Methodology

We operate to strict guidelines in order for us to meet the criteria to obtain charitable status. Our sole intention is to solve problems met by the NHS, Red Cross or Medicine Sans Frontiers – or any other not-for-profit healthcare body – at no cost to them. If we develop something along the way that may make money then all the better – that money can go back to the same bodies as donations. To this end we have developed a strict methodology to accept projects.

Foresight team

Our foresight team is the first point of contact with potential candidate problems. They explore said problem with the proposer and end-users of the problem to produce a statement of need. The statement of need brings the problem into focus, explores the potential impact and its contribution to our not-for-profit ambitions. Once produced the statement of need requires approval before the project can move onto the next stages.

The next stage of the project is to produce a detailed Specification for the solution of said problem. This is conducted by one of the volunteers who becomes the project lead. Normally this project lead follows the project to final solution. They do not do this by themselves, we have volunteers – from a variety of specialisms – who support them.

Representation of our process

Medical Devices Conformance

Our processes and procedures have been designed to meet current medical devices regulations, as managed by the MHRA.

Exploitation

There is a distinct possibility that one of our solutions “has legs“: that is it has the potential to become a product in its own right. Again we have strict rules. If the product falls outside of medical devices regulations or is a Class I medical device we may choose to assume the role of manufacturer. If we decide not to, or if the product is in a higher medical devices classification we will find someone else (i.e. another company) to assume the role of manufacturer: in order to assure compliance with charity commission rules the directors / trustees will not have interests in these companies. Any profits from sales, license agreements, or sale of IP will be used to support our aims and the not-for-profit healthcare sector. Any income we generate will be used in one of three ways:

  • Support ENG4 activities
  • Be provided to the NHS and other not for profit healthcare bodies as donations.
  • Provide funding for necessary research identified by ENG4.

It is important to stress, we do not have shareholders or owners. All of our funding supports our aims.