Invention Pathway

Invention

The creation stage of the pathway, where regulations need to be considered. Key stakeholders should also be identified, and engaged as early as possible to aid in product development.

Considerations

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Prototypes may need to be tested and refined as this is an iterative process

Relevance:Devices and DiagnosticsDigital

Inventors should continue to refer back to the unmet needs of the NHS and patients

Relevance:Devices and DiagnosticsDigital

Considering involving end-users in this stage is helpful

Relevance:Devices and DiagnosticsDigital

Consider what clinical evaluation will be required to verify safety and performance dependent on the class of devices. For medical devices, product testing 
requirements are dependent on 
the class of Medical Device, with higher risk devices requiring more extensive clinical testing

Relevance:Devices and DiagnosticsDigital

Consider the new European regulations are coming into effect from 2017

Relevance:Devices and DiagnosticsDigital

Identify key stakeholders to input into your trial design

Relevance:Devices and DiagnosticsDigital

Engage with external stakeholders such as the NIHR and NICE Office of Market Access when designing any study to ensure that it is appropriate for regulatory approval processes

Relevance:Devices and DiagnosticsDigital

The aim of Phase I trials is for researchers to test a new drug or treatment in a small group of people to evaluate its safety, determine dosage ranges and identify side effects

Relevance:Pharmaceutical

Phase II trials further evaluate a drug’s safety with a wider group of people (can be up to 100)

Relevance:Pharmaceutical

Whereas Phase I uses healthy volunteers, Phase II volunteers are usually receiving their first treatment; and pharmaceutical companies have the following aims:

  • To test whether the new treatment works, and if it works well enough to continue to Phase III
  • To deepen understanding of side effects and their management
  • To understand dosing levels or test options around formulation and presentation
Relevance:Pharmaceutical

Medical devices, including software are defined as those used to diagnose, prevent, monitor, treat or alleviate disease or injury; to diagnose, monitor, treat, alleviate or compensate an injury or handicap, to investigate, replace or modify the human body or a physiological process; or as a contraceptive. Medical devices may be classified as Class I, Class IIa, Class IIb or Class III according to their associated complexity and risk. Class I has the lowest risk and Class III the highest

Relevance:Devices and Diagnostics

In vitro diagnostic medical devices are defined as: medical devices, such as reagents, calibrators, control material test tubes, to perform a diagnostic test, like checking blood for signs of infections or urine for the presence of glucose, using material from the human body. In vitro diagnostics are also categorised according to risk: General (low risk), Self test, Annex II List B, Annex II List A (high risk)

Relevance:Devices and Diagnostics
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