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VOLUME 4, ISSUE 2  
 2021 

 

STAKEHOLDER  PERSPECTIVES 

Opitz M, Fröhlingsdorf P. The digital O&P workshop. Canadian Prosthetics & Orthotics Journal. 2021; Volume 4, Issue 2, No.15. 

https://doi.org/10.33137/cpoj.v4i2.36349 

This article has been invited and reviewed by Co-Editor-In-Chief, Dr. Silvia Ursula Raschke. 
English proofread by: Karin Ryan, M.A., B.Sc., P.T. 
Managing Editor: Dr. Hossein Gholizadeh 
 

SPECIAL ISSUE 

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Opitz M, Fröhlingsdorf P. The digital O&P workshop. Canadian Prosthetics & Orthotics Journal. 2021; Volume 4, Issue 2, No.15. https://doi.org/10.33137/cpoj.v4i2.36349 

 

 

 
STAKEHOLDER  PERSPECTIVES 

 

THE DIGITAL O&P WORKSHOP 

Opitz M.*, Fröhlingsdorf P.  
 

MECURIS GmbH, Lindwurmstraße 11, 80337 München, Germany. 
 

 

 

 

  

 

 

 

 

 

CONVERGING TRENDS DRASTICALLY 

DIGITALIZE O&P WORKSHOPS 

Digitalisation alone is just a meaningless buzzword. 

Digitalisation is not a trend. In the scientific discipline of 

future studies,1 digitalisation would be tagged as a 

megatrend. Megatrends span several sub phenomena we 

call (tech) trends like 3D scanning, 3D modelling and 3D 

printing.  

Several of these trends currently converge and speed up 

change in orthotics & prosthetics (O&P) workshops up to a 

so-called tipping point. This means from a certain point in 

time or rather a rate of adoption, change fuels itself in a 

vicious circle and cannot be stopped anymore. Popular 

examples are “flatten the curve” efforts versus the Covid 

pandemic,2 “network effects” in social networks like 

Facebook,3 global warming tipping points in climate 

change.4  

In addition, Covid-19 broke up traditional ways of working. 

Such unforeseen events are called wildcards. Wildcards 

drastically reduce the resistance to behavioural change and 

establish “new normals”. After such an event, things tend to 

snap “back to normal”.  But, the longer the current crisis 

continues, the more routines have already changed 

permanently. 

The likelihood of future scenarios is strongly influenced by 

boundary conditions that are unlikely to change as rapidly 

as the fundamental needs of the end users, the regulatory 

framework and reimbursement. 

It is impossible to say what the future will look like.  We can 

only describe scenarios and estimate their probabilities 

(Figure 1). All probable scenarios currently foresee a fast-

paced change towards a more digital manufacturing 

process. There is no “if”, just “when”. That means, all those 

who do not want to “suffer change” but instead create the 

future of O&P, now have to openly debate the “how”. In 

particular, how do we want the future of assistive device 

production to look like? Is there a scenario in which all 

healthcare customers benefit: end users, providers and 

payors? 

This paper focuses on the O&P workshops and, in the first 

section, provides an overview of the trends around 

digitalisation that are about to converge and potential future 

adoption scenarios. The next section reviews how much 

boundary conditions prohibit or foster change in O&P care. 

In the final section, the impact of the Covid wildcard will be 

assessed and we describe a desirable scenario that works 

as a north star for end users, providers and payors. We 

conclude with a call to action to all stakeholders, 

summarizing the next steps to be taken to increase the 

likeliness of this favourable scenario. 

 
OPEN  ACCESS Volume 4, Issue 2, Article No.15. 2021 

 

 

Journal Homepage: https://jps.library.utoronto.ca/index.php/cpoj/index 

 

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.  

CITATION 

Opitz M, Fröhlingsdorf P. The digital O&P 

workshop. Canadian Prosthetics & Orthotics 

Journal. 2021; Volume 4, Issue 2, No.15. 

https://doi.org/10.33137/cpoj.v4i2.36349 

KEYWORDS 

Digital Transformation, Central Fab, Digital 

Process Chains, FDA, Custom-Made 

Device, Prosthetic Feet, Orthotic Brace, 

Quality Assurance, Additive Manufacturing, 

Trends 

 

* CORRESPONDING AUTHOR 

Manuel Opitz,  
MECURIS GmbH, Lindwurmstraße 11, 80337 München, Germany. 

E-mail: mo@mecuris.com 

ORCID number: https://orcid.org/0000-0001-6098-1881 

Special Issue: Health Economics in Prosthetics & Orthotics 

https://doi.org/10.33137/cpoj.v4i2.36349
https://jps.library.utoronto.ca/index.php/cpoj/index
https://doi.org/10.33137/cpoj.v4i2.36349
mailto:mo@mecuris.com
https://orcid.org/0000-0001-6098-1881


 

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Figure 1: Framework for classifying scenarios based on their          

probabilities. 

