The prosthetics and orthotics sector is entering a period of transformation across the United States and North America. The focus is gradually shifting from simply supplying a prosthetic limb or orthotic brace toward delivering a more complete patient solution.
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Today, patients, clinicians, healthcare providers, payers, and manufacturers are increasingly focused on questions such as:
- Can the device be customized more effectively?
- Can fitting and adjustment take less time?
- Can companies use digital tools to improve clinical workflows?
- Can manufacturers demonstrate better patient outcomes?
- Can new technologies fit within existing reimbursement and regulatory requirements?
For companies operating in prosthetics and orthotics, the opportunity is significant—but so is the complexity. Success increasingly depends on combining technology, clinical evidence, manufacturing capability, reimbursement knowledge, and a deep understanding of patient and provider needs.
What Is Driving Change in the U.S. and North American Prosthetics and Orthotics Landscape?
1. Personalization Is Becoming a Core Competitive Factor
Traditional prosthetic and orthotic development often relies heavily on manual measurements, casting, fitting, and repeated adjustments. The industry is increasingly moving toward digital scanning, computer-aided design, and digitally enabled manufacturing workflows.
The goal is straightforward: develop devices that better match an individual’s anatomy and functional requirements.
For companies, this means that customization is moving from being a premium capability toward becoming an important competitive differentiator.
The future opportunity is not simply producing more devices. It is reducing the time between assessment, design, fitting, adjustment, and final delivery.
2. Digital Design and Advanced Manufacturing Are Reshaping Workflows
Digital scanning, CAD/CAM systems, additive manufacturing, and automated production workflows are becoming increasingly relevant across orthotic and prosthetic development.
These technologies can potentially help companies:
- Standardize parts of the design workflow
- Reduce dependence on purely manual processes
- Improve repeatability
- Create more customized geometries
- Reduce turnaround time
- Build digital patient and device records
However, technology adoption also creates new questions around workflow integration, clinical validation, manufacturing economics, quality systems, and regulatory requirements.
The important question for companies is therefore not:
“Should we adopt digital manufacturing?”
Instead, it is:
“Which parts of the workflow should be digitized first, and where will technology create the strongest clinical and commercial value?”
3. Smart and Connected Devices Are an Emerging Direction
The next phase of prosthetics and orthotics is likely to involve greater use of sensors, software, connected systems, and data-driven monitoring.
Potential applications include:
- Monitoring device use
- Tracking mobility patterns
- Identifying changes in gait
- Supporting rehabilitation
- Monitoring pressure or loading
- Improving follow-up and device adjustments
This creates an opportunity to move from a one-time product transaction toward a more continuous patient relationship.
For manufacturers, however, connected devices also introduce new responsibilities involving software development, cybersecurity, data management, clinical validation, and user trust.
Companies that collect patient or device data will increasingly need a clear strategy for answering:
- What data should be collected?
- Who owns and manages it?
- How will clinicians use it?
- Does it improve patient care?
- Does it support reimbursement or clinical evidence?
4. Reimbursement Strategy Will Continue to Influence Innovation
In the United States, innovation alone does not guarantee commercial adoption.
A prosthetic or orthotic technology must also fit within the realities of coding, coverage, payment, documentation, and supplier workflows.
CMS continues to maintain detailed payment and coverage frameworks for prosthetics, orthotics, prosthetic devices, and related DMEPOS products. The agency also continues to update fee schedules and payment policies. For companies introducing new products, the pathway for establishing payment can involve continuity of pricing, comparability with existing products, or gap-filling when an appropriate comparable payment amount does not exist.
CMS also identifies specific DMEPOS items that may be subject to additional payment conditions, including prior authorization or documentation requirements. This makes reimbursement intelligence and documentation readiness an important part of product strategy rather than something considered only after commercialization.
The business implication is clear: product strategy, clinical evidence, coding, and reimbursement planning need to be developed together.
5. Companies Need to Focus More on Clinical and Economic Evidence
Healthcare providers and payers increasingly need to understand not only what a new device can do, but why it should be adopted.
A company introducing a new prosthetic or orthotic solution may need to demonstrate areas such as:
- Patient comfort
- Functional improvement
- Durability
- Ease of fitting
- Reduction in adjustment requirements
- Clinical workflow improvement
- Rehabilitation support
- Total cost implications
This creates a growing need for structured evidence strategies.
A strong product may fail to scale if the company cannot clearly communicate its value to clinicians, payers, rehabilitation providers, and procurement teams.
What Companies Need to Do
1. Move From Product Development to Solution Development
Companies should avoid looking only at the physical device.
