Opportunities for Additive Manufacturing in Medical Devices - Prosthetics, Orthotics and Audiology

  • ID: 4431209
  • Report
  • 126 pages
  • SmarTech Markets Publishing LLC
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3D Printing Technologies to Significantly Disrupt Business Models and Process Chains in Orthotics and Prosthetics Market, Impacting 35 Percent of All Medical Devices by 2027

FEATURED COMPANIES

  • 3D Systems
  • Earlens
  • GN ReSound
  • Mecuris
  • Phonak (Sonova)
  • Siemens
  • MORE

As the medical 3D printing segment continues to evolve in ways which set it apart from the rest of the rapid prototyping and industrial additive manufacturing markets, interest in apply various technologies into the fabrication of medical devices has grown significantly. On the success of the orthopedic implants, surgical guide, and dental segments, now other medical practice areas have begun exploring digital manufacturing processes as a means to improve efficiency, and build a global supply chain to patients in need.

Prosthetic devices are the third major area of exploration for 3D printing technologies in medicine today, marked by two distinctly different medical treatment areas - audiology and the orthotics & prosthetics (O&P) markets. Such externally applied devices now being made with 3D printing technologies include hearing aids, upper and lower extremity prosthetics and componentry, and orthotic insoles and braces.

Where orthotic and prosthetic devices are just emerging as an area of interest and commercial opportunity with strong growth potential, the use of 3D printing in hearing aids has been long established. The outlook and market analysis in each area is therefore compared and contrasted, including an up-to-date outlook for continued growth opportunities for 3D printing in the hearing aid segment which has often incorrectly been written off as totally saturated.

This report seeks to define and clarify opportunities for 3D printing technologies in the production of these areas.

This study seeks to provide:

  •     Industry coverage and opportunity analysis in the three primary application areas for 3D printed medical devices - prosthetics, orthotics, and audiology devices
  •     A comprehensive analysis of the value proposition for 3D printing technologies in these areas, combined with a penetration and economic impact analysis for the application of 3D printing into these well established global markets
  •     Segmentation of the various applications in each segment by component type, material selection, and potentially relevant printing processes and technologies
  •     Production volume forecasts for printed components and devices in each market segment from 2014 to 2027
  •     Ten year market forecasts for opportunities related to 3D printing hardware, materials, software, and print services in the areas of O&P and audiology markets, including breakouts by print technology forecasts of revenue and unit sales, install bases, material shipments by class and polymer/alloy family, services revenues by segment, and more

AM/3DP technologies are bringing serious disruptive potential in O&P through their ability to completely bypass much of the traditional supply constraints for prosthetic devices which limit the ability of amputees to gain access to a prosthetic. Meanwhile, market dynamics in the hearing aid industry continue to shift, and through recent innovations in 3D printing technologies in photopolymerization and metal powder bed fusion segments, the scales may be tipped towards strong continued penetration of 3D printing in audiology.

This study identifies where the money will be made and lost as these trends play out.  It will be vital reading not only for executives in the 3D printing/additive manufacturing space, but also for marketing and product managers at companies in the medical materials, medical device and healthcare industries.

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FEATURED COMPANIES

  • 3D Systems
  • Earlens
  • GN ReSound
  • Mecuris
  • Phonak (Sonova)
  • Siemens
  • MORE

Chapter One: Characterizing 3D Printing Technology in Selected Medical Devices: Prosthetics, Orthotics, and Audiology 
1.1 Major Trends in Medical 3D Printing Relevant to Medical Device Development and Production  
1.1.1 Integration of 3D Technologies Directly into Primary Healthcare Environments
1.1.2 Development of Application Specific 3D Printing Materials and Solutions      
1.2 Defining Value Propositions for 3D Printing Technology in Various Medical Device Segments      
1.2.1 Socioeconomic Factors Launch 3D Printing as a Promising Production Tool for Medical Devices in the Third World    
1.2.2 Printer Hardware Innovations to be Applied to Medical Device Manufacturing in Hearing Aids, Orthotics    
1.3 Summary of Penetration Analysis for 3D Printing in Medical Device Segments 
1.4 The Role of Tertiary Technology – Software and Scanning       
1.5 Market Observations, Outlook, and Growth Projections