 

CONVERGING 3D TECHNOLOGY TRENDS  

In digitizing the laboratory, we have to look at the three 

major steps of the process: 

1.Input (e.g. enabled by 3D scanning) 

2.Processing ( e.g. enabled by 3D modelling software) 

3.Output (e.g. enabled by 3D printing or CNC milling) 

Input - Smartphone 3D scanning apps validated for O&P 

lead to data explosion 

3D scanner adoption varies a lot by country. Some countries 

like France with few O&P clinics serve large areas with 

central fabrication done by unskilled workers and, with 

favourable reimbursement systems, have almost full 3D 

scanner adoption. In Germany, adoption is around 64.4%, 

with another 22% planning to use 3D scanners soon  

(Figure 2), according to a 2017/18 survey among 118 

German CPOs.5 The US and Canada are surprisingly non-

digital in this category. 

 

Figure 2: Use of a simple, tablet-based 3D scanner. Persons in 

image have given informed consent to publication. 

As of now, almost every CPO practicing in Canada or the 

US has a 3D scanner in their jeans pocket. Most current 

smartphones support 3D scanning but most generic 3D 

scanning apps6 for both Android and iOS, have not been 

validated for patient scanning. With the advent of more and 

more scanning apps specifically targeting O&P, validating 

patient scanning is beginning to happen,7,8 usability and 

scanning quality are being greatly increased and adoption 

rates are growing fast. Since the iPhone X,8 most models 

currently in use support these O&P scanning apps to an 

accuracy of ±1mm. 

In considering this, the tipping point for widespread adoption 

of ready-to-scan smartphones already lies in the past. The 

only question is, if the future follows a scenario with 3D 

scanning apps going mainstream in O&P in 2021 or 2022, 

or if some unforeseen event still changes this trajectory. 

Processing - Workflow-based Software-as-a-Service 

(SaaS) modeling software pulverises entry barriers 

3D modelling software has been used in all larger O&P 

workshops for several decades.9 However, two major 

factors prohibited widespread adoption  in smaller 

workshops: 

1. The high cost of  $20’000 or $30’000 for a single 

license. Annual maintenance fees add to the initial cost. 

2. High expertise in CAD design is needed. In many 

countries this is not threaded into the P&O educational 

curriculum and post-graduate training in these skills is 

costly, time-consuming and results in a lower level of 

competence than if it were integrated into the core P&O 

curriculum. 

Additional minor factors include too few software updates, 

issues due to licenses being fixed to a single machine, high 

demand of processing power in a local machine, the 

requirement for specific tools like CAD pens, etc. 

These issues are not exclusive to the O&P industry. In other 

industry areas, they already have been solved with modern 

CAD tools. 

The high initial cost barrier was overcome by SaaS 

offerings. Every CPO uses SaaS in their private life, e.g. 

through streaming services like Netflix or Spotify. The 

accountability of monthly fees for products is also increased 

thanks to that. On the technical side, subscription, web-

based software that requires a monthly fee allows for 

access from any device, paving the way not only for SaaS, 

but also for faster updates and bug fixes, while reducing 

requirements for local hardware by allowing for processing 

directly in the cloud. 

Modern software focuses on usability. For widespread 

adoption, a clean and intuitive user interface is key  

(Figure 3). This runs counter to classic CAD software 

offering up several dozen tools in one interface. Workflow-

based software, in contrast, follows the “natural”, manual 

way CPOs are used to and expect (Figure 3).  

Time 

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This modern software offers only the few really necessary 

tools required for a certain process step. FAQs and 

feedback/help tools are also specific for every step.10 Thus, 

little to no training is required and providers are “trained on 

the job”. Again, cloud technology enables powerful smart 

features like an assisted posture correction of a scan or 

suggestions for functional form creation using machine 

learning.10  

Right now, such tools are primarily being offered to 

providers by startups. Most focus on one application area, 

e.g. sockets11 or wrist braces.12,13 Only a few enable 

several applications such as a classic CAD tool for the 

orthotics and prosthetics side.10 However, the two leading 

manufacturers have also started in this direction, with 

Ottobock investing in several startups14 and now developing 

their own workflow-based orthotics modelling software and 

Össur, this year, announcing the purchase of parts of the 

socket modelling software from Standard Cyborg.15 

The 7-digit investments made by dominant market players 

like Ottobock and Össur into process-based modeling 

software and the variety of new ideas by startups clearly 

indicate that the market is already tipping in this direction. 

Fueled by the abundance of available 3D scanning data the 

remaining question is not if, but when 3D modelling software 

goes mainstream in O&P: 2022 or 2023 or 2024. 

Output - Proliferating 3D printing service allows direct 

print of final design 

Today, two ways of manufacturing dominate global 

production: Injection moulding for mass production and 

manual hand crafting for custom products (Figure 4). But, 

over the last few decades, mass customization enabled by 

the advent of new manufacturing technologies has begun to 

bridge the chasm between those two extremes. Most 

relevant for O&P are computerized numerical control (CNC) 

milling and, more recently, additive manufacturing (AM), 

often referred to as 3D printing. 

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.  

Automation offers the highest leverage with large quantities, 

even for individual care. Therefore, CNC milling machines 

were first and most successfully adopted in high volume 

individual care industries, as in dental or orthopedic insoles. 

However, severe restrictions on the complexity of the 

design limited the use of CNC milling machines.  This was 

the case with the manufacturing of hearing aids, which could 

not be widely manufactured CNC milling, other than for 

some of the internal parts. Therefore, the hearing aid 

industry was able to leapfrog CNC milling and went directly 

    Original Scan                               Corrected Scan                             Functional Form                           Finished Orthotics 

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.  

