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What defines 'custom made' foot orthotics

Discussion in 'Biomechanics, Sports and Foot orthoses' started by Boots n all, Aug 25, 2016.

  1. Boots n all

    Boots n all Well-Known Member


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    We will talk orthoses, what is defined as Custom made? Modified? Customised?

    1/Individual components designed and made to produce an individual device for an individuals needs

    2/Prefabricated components put together to make an individual device for an individuals needs.

    3/Prefabricated device with prefabricated portions added or removed for an individuals needs

    4/Prefabricated device heat moulded for an individuals needs

    5/An individual STL file to produce an individual device

    6/An pre designed STL file modified for an individuals needs.
     
  2. Craig Payne

    Craig Payne Moderator

    Articles:
    8
    Re: What defines custom made

    That is exactly the problem!
    The lines between different types are so blurred, there can be no definition.

    I prefer the (and am working on this) 'pathways to the final product' definitions.

    1) there are various negative model permutations (volumetric and non-volumetric methods; and 'eye balling')

    2) (1) then leads to various positive modelling methods or this step can bypassed (library or prefab or pre-deigned STL or etc)

    3) Then there are the various production methods used or prefab/library devices

    --> impossible to define custom made vs not

    --> easy to define different pathways towards the final product

    --> there are so many permutations along that pathway, its complicated

    --> different routes through the pathway using totally different methods, can end up with a product with the exact same design features
     
  3. Boots n all

    Boots n all Well-Known Member

    Re: What defines custom made

    Thats just my point Craig.

    A while ago Health insurance were asking that we define our custom made orthoses.

    "Made from the scan or cast of the clients foot"
    If your adding to a prefab, your not taking a scan or cast, so then its not custom under their definition.

    So who decides what is custom made and what is not and how?

    For footwear, custom made is very defined.
    Individual pattern for an individual Last for individual footwear.

    Then we have modified footwear, a prefab shoe that is altered by relasting or a sole build up, these adjustments or modifications dont make that footwear custom, yet the same done to an orthoses make it custom.

    Its all coming down to insurance terminology, not the client outcome.
     
  4. Petcu Daniel

    Petcu Daniel Well-Known Member

    Re: What defines custom made

    In my opinion the most appropriate definition comes (et least in the EU) from the law concerning medical devices ( http://ec.europa.eu/consumers/sectors/medical-devices/files/revision_docs/2007-47-en_en.pdf , page 24), because foot orthotics are medical devices:

    "?custom-made device? means any device specifically made in accordance with a duly qualified medical practitioner's written prescription which gives, under his responsibility, specific design characteristics and is intended for the sole use of a particular patient. Mass-produced devices which need to be adapted to meet the specific requirements of the medical practitioner or any other professional user shall not be considered to be custom-made devices;"

    In this context, the questions are:
    -who is the "duly qualified medical practitioner" ?
    -what exactly the prescription is ?

    Daniel
     
  5. Petcu Daniel

    Petcu Daniel Well-Known Member

    Re: What defines custom made

    In the same time I see a contradiction in this definition because "an adapted mass-produced device" is not the same thing as the "initial mass-produced device" as for example, the shape of a modified positive cast is not the same thing as the shape of the initial foot cast. I remember Simon has correctly written in a thread that you can obtain the final shape of foot orthoses starting from a cube and not from the foot shape. So, at the end what it counts: "to meet the specific requirements" or "HOW to meet the specific requirements" ?

    Daniel
     
  6. davidh

    davidh Podiatry Arena Veteran

    Re: What defines custom made

    We may also like to consider the soft eva devices which are prescription-made for the individual patient (they even have a custom sticker on the bottom). These are made with no regard to materials performance for the individual, and are widely used in the NHS here in the UK.
     
  7. Petcu Daniel

    Petcu Daniel Well-Known Member

    Re: What defines custom made

    Maybe one solution is:
    -to split the process between "prescription" and "manufacturing",
    -to define different "levels of customization", "degrees of difficulty" ( https://en.wikipedia.org/wiki/Degree_of_difficulty ) or Best Available Techniques (BAT) ( http://eippcb.jrc.ec.europa.eu/reference/ ) of the manufacturing process, avoiding to use only a too general category of "custom-made" device

    Daniel
     
    Last edited: Aug 26, 2016
  8. Boots n all

    Boots n all Well-Known Member

    Re: What defines custom made

    The dominate issues here should be the outcome

    The outcome is everything, but for some the rebate from PHI is also a major issue.

    As PHI tighten up what they will or will not pay, we need define what is custom made and for no other reason.

    So what definitions are out there?
     
  9. BrisFoot

    BrisFoot Member

    Re: What defines custom made

    Good point. The outcome is the outcome from the client point of view but not the PHI p.o.v.

    And a definition of "custom" may only last until the next technology is realised.
     
  10. Boots n all

    Boots n all Well-Known Member

    Here is an example from DVA, note there is not even a definition to allow for a scanned foot model to be used in their process?

    Custom Moulded Thermoplastic rigid orthosis (single)
    (custom-made to plaster model, with reference to biomechanical
    measurements, with intrinsic or extrinsic forefoot or rearfoot
    $183.45 modification to influence foot and lower limb alignment)

    F268
    Custom Moulded balance orthoses (pair) - non-cast thermoplastic
    (thermoplastic moulded direct to foot)

    http://www.dva.gov.au/sites/default/files/files/providers/podiat.pdf
     
  11. Petcu Daniel

    Petcu Daniel Well-Known Member

    Re: What defines custom made

    In your opinion, which is the problem with "custom-made" definition from EU law regarding the medical devices ?

    Daniel
     
  12. Boots n all

    Boots n all Well-Known Member

    The EU definition is excellent in the definition of custom made and should be accepted.
    Its not bogged down or dated by technology, materials or process.

    PHI should pay for evidence based outcomes, not process.

    For example, we use the inshoe fscan pressure mapping system for our diabetic clients, l have evidence to support the outcome so the rebate should be 100%.

    I understand that some EU PHI are already talking about rebates on evidence based outcomes, fantastic.

    l am heading off to Japan Friday, visiting a number of Pedorthic facilities and the Uni to market our custom made Last, l plan on asking a few what their definition is and how their rebate system works.

    If l was to change anything.
    Custom-made
    Any device specifically made in accordance with a duly qualified medical practitioner's written prescription which gives, under his responsibility, specific design characteristics and is intended for the sole use of a particular patient supported by accepted evidence based outcomes.

    Modified
    Mass-produced devices that must be adapted and modified in accordance with a duly qualified medical practitioner's written prescription which gives, under his responsibility, to meet the particular patient specific requirements of the medical practitioner or any other professional, supported by accepted evidence based outcomes"
     
  13. Petcu Daniel

    Petcu Daniel Well-Known Member

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