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Actual Cost of Modified Prefab vs. Custom Molded Orthoses

Discussion in 'Biomechanics, Sports and Foot orthoses' started by Kevin Kirby, Jan 8, 2008.

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    I have started a new topic for discussion from my last posting in the thread Presciption Writing for Foot Orthoses.

    Last edited: Jan 8, 2008
  2. Craig Payne

    Craig Payne Moderator

    I often raise a few eyebrows when doing seminars for non-podiatrists in which I enjoy saying "custom made orthotics are cheaper than prefabricated", just to get a reaction!
  3. Atlas

    Atlas Well-Known Member

    A lot of what you say here makes sense Kevin.

    Even though we are all making custom moulds for every 'individual' orthotic patient, I think that about 80% of devices prescribed as customised, could easily be effective if fitted and contoured to another person. Most orthotic labs could in theory accept 50-200 custom moulds and make a library. And after that, I think they could 'mix and match' and find from the library, a positive mould that matches the 'newly customised' negative mould that has just arrived (in about 80% of cases).

    What I am saying is that pre-fabrication is in its infancy. When we buy a pair of pants, most don't get them customised; yet it is rare to purchase on the basis of small or medium or large. We look at leg length, hip/tummy girth etc....

    So in years to come, a pre-fabrication range will exist that is more complex than what we now know. It will factor it heel width, arch position, contour shaft length, additions etc. etc. You wont have 8 different sizes; instead you might get 64+....which I think will cater for 80% of the market.

    It will hurt our hip pockets, but I think that prefabs will become more cost-effective...unless there is a sudden mutation or evolutionary change...or some super-relevant clinical finding that emerges...or technology allows the clinician to outsource manufacturing at much lower costs (difficult because the wholesale cost is already low IMO).
  4. Ron:

    This type of process that you outline has already been in existence here in the US in some foot orthosis labs for at about 5 years. However, it has not caught on the way you have predicted. I disagree with your assessment that this process will "hurt my pocket", be more cost-effective or be any better for patients.

    The reason that your process will never work well or become widespread is that the number of permutations that an experienced orthosis clinician uses in their patients' orthoses is just too numerous to make it economically viable to store that many orthoses in a central warehouse. I have calculated the number of permutations of foot orthosis designs that a central warehouse would need to store on their shelves to be able to accommodate only some of the orthosis design parameters that I currently order to give my patients optimum therapeutic function from their foot orthoses for their many styles of shoes. Here are the orthosis design parameters I used in my calculation, which, by the way, is not a full listing of all the orthosis design parameters that I currently use on a daily basis.

    1. Thicknesses of orthosis shell material = 4.

    2. Thicknesses of heel contact point = 4

    3. Plantar fascial accommodation depth = 3

    4. Foot lengths = 10.

    5. Heel cup widths = 6.

    6. Heel cup depths = 4.

    7. Medial heel skive/lateral heel skive depths = 5.

    8. Anterior edge parabola shapes = 2.

    9. Anterior edge thicknesses = 3.

    10. Topcover materials = 4.

    11. Forefoot extension lengths = 2.

    12. Forefoot extension types = 10.

    13. Presence or absence of metatarsal pad = 2.

    14. Medial longitudinal arch height = 3.

    15. Angle of inversion/eversion of orthosis = 6.

    16. Anterior width of orthosis = 3.

    Ron, when you start up your orthosis warehouse business to be able to premake most of the orthoses for a practitioner like myself, you will only need to stock 2 billion, 985 million, 984 thousand (2,985,984,000!) types of orthoses on your warehouse shelves. Or you could just custom make them one at a time in a relatively small lab space, like every other custom foot orthosis laboratory does.:rolleyes:.
  5. Atlas

    Atlas Well-Known Member

    What you are saying then Kevin, is that it is pivotal for foot orthoses to be fine-tuned to the nth degree, incorporating at least 16 variables. If that was the case, an over-the-counter orthotic that improves signs and symptoms would be ultra rare. It is not, as you know.

    Considering all of the 16 variables for 100% of orthotic patients is overkill and pedantic, but great in theory. Probably worthwhile considering in a minority of presentations.

    We overstate the orthotic reaction forces and orthoses complexity needed to achieve subjective and objective gains in the middle of the bell-shaped curve.

    If your 3 trillion theory is correct Kevin, then the average podiatrist should be prepared to make as many re-adjustments before definitively concluding "it looks like orthotics will not solve your problem".
  6. Ron:

    I don't make custom-molded foot orthoses for those many patients that have gained therapeutic benefit from pre-made foot orthoses. I only make custom-molded foot orthoses for those patients that want a medical treatment that has the greatest potential to heal their injuries that have not responded to pre-made orthoses.

    Since I have been practicing now for over 22 years, have made over 12,000 pairs of custom-molded foot orthoses during that time and currently order about 90 pair of custom-molded foot orthoses per month in my practice, there does not seem to be any problem with my ability to attract patients to my practice here in Northern California who understand the great therapeutic benefit of a true custom-molded prescription foot orthosis versus pre-made foot orthoses. Possibly the people in your country are different than they are in my country.