Mass production 
e.g. injection 

moulding 
 

Regulated as 
medical device 

Manual production 
e.g. hand-crafting 

 
Regulated as 

custom made device 

Manufacturing of O&P Devices till 1990 

Manufacturing technology continuum 

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to AM showing a concerted progress within a few years. 

Using this strategy, the hearing aid industry was able to 

move to directly producing the final product - without any 

mold or pre-product. 

By lowering costs per part, growing build volumes and 

increasing process stability, AM has now reached maturity 

for O&P applications beyond orthopedic insoles. This finally 

enabled a fully digital process chain. Before, it was aborted 

with the functional form that is milled and then used as a 

negative for thermo forming of an orthosis. This also meant 

a “dirty” workshop was still necessary. Now, the (negative) 

functional form can be digitally “wrapped” with a (positive) 

final orthosis (or socket) design. This design, in turn, is 

directly manufactured using AM. Digitalising this last step 

saves a lot of working time for the provider, e.g. 3.7h for a 

foot orthosis.16 For larger providers, this quickly scales into 

a substantial economical advantage. 

The clear downside with AM is the exponential cost scaling 

with increasing build volume. Therefore, it is less a question 

if prosthetics or orthotics are economical to print. The 

question rather depends on the build size of the application. 

Small O&P devices especially in pediatrics are already 

much cheaper to print compared to manual production, 

often even milling. This includes pediatric prosthetic feet, 

AFOs, DAFOs, night splints, wrist orthotics and baby 

helmets. For larger build volumes, CNC milling however 

remains the mass customization method of choice. This is 

true especially for large bracings for adolescents or adults 

that have to endure high stress and have to be built in one 

part, e.g. corsets. 

The paradigm shifts from subtractive to additive and also 

more unique selling propositions (USP): Less waste. In 

times of rising environmental awareness, saving 1.5kg of 

waste and 1.6kg CO2 equivalent in the manufacturing of a 

0.5kg foot orthosis by using AM instead of hot forming is 

important to many end users.16  

A more long-term scenario includes the widespread shift in 

thinking from recreating traditional, subtractively 

manufactured devices with 3D printing towards more 

natural, generative designs.17 This shift in mindset rivals 

another scenario, in which a widespread availability of more 

materials, especially those known in the O&P space, lead 

towards another jump in adoption. 

 In conclusion, the 7-digit investments made by dominant 

market players like Hanger and Ottobock as well as national 

purchasing associations e.g. in Germany18 into industrial 3D 

printers and post processing machine parks clearly indicate 

that they expect additive manufacturing to gain a 2-digit 

market share in the very near future. Most scenarios predict 

3D printing as one more production tool and not the 

dominant technology overall, likely on par with CNC milling, 

injection moulding (Figure 5) and, yes, some minor 

modifications still being done by hand. 

 

Figure 5: Schematic comparison of manufacturing technologies by 

cost-per-part and quantity of produced parts.   

Due to the aforementioned high investment cost, most 

providers except the very large players like Pohlig in 

Germany or EastPoint19 in the US  will either rely on a 

dominant OEM for 3D printing, together with their peers co-

fund a 3D printer in a central fab20 e.g. within the framework 

of a purchasing association, or rely on a “neutral” 3rd party, 

the mushrooming number of 3D printing service bureaus. 

The scenarios for the future digital supply chains vary a lot 

by country and the competitive situation. It is likely that after 

the current adoption wave fueled by O&P-ready printing 

hubs and sinking costs, there will be another spike of 

adoption in a few years with the availability of more 

materials or the understanding of the new freedom of design 

enabled by AM.  

BOUNDARY CONDITIONS 

Regulation driven by FDA separates Custom + Patient-

Matched Device 

Now that the fully digital process chains are capturing more 

and more medical markets, regulators are adjusting the 

framework in which manufacturers are allowed to operate. 

Former regulations often did not cover these areas, or they 

allowed too much or too little legroom for manufacturers for 

patient safety. This caused a flurry of updated or new 

definitions and guidelines by national and international 

authorities. Most productive has been the FDA with 

advanced regulations for AM of medical devices,21  software 

as a medical device (SaMD), in silico-trials (virtual testing) 

and more. The FDA has worked alongside other national 

regulators in the International Medical Device Regulators 

Forum (IMDRF) to assure a globally consistent definition for 

new terms like SaMD or patient-matched medical device. 

The IMDRF has also filled the regulatory chasm between 

manual and mass manufacturing (Figure 6), defining sub-

types for personalised devices and providing technology 

examples for mass customisation like 3D printing: “It is now 

possible to produce medical devices, which are 

Quantity 

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individualised e.g. by additive manufacturing methods (3D 

printing) based on patient CT scans, on a commercial rather 

than a manual scale. The original GHTF documentation 

does not adequately address such devices.”22 Further 

motivation was to make sure that the regulatory reliefs 

granted to custom made device manufacturers are not 

abused by industrial manufacturers to produce large 

quantities: “In other jurisdictions, the derogations were 

established with the intention that the number of custom-

made devices would necessarily be small, as they could 

only be used in special cases.”22 The FDA explicitly limits 

the production of custom made devices "to no more than 

five units per year of a particular medical device".23  

Today, the IMDRF distinguishes between 3 subclasses of 

personalised medical devices:22 

1. Custom-made products: A custom-made medical device 

on the written order of an authorised (medical) professional. 

