Within my senior capstone course I utilized many of the design control requirements without even realizing it. My capstone team developed a seven degree of freedom impedance controller for an intelligent assistive rehabilitation manipulator (iARM). We had to create a proposal on the idea we had which was supported by lots of research. We had our Professor act as the manager and decide whether or not our idea was sufficient enough to be a project. We had to type up a project proposal on what are device was and how it would fill a market gap. Then we had to write a DDP which explained how we were going to go about the project. Each group member was given a responsibility, we scheduled weekly meetings with our Professor and Adviser. Within our first semester we had to formulate a DID which explained the basic model of our controller. It included the number of degrees of freedom we desired, who we would market it to based on the customer needs which was determined from our Adviser. I was held accountable for the mechanics of the controller therefore, in our requirements document (similar to DSD & Design transfer) I had to report CAD models of the controller with detailed information on how to build and assemble it. We developed a test plan (similar to a design verification) to test each of our requirements (DID). In capstone, we were not responsible for design validation because our outputs were our customer needs. The second semester of the course was all about manufacturing the product and testing it. At the end of the term we had to submit all of our documents and meeting notes which accumulated into our DHF.

These nine parts in design control are crucial from my experience because it allows your team to break down your project into fine details so that you can figure out what errors you might encounter and how to avoid them without wasting time or money. I do believe that the design controls that medical device companies go through are similar to other companies such as software. The content will be different but the nine parts will be very similar for any project.

While working at General Dynamics Electric Boat on submarines, I took part in most of the design controls outlined in lecture and my experience was fairly similar to what was outlined in class except my company could benefit from some design controls we don't have (no DHF). For the most part, I think it is similar across industries and very necessary.  
 
In my experience, the planning stage is pretty much what was outlined in lecture. We would put together a DDP (didn't call it that but same thing) and gather design input. A DSD (didn't call it that but same thing) would be made to outline specifications or how we plan to do the design input. Verification was the same but validation was a little different. Validation wasn't so focused on the user, rather, it was emphasized that one should engineer something that is functional first and then consider the user second. We were told to engineer what the user had in mind but to remember that sometimes the user doesn't have an engineering background and can ask for some rather dangerous things. That being said, safety, functionality were first and what the user wanted or "feel" was last or not considered at all. Design transfer, design change requests and design review meetings was pretty much exactly what was described.

My experience with design controls so far was another course I took with Dr. Simon. The class idea was to come up with a project of a medical device and go through all the paperwork and official documents that implementing a real project would require. Every part of the design controls was emphasized and utilized to implement the "project" successfully. As Betty mentioned about Capstone, I am just starting the first semester of capstone. Utilizing design controls to breakdown and ease the process of the entire project is gonna be necessary and very beneficial to the whole team. I think that across fields those design controls are very similar.

In my senior capstone class, I used a many of the design control requirements without acknowledging it. My Capstone team built 3D BioPrinter. We used regular 3D Printer and converted into Bioprinter. We had to create a proposal on the idea we had which was supported by lots of research. At the same time, Dr. Schesser acts as the manager and decide whether or not our idea was sufficient enough to be a project. Then we had to come up with our customer need and Dr. Lee acts as the customer. Then we had to come up with our 3 design which leads to slow the problem for our customer. My team also does the elevation of the 3 design based on which customer need is the most important (planning). Next, we had to write market research and technical research ( to support our idea). For capstone 2 we developed documents and test plans( Execution). We are still working on the execution phase.

My experience with design control was with Triangle Manufacturing when I was working as a Quality Engineering co-op. One of my responsibilities was to take part in design meetings and assist the project manager to create BOM (Bill of Materials). I completely agree with the design controls as outlined in this week lecture. Most medical device manufacture companies use the similar design controls except they are named differently.

After we look at the blueprint, we have design review meeting and we identify the key process on how we are going to make that product accurately and efficiently essentially DDP (not called the same thing). Next step is to create a BOM (Bill of Materials) from the approved vendors. Verification and Validation are referenced the same in most medical companies. However, validation was little different in a way as we have to validate all the machines, that the specific product will be manufactured. That includes transferring from one machine to another and also if the same machine (same brand) is in a different building still needs validation. Furthermore, any design changes in mid production has to be noted on a special form which when the product is finished gets put in the DHF (Device History File).

All in all, the nine parts of design controls are very important in medical devices. In my opinion, they should be implemented in all the manufacturing companies as it reduces errors and helps manufacture products efficiently and accurately.

