369 Innovations is a global Center of Excellence delivering FDA-ready medical device R&D and scalable contract manufacturing for healthcare leaders worldwide.

Engage Our Leadership Team

Engineering the Future of Medical Devices

We partner with global medical device companies and growth-stage innovators to take products from clinical insight to regulated, scalable manufacturing. By combining FDA-ready engineering, deep manufacturing capability, and India-based cost-efficient scale, we act as an extension of our clients’ R&D and manufacturing leadership.

369 Innovations is where global medical device strategy meets execution excellence.

What Sets Us Apart

Execution-driven differentiation across the medical device lifecycle

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End-to-End Product Execution

Complete medical device development from concept definition, engineering, verification, validation, and scalable manufacturing — under one accountable partner.

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Multi-Domain Device Expertise

Proven experience across diagnostics, patient monitoring systems, connected wearables, and hospital-grade medical devices.

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India-Based Scale, Global Delivery

A strong India-based engineering and manufacturing ecosystem delivering cost-efficient scale while meeting global quality and delivery standards.

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Regulatory-First Engineering

Deep understanding of US FDA, CE, and international compliance pathways ensuring audit-ready, market-acceptable products.

Our Services

End-to-End Medical Device Innovation & Manufacturing.

We provide integrated services across the medical device lifecycle — eliminating handoffs, reducing risk, and accelerating time-to-market.
We operate as a single accountable partner across the medical device lifecycle. Our services are designed for organizations that need execution certainty under regulatory, quality, and commercial constraints. From early feasibility to audit-ready manufacturing, we help our partners build devices that scale.

Medical Device R&D & Product Development

  • Clinical need & product strategy
  • Industrial & mechanical design
  • Mechanical, electronics & embedded systems
  • Software, connectivity & IoT
  • Verification & validation planning
  • Rapid prototyping & iteration

Contract Manufacturing & Scale-Up

  • EVT / DVT / PVT builds
  • Low-to-mid volume production
  • Supply chain & vendor qualification
  • Functional testing & calibration
  • Packaging, labeling & documentation

Manufacturing Capability & Infrastructure

  • CNC & precision machining
  • Electronics assembly & testing
  • Pilot production lines
  • Scalable capacity beyond 50,000+ units/year

India Manufacturing Partnerships

  • Partner identification & audits
  • Cost localization strategy
  • Quality & performance monitoring
  • Ongoing operational governance

US–India Innovation Bridge (CoE Setup)

  • Dedicated engineering teams
  • CoE facility & process setup
  • Program governance & reporting
  • IP protection frameworks

Diagnostics & Healthcare Infrastructure

  • Market research & feasibility
  • Diagnostic center planning
  • Equipment sourcing
  • Operational workflows

Medical Device Trading & Market Expansion

  • Product-market fit analysis
  • Regulatory pathway guidance
  • Distribution & partnerships
  • On-ground execution

Who We Work With

Global Medical Device Companies
Healthcare & Diagnostics Enterprises
VC-Backed & Series B+ HealthTech Startups
International Firms Setting Up India-based Centers of Excellence

Our Works

Innovative, validated medical devices across clinical domains

Parkinson Device
Parkinson’s Assistive & Monitoring Device
Alzheimer Platform
Alzheimer’s Disease Identification & Neuron Activation Platform
NICU Monitoring
NICU Pediatric Tracking & Monitoring Device
Motor Function
Motor Function Detection & Muscle Activation System
Drug Adherence
Patient Drug Adherence Monitoring Device
Remote Medication
Remote Medication Adherence Device
Vein Identification
Vein Identification Device

About 369 Innovations

Founded by Builders. Built by Operators. Driven by Innovation.

369 Innovations was founded to address a critical gap in the medical device ecosystem — the need for execution-focused partners who can design, industrialize, and manufacture medical devices under real regulatory and commercial constraints.

We are not consultants. We are builders and execution partners. Operating as a global Center of Excellence, we work as an extension of our partners’ R&D and manufacturing leadership, delivering FDA-ready engineering and scalable manufacturing from India to global markets.

Our Philosophy

  • Design for manufacturability from Day 1
  • Regulatory readiness embedded, not added later
  • Innovation focused on clinical and commercial impact

Founder’s Vision

To build one of the world’s most reliable platforms for medical device R&D and contract manufacturing — emerging from India and trusted globally.

Global Footprint

  • India – Engineering, Manufacturing & CoE
  • United States – Innovation & Client Partnerships
  • Middle East & Africa – Diagnostics & Market Access

Contact Us

Email: business@369innovations.com

Website: www.369innovations.com