This professional, on his own responsibility, gives the 

medical device specific design features, even if the design 

was developed with a manufacturer. In a nutshell, the 

provider controls the design step. It does not matter: 

1.1. if the provider uses a 3rd party software to do so. 

1.2. if the manufacturing is carried out by a 3rd party. 

1.3. whether the device is hand-crafted or 3D printed. 

2. Patient-matched medical device: It is designed and 

manufactured under the responsibility of a manufacturer, 

even if the design was developed in consultation with an 

authorised healthcare professional. In a nutshell, a 3rd party 

manufacturer controls the design step. It does not matter: 

2.1. if the provider supports with initial patient data or 

other design inputs. 

A practical example are plaster casts and/or 3D scan of a 

patient anatomy that is sent to a manufacturer who adapts 

a digital orthosis model to fit this patient anatomy and then 

returns a patient-specific manufactured orthosis. 

3. Adaptable medical device: A mass-produced product that 

is adapted, adjusted, assembled or shaped at the point of 

care, in accordance with the manufacturer's validated 

instructions. It does not matter: 

3.1. whether the healthcare professional or the patient 

him/herself adapts or adjusts the device. 

A practical example are orthoses that are adapted to the 

patient through thermoforming, and/or are adjusted by the 

patient.  

This means that the globally valid definition distinguishes a 

patient-specific medical device from a custom-made 

product primarily because the design step is within the 

responsibility of the manufacturer, not the provider. The 

Medical Device Coordination Group (MDCG), a group 

formed on request of the European Commission 

representing all member states, has just now adopted this 

definition in their MDCG 2021-03 guideline on custom-made 

devices.24  

The trend scenario will thus see a continuation of new 

guidelines25 or updates of current ones, especially in the EU 

that was so far busy releasing the MDR. A harmonization of 

global definitions as national directives like the MDR or 

guidelines (EU, Australia, FDA) will probably take up to 5 

years. Canada also has not yet updated their regulations26 

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. 

Mass production 

e.g. injection moulding 

regulated as 

Manual production 

e.g. hand-crafting 

regulated as 

custom made device 

Mass customisation 

e.g. CNC, AM 

regulated as 

Manufacturing of O&P Devices Today 

Manufacturing technology continuum 

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and guidelines27 to account for mass customised devices. 

However, it is likely that the EU and FDA have adopted the 

IMDRF definitions, most other countries follow in their wake, 

which hopefully leads to a more unified regulatory 

landscape. More long-term, regulators might go after 

manufacturers misusing the custom device reliefs. It seems 

likely though that O&P manufacturers will benefit from a 

grace period compared to medical manufacturers in higher 

risk classes that pose a higher risk to patient safety. 

Providers will always benefit from these reliefs. One 

scenario might be a care provider suing a large 

manufacturer that tries to grab a larger part of the value 

chain by not only offering modelling software or 

manufacturing services, but also internalising the design 

control. An alternative scenario might be a lawsuit by a 

competing manufacturer. 

Reimbursement’s major Impact could Stifle or Speed 

up Digitalisation 

Payors also want to benefit from this innovative process. 

The megatrend of ageing population in countries of the 

Global North and thus more patients per capita forces 

payors to constantly lower reimbursement rates to 

rebalance overall healthcare costs. Growing margins for 

providers that have adopted a digital process chain 

increases the likelihood for future scenarios in which payors 

will once more target O&P reimbursement levels. These 

scenarios will force manual manufacturing providers to 

either switch or shut down. The most likely scenario drives 

all providers to digitize their process of care giving in a short 

time frame, all but a few highly specialised providers that 

operate in a niche like pediatrics or para athletes and/or 

providers that increase their margin by out-of-pocket 

payments. However, since the year 2000, out-of-pocket 

payments have been constantly in decline in the US and 

Canada.28 

Another long-term benefit for both regulators and payors is 

the perfect measurability of digital processes. Providers will 

gain unprecedented quantitative insights into their 

manufacturing process. From scanning to printing, every 

step is monitored and evaluated. This enables a continuous 

improvement process as adopted in most industries by 

now,29 leading not only to less errors for providers, but also 

improved results for end users. Less complications and 

better patient outcomes are also the goals of regulators and 

payors, reducing secondary costs like refittings, 

rehabilitation, and product replacements. In an unlikely 

scenario, payors therefore use their foresight to pay extra 

for custom made devices that were additively manufactured 

to drastically reduce adoption time and thus reap the 

benefits much faster. One example of this was the increase 

in reimbursement rates for O&P devices reinforced with 

carbon fibre for increased durability as the decisive factor 

for the sudden widespread adoption across all providers. 

 

CONCLUSION 

Covid Wildcard 

Due to its long duration and global impact for all citizens, the 

Covid crisis has a tremendous impact, even compared to 

other wildcard events like 9/11 or the Fukushima reactor 

catastrophe. This means the likelihood of future scenarios 

requiring more drastic behaviour changes increases, the 

longer this crisis endures. 