Chapter Two: 3D Printing of Limb and Other Medical Prosthetics
2.1 Review of Value Proposition for 3D Printing in Prosthetic Devices     
2.1.1 Digitizing the Traditional Prosthetics Fabrication Process Chain
2.1.1.1 Optimizing the Impression Process
2.1.1.2 Fabrication Techniques for Sockets  
2.1.2 Cost Comparisons for Printed Prosthetics versus Traditional Methods       
2.2 Specific Application Segments in Prosthetics with Commercial Potential     
2.2.1 Upper Extremity Prosthetics – Arms, Hands, and Fingers       
2.2.2 Lower Extremity Prosthetics – Legs and Feet
2.2.3 Facial and Breast Prosthetics
2.3 Print Technologies and Materials for Production of Prosthetics 
2.3.1 Material Extrusion Technologies and Materials
2.3.1.1 Materials for Extrusion 3D Printing and Prosthetics
2.3.1.2 Hardware Pricing Trends
2.3.2 Polymer Powder Bed Fusion Technologies and Materials       
2.3.3 Light-Cure Processes and Materials (Photopolymerization and Material Jetting)     
2.3.4 Metal Powder Bed Fusion Technologies and Materials       
2.4 Extremity Prosthetic Devices, Markets and Adoption of 3D Printing Technologies    
2.4.1 Business Models and Go-to-Market Strategies for 3D Printing of Limb Prosthetics versus Facial and Other Prosthetics       
2.5 Outlook and Penetration Analysis for 3D Printing in Prosthetic Devices

Chapter Three: 3D Printing of Hearing Aids and Audiology Devices      
3.1 Current State of 3D Printing Technologies in Hearing Aid and Audiology Device Market   
3.1.1 Review of Value Proposition for 3D Printing Technology for Hearing Aid Production       
3.1.2 Current Competitive Makeup of Hearing Aid Market and 3D Printing Deployments
3.1.3 Segmentation of Hearing Aid Market by Product Type       
3.1.3.1 Shifting Back to Custom Products    
3.1.3.2 Increasing Penetration in Traditionally Non-Custom Products    
3.1.3.3 Production Forecasts for Printed Hearing Aids     
3.2 Print Technologies and Materials for the Production of Hearing Aid Shells and Custom Audiology Devices 
3.2.1 Traditional Photopolymerization Technologies
3.2.2 Next-Generation Photopolymerization Technologies
3.2.3 Metal Powder Bed Fusion Technology  
3.3 Business Considerations and Learning Points from the Hearing Aid Industry for Medical 3D Printing Disruption   
3.3.1 Digital Disruption and 3D Printing Technologies     
3.3.2 Shifting Focus to Long-Term Design Innovations    
3.4 Outlook and Penetration Analysis for 3D Printing in Hearing Aids and Audiology

Chapter Four: 3D Printing of Orthotic Devices – Insoles and Braces
4.1 Review of Value Proposition for 3D Printing for Orthotic Devices     
4.1.1 Digital Manufacturing Disrupts Analog Fabrication Process in Orthotic Devices
4.1.1.1 Analog Processes for Ankle-Foot Orthotics 
4.1.1.2 Innovation Through Digital Processes
4.1.2 Tailorable Characteristics in Insoles Provide Custom Performance
4.2 Segmenting 3DP Orthotic Applications by Commercial Relevance  
4.2.1 Ankle-Foot Orthotic Braces       
4.2.2 Medical Insoles     
4.3 Print Technologies and Materials for Orthotics  
4.3.1 Composite Materials and Additive Manufacturing for Ankle-Foot Orthotics      
4.3.2 Technologies and Materials for Printed Orthotic Insoles       
4.4 Orthotic Devices Market and Adoption of 3D Printing Technologies
4.4.1 Disrupting Podiatry through a Distributed Digital Manufacturing Chain      
4.4.2 3D Printing Blurring Traditional Lines Between Medical Products and Consumer Products      
4.5 Outlook and Penetration Analysis for 3D Printing in Orthotic Devices     

