Formulating a Design Input Document (DID) can require participation from every department involved on any given project. As mentioned in lecture, while marketing has a strong influence over a product's design, it is also imperative to include a member from customer support as they have more experience with the customer's personal needs. Researchers and engineers for example, may not take a patient's comfort or quality of life into consideration when designing a hip stem, in which the hip stem may be functional, but makes a squeaking noise with each step the patient takes. This can be avoided by valuing the opinions provided by customer-support, which should ideally yield a more friction-less hip implant and in turn, a rise in sales.
In terms of efficiently conveying design inputs into the DID, one must take into consideration the communication between the design team and the technical writers. For example, if a user need requires a device to be portable, then the degree of its portability must be defined to the writer to add clarity to the DID such as by stating that "the pacemaker must weigh approximately 5 lbs and have a compact shape with as little bulkiness as possible."
The DID also requires a risk management document that addresses any risks and hazards that the project may face as it progresses. What risks/hazards may result from a lack of description in the DID? What about from being overly descriptive (i.e. strictly specifying a device's dimensions, weight, color, power consumption, etc)? Can a risk management document be constructed in a way that accounts for misinformation in the DID itself (i.e. instead of stating that a pacemaker must transmit 100 pulses per minute, a zero may get forgotten and the device was mistakenly designed to transmit 10 pulses per min.)?
I believe that design input should generally be managed by the marketing team, this is because these individuals have the knowledge to know what is in demand, and therefore will design a product that will sell and make money. However, although the marketing team has to set the design needs, it is the job of the engineering team to report back and say what can realistically be done. If everything the marketing team suggested can be done then great. If there are certain things that cant be achieved then now the marketing team and engineers have to work together in order to produce a functional project that still sells. Notice in the beginning I said "generally" and that is because there are some special occasions in which there will be more people added into the process. For example, as some of my peers have said above, when building a prosthetic the needs of the customer are taken into consideration as well.
It's true that marketing team brings most of the inputs for DID as they are the one who handle all the service requests and know what is wrong with the device.
Learn from the mistakes of the earlier generation device.
Apart from that I feel doctors who use the device can give useful inputs for the device.
Also we should consider the competitor's products with ours if both do the same task and try making changes accordingly.
I think the most effective would first be getting the customer's needs to draw baseline from there look into competitors in the field with same background in order to create a better device. Looking into competitors will help improve or better the device input. Next, to me would be working with regulatory and quality control department. Regulatory will help make sure device follows FDA and other agency rules, if something is missing we can add to design input to regulate the device. Quality control will establish all risk, which the team can add or change design inputs to make medical device safe. The last process would be going to the customers whether being a corporation, surgeon, scientist, engineer, etc for final check because the customer will be buying the product, the device needs to meet customer desire, safety, and efficient.
There are plenty sources of input to pool from when developing the Design Input Document (DID). Other than the marketing department you should be collecting information from external such as consumers and doctors. Consumers can be useful by supplying knowledge in the form of surveys and focus groups to see what types of features in a device they would be interested in. For doctors, sales representatives should be spending their time in hospitals communicating with the doctors to establish performance deficiencies and which tools need improvement. They could also be sitting in on procedures and analyzing what they feel the doctor is having a tough time with. By gaining information from patients and doctors you can cover the entire spectrum of the product and determine where to allocate resources to improve the design.
I don't think there is a specific way that is the "most efficient" way to brings DID specification to the device. It depends on the device type, design team, etc. I would agree with other replies above, which emphasize that engineers would play a big role in determining the right specifications for a device in order to make it pass the validation and verification steps and meet the user (clinician & patient) requirements and needs. Regulatory and marketing members would also assist a lot in managing how well the device will succeed in meeting the relevant standards marketing and regulatory requirements in the individual market that the device will be sold.
As mentioned in the lecture, it's easier to address changes at the beginning stages of the project. In order to meet all customer needs, I believe marketing, engineering, manufacturing, and representatives from other departments should be present when determining design inputs. Input from all these disciplines will provide transparency as to the feasibility of the customer design requirements and will help foresee possible risks earlier on. Collaboration from all the disciplines at an early stage will help keep the project on track with deadlines.