For end users, the sudden advent of telehealth will increase 

the demand for less physical appointments also in O&P 

care. This was clearly unthinkable at the beginning of 2020. 

Taking a more active and informed approach towards 

healthcare will also increase demand towards providers to 

be treated accordingly. 

Providers, in turn, would not have expected to work in home 

offices in O&P care. As most CPOs do not have a plaster 

cast room at home, digital and distributed workshops 

suddenly became very important. These new tools are not 

part of the current reimbursement landscape. 

Therefore, payors that have already been quick to provide 

temporary reliefs like waiving or accepting digital 

prescriptions or bonuses for protective equipment will also 

have to address such requests. Tremendous costs on the 

one side were partly offset by drastically reduced spending 

for elective surgery and other healthcare treatments, 

evidently showing that healthcare spending is much less 

fixed than assumed for decades. 

Desirable Scenario for End Users, Providers and 

Payors 

Two paradigms seem constant for most future scenarios. 

First, the ageing population, which in turn leads to 

decreasing reimbursement rates by payors and thus 

increasing cost pressure for providers or out-of-the-pocket 

spending for end users. A second constant seems to be that 

digitalization as a technology will not replace human 

interaction and improve healthcare on its own, but empower 

all stakeholders with new tools and thus change how care 

is delivered in the future. Based on these assumptions, we 

will draw a likely and desirable trend scenario for the O&P 

care of the new future in following: 

In 2022, Tim needs a new AFO as his old one broke 

yesterday during work. Due to his impaired mobility, he 

schedules a quick video call with his orthotist Emma. After 

a quick look at the orthosis, Emma decides it is beyond even 

temporary repair, snaps a few pictures and files a complaint 

so the next AFOs will have a sturdier design for Tim. The 

health insurance is informed, too. 

The next day, Emma visits Tim at home to collect the broken 

orthosis. As always, she takes inventory on joint mobility 

and muscle status and of course skin irritations, too. Thanks 

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to this checkup, Emma identifies a recent pressure ulcer on 

the left side of his ankle,  unrelated to the defect. She finally 

scans his foot with her mobile phone. Tim picks green and 

yellow as colors for his new AFO and a wavy pattern for the 

backside. When he is fully happy with the 3D preview, he 

adds his initials on the design - just like an artist would do 

after expressing himself. With the technical information 

quickly collected, Emma uses the rest of her time to 

understand Tim’s recently changing activity profile and 

builds their relationship of trust. 

After visiting several more of her patients, Emma receives 

approval to create a new orthosis from the payor thanks to 

her digital defect report. Despite the premature defect, they 

are happy that Tim is evidently very active and thus lowers 

the risk of higher follow up costs if his mobility decreases. 

Emma uses 30 minutes in the afternoon to configure Tim’s  

new AFO on her workstation at home. She reloads the 

previous AFO design for Tim and asks the software to resize 

it based on today’s 3D scan. She then reinforces the defect 

area and reshapes the pressure point so she can add more 

padding for Tim’s ankle. She then runs a quick computer 

simulation to assure the design changes have not increased 

the risk of failure or impaired the functionality of the 

device.30,31 She also invites colleagues at her workshop, 

Bob and Tommy, to review her design changes digitally 

(Figure 7). 

When Emma arrives in her workshop the next day, she 

receives a notification that due to an anomaly during the 

printing process, the material of the printed shell has slightly 

darkened. It seems to her like coloring issues in orthosis 

manufacturing have “successfully” transitioned from manual 

to digital manufacturing. Thus, she quickly sends a new 3D 

preview to Tim using a darker orange instead of the bright 

yellow so the darkened material does not shine through. Tim 

is very happy with the new color. However, he had second 

thoughts about “signing off” his AFO and asks Emma to not 

color his initials too prominently, as he is afraid it might look 

too cocky. 

 

Figure 7: Review of design changes using digital tools. Persons in 

image have given informed consent to publication. 

The next day, Emma receives the colored shell and quickly 

inspects the quality and documents it with a few photos. She 

then adds the straps and padding, especially on the left side 

of the ankle. In the afternoon, she visits several end users, 

including Tim. He tries out the new AFO and is impressed 

with the consistent, perfect fit and the small improvement of 

the padding. Emma captures a few videos of his gait to 

document the great functionality for her colleagues and the 

payor. Tim also answers a quick satisfaction survey, 

stressing that he is not only very happy with the result of his 

new orthosis, but also the effortless complaint procedure 

with the provider and the payor. Not only is he mobile again, 

but also a proud co-creator of his personalised assistive 

device. 

CALL TO ACTION 

To all end users: As described above, you can now take part 

in the aesthetic design of your custom patient aid. This is 

just one example of how digitalisation empowers you to 

become the co-creators of your own devices, together with 

your trusted provider. 

To providers: If you care more about patient outcomes than 

the manual craftsmanship in your workshop, digitalisation 

enables you to shift your focus while increasing customer 

satisfaction and productivity. No software or 3D scanner is 

going to replace the unique bond you have with your clients, 

but if you prefer tinkering over caring for patients, payors will 

make your life much more difficult in the future. 

