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The prosthetics and orthotics (P&O) industry is approaching a challenging time. The population is aging and the number of athletic injuries and instances of diabetes, cardiovascular disease, and amputations are increasing each year.2 In parallel, the number of prosthetic and orthotic technicians is declining, educational CPO programs are scarce, and P&O manufacturers are struggling to keep up with demand.
Like other industries, P&O companies are leveraging technology to improve their business operations and customer experience. With robotics and 3D printing, next-level improvements, such as for example the 3D printed bionic arm, are moving from science fiction to mainstream. Read on to learn about how 3D printing prosthetics is transforming the industry.
3D printing prosthetics benefits across the ecosystem
When 3D printing prosthetics, new digital workflows are employed, and they deliver benefits across the P&O Industry’s entire value chain:
- Supplier - Increased automation capabilities and improved output quality simplify manufacturing operations
- Clinic - Frees up the schedule of the clinician, giving them more time to see patients rather than spending valuable time building molds and conducting re-fittings with traditionally manufactured molds.
- Patient - Enhances the patient’s quality of life by providing a perfect fit, a lightweight and slim device, and a modern, visually appealing design.
3D prosthetics change the manufacturing paradigm
From a business point of view, 3D printing prosthetics offers myriad benefits when compared with traditional manufacturing. However, making the switch from traditional to digital manufacturing requires staff to become familiar with three important aspects of the technology: 3D scanning, 3D design, and 3D printing. Discover more details on what this entails in the 3D printing prosthetics whitepaper.
When switching from traditional manufacturing to 3D prosthetics, clinics also transition from an “art” where paper or mental records of measurements and designs (and only digital copies of patient data) are kept, to a highly repeatable “industrial” process with electronic records, which centralizes knowledge by storing patient and part specifications.
3D prosthetics don’t use molds
Traditional manufacturing techniques rely on plaster cast molds, which have several limitations. Physical measurements are taken, and molds are made by a Certified Prosthetist Orthotist (CPO). They are shared with other experts who often use varying methods, which can lead to inconsistent product quality. After multiple manual adjustments of the mold, the original impression data can be lost, leading to suboptimal comfort.
Traditional prosthetics also struggle with aesthetics and fitment issues. A two-step process is involved wherein the clinician typically fits the patient for a test device and then finishes the device with some adjustments; optimization requires manual work and multiple visits. Aesthetics are often limited due to design and product limitations.
3D printing prosthetics begins with the creation of a 3D digital image which can be saved for comparative purposes and to support future treatment. The innovative design capabilities available with 3D printing turn prosthetics into customized consumer products. 3D printing only requires a one-step process as optimization occurs prior to manufacturing, providing the right fit the first time. 3D prosthetics made with HP’s Multi Jet Fusion (MJF) 3D printing technology result in consistent, industrial grade quality3 parts.
How 3D prosthetics will revolutionize the industry
Companies drive innovation by investing efforts in research and development, and by successfully adopting new technologies. 3D printing has the power to transform prosthetics by enabling a more consumer-centric approach.
Data courtesy11
When incorporating 3D printing, companies must be mindful of the impact on their product design and engineering workflows. Design for Additive Manufacturing (DfAM) principles can enable them to improve the aesthetics and capabilities of their products. In the P&O industry this creates an opportunity to rethink how prosthetics look, function and perform.
When implementing 3D printing, P&O companies have many important design considerations, including:
- Improvements to current designs
- “Clean-sheet” redesigns
- Part consolidation
- Branding and personalization
Learn more about DfAM strategies in the 3D printing prosthetics whitepaper.
Benefits of 3D printing prosthetics with HP MJF technology
HP Multi Jet Fusion (MJF) 3D printing technology offers many advantages for manufacturers of prosthetics and other P&O products, including:
Material properties
The consistent, industrial-grade qualities3 of the 3D printing materials used with MJF (such as HP 3D High Reusability [HR] PA 11) deliver excellent impact resistance, ductility4 and enhanced elongation at break4. In addition, select HP 3D Printing materials have passed evaluations for irritation and skin sensitization; therefore, parts made from these materials, under similar conditions, meet the compliance requirements of USP Class I-VI and FDA guidance for Intact Skin Surface Devices.5
Isotropic properties
HP MJF is ideal for the production of orthotic and prosthetic devices such as a 3D prosthetic arm because it can deliver enhanced isotropic properties6 thanks to the proprietary fusing agents applied during the printing process.
Optimized productivity
Produce more parts per day with continuous printing7 - learn more about how it works here.