Chapter Five: Ten-Year Opportunity Forecasts for 3D Printing in Selected Medical Device Segments
5.1 Discussion of Methodology and Assumptions   
5.2 Contextual Medical 3D Printing Opportunities  
5.3 3D Printing Hardware Market Opportunities in Selected Segments  
5.3.1 Low-Cost 3D Printer Hardware Analysis in Selected Markets     
5.4 3D Print Material Opportunities Resulting from Orthotic, Prosthetic, and Audiology Applications
5.4.1 Material Forecasts by Market Subsegment    
5.5 3D Printing Services and Software Opportunities in Prosthetics, Orthotics, and Audiology  

About the Analyst
Acronyms and Abbreviations Used In this Report   

List of Exhibits
Exhibit 1-1: The Role of Healthcare 3D Printing in the Global Additive Manufacturing Market 
Exhibit 1-2: Summary of Value Proposition for 3D Printing Technologies in Medical Device Segments    
Exhibit 1-3: 3D Printing Penetration Estimates for Custom Insole Market, by Impact Category, 2014-2027     
Exhibit 1-4: Total Projected Revenue Opportunities for 3D Printing in Selected Medical Device Markets, by Category, 2014-2027 
Exhibit 1-5: Total Projected Market Value of Selected 3D Printed Medical Device Components, by Application Type, 2014-2027 
Exhibit 2-1: Total Process Chain for Fabrication of Lower Extremity Prosthetic Interface  
Exhibit 2-2: Cost Estimates for Various Prosthetic Devices
Exhibit 2-3: Example of Component Level Costs for Advanced Lower Extremity Prosthetic      
Exhibit 2-4: Projected Production Volumes for 3D Printed Upper Extremity Prosthetic Devices, All Types, 2014-2027
Exhibit 2-5: Critical Factors Affecting Prosthetic Interface Design and Manufacturing       
Exhibit 2-6: Projected Production Volumes for 3D Printed Lower Extremity Prosthetic Devices, All Types, 2014-2027
Exhibit 2-7: Summary of Early Stage Direct Silicone 3D Printing Processes for Commercial Use 
Exhibit 2-8: Projected Production Volumes for 3D Printed Facial Prosthetic Devices, All Types, 2014-2027    
Exhibit 2-9: Current and Projected Material Extrusion Hardware Average Selling Price, Medical 3D Printing Applications, 2015-2027
Exhibit 2-10: Current and Projected Polymer Powder Bed Fusion Hardware Average Selling Price, Medical 3D Printing Applications, 2015-2027
Exhibit 2-11: Summary of Current Go to Market Strategies for 3D-Printed Prosthetics   
Exhibit 2-12: Estimated Ten-Year Production Penetration of 3D Printing in Prosthetic Limbs and Facial Devices, 2014-2027       
Exhibit 3-1: Summary of Value Proposition for 3D Printing in Hearing Aids
Exhibit 3-2: Major Market Leaders in Hearing Aid Production and Known Printer Deployments
Exhibit 3-3: Summary of Segment Driven Adoption Scenarios for 3D Printing Technology in Hearing Aid Markets 
Exhibit 3-4: Projected Production Volume of 3D Printed Hearing Aid Shells and Components, by Material, 2014-2027       
Exhibit 3-5: Average Selling Price for Metal Powder Bed Fusion Technologies in Medical 3D Printing Markets, All Products, 2015-2027 
Exhibit 3-6: Estimated Ten Year Production Penetration of 3D Printing in Hearing Aid and Audiology Devices, 2014-2027
Exhibit 4-1: Current Development Opportunities for Ankle-Foot Orthotic Manufacturing Processes      
Exhibit 4-2: Ankle-Foot Orthotic Device Variations and Design for Manufacturing Considerations      
Exhibit 4-3: Projected Production Volumes for 3D Printed Orthotic Braces, 2014-2027     