To payors: To reap the true benefits of digitalisation in O&P 

care, a small reimbursement incentive drastically increases 

adoption time, thus lowering long-term post-treatment costs 

thanks to high and consistent health outcomes. 

To regulators: Despite not being a healthcare customer, you 

have the power to guide efforts for improved patient 

outcomes without harming innovation. The main need is not 

for additional regulation, but further, more tangible 

guidelines, ideally globally harmonised. This stretches from 

SaMD to mass customisation and fabrication to prevent the 

misuse of custom made device reliefs. 

ACKNOWLEDGEMENTS 

None. 

DECLARATION OF CONFLICTING 

INTERESTS 

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. 

SOURCES OF SUPPORT 

Parts of this article have been enabled through the research project 

SIGMA3D. This includes the cited works on regulation of custom-

made devices and the MDR of Ann-Kathrin Carl from University of 

Applied Science Münster. Mecuris is the project leader and the 

https://doi.org/10.33137/cpoj.v4i2.36349


 

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Opitz M, Fröhlingsdorf P. The digital O&P workshop. Canadian Prosthetics & Orthotics Journal. 2021; Volume 4, Issue 2, No.15. https://doi.org/10.33137/cpoj.v4i2.36349 

ISSN: 2561-987X 
THE DIGITAL O&P WORKSHOP 

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project is funded by the German Federal Ministry of Education and 

Research under the funding code 16SV8386. The responsibility for 

the content of this publication lies with the authors. 

REFERENCES 

1.Futures studies [Internet]. Wikipedia. [cited 2021 Feb 10]. 

Available from: 

https://en.wikipedia.org/wiki/Futures_studies#Futures_techniques 

2. Stevens H. Why outbreaks like coronavirus spread exponentially, 

and how to “flatten the curve.” [Internet]. Washington Post, 2020; 

[cited 2021 Feb 10]; Available from: 

https://www.washingtonpost.com/graphics/2020/world/corona-

simulator/ 

3.Hunter B. Tipping Points in Social Networks [Internet]. Stanford 

University. [cited 2021 Feb 10]. Available from: 

https://web.stanford.edu/class/symbsys205/tipping_point.html 

4.Scientists four future international [Internet].  scientists4future.org 

[cited 2021 Feb 10]. Available from: http://scientists4future.org/we-

are/facts/ 

5.Böcker C. Berufsbildung 4.0 – Fachkräftequalifikationen und 

Kompetenzen für die digitalisierte Arbeit von morgen: Der 

Ausbildungsberuf „Orthopädietechnik-Mechaniker/-in“ im 

Screening [Vocational Training and Education 4.0 - Skilled labour 

qualifications and competences for the digitalised work of 

tomorrow: the vocational training occupation "certified 

prosthetist/orthotist" in screening] [Internet]. German Federal 

Institute for Vocational Education and Training; 2020;  

[cited 2021 Feb 10]. Available from: 

https://www.bibb.de/veroeffentlichungen/de/publication/show/1049

4 

6.Top 3D scanning software: photogrammetry, laser and light 

scanning, and scanning apps for your phone [Internet]. Sculpteo. 

[cited 2021 Feb 10]. Available from: 

https://www.sculpteo.com/en/3d-learning-hub/3d-printing-

software/3d-scanner-app/ 

7.Body measurement technology at your fingertips [Internet]. 

TechMed3D. [cited 2021 Feb 10]. Available from: 

https://techmed3d.com/products/3dsizeme/ 

8.The App [Internet]. Comb O&P. [cited 2021 Feb 10]. Available 

from: https://www.combscan.com/the-comb-app 

9.Tate TS. Unlocking the Potential for CAD/CAM in Today’s O&P 

[Internet]. The Academy Today. 2013; [cited 2021 Feb 10]. 

Available from:  
http://digital.publicationprinters.com/publication/index.php?m=215

80&i=559112&p=11&pp=1&ver=html5 

10.Mecuris solution platform-your digital workshop [Internet]. 

Mecuris. [cited 2021 Feb 10]. Available from: 

https://www.mecuris.com/ 

11.The pandofit solution [Internet]. Prosfit. [cited 2021 Feb 10]. 

Available from: https://prosfit.com 

12.Discover the full potential of mass-customised 3D printed 

orthotic devices [Internet]. Spentys. [cited 2021 Feb 10]. Available 

from: https://www.spentys.com/products 

13.Xkelet [Internet]. [cited 2021 Feb 10]. Available from: 

http://www.xkelet.com/en 

14.3D printing: patients benefit from custom orthoses [Internet]. 

ottobock.com. 2018; [cited 2021 Feb 10]. Available from: 

https://www.ottobock.com/en/newsroom/news/3d-printing-

patients-benefit-from-custom-orthoses.html 

15.Össur Acquires Scanning and Design Technology from 

Standard Cyborg [Internet]. Ossur. 2020; [cited 2021 Feb 10]. 

Available from: https://www.ossur.com/en-us/about-

ossur/newsroom/ossur-acquires-scanning-and-design-technology-

from-standard-cyborg 

16.Weiser A. Economic and ecological sustainability assessment of 

the digitalization of orthopedic technology using 3D printing - 

focusing on positioning pediatric splints [Undergraduate thesis]. 