    As far as my "theory", please tell me, Ron, how many orthosis design parameters would you include in this idea you have of making a more complex pre-made orthosis that orthosis labs could stock on their shelves. Also include how many choices you would give the prescribing clinician for each parameter (e.g. how many heel cup width choices, how many orthosis shell stiffnesses, how many medial and lateral heel skive choices, how many foot sizes, how many heel cup depths, how many orthosis widths, how many topcovers choices, with or without rearfoot posts, with or without first ray cutouts, how many forefoot extension choices, etc). Be sure to also include the method by which clinician is going to know how to order the proper medial arch geometry, lateral arch geometry and heel cup geometry in your proposed scheme of making a more complex pre-made orthosis available for clinicians that could be supplied off the shelf of an orthosis warehouse.

    Remember, you originally stated "Most orthotic labs could in theory accept 50-200 custom moulds and make a library." It will be interesting to see how many permutations of orthosis design you propose will be sufficient to satisfy the needs of an experienced foot orthosis clinician once we see what design parameters you will allow for your prescribing clinicians to choose from. Mathematics doesn't lie.
  7. Craig Payne

    Craig Payne Moderator

    Maybe part of the problem is that for x% , short term use of an OTC/prefab is all that is needed; and for z% they do need the minute ultrafine tuning over a long term; and there is y% inbetween. The problem is we do not know how big x, y and z are and how to pick them in advance.
  8. Craig and Ron:

    Maybe I am misunderstanding what Ron is trying to say here. I agree with Craig's idea that x% + y% + z% = 100% of patients that need treatment with pre-fab and custom-molded foot orthoses. However, the majority of what I treat with custom-molded foot orthoses are the z patients that have failed pre-fab therapy. I treat many of the x patients with 3-4 types of prefab orthoses with good success. The y patients could probably benefit well either from standard custom-molded foot orthoses or modified pre-fab orthoses. However, I can't, for the life of me, see how Ron's idea of making more permutations of prefab orthoses is going to help any of my z patients which form the bulk of my prescription foot orthosis practice since the number of types of orthoses that would need to be stockpiled would need be astronomical.

    Ever wonder why the shoe industry only sells shoes in length and width and not in depth, even though the shoe last accounts for shoe depth.......too much inventory for the shoe stores caused by the extra dimension of only adding the shoe depth parameter!
  9. Personally, I think we are more likely to see prefabs which have built in "modifications" which can be manipulated and set-up as required such that a small series of prefabs can be be employed to meet as wider number of the permutations listed by Kevin as possible, rather than a multitude of devices. I predict that this series will be based around shoe-size, but will be capable of ticking many, many boxes in terms of prescription variables.
  10. Atlas

    Atlas Well-Known Member

    Agree totally; and this is exactly what another podiatrist and myself have been talking to a patent lawyer about. However the hard part is settling on a mechanism for alteration; the device being practical, effective, low-bulk, cost-efficient etc...
  11. Already has been done and currently being marketed by RxLabs as Biobasics Component Insole System which gives the prescribing clinician 128 permutations of orthoses to choose from for their patients.
    Last edited: Jan 10, 2008
  12. Boots n all

    Boots n all Well-Known Member

    There are a number of products already fitting this description in various forms
    here is another one that Vasily have just started selling


    Kevin must have posted as l did LOL
  13. I wonder when they are coming out with the VASYLI-Simon Spooner (TM) foot orthosis or VASYLI-Craig Payne (TM) foot orthosis?
  14. Boots n all

    Boots n all Well-Known Member

    LOL, who knows what's in the pipe line with these companies?
    l think it might be part of a promotion as he is out here shortly for a series of lectures, when are you coming out Kevin....to lecture that is:D
  15. I doubt that there will ever be a VASYLI- Simon Spooner (TM)- it's not that I'm not open to offers, just that I'm not photogenic enough to appear in the marketing campaign. Can you imagine a full page black and white phote of me, complete with pint in one hand and cigar in the other: "Introducing the barfly orthotic, specially designed to reduce falls, aggressive behaviour and talking sh!te in heavy drinkers..."

    Nice research study to test out the efficacy though.:drinks

    How come everyone has got a patent in progress these days?????? Should have patented those heel skives Kevin, you'd be a multi-billionnaire now. Still I suppose it's more rewarding and easier to sleep at night knowing that you have helped millions of people around the world, without sticking a dollar sign on every idea you've ever had.
    Last edited: Jan 10, 2008
  16. Lawrence Bevan

    Lawrence Bevan Active Member

    I wade in...

    we use prefabs extensively in my NHS (UK statefunded "salaried") dept. We use the "slimflex plus" from Algeos.co.uk.

    Its v good, can be modified in any number of ways to suit a large percentage of people, even those requiring significant orthotic support. You need a lab/workshop to make the most of it and we find that in 20 mins we can produce a device that suits many and the total cost? -
    £7.50 (US$15). how long do they last - about a year. Patients dont pay for appnts or devices with us.

