model of the upper extremity that trains physical therapy and medical students to perform ligament integrity tests and joint reductions. The prototype incorporated mechanically relevant soft tissue structures and provided real-time force feedback through a…   Read more»

I think the four columns are a great starting point, but they might not capture the full story of the design process on their own. Inputs, specs, validation, and verification give a solid technical framework, but they don’t always reflect…   Read more»

I think the four columns are a great starting point, but they might not capture the full story of the design process on their own. Inputs, specs, validation, and verification give a solid technical framework, but they don’t always reflect…   Read more»

I think our current design control systems are much stronger, but not entirely error-proof. The Therac-25 tragedy definitely pushed the industry toward stricter verification, documentation, and risk management standards, which have made a huge difference. However, with AI and increasingly…   Read more»

I agree that the Therac-25 incident changed how we think about design controls; however, I think that the next “Therac moment” might come from overconfidence in verification rather than poor verification. ISO 13485 and IEC 62304 have made verification extremely…   Read more»