Hochschule München; 2020. 

17.Kienzle C, Schäfer M. Integration of additive manufacturing 

processes in orthopedic technology fitting routine. Orthopädie 

Technik. 2018;(5). 

18.Verlängerte Werkbank [Extended Workbench] [Internet]. 

Nowecor. [cited 2021 Feb 10]. Available from: 

https://www.nowecor.de/Unternehmen/Werkbank 

19.AdditiveAmerica [Internet]. [cited 2021 Feb 10]. Available from: 

http://www.additiveamerica.com 

20.Otto JP. The Perfect Wave? Central Fabrication Rides the Tide 

as O&P Evolves [Internet]. The O&P Edge. 2018; [cited 2021 Feb 

10]. Available from: https://opedge.com/Articles/ViewArticle/2018-

08-01/the-perfect-wave-central-fabrication-rides-the-tide-as-op-

evolves 

21.Technical Considerations for Additive Manufactured Medical 

Devices [Internet]. Food and Drug Administration. 2017; [cited 2021 

Feb 10]; Available from: 

https://www.fda.gov/media/97633/download 

22.Definitions for Personalized Medical Devices [Internet]. 

International Medical Device Regulators Forum.  2018; [cited 2021 

Feb 10]; Available from: 

http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-181018-

pmd-definitions-n49.pdf 

23.Custom device exemption - guidance for industry and food and 

drug administration staff [Internet]. Food and Drug Administration. 

2014; [cited 2021 Feb 10]. Available from: 

https://www.fda.gov/media/89897/download 

24.MDCG 2021-03 questions and answers on custom-made 

devices & considerations on adaptable medical devices and 

patient-matched medical devices [Internet]. Medical device 

coordination group. 2021; [cited 2021 May 25]. Available from: 

https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdc

g_2021-3_en.pdf 

25.Digital process chains in industrial manufacturing for medical 

devices [Internet]. VDI- The Association of German Engineers.  

2021; [cited 2021 Feb 10]. Available from: 

https://www.vdi.de/richtlinien/details/vdi-5705-blatt-1-digitale-

prozessketten-in-der-industriellen-medizintechnik-herstellung-von-

sonderanfertigungen 

26.Medical devices regulations [Internet]. Canadian Minister of 

Justice. 2019; [cited 2021 Feb 10]. Available from: https://laws-

lois.justice.gc.ca/PDF/SOR-98-282.pdf 

27.Guidance for Health Care Professionals on Special Access and 

Custom-Made Medical Devices [Internet]. Canadian Minister of 

Health. 2016; [cited 2021 Feb 10]. Available from: 

https://doi.org/10.33137/cpoj.v4i2.36349
https://en.wikipedia.org/wiki/Futures_studies#Futures_techniques
https://www.washingtonpost.com/graphics/2020/world/corona-simulator/
https://www.washingtonpost.com/graphics/2020/world/corona-simulator/
https://web.stanford.edu/class/symbsys205/tipping_point.html
http://scientists4future.org/we-are/facts/
http://scientists4future.org/we-are/facts/
https://www.bibb.de/veroeffentlichungen/de/publication/show/10494
https://www.bibb.de/veroeffentlichungen/de/publication/show/10494
https://www.sculpteo.com/en/3d-learning-hub/3d-printing-software/3d-scanner-app/
https://www.sculpteo.com/en/3d-learning-hub/3d-printing-software/3d-scanner-app/
https://techmed3d.com/products/3dsizeme/
https://www.combscan.com/the-comb-app
http://digital.publicationprinters.com/publication/index.php?m=21580&i=559112&p=11&pp=1&ver=html5
http://digital.publicationprinters.com/publication/index.php?m=21580&i=559112&p=11&pp=1&ver=html5
https://www.mecuris.com/
https://prosfit.com/
https://www.spentys.com/products
http://www.xkelet.com/en
https://www.ottobock.com/en/newsroom/news/3d-printing-patients-benefit-from-custom-orthoses.html
https://www.ottobock.com/en/newsroom/news/3d-printing-patients-benefit-from-custom-orthoses.html
https://www.ossur.com/en-us/about-ossur/newsroom/ossur-acquires-scanning-and-design-technology-from-standard-cyborg
https://www.ossur.com/en-us/about-ossur/newsroom/ossur-acquires-scanning-and-design-technology-from-standard-cyborg
https://www.ossur.com/en-us/about-ossur/newsroom/ossur-acquires-scanning-and-design-technology-from-standard-cyborg
https://www.nowecor.de/Unternehmen/Werkbank
http://www.additiveamerica.com/
https://opedge.com/Articles/ViewArticle/2018-08-01/the-perfect-wave-central-fabrication-rides-the-tide-as-op-evolves
https://opedge.com/Articles/ViewArticle/2018-08-01/the-perfect-wave-central-fabrication-rides-the-tide-as-op-evolves
https://opedge.com/Articles/ViewArticle/2018-08-01/the-perfect-wave-central-fabrication-rides-the-tide-as-op-evolves
https://www.fda.gov/media/97633/download
http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-181018-pmd-definitions-n49.pdf
http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-181018-pmd-definitions-n49.pdf
https://www.fda.gov/media/89897/download
https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-3_en.pdf
https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-3_en.pdf
https://www.vdi.de/richtlinien/details/vdi-5705-blatt-1-digitale-prozessketten-in-der-industriellen-medizintechnik-herstellung-von-sonderanfertigungen
https://www.vdi.de/richtlinien/details/vdi-5705-blatt-1-digitale-prozessketten-in-der-industriellen-medizintechnik-herstellung-von-sonderanfertigungen
https://www.vdi.de/richtlinien/details/vdi-5705-blatt-1-digitale-prozessketten-in-der-industriellen-medizintechnik-herstellung-von-sonderanfertigungen
https://laws-lois.justice.gc.ca/PDF/SOR-98-282.pdf
https://laws-lois.justice.gc.ca/PDF/SOR-98-282.pdf


