I think these 9 design controls are necessary as a good checklist to ensure the project proceeds smoothly. While I don’t work in a medical device company, we follow a similar structure where I work. I’m part of the design and review aspect of the 9 design controls. Once the part is designed and reviewed, we order a sample in order to do fitment checks and verify that the product does what the customer had asked us to do. Sometimes we will send it out to customers to validate that it meets their needs and is how it’s supposed to be. We also order additional quantities of the part once, the initial sample is reviewed to see if manufacturing can meet our tolerance range. We have a documentation team that keeps track of and records design changes and the project history. So even though medical device companies required to use Design controls, I think it beneficial for other companies in different industries to also use these guidelines/controls.

I have been in the medical device industry for 14 years and have worked on many aspects of design controls. Most of our recent projects have been where instead of developing a device from the beginning internally, we purchase a device that was developed by a smaller company. This device may already be on the market or may be nearing launch. A lot of my work includes taking the design controls that were created by this other company and transfering them into our quality system. In some cases we can take the design control documents and put them directly into our system, in other cases documents need updated and some testing needs to be repeated or completed. For example we may require this device to be compatible with our accessory devices. This would require us to do some sort of validation testing to ensure that a stent systems is compatible with our guidewire/guide catheter/introducer sheath. This would also mean updates to Design inputs and outputs. I definitely see these design controls as necessary in industry. I don't have a lot of experience in other industries but I would hope in any industry where lives are put at risk (construction, aerospace, etc) that similar controls are used.

From my senior year of undergrad at Rutgers University New Brunswick I was part of a project team that was working on developing a portable ultrasound device with position micron tracking so that we can accurately diagnose scoliosis. In this project group we had to follow almost all of the nine steps laid out in the lectures. We had to plan out what were goin to do over the course of the year and where we would need to start based on where the other project team before us had left off. There wasn't really a project proposal since we picked the group and project that we wanted to work on individually. However, we did set up a design development plan on how we were going to calibrate and test our portable ultrasound device. Our Design Development Plan had outlined when were going to the meet during the week and for how long we were going to meet. We had out project team members known and we had to develop a Gantt Chart for class going over all of the specs of our project. We then weighed, assessed and compared our Gantt chart at the end to see how we've done. We basically had compared our input to our output with statistically significance and taking the sensitivity and specificity when comparing the measurements we took to real life measurements. Yes, I do believe all 9 steps are necessary as they create a solid concrete platform that ensures safety and moral standards that everyone should abide by. Even though it may not apply to every project group, it makes sure that everything is safe regardless and it doesn't leave anything up to chance.