Research into the development of exoskeletons for assistive or rehabilitative purposes has drawn considerable interest within the robotics community. Often, the ultimate goal of such research is to develop a device that can be mass-manufactured and commercialized to benefit a community of end users. With such exciting and novel tech it is natural to put all your effort into tech development and, as a result, informative market research can take a backseat. This article reviews two examples of high-tech medical devices that illustrate the importance of understanding your market if your goal is to translate your research into a commercial product.
Bionic hands are an area of cutting-edge research that has potential to improve the lives of many people. The challenges startups face in this space, however, are due to a very small market size. To illustrate this point, consider the example of an advanced myoelectric arm designed for below the elbow amputees. A rough calculation of potential market size follows below.
Potential Market Calculation for a Below the Elbow Advanced Myoelectric Arm
|US civilians living with a major limb amputation -not hands or fingers (2005)1||41K|
|Using amputation level data from the literature2 the number is narrowed down to those with a below the elbow amputation||19K|
|Add in an estimate of veterans treated at the VA with a below the elbow amputation3||+2K|
|Add an estimate of children with a below the elbow congenital limb difference4||+2K|
|Estimated Potential Market||
|People with a below the elbow amputation or limb difference in the US that could potentially use an advanced myoelectric arm|
Keep in mind there are many solutions, both high and low tech, available to this small population. In addition, many folks, especially children4, choose not to use a prosthesis. According to Medicare reimbursement data, multi-articulated myoelectric solutions, like the bionic hand in this example, only accounted for 17% of the prosthetic hands reimbursed in 20175. This low percentage is due to a reluctance on the part of insurers to pay for high tech solutions. To use this information to estimate the market size, apply this 17% (to the 23K) and it results in a total of only 4K candidates in the US eligible for a multi-articulated myoelectric prosthetic hand. Innovators in this space should consider carefully if this is a large enough population to recover their development costs.
Another technology that has drawn much interest from the robotics community is lower extremity powered medical exoskeletons. Several of these devices are indicated for spinal cord injury (SCI) and are labeled for personal use in ambulating (under the supervision of a specially trained companion for SCI levels T7-L5)6. The National Spinal Cord Injury Statistical Center estimates approximately 291,000 people are living in the US with an SCI7– thus this technology with a price around $100K per unit has a much larger potential market than the prior example8.
Where lower extremity powered exoskeletons have stumbled is reimbursement. Many private insurers, deem the technology investigational and it is therefore not covered10. In their decision-making, private insurers cite the lack of data on the effectiveness of exoskeletons in everyday living environments (such as on uneven sidewalks)10. They also note the lack of information on users’ experiences with an exoskeleton in activities of daily living9. Most studies to date have been conducted in institutional settings with the support of a trained therapist. In the clinical performance evaluation to support FDA clearance of the first exoskeleton most subjects did not ambulate on real-world surfaces such as carpet, concrete, bricks, and grass6. Currently, the features and benefits of the exoskeleton are not understood well enough for insurers to agree to cover the device. Early market research with stakeholders like insurers may help future exoskeleton developers inform their testing and study designs so they come to market with the right design and evidence to support favorable reimbursement decisions.
In conclusion, in the first example, the market for a bionic hand is quite small (at least in the US). In the second example of the lower extremity powered exoskeletons, while it seems as if there is a large market for the device, that market depends on reimbursement by insurers who have not found the design and testing adequate to support payment.
TREAT recommends that inventors take the time to thoroughly research their market before investing time and money into developing their technology. Early market research can help inform technology development decisions and mitigate startup risks. Do you need help researching the market for your medical device or consumer health product? Reach out to us for early commercialization support services.
Laura Bleyendaal, MBA, is an Entrepreneur Fellow at TREAT. Her background includes eight years of experience working in regulatory affairs for the DePuy Synthes companies of Johnson & Johnson where she focused on commercialization of spinal surgery medical devices. Laura received her MS in Regulatory Affairs from the Northeastern University College of Professional Studies and her MBA from Babson College.
- Ziegler-Graham K, MacKenzie EJ, Ephraim PL, et al. Estimating the prevalence of limb loss in the United States: 2005 to 2050. Arch Phys Med Rehabil 2008; 89:422.
- Supporting literature used in calculations: Dillingham T, Pezzin L, MacKenzie E. Limb amputation and limb deficiencies: epidemiology and recent trends in the United States. South Med J 2002;95:875-83.
- Supporting literature used in calculations: Richman M. Study to explore needs of upper-limb amputees. VA Research Currents. Available at: https://www.research.va.gov/currents/1216-6.cfm. December 22, 2016. Accessed March 11, 2020. Resnik L, Ekerholm S, Borgia M, Clark MA. A national study of Veterans with major upper limb amputation: Survey methods, participants, and summary findings. PLoS ONE. 2019; 14(3): e0213578. https://doi.org/10.1371/journal.pone.0213578
- James MA, Bagley AM, Brasington K, Lutz C, McConnell S, Molitor F. Impact of prostheses on function and quality of life for children with unilateral congenital below-the-elbow deficiency. J Bone Joint Surg Am. 2006;88(11):2356–2365. doi:10.2106/JBJS.E.01146
- Medicare data used in calculations: Medicare-national-DMEPOS-HCPCS-Aggregate-CY2017. CMS.gov. Available at: https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/Medicare-Provider-Charge-Data/DME2017. 2017. Accessed March 5, 2020.
- Evaluation of Automatic Class III Designation (De Novo) for ARGO ReWalk™. FDA.gov. Available at: https://www.accessdata.fda.gov/cdrh_docs/reviews/den130034.pdf. Accessed March 11, 2020. K152416 510(k) Summary. FDA.gov. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf15/K152416.pdf. February 26, 2016. Accessed March 12, 2020.
- Spinal Cord Injury Facts and Figures at a Glance. Available at: https://www.nscisc.uab.edu/Public/Facts%20and%20Figures%202019%20-%20Final.pdf. 2019. Accessed March 11, 2020.
- Heinemann AW, Jayaraman A, Mummidisetty CK, et al. Experience of Robotic Exoskeleton Use at Four Spinal Cord Injury Model Systems Centers. J Neurol Phys Ther. 2018;42(4):256–267. doi:10.1097/NPT.0000000000000235.
- Aetna policy number 0578 including robotic lower body exoskeleton suits. Aetna.com. Available at: http://www.aetna.com/cpb/medical/data/500_599/0578.html. Last reviewed February 13, 2020. Accessed March 10, 2020. Kaiser Permanente Health Plan of Washington Clinical Review Criteria Exoskeleton. ghc.org. Available at: https://provider.ghc.org/all-sites/clinical/criteria/pdf/exoskeleton.pdf. Last reviewed November 1, 2016. Accessed March 10,2020.
- BlueCross BlueShield of North Carolina Powered Exoskeleton for Ambulation in Patients with Lower Limb Disabilities. BlueCrossNC.com. Available at: https://www.bluecrossnc.com/sites/default/files/document/attachment/services/public/pdfs/medicalpolicy/powered_exoskeleton_for_ambulation_in_patients_with_lower_limb_disabilities.pdf. Last review February 2020. Accessed March 11, 2020.