Exhibit 4-4: Summary of Competitors Active in 3D Printed Orthotic Insoles   
Exhibit 4-5: Projected Production Volumes for 3D Printed Orthotic Insoles, 2014-2027    
Exhibit 4-6: Considerations for AFO Material Selection and Manufacturing     
Exhibit 4-7: Illustration of Impacts to Industry Models in Podiatry Resulting from 3D Printing Adoption
Exhibit 4-8: Projected 3D Printed Penetration In Custom Orthotic Insole Manufacturing by Production, 2014-2027 
Exhibit 4-9: Projected 3D Printed Penetration In Lower Extremity Orthotic Brace Manufacturing by Production, 2014-2027
Exhibit 5-1: Comparison of Total Medical AM/3DP Revenue Opportunities, by Category, 2014-2027(e)  
Exhibit 5-2: Total Projected 3DP Orthotics, Prosthetics, and Audiology Revenue Opportunities, by Region, 2014-2027(e)       
Exhibit 5-3: Projected Hardware Revenue for All Audiology and O&P Applications, 2014-2027(e)
Exhibit 5-4: Projected Hardware Revenues for Orthotic and Prosthetic Markets, 2014-2027(e)     
Exhibit 5-5: Projected Hardware Revenues for Audiology Markets, 2014-2027(e)  
Exhibit 5-6: Projected Hardware Unit Sales for All Audiology and O&P Applications, 2014-2027(e) 
Exhibit 5-7: Projected Hardware Unit Sales for Orthotic and Prosthetic Markets, 2014-2027(e)     
Exhibit 5-8: Projected Hardware Unit Sales for Audiology Markets, 2014-2027(e)  
Exhibit 5-9: Total 3D Printer Installations in Orthotics, Prosthetics, and Audiology Markets, by Technology, 2014-2027(e)     
Exhibit 5-10: Projected Material Extrusion Hardware Unit Sales by Printer Class, All Segments, 2014-2027(e)       
Exhibit 5-11: Projected Photopolymerization Hardware Unit Sales by Printer Class, All Segments, 2014-2027(e)
Exhibit 5-12: Projected 3D Print Material Revenues Resulting from Printed Orthotics, Prosthetics, and Audiology Devices, by Material Family, 2014-2027(e) 
Exhibit 5-13: Projected 3D Print Material Shipments by Weight Resulting from Printed Orthotics, Prosthetics, and Audiology Devices, by Material Family, 2014-2027(e)  
Exhibit 5-14: Aggregated Primary and Secondary Print Material Revenue Opportunities in Selected Segments, Including Print Service Provider Consumption, 2014-2027(e)
Exhibit 5-15: Projected Thermoplastic Filament Material Revenue Opportunities Resulting from 3D Printed Orthotics and Prosthetics, by Polymer Group, 2014-2027(e)       
Exhibit 5-16: Projected Thermoplastic Powder Material Revenue Opportunities Resulting from 3D Printed Orthotics and Prosthetics, by Polymer Group, 2014-2027(e)       
Exhibit 5-17: Projected Photopolymer Material Revenue Opportunities, by Segment and Technology, 2014-2027(e)       
Exhibit 5-18: Projected Metal Powder Material Revenue Opportunities in Orthotics and Prosthetics, by Alloy family, 2014-2027(e)      
Exhibit 5-19: Projected Metal Powder Material Revenue Opportunities in Audiology Markets, by Alloy family, 2014-2027(e)     
Exhibit 5-20: Total Projected Outsourced 3D Printing Service Revenue Opportunities in O&P and Audiology Markets, by Application Group, 2014-2027(e)      
Exhibit 5-21: Total Projected 3D Printing Service Revenue Opportunities in O&P and Audiology Markets, by Region, 2014-2027(e)     
Exhibit 5-22: Total Projected 3D Printing Software Revenue Opportunities in O&P and Audiology Markets, by Tool Functionality, 2014-2027(e)    