 

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ISSN: 2561-987X 
THE DIGITAL O&P WORKSHOP 

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Special  

 

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L

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https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/dhp-

mps/alt_formats/hpfb-dgpsa/pdf/acces/sap-md-dg-as-im-ld-

eng.pdf#page=20 

28.Out-of-pocket expenditure (% of current health expenditure) - 

Canada, United States [Internet]. The World Bank.  [cited 2021 Feb 

10]. Available from: 

https://data.worldbank.org/indicator/SH.XPD.OOPC.CH.ZS?locati

ons=CA-US 

29.Kaizen [Internet]. Wikipedia. [cited 2021 Feb 10]. Available from: 

https://en.wikipedia.org/wiki/Kaizen 

30.Verbesserter Patientennutzen: Digitale Abmessung und 3D 

modellierte Orthesen [Internet]. German Federal Ministry of 

Education and Research. SIGMA3D. [cited 2021 Feb 10]. Available 

from: https://www.interaktive-technologien.de/projekte/sigma3d 

31.Interdisciplinary research project for the digitalization of orthotics 

[Internet]. Mecuris. SIGMA3D.  [cited 2021 Feb 10]. Available from: 

https://www.mecuris.com/sigma3d-projekt?lang=en 

 
  

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

AUTHORS SCIENTIFIC BIOGRAPHY 

Before starting several 

medtech ventures, Manuel 

Opitz studied industrial & 

bioengineering at RWTH 

Aachen and Trinity College 

Dublin (MSc). After first 

experiences in innovation and 

operations management in 

Germany, China and 

Switzerland, he finished 

postgraduate studies in 

economics at the trinational 

CDI in Paris (MBA). 

Afterwards, he focused on 

medical technologies as a 

patent broker and startup consultant. He successfully raised funds 

for three different medtech ventures. As co-founder of Mecuris 

(CEO & COO), he analyses orthopaedic manufacturing processes 

to unlock digitalisation potential for orthotists/prosthetists and 

patients. With his newest venture (CEO), he aims at reducing 

diagnostic errors and patient visits using AI software as a second 

opinion for doctors. As a regular speaker at healthcare conferences 

(OTWorld, ISPO, …), innovation (TEDx) and startup conferences, 

he works on bridging the gap between digital technologies and the 

healthcare system. He is co-author of an industry guideline on 

“digital process chains in medical technology” and contributed to 

books on 3D printing as well as digital business models in the 

healthcare sector. 

Master craftsman and 

certified prosthetist & orthotist 

Peter Fröhlingsdorf gained 

hands-on experience in 

patient care with his own 

handicraft production for 10 

years before he successfully 

took over the responsibility for 

setting up a central production 

for orthopaedic and 

orthopaedic shoe technology 

aids in one of the largest 

medical supply stores in 

Germany. There he later 

expanded and developed the 

area of children's and youth care as managing director. Further 

career stages include 5 years of sales experience with an Icelandic 

prosthesis manufacturer and setting up a European sales hub and 

force for assistant robots of a Canadian manufacturer. Peter 

Fröhlingsdorf has been CEO of Mecuris GmbH since January 2020. 

He is a regular lecturer at the Federal College for Orthopaedic 

Technology in Dortmund, OTWorld, RehaKind, Focus CP, Accident 

Insurance Association and more. He is also 2nd chairman and 

treasurer of Cerebral Palsy Network e.V. and is passionate about 

innovation in orthopaedic technology. 

 

 

 

https://doi.org/10.33137/cpoj.v4i2.36349
https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/dhp-mps/alt_formats/hpfb-dgpsa/pdf/acces/sap-md-dg-as-im-ld-eng.pdf#page=20
https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/dhp-mps/alt_formats/hpfb-dgpsa/pdf/acces/sap-md-dg-as-im-ld-eng.pdf#page=20
https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/dhp-mps/alt_formats/hpfb-dgpsa/pdf/acces/sap-md-dg-as-im-ld-eng.pdf#page=20
https://data.worldbank.org/indicator/SH.XPD.OOPC.CH.ZS?locations=CA-US
https://data.worldbank.org/indicator/SH.XPD.OOPC.CH.ZS?locations=CA-US
https://en.wikipedia.org/wiki/Kaizen
https://www.interaktive-technologien.de/projekte/sigma3d
https://www.mecuris.com/sigma3d-projekt?lang=en

