Individualized orthotic systems for neurological conditions.
Neurological care is inherently individualized. Delivering it can mean tradeoffs between time and comfort.
FormNeuro is developing an orthotic system and workflow. The objective is to make comfort and clinical time compatible to support clinicians who make individualized care possible. The workflow is designed to minimize the in-clinic time traditionally spent measuring and adjusting orthoses, without sacrificing clinical quality.
FormNeuro is developing a medical device. The device has not been evaluated by the U.S. Food and Drug Administration and is not available for sale.
Why this matters
Neurological presentations vary between individuals, and within one individual over time.
Anatomy differs between people. And within one person, muscle tone changes over time, and comfortable positioning changes with it.
These factors constrain neurological orthotic care. They make comfortable, individualized care a difficult clinical problem, since an orthosis can only do its job while it's worn.
Today's options
Current approaches are thoughtful compromises.
| Orthoses type | What it offers | What it asks in return |
|---|---|---|
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Off-the-shelf orthoses
widely available
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Quick to obtain and an important option for many patients and settings.
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Multiple measurements, size selection, and compromises in anatomical fit from a limited range of sizes.
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Fully custom orthoses
made for one person
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A highly individualized fit, created specifically for the person at a moment in time.
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Specialized clinician expertise, multiple appointments, fabrication time, and clinical resources that could otherwise support therapy.
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Either way, delivering individualized care takes measurement, fitting, adjustment, and follow-up. None of that is wasted work. But it costs time and clinical capacity, and that cost falls on clinicians, health systems, patients, and caregivers.
All of it also assumes a clinician is within reach. Distance from specialty care, travel a caregiver can't repeat, and limited local availability put individualized fitting out of range for some people.
How might individualized comfort become more practical and accessible?
Design objective
Individualized comfort, made practical and accessible at scale.
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Begin with the individual
Every design decision starts with the person's anatomy, neurological presentation, and tolerance for wear.
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Respect biological variability
Neurological conditions vary across people and within one person over time. That variability is a design input.
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Expand access, support expertise
Where clinicians are available, technology reduces unnecessary complexity and supports informed decisions. Where access is limited, better systems create practical pathways to individualized care.
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Apply engineering in service of people
Engineering reduces barriers and makes individualized care practical.
Our approach
A device and a workflow, designed together.
A mechanical orthotic system designed to make comfort achievable. An individualization workflow designed to make delivering it practical. Neither does the job alone.
The device
The device is designed to be modular. The parts that apply force reposition and interchange along the support structure, so it can be adjusted as a person's needs change rather than replaced. A pending patent covers that architecture. Sizing is the workflow's job, which dynamically generates the geometry from a person's measurements. Each individualized device follows the same generation and production path.
What the device is designed to do
Fit the individual
Designed around one person's anatomy and neurological presentation rather than selected from a range of sizes.
Be comfortable enough to wear
An orthosis can only do its job while it's worn. The mechanical system is built around the objective to achieve comfort in long-term daily wear.
The individualization workflow
There are two inputs that go into every splint — the person's measurements, and the clinical orthotic decisions. Software combines them and generates each part's geometry from those inputs and FormNeuro's own manufacturing knowledge. There's no standard size underneath it. A person can be re-measured without disturbing the decisions, and a decision can change without re-measuring the person. Every run records its exact inputs and the software version behind it, so any device can be regenerated identically.
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External inputs — clinician
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Step 01
Measurement
Photos of the hand as it presents, with a printed scale reference rather than a 3D scanner. No manipulation into a target pose.
In development -
Step 02
Configuration
The clinician specifies the parameters that shape the design, like wrist angle, through FormNeuro's configuration interface.
In development
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FormNeuro operates
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Step 03
Generation
The pipeline produces the splint geometry from the measurement and parameters.
In prototype -
Step 04
Production & delivery
FormNeuro produces and ships the finished orthosis. No printer or fabrication capacity needed on the clinic's side. Small-scale manufacturing has produced the mechanical design in prototype quantities; scaled production is being built.
In prototype
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What this workflow means
Supporting clinical expertise
Clinicians remain central. The technology is there to remove unnecessary complexity and improve consistency, so clinical decisions stay with the clinician.
Expanding access
The only external inputs are a photo and a set of parameters. FormNeuro handles production. A clinic shouldn't need local fabrication or scanning capacity to offer individualized care.
The device and the workflow serve the same objective — fewer barriers between a person and an orthosis made for them.
Moving this forward together
FormNeuro is building relationships, not selling products.
Clinical practice, research, and engineering all have a stake in this problem. We welcome early input and feedback. If the problem is familiar to you, we'd like to talk.
Who we're hoping to meet
- Occupational therapists
- Certified hand therapists
- Orthotists
- Physical medicine & rehabilitation (PM&R) physicians
- Neurologists
- Rehabilitation researchers
- Biomedical engineers
- Startup advisors
- Incubator & accelerator partners
- Grant collaborators
- Strategic industry partners
Current conversations: clinical insight, product feedback, research collaboration, workflow discussions, strategic partnerships, and early advisory relationships.