By: Erin Kidd

The earliest known functional prosthetic device dates all the way back to anywhere between 950-710 BC.[1] The field has been innovating ever since and new technologies, particularly 3D printing, potentially stand to push it forward farther, and faster, than ever before.[2] However, looking at the achievements such as those of The Alternative Limb Project, where UK-based Sophie de Oliveira Barata uses her design expertise and special effects background to create state-of-the-art, completely unique prosthetics,[3] the word innovation starts to feel almost inadequate.

In 2016, de Oliveira Barata and a team of artists, craftsman, 3D modelers, and 3D printers created “The Phantom Limb” for biological science graduate and “amputee gamer” James Young.[4] The project was sponsored by Konami and developed in collaboration with Open Bionics and GTR motorsport and aerospace manufacturers.[5] The result features a 3D-printed hand which receives signals from electrodes in an attached harness to form various grips and gestures, which allow the wearer to form various grips and gestures, using buttons in the forearm.[6] It also features a mechanical elbow, a “Social Space” that can hold and charge devices including a paired quadcopter, built-in lights which can respond to the wearers heartrate, and, last but not least, a Bluetooth enabled wrist with a USB port and a small screen for viewing message, emails, and social media updates.[7] “It is, in short, a prosthetic masterpiece.”[8]

The Phantom Limb is far from the only masterpiece de Oliveira Barata has created, from a leg that can hold art supplies for a creative child to a Swarovski Crystal showstopper, she is “blurring the line between everyday prostheses and body modification”[9] and helping reframe the discussion around prosthetics along the way.[10]

The ability to fully customize a prosthetic, and the resulting body positivity that many people feel when able to do so,[11] is only one of the benefits 3D printing stands to bring to the prosthetics field. The biggest benefits are in time and cost.[12] Where traditional prosthetics could cost anywhere from $5,000 to $50,000 and take anywhere from weeks to months to receive,[13] 3D printed prosthetics can be dreamed up “prototyped, printed and tested in a matter of days [, sometimes hours]”[14] for as little as $50.[15]

There is also another form of customization: fit. Dan Ignaszewski, chief policy and programs officer with the Amputee Coalition of America, estimates about 2.1 million people in the U.S. are living with limb loss and nearly 200,000 amputations occur in the United States every year.[16] Yet, despite such high number, only around half of all amputees receive a prosthetic.[17] Some of these are by choice and most commonly that choice has to do with uncomfortable weight and fit that cannot be overcome by utility.[18] It most commonly happens with arm and hand prosthetics.[19] But some of those going without prosthetics are not doing so by choice; sometimes the law gets in the way.

Over the past few years, the FDA has struggled to keep up with the rapidly changing field of 3D printing, or “additive manufacturing” as they typically refer to it. Overall though, the agency has decided to favor encouraging innovation over restricting through regulation.[20]

With the exception of certain preassembled lower limb prosthetics and types of myoelectric and microprocessor-controlled prosthetic devices, the FDA has largely classified prosthetics of all kinds as Class 1 medical devices which are exempt from much of the regulatory scheme currently in place.[21] In other words the FDA has mostly avoided placing taxing regulations on prosthetic devices that may limit public access to new and rapidly-developing prosthetic technologies. Many, in fact, are exempt from all but a complaint process.[22]

FDA policies on the matter, however, do not prevent states from creating barriers, even those that were not originally intended to act as such. Earlier this year Ohio changed its licensing laws for prosthetics manufacturers specifically to allow companies and charities to make and distribute 3D-printed prosthetics.[23] The previous 2001 law required prosthetic developers to get a license from Ohio’s Occupational Therapy, Physical Therapy, and Athletic Trainers Board (OTPTAT Board)—a license which required a bachelor’s degree, a residency program, a minimum of eight months working under the supervision of an already licensed prosthetist, an examination, and a fee. According to a press release from Lieutenant Governor Jon Husted’s office, the whole process would generally take at least six years to complete.[24]

Husted, along with Ohio Senator Rob McColley, was inspired to propose a change when a charity organization faced resistance and a possibly concerted push to prevent the unlicensed use of 3D printing in the prosthetics field from companies hoping to ward off competition.[25] The charity was Form 5 Prosthetics, which was created by an entrepreneurial twenty year-old business major named Aaron Westbrook, who himself was born with a limb difference which left him without a wrist or hand on his right arm, in order provide task-specific prosthetic limbs to children who normally would never be able to afford them.[26]

