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Stage – ID1: Define the Need

It is important to identify user needs and understand what drives your audience. This is why, healthcare experts are constantly working towards recognizing new clinical requirements that need improving as technology moves on. However, sometimes those working outside the healthcare sector may also see a medical application suited to their industry that could benefit from help or advice.

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Task Overview

After identifying the clinical need, you also have to understand how you can match it with innovative technology.

What you need to do:

Answer these eight important questions about your solution:

  • Is it really new; for example, does it use a new material?
  • How does it differ from what's been done before?
  • Is it a medical device subject to specific regulations?
  • Does it need to be assessed for biological safety, e.g. because it uses new material that may be in contact with the patient?
  • What other non-medical regulations are relevant, such as electrical device safety?
  • Must it conform to ISO, European, British, ASTM or other standards?
  • How might you use functional controls, personal advice, service delivery, etc to enforce any constraints on its use?