Why medical device requirements are like eggs and soldiers

Son: “Dad… I want my toast cut zig-zag.”
Me: “Like this?”
Son: “No Dad, like triangles… it needs to be cut this way!”
Me: “But triangles have 3 sides, not 4.”
Son: “Silly Daddy!”

This typical conversation with my son held a similarity with device development. Be it shaping toast or developing a medical device, understanding a project’s requirements is fundamental.

Goal – Toast shall be cut into a zig-zag shape.

The most important requirement is the goal of the project. This could range from a straightforward definition of a device to a more ambiguous vision of who you wish to be helping when the project has completed. Projects naturally follow convoluted routes towards their goal. However, defining the objectives with stakeholders helps you keep on track whilst in the midst of the project.

“Defining project goals, ensuring understanding and iteratively evolving requirements with stakeholders ensures your project delivers what your stakeholders really want.”

Understanding – Zig-zag is like triangles.

Having a defined goal is a great start, but doesn’t mean everyone is on the exact same page – is there a shared understanding of what that goal means? Different stakeholders – sectors, organisations, departments or individuals – may have differing interpretations and understanding of your project goal. I’ve found it useful to establish and document common vocabulary between stakeholders, to reinforce the definition and establish shared expectations.

Requirement – These triangles should have 4 sides.

As high-level requirements (marketing, user, product) are established from the project stakeholders, these are interpreted within the context of the project goal to define the system. Requirements are dynamic, so will evolve to better reflect understanding the of the project and its complications over time. Even with established definitions and common vocabularies, checking requirements with stakeholders can often highlight misunderstandings. To ensure clarity of the requirements and to move towards the project’s goal, stakeholder feedback is essential.

Feedback – Toast shall be cut in a rectangular shape i.e. like classic soldiers.

Defining project goals, ensuring understanding and iteratively evolving requirements with stakeholders ensures your project delivers what your stakeholders really want. Because if you cut your soldiers into the wrong shape, you could end up with egg on your face… “Silly Daddy!”