Husted and McColley’s proposed change was successful and, starting October 17, 2019, Ohio prosthetic developers working with 3D printing kits will be allowed to work without a license as long as the they seek and receive approval from the OTPTAT Board.[27] But Ohio is one of just fifteen states that regulates the licensure of prosthetics developers and manufacturers.[28]

Perhaps the larger barrier, though, is insurance and how it can differ from state to state. Generally speaking, all insurance providers will cover at least some prosthetics devices to at least some extent, not all insurances are created equal in this light.[29]

Due to the Affordable Care Act (ACA), all individual and small group insurance plans[30] currently cover ten categories of “Essential Health Benefits,” and among those are “rehabilitative and habilitative services and devices.”[31] So, too, do all states participating in the Medicaid expansion.[32] However, federal law does not mandate how much insurance plans have to cover under the ACA and the Department of Health and Human Services elected to allow states to define their own EHBs.[33] According to The Amputee Coalition, a Virginia-based non-profit and advocacy group, this creates a problem where state Medicaid plans can “cut corners,” and those in need face inconsistent care depending on where they may live.[34]

Even though all states seem to cover prosthetics as a Medicaid benefit to some extent, most still allow all sorts of exceptions and exclusions.[35] For instance, Florida’s Medicaid program only covers one prosthetics per lifetime.[36] Even Utah, the only state which did not officially recognize prosthetics as an EHB as of 2018, allows coverage of one prosthetic every five years.[37] As of this year, only fifteen states cover prosthetics without explicit type-based exclusions of some kind.[38] Most frequently, type-based exclusions prevent access to more advanced devices, especially myoelectric prosthetic arm prosthetics, even though they have been available for more than a decade![39]

The previously mentioned Amputee Coalition is at the center of a significant, ongoing advocacy initiatives to change the situation for those in need. The nonprofit drafted a model bill, “Insurance Fairness for Amputees,” and, to date, twenty-one states have adopted legislation based off the model bill.[40] Virginia is one such state, though efforts to strengthen the adopted legislation is still ongoing.[41]

Despite these improvements, it can still be a long-uphill battle for approval and appeals or legal disputes over what counts as “medically necessary” enough to be covered are commonplace even where coverage is available.[42] Battles for coverage, and limited coverage in general, are particularly taxing on families that require access to prosthetics. A traditional prosthetic has an average lifetime of five years, but children and young adults can go through them much faster, either by growing or just by acting like normal kids.[43] With insurance limitation, many families can only afford one general use prosthetic per year for a child, especially when everything supporting a prosthetic typically must be paid for out of pocket.[44] Many insurance policies do not cover repairs, extra unanticipated prosthetics fittings, or physical therapy, let alone a whole new device for when a young child grows too quickly. This also leaves many children without access to task-specific prosthetics which can be designed for sports, playing an instrument, or even just safely riding a bicycle.[45]

It is past time for many states to review their licensure and insurance regulations. In the words of Ohio’s Lt. Governor Husted, “Laws and regulations need to keep people safe and healthy, but we can’t have our regulations ever standing in the way of innovation . . . especially when innovation can improve people’s lives.” Until then, many families will continue to turn to where 3D-printed prosthetics revolution first began: the internet. [46] Until 3D prosthetics can inspire state legislatures to act and improve official access, more and more families (and charity organizations) will continue relying on makerspace designs and software collaborations, along with a good, old fashioned DIY spirit, for more affordable, customizable prosthetic limbs.[47]

image source: https://www.look4ward.co.uk/inspiration/alternative-limb-project-artificial-limbs-turned-works-art/

[1] Jen Owen, Prosthetics Through the Ages, Enabling the Future (Jan 23, 2014), http://enablingthefuture.org/2014/01/23/prosthetics-through-the-ages/.

[2] See, e.g., Meg Bryant, 3D Printing Poised to Disrupt Healthcare, MedTech Dive (Nov. 12, 2018), https://www.medtechdive.com/news/3d-printing-poised-to-disrupt-healthcare/541540/.