    I find that Kevin's costings are great "if" the devices are worn that long. We find that a device that costs as little as ours but has been adapted so that it is virtually semi-custom is at least as cost effective. PLUS it is v. v. quick, easily altered, takes far less training to know how to manufacture and uses less machinary = less wear/tear and less health and safety consideration. PLUS in a system where treatment is provided free to all we have to very much watch we dont over-treat and issue orthoses to those that would improve in other ways. Many many patients (at least ours) dont wear orthoses for 20 years so if we gave them all custom-moulded devices we would be wasting money and because they are "free" patients don't worry about making them last 20 years believe me!!

    Any way up £7.50 a year beats most models of delivery on cost. I know you could multiply that by 5 or 10 and say is that more or less than a custom-moulded but for how many patients does that hold true? Especially when they dont have to reach into their own pockets??
  17. Atlas

    Atlas Well-Known Member

    What about the "Support stand for use in X-raying a human foot". That probably explains more time on here, less time in bed. Do as I say, or do as I do?
  18. I've never patented a support stand for the human foot Ronald, but I'd say with your many years of experience with foot orthoses, you're just the right person to be patenting your designs. Sleep well.
  19. Rumor has it that I may be lecturing in Oz in 2008 with one of the more prestigious podiatrists from Podiatry Arena. When more information is available, I will pass it along.
  20. Atlas

    Atlas Well-Known Member

    I think you might find Kevin did.
  21. Boots n all

    Boots n all Well-Known Member

    Cool, l will hope its in Melbourne:drinks
  22. I patented the anterior axial positioning device after I completed the following study over 20 years ago during my Biomechanics Fellowship (Kirby KA, Loendorf AJ, Gregorio R: Anterior axial projection of the foot. JAPMA, 78: 159-170, 1988). Actually, I lost money on the device due to the cost of the patent process.

    However, it is nice to see that other podiatrists have used the device for the benefit of their patients (Clark JR, Gerbert J, Jenkin WM: The Kirby view: A radiographic view for flatfoot evaluation. JFAS, 43:436-439, 2004). This is what it is all about with all the other techniques, tests and theories I have created...doing it for the benefit of my and other clinician's patients.
  23. Atlas

    Atlas Well-Known Member

    So, what is the point of going for a patent then?

  24. Ron:

    I would have thought that would have been one of the first questions you asked your patent attorney. Did you ask?
  25. Atlas

    Atlas Well-Known Member

    At $300 an hour, I was afraid to ask, in case he went off on a tangent. You're a cheaper option, but I would understand if you wanted to keep your IP to yourself.
  26. Ron:

    I would not consider myself an expert on the patent process. The patent allows you to be legally protected from someone copying your idea. In my case, since I never sold any of the anterior axial positioners for profit, then I lost money on the patent process. But it is kind of cool to have patented something and be able display the plaque of my patent on my wall, but probably not worth the money it cost.

    You must remember that if someone starts to infringe on your patent, it will cost you plenty of money and time to legally pursue these individuals in order to stop them from manufacturing the product. In addition, you may need a separate liability insurance policy if you manufacture the product yourselves in case someone claims injury from your product. I would think that all of these points should be reviewed with your partner and your patent attorney before you proceed any further with your plans.
  27. Great point Kevin, I was thinking something similar regarding this today: how many people make orthoses on a daily basis with something remarkably similar to the patented "kinetic wedge"? How many people have been successfully pursued for infringement? Are the labs who are advertising kinetic wedge, have a kinetic wedge option on their prescription form and are manufacturing orthoses with a kinetic wedge paying royalties? Howard, are your lawyers pursuing all these copycats?

    The problem is that when Ronald launches his patented design, I can simply buy one pair, scan them in and "reverse engineer" (= reproduce) them. I could be selling these to my patients and how would Ronald even know?
    Last edited: Jan 11, 2008
  28. admin

    admin Administrator Staff Member

    9th Aug in Sydney and 10th Aug in Melbourne - watch around here for the official announcement ;)
  29. I'll be in Sydney and Melbourne on those days watching Craig lecture....and maybe getting to say a thing or two when I get a chance.:rolleyes::drinks
  30. choularto

    choularto Welcome New Poster


    As I am sure you are aware prefab orthotics suppliers have been marketing their products to their customers in the outdoor industry for decades. It has become big business and many non podiatry and podiatry professional alike utilize them for their respective clients. In many cases they have little success with these prefab orthotics. Ranging in price from £30 to £45 it is some times a shot in the dark even with modification wether these offer not only real benefits but value for money.
    I know many Cped and orthotists that utilise direct casting methods for orthotics and can fabricate a custom orthotic to a medical standard with all relevant perscritive corrections for £150 or $150. They last longer, can be easily reposted and are infinately adjustable for any foot type. Surely the use of prefab products should be limited to neutral applications? By that I mean for non medical applications where training and experience often limit technicians ability to understand mechanics and proper appplication. Once you add in gait analysis and man hours spent during assessment, manufacturing, and follow up: $300.00 for a product that will have a far higher success rate is a bargain.
    By the way great topic
    Kind Regards

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