Sustainability and cost savings
HP’s MJF technology minimizes waste with its industry-leading powder reusability.8 In addition, unlike subtractive manufacturing processes like CNC machining, HP MJF (an additive manufacturing process) only uses the exact material required to “build” each part. In some cases, this can result in as much as a 97% reduction of material waste.9
HP Jet Fusion 3D printers are a complete all-in-one 3D printing solution. It automates much of the process and allows operators to manage multiple machines simultaneously. In some cases, this can lead to an 8X reduction in manual labor time.10
3D printing prosthetics – case studies
HuloTech
HuloTech is a 3D printing service provider that works with the P&O industry to develop 3D printed prosthetic legs and other medical devices. Traditional manufacturing methods, which involved making a plaster cast and developing a handmade socket, required long lead times and were difficult to fit. With MJF, they were able to eliminate much of the hand work and reduce the time it took to make and deliver a socket from weeks or even months, down to just a few days.
Read full Hulotech 3D printing prosthetics case study
ProsFit
ProsFit is focused on industrializing prosthetic socket manufacturing. Their PandoFit software solution allows prosthetists to design and order 3D prosthetics for patients. Before working with HP, they used another 3D printing technology, but struggled with quality control and patient complaints. With MJF they were able to improve the surface finish of their 3D printed leg, while eliminating nearly all of the manufacturing inconsistencies they previously faced.
Data courtesy12
Read the full ProsFit 3D prosthetics case study
Glaze Prosthetics
Glaze Prosthetics helps patients express their creativity and individuality by providing customized 3D printed limbs. They recognized that traditional prosthetics were uncomfortable, costly, and difficult to manufacture. Glaze experimented with other 3D printing technologies but found them to be costly and inefficient. With HP’s MJF, they were able to more quickly produce parts that were less expensive, lighter, and of higher quality.
Read the full Glaze 3D printing prosthetics case study
Prensilia and Elastico Disegno
Prensilia manufactures 3D printed prosthetic hands and sells them to organizations that specialize in prosthetics and research. They worked with Elastico Disegno, a design and innovation consultancy to develop 3D printed hands. They needed a technology that offered exceptional accuracy and surface quality. With MJF, they were able to reduce their investment and production time, without compromising performance and surface finish.
Read the full Prensilia 3D prosthetics case study
To learn more about how 3D printing prosthetics can transform your manufacturing process, contact a prosthetics 3D printing expert
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Footnotes and disclaimers
- Data courtesy of Prensilia s.r.l.
- As reported in the following studies: Orthotic Devices Market: By Type; By Application; By Geography – Forecast (2018-2023) and Global Orthopedic Prosthetics Market 2017-2021.
- Based on HP’s unique Multi-Agent printing process. Excellent dimensional accuracy and fine detail within allowable margin of error. Based on dimensional accuracy of ±0.2 mm/0.008 inches on XY for hollow parts below 100 mm/3.94 inches and ±0.2% for hollow parts over 100 mm/3.94 inches, using HP 3D High Reusability PA 12 material, measured after sandblasting. See hp.com/go/3Dmaterials for more information on materials specifications.
- Testing according to ASTM D638, ASTM D256, and ASTM D648 using HDT at different loads with a 3D scanner for dimensional stability. Testing monitored using statistical process controls.
- Based on HP internal testing, June 2017, HP 3D600/3D700/3D710 Fusing and Detailing Agents and HP 3D High Reusability PA 11 powder meet USP Class I-VI and US FDA’s guidance for Intact Skin Surface Devices. Tested according to USP Class I-VI including irritation, acute systemic toxicity, and implantation; cytotoxicity per ISO 10993-5, Biological evaluation of medical devices–part 5: Tests for in vitro cytotoxicity; and sensitization per ISO 10993-10, Biological evaluation of medical devices–Part 10: Tests for irritation and skin sensitization. It is the responsibility of the customer to determine that its use of the fusing and detailing agents and powder is safe and technically suitable to the intended applications and consistent with the relevant regulatory requirements (including FDA requirements) applicable to the customer’s final product. For more information about the biocompatibility of HP’s materials, please view the Biocompatibility Statements at hp.com/go/statementsPA11 and hp.com/go/statementsPA12.
- Based on the following mechanical properties: Tensile strength at 48 MPa (XYZ), Modulus at 1700- 1800 MPa (XYZ). ASTM standard tests with HP 3D High Reusability PA 12 material.
- Continuous printing requires an additional HP Jet Fusion 3D build unit (standard printer configuration includes one HP Jet Fusion 3D build unit).
- Industry-leading surplus powder reusability based on using HP 3D High Reusability PA 11 and PA 12 at recommended packing densities and compared to selective laser sintering (SLS) technology, offers excellent reusability without sacrificing mechanical performance. Tested according to ASTM D638, ASTM D256, ASTM D790, and ASTM D648 and using a 3D scanner. Testing monitored using statistical process controls.
- According to HP customer research, 97% of material used in the manual insole production process is wasted. An average pair of 77-gram insoles can produce 2100 grams of waste material using manual production methods. A pair of insoles produced with HP MJF can produce only 100 grams of waste.
- According to HP customer research and inputs, HP MJF can result in reduction of manual labor time from 1 working day to 1 hour.
- Data courtesy of Glaze Prosthetics
- Data courtesy of ProsFit