Working at the dental implant company, I have been exposed to the design control that have been mentioned in the lecture. During the beginning of the project, the general purpose of the medical device or its function is established. This is defined as the user needs which are communicated by the marketing team. After that design and development stages & activities are identified. The responsibilities and the appropriate resources are defined during this stage too. Design reviews take place when the user needs are drafted and design input are established. Design validation and verification are also carried out during the product development. Finally the design transfer is initiated and completed.

I am also currently doing my senior design project as well. It is clear to see that it simulates the design control process. I would like to add that we have a design review coming up to go over the project design requirements. I believe this will give us a better understanding of the process. Learning about it beforehand in this course will only solidify this.

As other individuals have mentioned, my first experience with design control came from my Capstone Senior Design class at NJIT. Our course instructors and team advisors performed the role of external agencies (customers, FDA, consultants, project manager). Using their input and suggestions combined with research performed by individual team members, we were able to proceed through the project proposal process (PDF). We did market research to target customer needs, and developed our project scope. The team then moved onto the design development phase (DDP). We further refined our project objectives, scheduled multiple weekly meetings, defined team member roles, and established timetable (Gantt chart). While the overall objective remained the same throughout, every week required short term objective refinement, plans for achieving said objectives, and reshaping roles to fit needs and meet goals.

Design transfer was never realized, as the objective of the project was to develop a working prototype of our project. However, design input, design output, design specification, design verification, and design validation were all realized and documented by the end of the 2 semester capstone experience. Each step was only possible with considerable guidance from our instructors who provided critical project management.

I have had design control experience in the industry as well as in academics. In the industry, I have had only the chance to read through all the design controls. But when I took Dr. Simon's class last semester, I learned much more and when he asked us to come with a new medical device and do all the paperwork behind it. Along with that, for capstone, I have had to do the similar thing. Actually writing the design controls, helps you learn more about the product and how to do the paperwork properly.

In worked on a med-device for soft bone injuries that that I built with a group of 4 people. The design was based on a modification to a cam walker boot. The design was already similar in physical trails to the boot, however we automated various function that brought together features that would usually be separate but needed in cases with soft bone injuries. The design was all mechanical and electrical. Most of the automation was done via coding in a microcontroller. The added features all came with a different part that we had to test for safety and efficacy. All of our design controls had to meet the costumer needs. The specification had to distinguish all the components and its function, it even included the coding and the electronic outline. I work with the mechanical aspects of the design and had to calibrate the sensors as well as insure all reading were mathematically correct.

Our roles were not all on physical design. Some members of the groups focused on the materials and the paper work. The market researched shoed that our device was a bit unique and would be considered a class II device due to the additional features.

In my current position, my team and I focus on Design Verification that is within Design Controls. Design Controls is an extremely important guide to engineers within the Medical Device industry. I believe that all of the steps of the Design Control process are relevant to any and all experience because it defines the product development process from start to finish. Each step is equally valuable. I currently verify and validate test methods to ensure that the process instructions to manufacture each subassembly are valid. In other words, I ensure that the current manufacturing process that is done is the only way that can be done and why it works to produce the subassemblies and products we have.

Currently this semester I have been working on my capstone project in a group of my fellow students. This semester has been dedicated to executing our design utilizing the design control requirements we established last semester. In the fall semester we were able to lay out our customer needs that were validated by our advisor and our "customer", then we came up with 3 design ideas. Using our customer needs we were able to decide on one of our designs to execute. Now that the customer needs and the design input have been validated and verified we are now beginning the design output part of our project. We are building our medical device based on the customer needs, the design idea, and the high level requirements that we laid out for ourselves. The 9 design controls are very essential for making a medical device, or executing any design because ensures the process goes smoothly.

Hello everyone ,

For the last one year i was working as a quality control analyst at Impax laboratory. I was in charge of new drug development. Protocol testing , R&D testing. I was able to work on oxycodone drug release for the company. We followed the 9 design control as mentioned in the lecture. Being new to the industry, It was a really good experience for me.Design control and the Final FDA submission is really important.

I've practiced the most, if not all of the 9 design controls covered in this week's lecture in both school and work. For my undergrad senior capstone class we had to practice design controls over the span of two semesters. Our project was to construct a rat sociability chamber with programmed software capabilities. We wrote a MATLAB program to determine sociability in TBI rats based on (x,y) position and time stamps extracted from a position tracking software. Throughout the course of this project, we went through design controls but rather than creating a DHF for step 9, we documented all our results into a final report since this was a one time project that not being continued after the class ended. At work, I have seen projects go through all 9 phases of design control until completion and some not until completion due to an impediment in the project cycle. Following these 9 steps are very important to successfully bring a product out to market. I think other fields also utilize very similar procedures in their projects. I think the med device design controls are quite broad that it can be applied outside of this particular industry.