In the previous post, I examined the crucial subject of user requirements, and I went ahead to define what it was and gave an analysis to support the claims. I figured out that I had done enough justice to the topic, as you might have found out already.
However, after publishing the post, I had an interesting discussion with a friend. And I have decided to revisit the subject to provide some, hopefully useful, information regarding writing quality user requirements.
Why User Requirements Are Important?
As a quick recap: User requirements are a critical part of the medical device creation process and are essential for a solid foundation in product development.
And if poorly written or overlooked, user requirements will lead to an unsuccessful product.
What Should A Well Written User Requirement Include?
To have a high-flying user requirement that yields customer satisfaction and high sales conversion, it’s necessary to first; understand; what it takes to write it correctly, and here are some of the essential factors to consider:
Be ‘Solution Neutral’
When writing a quality user requirement, it must describe WHAT a product should do; to address the customer-need, but not HOW that product should do it.
In case you’re asking why? Well, the answer is simple!
If the user requirement specifies HOW, it will limit your concept exploration, limit the liberty for innovation and probably lead to inferior solutions.
Consider these examples:
Suppose you are addressing the need of the surgeon to operate a powered device from the sterile surgical field. And you formulate the user requirement in this way “as a surgeon, I shall be able to operate the device with a foot pedal;” you are defining the “how,” and this kind of requirement places a limit on your innovative engineers.
A more appropriate approach is “as a surgeon, I shall operate the device from the sterile field”.
Similarly, for an insulin pen injector “as a patient, I shall be able to set the dose” is better than “as a patient, I shall be able to set the dose by twisting the dial.
A Good User Requirement Should Be Justifiable
Now, here is what we mean:
The requirement must have a reason to be included in your list.
You should also include references as justification; to either your data (VOC, market research, etc) or to external sources (regulations).
It Must Be Concise, Clear, and Unambiguous
The meaning of the requirement must be crystal clear to everybody in the development team, especially to the engineers, because often they are less familiar with the customers and clinical applications.
Simply; because more than one interpretation of the requirement can produce misalignment between the requirements and design inputs.
Likewise, the content of the requirements should be concise, and unneeded text needs to be eliminated.
It Must Have A Focus
Every single requirement must focus on a single item. Similarly, if a user requirement is combined, then multiple requirements must be split into separate processes.
Self-Contained and Unique
The requirement must be easy to understand without any additional information.
That is, it should be self-explanatory.
It must also be unique. And in the list of the user requirements, there should not be more than one requirement that describes the same aspect.
It Needs To Be Essential And Significant
The requirement is necessary for the product to perform as expected and to be successful.
It Should Be Directly Related To Customers Jobs
The user requirement must be related to the customer jobs; (functional, social, personal, and emotional). According to the value proposition canvas.
Testable And To Be Validated By Any User
The requirement must be tested and validated during the development process.
Also, it is important that the requirement; can be easily validated by any other user and not only by a specific population of users.
It Should Be Consistent
An effective; user requirement must be well-aligned, and there should not be any conflict between requirements.
Uniformity
The requirements list must be uniform in terms of language, grammar, and tenses. That way, it is easy to understand and execute.
Bonus
As with other design activities, writing and developing user requirements is an iterative process. And you don’t have to be 100% sure the first time.
Even if you have to go back and forth, compare your requirements with your data, and ask for feedback from stakeholders, eventually, you will refine your ideas.
Conclusion
No doubt, generating a properly written user requirement may seem slower than necessary.
Also, it is quite common for companies to compress this step and just get to work on making the new product.
As even in large companies, there is an underlying pressure to go fast and show milestones reached.
However, a well-defined and complete user requirement set; proves invaluable throughout the development process because it ensures a complete solution for the customer and stimulates innovation.