I worked on a project to develop a needle that when used by the patient "Does not hurt as much". That was the user requirement. So in order to asses what that meant or how to change that into product requirement the team sat with the medical affairs team and came to an agreement. Pain is associated with nerve simulation. Therefore the needle had to be small enough to penetrate epidermis but barely penetrate the dermis in order to successfully transfer the drug.

So from my experience I would sat that determining the user requirement would need a high level of understanding of the product and the physiology of the body and how the two relate.

When trying to decide user needs a couple questions that I think we would need to ask the users is how happy they are with the product? How effective would you say the product is in serving its desired purpose? Was the process and overall quick and pain free experience (if the product can cause any significant harm to the user)? What do you think are some improvements that we can make to the product in question? In the company I worked for patient feedback was talked about in weekly complaint meetings so that the company can go over problems with the product. We would look at what are some significant problems reported and what are some complaints that people had about ways the product had malfunctioned or had stopped serving its purpose. Then the engineering team would explain ways in which the problem can be avoided and fixed. The communications department also kept track of problems that the salesmen had reported about the product from their buyers. The design plan initially starts with brainstorming and getting rid of any bad ideas that may float into the mix. Then the a design development plan is put into place, a design specification about the medical implant is produced and distributed to all the users, and after that is verifying and validating that product through the steps that were outlined in this weeks lecture.

This is a timely question to ask! I am in Capstone which is an academic setting however, the fundamentals are what is being taught due to time constraints. One fundamental concept is the customer needs which may be researched by the students and is guided by the academic overseer of the project. Most of the needs come from the overseer due to experience and wisdom they have acquired in the industry and/or in the medical field. My group is working on a modified adhesive bandage with a revolutionized pad for wound healing application. This bandage will hopefully promote a quicker rate of wound healing and reduce scarring at a low-cost, compared to conventional adhesive bandages. We did extensive research in the market of adhesive bandages in wound healing and found a market gap for our product. The most important need is a market gap for our medical device. If existing technology is out what makes our product different and to make money? Therefore, we found a market gap. The next step knowing the customer needs and applying the tools we have to accommodate those needs. We have may needs which were done in a chart to weigh the customers needs to the technologies and process currently available at NJIT to do. In addition, we evaluate 3 potential designs for this design concept with the chart. The design that has the highest number is the one we will design based of the customer needs. We also do design reviews and status meetings which is an industry standard.

For my capstone project during undergrad, my teams project was to improve an ambulatory walker. In order to assess what the user needs were we spoke to the expert assigned to our team. She has worked with many patients that use walkers and other ambulatory devices so we got her take on what needed to be improved. We also created a questionnaire and handed it out to residents at a nearby nursing home. We did research on similar devices on the market and created questions about different design aspects we found. We had to word our questions in a way so that the residents could easily answer them. We also had to ask questions that would allow us to take their answers and figure out our design inputs/user needs.

Currently, I am working on a capstone project to develop an innovative chair to assist Dr. Tara Alvarez in her neuroscience research to treat patients with visual convergence issues. Last semester, when developing our design, we met with Dr. Alvarez to determine customer needs, work out our budget, and create a design plan. When speaking with her the first question we asked her was why this project was important; why she couldn't use just a regular chair for her research. From this conversation we determined that she needed an innovative chair that was suitable for children as well as adults. The chair must restrict excessive movement but must also be as comfortable as possible in order to keep patients still for 30-60 minutes. We created our design plan by countless hours of research trying to find the most comfortable material and also found out that there are no chairs in the market that fit ever need of our customer.We came up with three potential designs for the chair and then researched the resources available to us to finalize which design we would pursue.

The majority of medical device must be developed under the FDA Design Controls. Design Control are the means by which the FDA validates the safety and efficacy of medical devices on the market. Design Control are an important safeguard. FDA Design Control provide an overview of each of the requirements and a map for meeting them. The goals of the plan are to: Describe a detailed development plan for the medical device.  - Create a realistic budget and request approval of the resources necessary to execute the project plan.  - Assign roles and responsibilities.

