Engineering should be involved when designing the DID. The engineers will be able to give a more educated feasibility rating. Also, even though details are not needed as much in the DID as other aspects of the project it is still important to be able to provide enough information that it could be understood. A customer and a marketer might have a great idea, but engineers will be able to make sure the project stays within reason. The customer also needs to be involved in the Design input document in that they need to make sure the product is following their desires and customer needs. A failure to meet customer needs is, in most cases, a failed project. You may stumble upon a new product, but most likely will result in having a project that is not desired by anyone. This results in a huge revenue lost for the company as now the projects cost has had zero return.

I think it depends on the device in question. While I think engineers are a key aspect of the building part and setting limitations on what can and cannot be done, when it comes to designing something like a prosthetic you would want someone focused on the biomechanics spearheading the project. This would ensure the design of the device meets all the physical, aesthetic, and practical demands. I agree with williamzembrick stating that the customer should be involved. This way you have a guaranteed and satisfied market, and a failed product if you cannot meet their needs.

I agree with the posts above that the inputs for the DID should be gotten directly from the end user or customer. In my company the marketing department is responsible for gathering VOC (voice of customer) inputs and using this feedback to compile the DID. The engineers are then responsible for translating the inputs into design specifications. This phase of the project is critical for its success, because it is extremely important that the right inputs are being gathered so that the resulting product that will be designed will meet the user needs and satisfy the majority of the customers. In my company we select surgeons to use as consultants on projects, but it is important that these surgeons are representative of the surgeon population that will be using the device.

I think we have to look at where Design Inputs come from. In medical devices Design Inputs come from the following.

Industry standards
Regulations
Previous projects / products
Competitor products
End-users
Prototypes

So marketing will certainly have a role in developing the inputs by gather VOC from the end-user. As well as R&D, Regulatory, even manufacturing should have a role as the inputs may include the device manufacturability requirements. The best design inputs process will include feedback from several different functional areas.

I agree with the majority of the above sentiments. Another important perspective to obtain would be that of the surgeon. Within my company, the R&D engineers work directly with the surgeons on designs and get their direct feedback on whether something like this would be feasible. They aid in developing some inputs to a design from their shear experience. Surgeons, even nurses, offer a great wealth of insight in terms of not only how the end user/patient would use this device but also functionally whether it is a design that would not impede the original flow of an operating room. Ergonomics, size, weight are all considerations to take into account with not only the patient but the surgeons and nurses who will be implanting this device per say.

Design inputs acts as a foundation for the medical devices so this becomes necessary for any device to get into market. I agree that getting inputs right is the most important thing for developing an device. Desihgn inputs comprises of requirements, criterias for performances, features and needs of the product. Few goals to consider are 1) capture all performance, safety and regulatory requirements. 2) Look for user needs. 3) Make things clear and objective. 4) State them in a way that allows to approve or disapprove them. It should include acceptance criteria.

I agree with all the points that Devarshi has made and would also like to add that Solid Design Inputs makes the rest of medical device product development easier too. Once Design Inputs are defined, you are ready to engage in core development. The design inputs for a successful medical device should include
a) functionality, performance, and safety requirements, according to the intended use,
b) applicable statutory and regulatory requirements,
c) where applicable, information derived from previous similar designs,
d) other requirements essential for design and development, and
e) output(s) of risk management

I agree with all the points mentioned above that design inputs should include functionality, safety requirements etc. We should document the Design Inputs in such a way that allows it's ability to objectively prove have been met. Along with that, we all know that design output shall also be documented, reviewed, and approved before release. The approval, including the date and signature of the individual(s) approving the output, shall be documented. What are all other specifications to bring the design output more efficiently?

The marketing team typically identifies the need based on market evaluation for a new product to be developed and often provides design inputs mostly from VOC (voice of customer). However from my experience if the project depends solely on marketing team’s design inputs, there is likely chance the project will be unsuccessful. Other sources must be assessed for design inputs and taken into consideration. For example, sometimes the patient is not the person actually using the medical device, it could be a nurse, doctor, etc. and their input is extremely important for DID and often not captured in the VOC from marketing. Pharmacists sometimes prepares the product for nurse/ doctor and can also provide input for packaging/ instructions for use design. Other groups I would include are the engineering team that has experience with similar medical devices can provide invaluable feedback and product complaint group that can provide evaluation of issues with similar products which can be mitigated in the new design.

Design input document states what the product objective and its purpose. Besides the marketing team compiling the document, the whole team, sponsor, and customers also give their input, since the Design input document gives the necessary desires for the products based on the market and customers input. Also, another department that provides information on the product in DID is the regulatory department. It lists the functional inputs, environmental inputs, user inputs, physical inputs, labeling inputs, and regulatory.

It is imperative for the specifications in the design input document during the planning phase to be accurate and clear. In order to accomplish this, there should be collaboration from many different people in order to cover all bases on this document. The customer needs need to be taken in mind in order for the engineers to plan out the details. All in all, the design input document needs to be very broad and also very specific in order to cover the entirety of the project and allow for an easy transition through the design phase.

The design input should be a collaborative effort between the initiating process team, customer support, and stakeholders. Input from the customer support department is required to state the needs of potential users, in order to fix any shortcomings of the previous products and prevent commercial failure. The stakeholders will set their expectations of the product (such as product boundary and protected revenue), while the initiating process team works on bridging any gaps between the stakeholder’s expectations and the team’s primary objective. The scope, objective, feasibility, customer needs, expected profit, and risks should be discussed between all groups before finishing the design input document. Addressing these needs from the very beginning will minimize delays and failures down the road due to setting unrealistic goals.

Input from any different department (e.g. Marketing, Regulatory, Engineering) can only help in improving the efficiency of the device. There many be someone who doesn't offer a feasible specification but it can always be rejected. Asking for input from any individual from any other department will allow the project team to address concerns and possible questions that may arise later because they are given different perspectives. The most efficient way to bring all inputs together would be to have a document in which people can access to so that they can write and describe their thoughts on what they think is a good input. People who are working on different projects or any history on previous project could serve as a source for new inputs into a DID. Anyone can offer good thoughts and ideas, which is why it's recommended that many different people should be allowed to put their ideas into the DID. Customers, the sponsor, other project managers, and certain departments like Regulatory, Clinical Research, Quality and Engineering should definitely be allowed to input their specifications into the DID.

In the industry, engineering usually equals R&D for most companies. For the design input document, another helpful source to discuss with is production. Since they are the ones who will be responsible for manufacturing the device itself, they will need to determine if and how the device will be made. Production can be a helpful type of organizational process asset if they already have the processes and equipment needed to make this device. However, if they don't already have the equipment needed, this project now became a bigger deal.