Bring AI Medical Devices to Market at the Speed of Software
Break free from the MedTech “Innovation Trap” without compromising safety-critical rigor.
Orthogonal bridges the gap between rapid AI advancement and strict compliance. We embed advanced AI engineering directly into rigorous design controls, helping you transform intelligent prototypes into cleared, revenue-generating medical devices.
Trusted by venture-backed startups to large medical device companies
Turn Compliance Into Your Speed-to-Market Advantage
When data scientists don’t understand design controls, and traditional QA teams don’t understand machine learning, projects stall. We bring these disciplines together under a single, unified engineering model.
“Applying modern engineering techniques to the development of SaMD is no easy feat. Orthogonal’s approach to blending these domains helped Tandem accelerate our product innovation cycle and outputs”
From AI Prototype to Regulated Product
Escaping the MedTech “Innovation Trap”
A working AI prototype is only a sandbox victory. Moving to a cleared product often stalls over “black box” regulatory friction.
Orthogonal bridges this gap, transforming AI models into compliant, market-ready medical software.
In-Product AI
Deploy Agentic AI and Generative Features with Clear Software Guardrails
An algorithm should not be treated as an isolated feature or an unpredictable black box. We design the entire supporting ecosystem, including user experience, data pipelines, cloud or edge architecture, and risk boundaries, to keep your product safe and compliant.
AI/ML-Enabled SaMD & Connected Devices
We help clients build AI-enabled medical device software for intelligent monitoring, predictive analytics, clinical decision support, signal processing, personalization, and data-driven patient or clinician workflows.
Generative AI & Agentic Workflows
We help MedTech teams explore and develop generative AI, LLM-powered, and agentic experiences within medical device software. We define intended use, user workflows, data boundaries, safety constraints, and product requirements before the capability reaches users.
AI Data, Infrastructure & Lifecycle Foundations
We help establish the infrastructure that guarantees your models perform reliably under real-world conditions, giving you total visibility into data quality and system health.
The AI Factory: Your Competitve Advantage
Shift from One-Off Experiments to a Regulatory-First Engineering Model
Have an AI capability you need to productize?
AI Under Design Controls
Ensure Traceability and Mitigate “Black Box” Risk
Innovation shouldn’t bypass your Quality Management System (QMS), it should be accelerated by it. Orthogonal embeds design controls directly into the AI engineering workflow from day one. We proactively evaluate and mitigate the unique risks introduced by AI systems, including model drift, demographic bias, cybersecurity vulnerabilities, and human factor friction.
Build for Product Evolution
Design for Post-Market Change, Not Just Initial Launch
AI models require tuning as real-world data flows in. We architect your data pipelines, testing loops, and Predetermined Change Control Plans (PCCP) so you can update and optimize algorithms post-launch without starting regulatory submissions from scratch.
Build & Scale AI Medical Software with Confidence
Partner with us to bring generative AI, machine learning, and automation to market without compromising MedTech rigor.
Frequently Asked Questions
1. How do we manage “black box” risk and explainability with Generative AI in a regulated medical device?
By wrapping the model in deterministic software guardrails. We enforce strict data boundaries, real-time validation agents, and runtime constraints so dynamic AI outputs always conform to the device’s defined intended use and FDA safety standards.
2. Can we genuinely apply Agile methodologies to an FDA-regulated environment for AI development?
Yes, by decoupling rapid development cycles from formal release gates. Our automated toolchains continuously generate design controls, traceability, and test documentation as code is written—enabling true Agile velocity with continuous, auditable compliance.
3. How does the “AI Factory” pattern align with FDA guidance on Predetermined Change Control Plans (PCCP)?
The AI Factory provides the operational infrastructure a PCCP requires. It delivers the automated data pipelines, regression testing, version control, and telemetry needed to safely execute pre-approved post-market model updates without triggering new 510(k) submissions.
AI-Accelerated Compliance: Operational Transformation
We Use AI to Speed Up Your Regulated Development Lifecycle by 2-3x
We do not just build AI into medical devices. Orthogonal uses specialized multi-agent AI workflows and deep automation to remove manual friction from regulated software delivery.
Case Studies
Case Study
EBT: External Nerve Stimulation for Overactive Bladder
Case Study
Neurostimulation Device for Dry Eye Disease
Case Study
Continuous ECG Monitoring with Nanosensors
Case Study
PhysIQ: Ambulatory Patient Monitoring
Build and Evolve AI-Enabled Medical Device Software with Confidence
If you are building AI-enabled SaMD, adding generative or agentic AI to a connected medical device platform, or looking to accelerate regulated software development with AI and automation, drop us a message.