In the academic setting, which is all I am familiar with, the lead investigator will tell the IRB at the institute about the project and then once they approve it and the investigator gets funding for the project by applying to grants, then the project starts. By the time the investigator is telling the IRB, they need to have a plan ready to go forward on this study. Normally, I think a good way to back up their project is by showing what other projects have done and how they resulted in success. The last thing anyone wants is to take on a project that has never been done before and then getting crushed by an injury of a subject or anything like that which would make the school liable for something it did not want. The plan the investigator has to propose involves budget, participants, and a plan for every step along the way.

Based on my experience in my undergraduate capstone project, where we created a research-based Scanning Acoustic Microscope (SAM) based on the needs of our professor (the client), important questions our group asked included those about budget, time-frame, and product specifications. Budget, time-frame, and product specifications are all very important questions to ask when regarding the user's needs, applicable to medical device projects both in research and industry. Firstly, having a clear budget plan is essential to knowing which materials are within reach and which are not. The time-frame is also important in that the user or client will likely want the device within a certain deadline, thus the group can plan accordingly and spread out tasks efficiently. Lastly, questions about the product specifications should also be asked, as this forms a core part of the medical device itself. It is important to mention that all three types of questions should be repeated throughout the course of the project, since the user's needs may change or the project team may have to adapt to new problems that occur unexpectedly. Thus, questions are very dynamic and not just asked once.

More than just having our design plan as a rigid project schedule, we would have brainstorming sessions that would not necessarily follow any project schedule, but find creative and exploratory ways to develop the device that the user needs, in order to be novel.

@sam-doksh

I agree with your plan that medical devices planning should start with FDA Design Controls, and within those controls, budget, and other necessary constraints, companies can start planning for their next product. It would be beneficial too to pull ideas from clinical studies, patient and doctor experiences, to figure out what future users would like to see. With anything being put on the market, it is important to understand the need of the product in society/ those who are using it. There's no point of using valuable resources, like time and money, for creating a product that has no market value. Getting user experience is a very important aspect of figuring out what the next product should be. 

After figuring out the qualitative logistics like timeline and budget, it is necessary to keep referring back to studies and the acquired experience because sometimes, the vision is lost when designing the product. The physician/ user should be present during meetings to make sure the device is what they want. 

Determining questions is probably one of the more tedious tasks asked of an engineer in my opinion. The need to research countless hours on current models, devices, or builds available in the market, the history of those devices and how they are applied and what current issues have been published. The most important question to ask would be, "what can be improved in *insert devices name here*?" Most of these questions are typically followed by suggestions on the engineer's end while asking the opinion of the physicians.

One of my research topics for my undergrad year was to develop a transdermal drug delivery device with my team that is capable of transmitting medicine through a patch. For us to come up with our project design, as a team, we sat and discussed current models in the market, efficient methods, and what improvements we can bring to the table. We performed tons of research and settled on the idea of using electrophoresis. Although we all thought it was a great idea and completed the project, our model was not successful as the medication we chose did not effectively penetrate the skin given the timeline we were given. Our biggest flaw was the lack of communication with physicians on how we can improve our method. This major flaw cost us time and money, but we learned a valuable lesson that day. From then on, I used what I learned and apply them at my current job.

The medical device project starts with an idea that comes to mind for a person to serve a specific purpose, and here begins the first stage of evaluation, which is evaluating the idea and formulating it by answering several questions:-

What problem does the idea address?

Is the idea applicable?

Has anyone ever done it?

To what extent has science and its applications reached in the field of this idea?

What are the available and possible solutions to address the problem?

What are the pros and cons of each possible and available solution?

What is the suggested design of the idea to treat the problem?

What is the supposed mechanism that design uses to treat the problem?

What is the goal achieved by the design?

If you have reasonable answers for these questions you can start the project.

The FDA Design Controls must be followed during the bulk of medical device development. The FDA uses design control to certify the efficacy and safety of medical devices sold on the market. Design controls are a crucial safety net. Each criterion is summarized by FDA Design Control, along with a road plan for achieving compliance. Because the vision can sometimes be forgotten when creating the product, it is important to constantly go back to studies and collected experience after determining the qualitative logistics, such as timeframe and budget. For the gadget to be what the patient/user wants, they should be present during meetings.