I assume that sources of design input would be marketing studies on what type of product is needed, key opinion leaders, and scientific experts. In the lecture, Dr. Simon commented that marketing puts this together through customer opinions and development team input. Design inputs can be such things as how the device should function, how long it should last, how its visual appearance should be, etc.

Design inputs do not only include physical and performance characteristics of the device. Design inputs should also include functional requirements, safety requirements, applicable regulatory requirements and -where applicable- information from previous similar designs. I have seen many companies struggle with what to include in their design input. My suggested strategy is:
1) understand your intended use and use environment. Use these information to derive your inputs.
2) understand the need for the product and use that information to determine safety, functional and performance requirements.
3) research applicable regulatory requirements and use those as input to your requirements.
4) search similar devices that are available in the market and use those as benchmark to develop your product.
5) talk to Subject matter experts (SMEs) such as intended users, physicians, nurses, practitioners. The easiest way is usually by conducting surveys and one-on-one meetings with your key stakeholders.

Design inputs ensure that your design requirements correspond with the intended use of the device, with a strong focus on the end users needs. After doing some research on design inputs, I've found that the inputs are based on the end users needs, but aren't simply a list of the end users needs. For example, if you are going to be developing a new syringe for home injection, your end user/patient may want the device to be easy to use and safe for home use. But, your design inputs wont be "easy to use" and "safe for home use". Your design inputs will be developed by the engineers and turned into quantitative and measurable design specs.

When developing an inputs document for a new product it may be a challenge to obtain or come up with the inputs and specifications. As mentioned in the lecture, R&D engineers may help support this by performing development tests or engineering studies. By experimenting, an engineer can come up with specs for mechanical inputs, such as torque, force until failure - by testing similar products, simulating the device function, or researching data from ASTMs and scientific articles. When an engineer can develop a possible range of values for an input, they can now devise a spec that the device must either pass or not pass.

ISO 13485 identifies design input requirements. These requirements are:

Functional (7.3.2a)
Performance (7.3.2a)
Safety (7.3.2a)
Statutory/Regulatory (7.3.2b)
Previous and Similar Designs (7.3.2c)
Essential Requirements (7.3.2d)
Outputs of Risk Management (7.3.2e)
Customer Requirements (7.2.1)
Organizational Requirements (7.2.1)

Design inputs are supposed to be objective criteria for verification that the design outputs are adequate. One example of a design input is that the catheter outer diameter must be no larger than a previous design that is an 8 French catheter. Another possible design input is that the catheter outer diameter must be less than a competitor product. In both examples, a simple measurement of the OD is all that is required to complete the verification. This also gives a design team much more freedom to develop novel products than a narrow specification of 23 +/- 0.05 mm allows for.

I agree with what has been said so far. The design input is the document that provides the basic requirements of the product. It takes the input from different sources like marketing, sales, direct team, customers in order to obtain the general idea for what is in demand within the market. The customers provide the input due to needing the specific product, the sales team are constantly interacting with customers and can provide feedback based on multiple customer’s concerns or suggestions. And marketing can work to understanding the trends by conducting market intelligence research to see if the possible product would provide benefit to the customer and also if it will fulfill a business need. Some examples of feedback that can help make the DID are: the product being portable, the ideal size and weight, possible temperature requirements, etc. These ideas and suggestions are then used as a helpful guide to understanding and working to identifying the need and use for the product. One thing to keep in mind is that most of the details for the product are all broad. Only until the product the DSD (design specification document) is when more of the exact dimensions and details of the product are written into the document.

Luisa

Design Inputs are the key for medical device development. This is basically how a company can build its foundation on a certain product. In my view, design input is the start up of a device. This device must be approved of all it’s design inputs, meaning all its designs and manufacturing process must be acsepted first. Any medical device, must be examined thoroughly and making sure it can be functional and it performs according to its functions. Also, safety requirements are fulfilled. Once the Design Inputs are approved, design of the device may begin.

http://www.fda.gov/RegulatoryInformation/Guidances/ucm070627.htm

In mechanical engineering, design inputs are otherwise known as design constraints. In simpler terms, design constraints state the mandatory criteria that must be met from the final product design. All of the topics that have been previously stated: functionality, performance, safety, etc. fall under this category. These design constraints must be documented in the initial stages of design to reduce inefficiencies.

The whole team is in charge of launching a product to a target customer. You gotta to have certain a target customer, people who are willing to use the product. The project manager would then put together all the documents required to get the project going. However, marketing is the team in charge of delivering the message to all the "target customers." If you don't have an effective marketing team, you could have a really good product that nobody is willing to buy because no one knows about it.
Additionally, whenever you test the product, you gotta have as many subjects as possible, they all should have different characteristics, weight, height, etc.. If the medical device (let's say a hip joint prosthesis replacement) reaches succeed, then you can move to the next point of your timeline in the project.

Sources for the design inputs are the background studies of product in term of physiological, technical and consumer research. The main basis of every product is customer needs, the device protocol is built upon the requirements a consumer wants for the overall effective outcome in the market. Looking at the potential design specification is the next step after background research. The requirements are documented with detail descriptions for all the component and exact parameter that will be used for the design output.

Design inputs can and will come from various sources. Depending of the type of design, input can come from the customer, market research, feasibility study, medical standards, past projects, FDA, ISO, etc. Also, design input can change based on needs of the end user, schedule or any of the above source.

Hello,

I believe there are many aspects that are required for design input. The first is user needs, or what the consumer is looking for in the product. These needs can then be used to devise design concepts and weigh them to find the final concept. This concept can then be used and translated into engineering requirements specifying device dimensions and build criteria. These requirements will ultimately be used to provide the design input to move the project forward.

Design inputs can be a wiede variety of notions, both physical and in the form of an implmented stragety like marketing inputs. A web search of design controls brings up the following

" Design controls designates the application of a formal methodology to the conduct of product development activities. It is often mandatory (by regulation) to implement such practice when designing and developing products within regulated industries (e.g. medical devices)."

so for inputs of the regulatory world, some are for instacne marekting has to be certain of the claims be done in the marketing sector, and no outragoues claim should be made.

While my company primarily deals with drug delivery systems in film form, there has always been discussion of developing a device to distribute films to patients. While most of the requirements would be determine by management, market research, users, etc., since this device would be interacting with a separate product, as a researcher my opinion is also taken into account. As someone who understands all the various aspects and properties of the films, I can provide insight into who the device needs to treat the product. When dealing with a device that must interact with another product or device, I believe it would be important to have the secondary products creators input.