Product Development

The Trap of False Problems in Medical Device Development

By François Gélinas

In the complex world of medical device development, it’s easy to get lost in the noise of different stakeholders’ demands and expectations.

It’s common for everyone to have strong opinions about what they believe is essential, but the key lies in our ability to discern true needs amidst this tumult. In other words, it’s crucial to understand the context of use, the real user needs, and the parameters that should be considered for informed decision-making.

Use Discernment to Understand the Real Need

When developing medical devices, the context of use is the guiding thread throughout the process. A customer may insist that their device be the quietest on the market, but without understanding where and how it will be used, this requirement might become an inconsequential whisper.

Consider a medical device in a hospital setting. Ambient noise can be far more disruptive than the device’s gentle hum. Understanding the context of use allows us to prioritize and allocate resources effectively.

Don't Lose Sight of Real User Needs

Real user needs can sometimes be obscured by specific requests. A request for “more quietness” might actually be expressing a need for a more soothing, focused user experience.
Engaging in a deep dialogue with the stakeholders involved in the project helps to uncover the roots of their requirements. By asking them open-ended questions, our experts can grasp the challenges they face and translate their desires into practical solutions.

Other Parameters to Consider

Every medical device designer knows that every detail matters. Parameters such as durability, ease of use, and safety are just as important, if not more so, than more obvious features.

Imagine an ultra-quiet medical device that isn’t suited for frequent cleaning or can’t withstand daily use. The pursuit of absolute quietness shouldn’t come at the expense of other crucial aspects.

Striking a Balance Between Stakeholders' Wishes and Real-World Imperatives

Medical device development is a careful dance between stakeholder wishes and real-world necessities. Understanding the context of use, deciphering real user needs and considering a wide range of parameters are the keys to informed decision-making.

When the noise of demands becomes overwhelming, it’s time to return to these fundamentals. This requires open communication, a willingness to look beyond the obvious demands, and a commitment to excellence in all aspects of medical device development.
By adopting this approach, designers can create solutions that go beyond superficial expectations to truly meet user needs, contributing to the advancement of medicine and the well-being of patients.

Author & collaborators

Written by
François Gélinas

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