User needs, medical devices, regulations, and Wardley maps

Before starting to develop a medical device, the prerequisite step is to identify the problem that the medical device will solve/help with. To complete this step successfully, talking to people who are affected by this problem is imperative, with a goal of identifying “user needs”. In the medical device space, patients are often the ones we are trying to help, but nurses, clinicians, and other professionals are also people to whom medical devices can provide a significant benefit — in diagnosis, treatment, monitoring, or in daily workflow. In the words of

“It is critical to understand the user needs and establish what are the actual requirements that your product needs to have in order to solve that problem.”

The concept of user needs appears in different aspects of medical device product development, and it is important to note why is it important to have them early on.

From a regulatory perspective, user needs are the foundation of the “intended use” and “intended purpose” statements, and serve as the starting point of Quality Management System (ISO13485) development. When it comes to branding, UX design, and marketing — user research, development of personas and user journeys all stem from user needs and are crucial for establishing the core components of a product or service. And finally, user needs instruct developers, software architects, engineers, and industrial designers how the product should be assembled and/or function.

This seems rather straightforward — each element of a medical device is predicated on clearly outlined user needs. And it seems that everyone involved benefits from having answers to the following questions:

Who are the people we are building our product/service for?

What is the problem they are facing?

How would our product/service help them?

What does it take to solve that problem?

But as I’m spending more time in healthtech, it is evident that the industry struggles with this step. Furthermore, the “solution-driven” approach often replaces the “problem-led” mentality, inevitably leading to a delayed-onset failure due to an illusion that this step can somehow be skipped by an “innovative”, “disruptive”, or “fill in the blank” technology that will solve everything. Among many experts in the industry who point to a general problem of poorly identifying user needs, I’ll use the quote from Greenlight Guru again:

“We don’t explore the needs of the user, and we don’t take into account all the interactions our medical device has with multiple parties”.

I’ve been thinking why is that the case and the most obvious solution is that we simply do not know (or don’t want to know) how to do it — more precisely, we don’t know about the tools that are sometimes a click away. Simply talking to people and finding out about their problem is a good start, but without a clear, structured, and sensible strategy for approaching this challenge, not much of that feedback can be effectively utilized.

A couple of months ago I was introduced to the concept of “Wardley Maps”, where user needs and interactions of users with a product are expanded to a whole new level. #Wardleymapping is a fascinating approach to explore user needs all the way to their fundamental components. Subsequent mapping of user interactions with your product, creating a value chain, and mapping the overall strategy of your product/business can undoubtedly facilitate rapid product development across all segments, and I intend on using this process for all of my future work. The most encouraging aspect of this approach is the community behind it — @Wardleymaps, @HiredThought, and others have been nothing but supportive and encouraging. For product managers and other people involved in medical device product development, I’d highly recommend looking into this approach, either through Simon Wardley and many of his inspirational videos, or by using Miro and the template created by @HiredThought.

Regardless of how user needs are identified, it is crucial for medical device manufacturers to take this step seriously — in the “Design Inputs” section of the QMS, where all of the requirements of the medical device will be laid out based on user needs. Without this step, there is no chance of getting regulatory approval to sell a medical device.

Building medical devices that will actually help solve a particular problem is a really complicated thing to do — it takes a lot of dedication, patience, and skill to create an environment where user needs are the north start of product development. I’ve seen that user needs are a common challenge for all industries, but we should take all the tools that are available to us in order to fully understand for whom are we building this device and what is the problem we are trying to solve.

Originally published at




Clinician at Huma, PhD student of Public Health focusing on hospital-acquired infections in ICUs. Building medical devices.

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Alex Despotovic

Alex Despotovic

Clinician at Huma, PhD student of Public Health focusing on hospital-acquired infections in ICUs. Building medical devices.

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