When a clinician tells you they want a specific device to satisfy an unmet clinical need – how do we know whether that specific solution is actually what they want and isn’t just what the clinician thinks they want because they aren’t aware of an alternative?
I attended a recent conference entitled ‘Clinical Needs and Sensing Solutions – Meet the Clinicians’ in which a number of clinicians presented their ‘bucket lists’ of unmet clinical needs which they believe could be satisfied by sensing solutions. I have no doubt that the problems mentioned are real clinical needs, but as a medical device developer what do you do? Develop the product the clinician can tell you they want now, or try and dig deeper into the bigger picture in order to develop the product they might not even know they want yet? The two approaches could result in two very different products developed – and only one could be the ‘right’ product.
Let’s take for example a problem highlighted at the conference by an orthopaedic surgeon, with diagnosing compartment syndrome. Groups of muscles in the arms and legs are separated from each other by fascia, which create confined ‘compartments’ and which contain the muscles tissue, nerves and blood vessels. Following a trauma or crush injury, the tissue inside the fascia can swell, but the fascia itself does not, leading to an increase in pressure within the compartment and causing ‘compartment syndrome’. If this pressure goes above a threshold, blood flow to the compartment will be blocked. This can lead to permanent injury to the muscle and nerves and if the pressure lasts long enough, the muscles may die and the limb may need to be amputated. The problem highlighted by the orthopaedic surgeon was that in order to diagnose compartment syndrome, the patient must have an invasive pressure sensor inserted into the muscles in an OR and under anaesthesia.
Therefore, his unmet need was for a non-invasive pressure sensor to replace his current invasive method. I am certain that a non-invasive pressure sensor would be a good solution, however, without digging any deeper into the problem how do we know whether a non-invasive pressure sensor is the ‘right’ solution? For example, what’s driving his request and what’s his overall goal? Is it to reduce costly OR time? Is it to minimize the need for anaesthesia? Is it to minimize pain to the patient? Is it to reduce the number of amputations that occur due to compartment syndrome? We also might want to know more about the trade-offs and what’s important to the clinician. Who are the other stakeholders involved? What’s the context of use for the product? Therefore, depending on the clinician’s goals, and a number of other factors, there could be many product solutions to the problem which don’t necessarily involve a non-invasive pressure sensor.
From a human factors perspective, this is a very interesting area. It is very important to ensure that a product is usable from a safety and design perspective, but if it’s not the right product in the first place will it be a success? I believe it’s really important to have clinical input right the way through the product development process; from early investigative work at the start to define the product opportunities and then continuing with regular touch points throughout concept generation to ensure that the ‘right’ product ends up in detailed development where the more safety critical aspects of usability can then be assessed.
So – what they say they want and what they really want – are these the same thing?
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