Taking a Product to Market

 

As with all technology development good innovation will start from one or more people having a bright idea - i.e. identifying a market either from knowledge of the unmet needs of a population, or, the potential of some novel technology to allow things to be achieved not previously possible or at a greatly reduced cost.

Essentially the process of medical device product development should apply:

  • Have the Idea

    •  

     

  • Verify Idea through discussion with a wider group preferably including
    some potential users.

    •  

     

  • Prototype / Mock-up Creation.

    •  

     

  • Gather and Refine the User Requirements using the Prototype

    •  

     

  • Revise the Prototype (If Neccesary) and use 'lab' testing

    •  

     

  • Start Processes to obtain any Statutory Required Certification

    •  

     

  • In-Practice Evaluation

    •  

     

  • Make further Revision to design as required

    •  

     

  • Repeat any of the steps and build user numbers to reach statistical
    significance;

    •  

     

  • If Findings Positive;

    •  

       

       

    • Complete any Outstanding measure to obtain Statutory Certification/Approval, and move on to Production Levels and Marketing etc.,

      •  

  • If Findings not Positive then;

    •  

     

    • Cancel the Project or Start again on some earlier step in Process.



In fact this approach to medical device development cannot quite be followed in the way that might be expected.

The history of Assistive Technology development over the last decades of the 20th century clearly showed that there were many ‘bright ideas' that were unfortunately targeted at the needs of just a few users. Consequently the devices failed to reach a big enough market of other users in what was a small market and then failed the creators, suppliers and indeed the wider community of people with disabilities. However in the latter stages of the 20th century, the need to carry out user requirements studies to ensure wider acceptability was increasingly embraced.

The development in the field of Telecare was some what different in that the potential market was readily recognized as being large. However in both fields the end-users of the technologies are not a well defined group in terms of their medical and/or social conditions.

Where the target population of users for specific ATT is large and in ways that matter the users are sufficiently similar, a traditional research and development or innovation programme, ensuring appropriate levels of clinical evidence etc. as with typical medical devices, should be used.

Where the potential target population or populations are individually small and/or have significantly different characteristics this approach is not straightforwardly possible. In these circumstances early stages of the former design process, involving small numbers of users from the target populations can be employed to create prototypes which can also be trialed by small numbers of users from the target populations in practice based situations. When this form of methodology is all that is possible then the highest levels of evidence normally expected for medical devices is unattainable.

The intention is that this section of the website will evolve over time; giving a useful guide to innovation in the assistive technology and telecare technologies market.