MedTech CTO & Advisor

Pravin Carvalho

Hands-on technology leader with 15+ years spanning medical device engineering, digital health platforms, and large-scale information systems. Currently CTO at Principias Systems.

Work With Me View Experience
15+ Years Experience
10+ Devices Delivered
12+ Years Leading Teams
Pravin Carvalho

About Me

I bring a rare combination of deep engineering expertise and clinical domain knowledge to medtech product development. From co-founding a clinical decision support startup to leading a boutique medical device engineering firm, I've guided products from initial concept through regulatory submission and commercialization.

My background spans safety-critical embedded systems, cloud-native health platforms, IoT medical devices, and hospital information systems. I hold a dual B.Tech/M.Tech from IIT Madras and completed Harvard Medical School's Biochemistry & Physiology program.

I'm passionate about building technology that improves patient outcomes — and helping other leaders do the same.

Full Lifecycle

User needs through regulatory submission under ISO 62304 & ISO 13485

Cybersecurity

Pre- and post-market cybersecurity risk management aligned with FDA guidance

Distributed Teams

12+ years leading cross-functional teams across India and the US

Clinical Insight

Published researcher with Harvard Medical School training in biochemistry & physiology

Experience

Chief Technology Officer

Principias Systems

2017 — Present

Boutique engineering firm for start-to-end medical device development. Built the team and established a reputation for delivering critical sub-systems on multi-million dollar medtech programs.

  • Led distributed teams across India and the US to deliver 10+ commercial medical device projects through regulatory submission
  • Established cybersecurity risk management capabilities aligned with FDA guidance
  • Certified ISO 62304 and ISO 13485 quality management system

Co-Founder

CareOps Solutions

2023 — 2025

Co-founded a clinical decision support startup for insulin therapy management in hospitalized patients, identified from a real clinical need at a leading hospital.

  • Built a cloud-native therapy management platform on Google Cloud
  • Completed pilot testing on 100+ patients with significant improvement in glycemic control
  • Secured regulatory test license and ethics committee approvals at two major hospitals

Head of Engineering

Gida Technologies

2012 — 2016

Led end-to-end delivery of healthcare IT and telecom software solutions that continue to generate revenue 10+ years later.

  • Deployed antibiotic stewardship dashboards in 1,000+ bed hospitals
  • Built data mining platform that improved diagnostic turnaround compliance from 70% to 98%
  • Architected telecom automation systems serving 20 million users nationwide

Assistant Manager

ITC Limited

2009 — 2012

Capital expenditure planning and manufacturing quality improvement using Lean Six Sigma principles. Led teams in a large-scale FMCG manufacturing environment.

  • Coordinated installation of production lines across 5 manufacturing locations
  • Certified lead auditor for ISO 9001 Quality Management Systems

Selected Projects

A sampling of medical device and health IT projects delivered across therapeutic areas

IoT / Cloud

Implantable Neurostimulation Device

Architected the IoT system for an implantable neurostimulator. Directed a critical cloud migration from Google to AWS within 4 weeks, ensuring uninterrupted continuation of ongoing studies.

Diagnostics

Molecular Diagnostic Testing Platform

Led mobile app development for a rapid molecular diagnostic kit supporting point-of-care, at-home, and multiplexed testing. The product earned CE marking and won a $6M XPRIZE award.

Therapeutics

Portable Nitric Oxide Therapy Device

Led development of a portable inhaled therapy device for interstitial lung disease, including safety Class C software and embedded firmware. Delivered on schedule despite supply chain challenges.

Imaging

Real-Time Medical Image Processing

Developed a visualization tool for processing live DICOM data from MRI machines, enabling immediate analysis and clinical review during procedures.

Cybersecurity

Medical Device Cybersecurity Program

Established pre- and post-market cybersecurity risk management for connected medical devices, including vulnerability monitoring and OS migration strategies aligned with FDA guidance.

Drug Delivery

Connected Dose Metering Device

Sole developer of an iOS app for a Bluetooth-connected dose metering system. The prototype won "Best Innovation in Drug Delivery" at a major industry conference.

Advisory Services

I help medtech companies, digital health startups, and hospital systems navigate technology decisions with confidence

01

MedTech Product Strategy

Technology selection, architecture review, and roadmap planning for medical device and SaMD products. From concept through regulatory submission.

02

Digital Health & SaaS

Cloud architecture, platform scalability, and clinical workflow integration for digital health products and hospital IT systems.

03

Cybersecurity & Compliance

Pre- and post-market cybersecurity risk management, FDA guidance alignment, and vulnerability monitoring programs for connected devices.

04

Engineering Team Building

Structuring and scaling distributed engineering teams, establishing quality management systems, and implementing Agile development for regulated environments.

Education

B.Tech & M.Tech in Chemical Engineering

Indian Institute of Technology Madras

2004 — 2009 · CGPA 8.41

HMX Fundamentals — Biochemistry & Physiology

Harvard Medical School

2019 · Certificate of Achievement

Publications

Prognostic significance of glycemic variability after cardiac surgery

Journal of Diabetes and its Complications, 2016

Feasibility, efficacy, and safety of a simple insulin infusion protocol in a large volume cardiac surgery unit

Indian Journal of Endocrinology and Metabolism, 2015

Medanta insulin protocols in patients undergoing cardiac surgery

Indian Journal of Endocrinology and Metabolism, 2014

Let's Connect

Interested in working together? Whether you need a fractional CTO, a technical advisor, or a strategic partner for your medtech initiative — I'd love to hear from you.

Other Ways to Reach Me

LinkedIn

What to Expect

  • Response within 24-48 hours
  • Free initial 30-minute consultation
  • Flexible engagement models
  • NDA available upon request