[3] See The Alternative Limb Project, http://www.thealternativelimbproject.com/about/the-alternative-limb-project/ (last visited Oct 9, 2019); Katie Armstrong, Interview: Sophie de Oliveira Barata, 3D Printing Industry (Aug 26, 2016), https://3dprintingindustry.com/news/interview-sophie-de-oliveira-barata-93878/.

[4] See The Phantom Limb, The Alternative Limb Project, http://www.thealternativelimbproject.com/project/phantom-limb/ (last visited Oct 9, 2019); Victoria Gruenert, The Alternative Limb Project: Artistic Prosthetic Design, Design Museum Foundation (Apr 30, 2018), https://designmuseumfoundation.org/blog/2018/04/30/alternative-limb-project-artistic-prosthetic-design/; Luke Dormehl, How the Alternative Limb Project is Transforming Prosthetics into an Astonishing Artform, Digital Trends, (Oct 18, 2016, 3:00 AM) https://www.digitaltrends.com/cool-tech/alternative-limb-project/;

[5] The Phantom Limb, supra note 4.

[6] See id.

[7] See id.

[8] Dormehl, supra note 4.

[9] Id.

[10] E.g., Armstrong, supra note 3 (“People like Sophie are helping change the conversation around amputees and prosthetics. Where in the past, where some people would feel pity, now are asking where these amazing limbs come from, which is a refreshing change.”); Dormehl, supra note 4 (“It helps break down barriers, and shows that people are quite happy with their prosthetics. It lets my clients take ownership of their prosthetic by having a piece of their imagination on show. (quote by de Oliveira Barata).

[11] See, e.g., Rachel Oakley, The Alternative Limb Project is the Best Thing to Ever Happen to Prosthetics, Lost In E Minor (Dec. 13, 2018) (“I could see that every year [a small girl needing a custom leg prosthetic] was getting really excited about coming in. And, it wasn’t something she had to do that other people didn’t, it was something she got to do that other people didn’t. It was a nice event for her psychologically.” (quote by Sophie de Oliveira Barata)).

[12] See, e.g., Schwartz, Jonathan, The Future of 3D Printed Prosthetics, TechCrunch (June 26, 2016), https://techcrunch.com/2016/06/26/the-future-of-3d-printed-prosthetics/.

[13] Id.

[14] Owen, supra note 1.

[15] See, e.g., 3D Printed Prosthetics | Where We Are Today, The Amputee Coalition (Feb. 8, 2019), https://www.amputee-coalition.org/3d-printed-prosthetics/; Schwartz, supra note 10.

[16] See Emily Sides, Manassas Woman Seeks Law Requiring That Insurance Cover a Wider Range of Prosthetics, Inside NoVA (Jan. 18, 2019) https://www.insidenova.com/news/prince_william/manassas-woman-seeks-law-requiring-that-insurance-cover-a-wider/article_b9ca6f30-1b21-11e9-97ad-1ff774a75f2d.html; Schwartz, supra note 10.

[17] Sides, supra note 14.

[18] See, e.g., Jelle ten Kate, Gerwin Smit & Paul Breedveld, 3D-Printed Upper Limb Prostheses: A Review, 12:3 Disability and Rehabilitation: Assistive Technology 300, 309 (2017) https://www.tandfonline.com/doi/pdf/10.1080/17483107.2016.1253117.

 

 

[19] See, e.g., Bryant, supra note 2.

[20] See, e.g., 3D Printing of Medical Devices, U.S. Food and Drug Administration (Sept. 27, 2018), https://www.fda.gov/medical-devices/products-and-medical-procedures/3d-printing-medical-devices; The 3 R’s of 3D Printing: The FDA’s Role, U.S. Food and Drug Administration (Dec. 21, 2016).

[21] E.g., 21 C.F.R. § 890.3025 (2001); 21 C.F.R. § 890.3420 (2001); see also 3D Printing of Medical Devices supra note 18.

[22] See generally 21 C.F.R. § 820.198 (2013).

[23] E.g. McColley Joins Lt. Governor Husted to Announce Prosthetics Initiative, The Ohio Senate, 133rd General Assembly (June 13, 2019), http://www.ohiosenate.gov/senators/mccolley/news/mccolley-joins-lt-governor-husted-to-announce-prosthetics-initiative.

[24] See, e.g., Id.