Design input is foundation of medical device development without which bringing up a new product to the market is difficult. Getting the design input right is the most important thing to make sure that the product is developed correctly. There are few goals that needs to be achieved to consider the design input such as capturing functional, safety and regulatory requirements, building upon user needs and intended use. Only marketing team cannot decide the design input as no one person of the team have the responsibility for the design input. When team is involved every team member’s experience and opinions makes a difference. There are other sources while defining the design inputs such as industry standards, end users, previous projects or products, competitor products. Getting feedback from the users improves the performance of the product and studying the competitors helps the team to improve the design of the product. Previous projects or products reference will improve the performance as there will be more added features or better technology is being used.
Defining requirements of a medical product early in the process is very important to prevent some costly revisions later and any delayed time to market. Key to success of the medical device is to take into consideration the total product life cycle. The research and development team (R&D), the quality team, marketing team, regulatory, and industry standards should have a role as they give the inputs for the requirements of the project. The inputs for the DID should also come directly from the customer or the end user. The engineers should be able to take the customer needs and translate them into requirements or specifications for the project. This phase of the project is very important because the success of the project will be based on how the inputs or the customer needs are being translating. Surgeons are also important parts of this phase, as it is important to work directly with surgeons to get as much feedback as possible on designs and the specifications.
I think the answer to this question depends on the nature of the project itself. For instance, while engineers are important for the building part and setting of the project, limitations on what can and cannot be done, when it comes to designing something like a prosthetic the ideal personnel to tackle this design would not necessary be the engineer, but rather someone focused on the biomechanics spearheading the project. This would ensure the design of the device meets all the physical, aesthetic, and practical demands. Moreover customer input should also be noted to anticipate future failures from the products.
In Design input document marketing Team brings most of the specification for the device. What would be the most efficient way to brings this input and who else can help to bring in more specification so that device can be more efficient and be more useful.
Although Marketing may come up with the general, high level inputs such as what the device is intended to do, the population this device will be used for, how the device should look, etc., the design engineers will actually be the ones coming up with the specific design inputs since they are the ones who will be designing and developing the device. They will also work with cross functional departments such as Manufacturing, Quality, Regulatory, and Clinical to come up with other inputs. The key to coming up with inputs is to involve all departments as early as possible to identify all the inputs up front. If additional inputs are brought up later in the process, then the entire project will need to backtrack and update their documents accordingly.
I do agree that the marketing team is a good group of people to figure out the specifications of the device, but I also believe that engineering and regulatory should be involved in the specifications. The marketing team knows what the users and customers will want from the device, which is where they come into play, but engineering can help in how it is designed and what manufacturing will need to look at to actually create the device. A user might want something specific but if manufacturing can’t create it then it’s hard for the device to be made. Regulatory is also needed in the discussion because they know the risks of most devices and if it can align with the customers. If a device is too risky to make, then those specifications should not be allowed for the device.
I think customer input should be taken into account when making a DID. Since the DID does not need to be specific an engineer would not be needed as much as the customers needs would be needed. The DID, as seen in the lecture is supposed to give the basic desires for the product. For example “ a green key” not “ a 5-cm key with the color green #9”. The DID should have input from the market because the product should be better and more efficient than what is on the market at the time. Engineers would be needed to realize if the product can realistically be made. By this I mean that if you just take all the customer needs and try to build a product it is highly unlikely that it will work and be functioning correctly. Here the engineer can be very helpful in realizing what can be made and what is out of range. Building a product is a team effort and even though in some steps certain members or information is more useful than others everyone needs to work together to successfully complete the product.
When it comes to asking for input for DID, it is important to at least have R&D and production engineers available during these meetings. Whereas marketing and the customer have a specific image in mind, the engineers are the ones who can confirm if their goals can be made a reality. If the engineers cannot make it to the meeting, the engineers and the marketing team should meet before and after the DID input meeting to make sure all concerns are brought up during the meeting and what the final inputs are. Production can also provide information on protocols that need to be be followed and what the estimated time it could take to finish the project.
I think the engineers and manufacturing individuals should be included in developing the design inputs. These individuals would be able to best ensure that the design inputs created are within the abilities of both those designing and manufacturing the device. The manufacturing individuals would also be able to determine that the resources needed to create the device are available.
Additionally, I think it is also important to continue to consider input from the customer to ensure that the customer's needs are still being met and that they are on the same page with the project team.
