I have never worked in quality assurance or control departments before, but bringing clients' opinions while developing devices would cause a lot of trouble. I believe each device has collected a lot of clients' views in the planning stage. But the final form of the device might be far from the customer's imagination. The process of opinion combination will become another task that costs a lot of time because not every client is an expert in device development. On the other hand, I believe the device with clients' attention would get more trust, and they will be more willing to use it. In conclusion, bringing the client's opinion might benefit for market or promotion, but how organize the clients' attendance more simply will be another problem.

I agree with the responder above, that often the device being developed should have started with input from the potential customer. The development of a device is for a user, and it seems obvious that the user or customer should have some oversite into the process. This is good for both parties. If the user or customer is not aware of steps being taken to make a device for them, and those steps are incorrect, they can be stopped right away. This means time and money are saved for the developer, because if they kept going, making a subpar product, they would have a product at the end that no one would buy. They would either take the complete loss or they would have to go back and change the design, costing a huge amount of time and money.

I agree with both posts above, while I don't have specific BME industry experience. In my personal exposure to industry (Telecom), clients are often removed by one degree. The large companies will interface with intermediates to the engineers. A lack of direct communication from client to firm is often what leads to delays and miscommunications. Filtering info through an intermediary is like playing a game of telephone with a couple stacks of cash on the line. It is important that the client has some input, but development should be driven by the customer input initially, after the scope has been outlined it is up to the client to interface with their contractors at the specified times. This way, reports and figures can be drawn up so real meetings can happen that generate substantive action. No vague emails or phone calls.

I think it is important to take the client's opinions into account when designing the device or product. This would normally occur in the beginning stages of design and development. If it is caught early on that a certain design aspect of the product could hinder its usage, this would ultimately save time and money on the company's end since it was still in the design phase. Of course, as mentioned in earlier posts, too many customer demands could lead to slower and inefficient product development, and as we have consistently learned in this course: in industry, time is money. I think the main way to combat this issue of too many customer needs is identifying the ones that are the highest priority and that can be achieved. Also being transparent about what limitations this device or product could have would be beneficial to the development team and the customer. For instance, if the customer wants ease of use but the ailment being targeted requires a complicated system, this could contradict this customer need. In instances like this, it is more important that the device is performing its intended function, but it is also important that though the device may be more complicated to use, it is not essentially unusable by the customer or general user due to its complexity. 

Although I have never worked in quality assurance for biomedical device development, I do believe bringing in clients/users to examine the devices during the final stages of development would be beneficial. I firmly agree with the prior statements that a successful device development process should ask for client's input earlier in the planning process, but also after the device is developed a client's input can also be worthwhile. The cliche "the customer is always right", fits perfectly here as they are the ones who will make or break whether or not this device will be successful or not at all. Yes, client's may demand more time and money to be spent on the product but allowing a customer to evaluate and provide input also sets a standard for customer service and care by the product team setting a high standard prior to the device even hitting the market. Client input will always have its pros and cons, but in order to be successful a company needs to assure the device appeals to the client's wants and needs the most.

@knd26 I admire your thought process behind the motives that may be seen in BME medical device development in industry. I think it is crucial for any company that is making a product, whether it is the first of its kind in that space or if it is taking an industry standard and improving it, to conduct proper market research as well as customer evaluations. At the end of the day, working in industry is about producing the most and the best products to help the company be as successful as possible - and the best way to do this is to listen to your audience. As @kaf43 said "the customer is always right" in this scenario is certainly applicable. I recently saw a talk about exoskeletons and understood that there is a large market gap in exo skeletons regarding ankle mobility and coverage. There are several effective exo skeletons on the market which help patients regain their walking abilities, however, there is a problem in the market where the exoskeletons do not address the ankle and this could potentially be an overlooked aspect of the exoskeleton. I don't doubt that there have been groups that have attempted to address this issue but the ability to mimic the ankle's movement as well as the natural ankle, while also helping the patient regain their abilities has proven to be a difficult task. Furthermore, asides from the gap in ankle support, the battery pack that is used for the exoskeleton is extremely heavy and gives a bulky feel for patients. Through Quality Assurance and customer surveys a company could potentially revolutionize this field by addressing two aspects of this device and in turn would ensure that this would be beneficial to the customer.

I absolutely believe that when a client is requesting a contract company to build out a medical device, it is absolutely necessary and recommended that the client come in as needed to observe, measure, analyze, and determine whether or not any adjustments is necessary. In terms of reputation, quality management, and market approval, there should be heavy involvement by the client to ensure all specifications are met and even exceeded to their design while also stamping out as many potential issues as possible that could later lead to problems, whether it be product, process, or guidelines related. At the same time, I agree with the above statements that often times, a mis-informed or brazen client might suggest making changes that can be considered unreasonable or inefficient to its main purpose or design. But as the contract manufacturer it should be their role to inform the client of the technical incapabilities for whatever reason it may be, suggest alterntives, and work with the client to compromise on the situation.

I believe that involving clients in the developmental stages of a medical device can be highly beneficial. Some reasons as to why include, the implementation of user-centered designs, having early feedback in the process, and having market insights. Having clients can help ensure that the medical device meets the user's needs from an early stage of development. This goes hand in hand with having early feedback in the developmental process which would allow the manufacturers to know exactly what it is the user is looking for. Additionally, having interactions with the clients early on can help manufacturers gain an insight into what the market is looking for and what is trending. However, it is important to manage client involvement carefully. If the client is involved too much in the process, it will take away the freedom of researching and exploring different avenues of how the device at hand can be made better because the manufacturers would be too constricted on ensuring that the client's needs are met. A well-defined plan on how often and how deeply should the client be engaged would be needed.