A stronger strategy considers the entire ecosystem:
Patient → Clinician → Device → Rehabilitation → Follow-up → Replacement or Adjustment
Companies that understand friction across this journey can identify opportunities that competitors may miss.
For example, the biggest problem may not be the prosthetic component itself. It could be:
- Slow fitting
- Limited clinician availability
- Difficult documentation
- Delayed reimbursement
- High adjustment requirements
- Poor patient follow-up
Solving these problems can create as much value as developing a completely new device.
2. Identify Where Digital Technology Creates Real Value
Companies should avoid adopting AI, sensors, 3D printing, or digital tools simply because they are emerging technologies.
Instead, they should identify a specific business or clinical problem.
Examples include:
| Business Problem | Potential Strategic Response |
|---|---|
| Long fitting times | Digital scanning and automated design workflows |
| High customization complexity | CAD/CAM and modular design platforms |
| Limited patient follow-up | Remote monitoring and connected care tools |
| High adjustment frequency | Better patient-device data and predictive analysis |
| Manufacturing inconsistency | Digital production and quality systems |
| Difficulty proving value | Clinical and health-economic evidence generation |
The strongest innovation strategies begin with a problem and then identify the technology required to solve it.
3. Build a Reimbursement Strategy Earlier
For companies targeting the U.S., reimbursement planning should begin during product development.
CMS classifies and pays for prosthetics and orthotics under established Medicare frameworks, with prosthetic devices and orthoses subject to specific benefit definitions and payment methodologies. CMS also publishes regular DMEPOS fee schedule updates, including updates implemented during 2026.
Companies should therefore evaluate:
- Existing coding pathways
- Comparable products
- Documentation requirements
- Coverage criteria
- Payment methodologies
- Potential evidence gaps
A reimbursement strategy developed too late can delay commercialization even when the technology is ready.
4. Use North America as Multiple Opportunity Zones, Not One Single Region
North America should not be treated as one homogeneous opportunity.
The U.S. and Canada have different healthcare structures, reimbursement environments, provider networks, and procurement dynamics.
Companies should evaluate:
- Which patient segments offer the strongest opportunity?
- Which clinical settings are most suitable?
- Where are provider capacity gaps creating demand?
- Which technologies are already well established?
- Where are reimbursement barriers highest?
- Which geographic regions should be prioritized first?
A targeted regional strategy is likely to be more effective than a broad launch strategy.
How Precedence Research Can Help in a Problem-Solving Way
Precedence Research can position its support beyond simply delivering an industry overview.
The stronger value proposition is helping companies answer specific business questions.
1. Opportunity Identification
Client Problem:
“We do not know where the strongest opportunity exists.”
Precedence Research Can Help By:
- Identifying high-growth application areas
- Mapping major demand drivers
- Evaluating end-user requirements
- Identifying underserved patient or clinical segments
- Comparing regional opportunities across the U.S. and North America
2. Competitive Intelligence
Client Problem:
“We know our competitors, but we do not know how they are positioning themselves.”
Precedence Research Can Help By:
- Mapping key companies and emerging players
- Tracking product launches and technology developments
- Identifying partnerships and acquisitions
- Comparing technology strategies
- Analyzing product portfolios and positioning
3. Technology and Innovation Assessment
Client Problem:
“We want to invest in digital technology but do not know what will deliver the strongest return.”
Precedence Research Can Help By:
- Tracking developments in digital prosthetics and orthotics
- Assessing CAD/CAM and advanced manufacturing adoption
- Evaluating connected device opportunities
- Monitoring sensor and software integration
- Identifying emerging innovation areas
4. Reimbursement and Regulatory Intelligence
Client Problem:
“We have a strong product, but we need to understand the commercial pathway.”
Precedence Research can support research into:
- CMS and Medicare developments
- DMEPOS payment updates
- Coding and comparable product landscapes
- Documentation and policy requirements
- Regulatory developments relevant to the product category
CMS’s current framework makes this particularly important because new DMEPOS items may require payment determinations based on continuity of pricing, comparability, or gap-filling, while payment and documentation requirements continue to evolve.
5. Voice of Customer and Stakeholder Research
Client Problem:
“We built the technology, but do we understand what clinicians and customers actually need?”
Precedence Research can help analyze perspectives across:
- Prosthetists
- Orthotists
- Rehabilitation providers
- Healthcare organizations
- Payers
- Distributors
- Patients and caregivers
Source https://www.precedenceresearch.com/prosthetics-and-orthotics-market
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