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. 2021 Sep 21;4(2):36349.
doi: 10.33137/cpoj.v4i2.36349. eCollection 2021.

The Digital O&P Workshop

M Opitz  1 , P Fröhlingsdorf  1
Affiliations

The Digital O&P Workshop

M Opitz et al. Can Prosthet Orthot J. .

Abstract

Digitalisation is the megatrend in healthcare, not only since the pandemic. We are two European digital health experts and industry leaders in the field of orthotics and prosthetics (O&P) and in this article we explored what are the underlying trends driving the adoption of digitalisation for customisation of prosthetics & orthotics. We showed that several trends in 3D image capture (input step), 3D modelling (processing step) and 3D printing (output step) currently converge and thus fuel the rapid transformation of the O&P industry. In short outlooks, we rated the probability and timing of adoption rates across the upcoming couple of years. We furthermore reviewed the impact of boundary conditions set by regulators as well as the reimbursement system. Towards the end of this article, we outlined a digital scenario of the near future by following around an orthotist during her work. We finished with a call-to-action targeting regulators, payors, prosthetists/orthotists, and patients to enable such a desirable future.

Keywords: Additive Manufacturing; Central Fab; Custom-Made Device; Digital Process Chains; Digital Transformation; FDA; Orthotic Brace; Prosthetic Feet; Quality Assurance; Trends.

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Conflict of interest statement

The authors are members of the executive management team and/or shareholders of the Munich-based company Mecuris. The Mecuris Solution Platform offered by Mecuris contains digital tools as described in the article.

Figures

Figure 1:
Figure 1:
Framework for classifying scenarios based on their probabilities.
Figure 2:
Figure 2:
Use of a simple, tablet-based 3D scanner. Persons in image have given informed consent to publication.
Figure 3:
Figure 3:
Focus on usability: clean and intuitive user interface and follows the “natural”, manual way CPOs are used to, with only a few tools that are required for a certain process step being visible.
Figure 4:
Figure 4:
Two predominant ways of manufacturing dominated global production: Injection moulding for mass production and manual hand crafting for custom products, with differing, clearly separated regulatory requirements.
Figure 5:
Figure 5:
Schematic comparison of manufacturing technologies by cost-per-part and quantity of produced parts.
Figure 6:
Figure 6:
Regulatory Overview by production technology: nowadays, there is no clear-cut border anymore between custom-made and mass-produced devices, as mass-customisation has filled the gap. Regulation cannot differentiate by production technology anymore, but needs to look at who is in charge of modelling and manufacturing.
Figure 7:
Figure 7:
Review of design changes using digital tools. Persons in image have given informed consent to publication.
See this image and copyright information in PMC

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