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FEATURED COMPANIES

  • 3D Systems
  • Earlens
  • GN ReSound
  • Mecuris
  • Phonak (Sonova)
  • Siemens
  • MORE

The latest medical 3D printing industry report projects a disruptive impact for a number of key 3D printing technologies and applications within the multi-billion dollar orthotics and prosthetics (O&P) market over the coming decade. Early research and applications have demonstrated a unique ability for 3D printing to completely revolutionize business models and access to custom and functional prosthetic and orthotic medical devices. Further adoption of 3DP in O&P markets from today’s early innovators is projected to eventually impact an estimated 35 percent of all devices produced, while generating hundreds of millions of dollars in economic impact and revenue opportunities for 3D printing solutions.
 
About the Report:
 
Early experiments with 3D printing of orthotic and prosthetic devices have proven 3D printing, as a digitally enabled process, can expand access to medical devices through disruptive cost-to-value ratio and flexible on-demand manufacturing.
 
Scott Dunham, Vice President of Research at SmarTech Publishing and author of Opportunities for Additive Manufacturing in Medical Devices – Prosthetics, Orthotics, and Audiology, stresses the importance in understanding the potential impacts that 3D printing/additive manufacturing will have in the O&P market.
 
“It’s important for stakeholders in the orthotics and prosthetics business to realize what the far-reaching potential impacts that 3D printing will have in how podiatrists and prosthetists can treat patients, and how consumers will shift their approach to treatment options for amputation and biomechanical dysfunction altogether in the future. When you see compassionate-use groups printing an entire transradial prosthetic hand for children in underserved areas that costs less than $500 and is competitive with a $15,000 traditional device, it’s important to understand how such a use case could be expanded to really disrupt the existing industry structure.”
 
The report focuses much of its 120 pages of content and market analysis on applications and industry adoption of 3D printing in orthotic and prosthetic devices, including upper and lower extremity prosthetic applications, to the manufacture of orthotic insoles and ankle-foot orthotic style braces. Report features include:

  • Ten year revenue opportunity forecasts for sale of printers by technology, print material by form factor and polymer/alloy family, print services by device type, and software by tool functionality
  • Penetration and economic impact analysis of adoption of 3D printing in the existing markets for prosthetic and orthotic devices, including total market valuation of printed medical devices or device components where relevant, and the penetration of 3D printing as a production process compared to incumbent methods of manufacturing
  • Production volume forecasts for printed prosthetics, orthotics, and related components by device type through 2027, split by print material where relevant

From the Report:

  • The manufacture of custom orthotic insoles using polymer powder bed fusion and material extrusion 3D printing technologies are expected to disrupt the business model and care structure for custom orthotics worldwide, and may significantly shift the role of the podiatrist in the dispensing of orthotic insoles in the future. This could spark adoption of low cost printing technologies directly in-office by foot care specialists.
  • In prosthetics, 3D printing holds promise as a production process to upend the traditional market where prosthetic devices often cost between $10,000 and $50,000 or more, and only have an expected useful product lifecycle of five years or less. Digital manufacturing allows not only for the potential for the creation of much more accessible devices from a cost perspective, but also for a much more sustainable approach to life-long amputee care through a digitally powered process using scanning and imaging technology.
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  • 3D Systems
  • Additive Orthotics and Prosthetics
  • Create Prosthetics
  • Earlens
  • EnvisionTEC
  • GN ReSound
  • Hewlett Packard Inc.
  • Mecuris
  • Naked Prosthetics
  • Phonak (Sonova)
  • RESA Wearables
  • Siemens
  • Widex
  • Wiiv
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