[25] Andrew Tobias, Ohio Officials Seek to Promote 3D-Printing of Prosthetics Via Law Change, Cleveleand.com, https://www.cleveland.com/open/2019/06/ohio-officials-seek-to-help-3d-printing-prosthetics-charity-via-law-change.html.

[26] See Id.

[27] Ohio Rev. Code Ann. § 4779.02 (LexisNexis 2019) (effective Oct. 17, 2019).

[28] See, e.g., Press Conference – Announcing Prosthetics Initiative, The Ohio Channel: A Service Of Ohio’s Public Broadcasting Stations (June 13, 2019), https://ohiochannel.org/video/press-conference-announcing-prosthetics-initiative.

[29] See, e.g., Open Enrollment for Health Insurance Coverage, The Amputee Coalition (Oct. 1, 2019), https://www.amputee-coalition.org/resources/open-enrollment-for-health/; Nikki McCoy, What to Expect During the Insurance Process for Functional Prosthetic Fingers, NP Devices (Mar. 10, 2018), https://www.npdevices.com/what-to-expect-during-the-insurance-process-for-functional-prosthetic-fingers/;  Bryan Ochalla, Will My Insurance Pay for Prosthetics?, QuoteWizard by Lending Tree (Dec. 27, 2018).

[30] The ACA does not impact large employers and the insurances they provide.

[31] Patient Protection and Affordable Care Act, 111 P.L. 148, 124 Stat. 119 (2010).

[32] For states without an expanded Medicaid program, prosthetics need only be an “optional benefit,” but according to the Kaiser Family Foundation, every state offers at least some Medicaid coverage for prosthetics devices when doing so is optional. See, e.g.,Ochalla supra note 29; see also Medicaid Benefits: Prosthetic and Orthotic Devices: 2018 Table, Kaiser Family Foundation, https://www.kff.org/medicaid/state-indicator/prosthetic-and-orthotic-devices/?currentTimeframe=0&sortModel=%7B%22colId%22:%22Location%22,%22sort%22:%22asc%22%7D

(last visited Oct. 9, 2019).

[33] Open Enrollment for Health Insurance Coverage supra note 29.

[34] Id.

[35] See, e.g., id; Medicaid Benefits supra note 32.

[36] See Medicaid Benefits supra note 32.

[37] See id.

[38] According to the Amputee Coalition, those states are as follows: Colorado, Georgia, Idaho, Indiana, Iowa, Maryland, Massachusetts, New Jersey, North Carolina, Ohio, Pennsylvania, South Carolina, South Dakota, Washington, West Virginia. Open Enrollment for Health Insurance Coverage supra note 29.

[39] See, e.g., Sides supra note 16.

[40] See State Issues, The Amputation Coalition, https://www.amputee-coalition.org/advocacy-awareness/state-issues/ (last visited Oct. 10, 2019).

[41] Virginia: State Outlook, The Amputation Coalition, https://www.amputee-coalition.org/advocacy-awareness/state-issues/virginia/ (last visited Oct. 10, 2019); see also Sides supra note 16.

[42]See, e.g. Schwartz supra note 12; Sides supra note 16; Ochalla supra note 29.

[43] See, e.g., 3D Printed Prosthetics | Where We Are Today supra note 15; Heidi Reidel, The Successes and Failures of 3D Printed Prosthetics; PreScouter (July 2017), https://www.prescouter.com/2017/07/3d-printed-prosthetics/ (last visited Oct. 8, 2019); Schwartz supra note 12.

[44] See, e.g. Tobias supra note 25.

[45] See, e.g., Sarah Sole, Form5′s Aaron Westbrook Helping Others With Task-Oriented Prosthetic Devices, ThisWeek Community News (July 13, 2019, 9:00 AM), https://www.thisweeknews.com/news/20190713/form5s-aaron-westbrook-helping-others-with-task-oriented-prosthetic-devices; Tobias supra note 25.

[46] See, e.g., 3D Printed Prosthetics | Where We Are Today supra note 15 (discussing the story of how Artist Ivan Owen’s design for a boy named Liam became the first 3D printed hand and the basis for non-profit, online collaborative initiative called e-NABLE).

[47] See, e.g., id.  Though spaces of these kinds inevitably raise their own issues of products liability—particularly as materials for 3D printing are still improving—and intellectual property.