Industry
Client Overview
"AuraVision AI" (fictional) is a venture-backed startup founded by two radiologists and a data scientist. Their vision was to create a cloud-based Software as a Medical Device (SaMD) that used AI to help radiologists detect early-stage lung nodules on low-dose CT scans, a critical task for improving lung cancer survival rates. As a startup, they faced immense pressure to develop a robust, compliant product quickly to secure their next funding round and gain a first-mover advantage. They had the clinical knowledge but lacked the engineering team to build a scalable, HIPAA-compliant, and FDA-ready platform.
Client Testimonial
"CIS was the engineering partner we dreamed of. They weren't just coders; they were strategists who understood the unique pressures of a MedTech startup. Their AI/ML Rapid-Prototype Pod delivered a functional prototype that wowed our investors, and their deep knowledge of the FDA's SaMD framework was instrumental in our successful pre-submission meeting. We view them as an extension of our own founding team." - Dr. Lena Petrova, Co-Founder & CEO, AuraVision AI.
Problem
AuraVision needed to build a complex, multi-tenant SaaS platform from scratch. The platform had to securely ingest DICOM images from hospitals, run a proprietary AI model, display results in a viewer for radiologists, and integrate with existing workflows-all while adhering to the stringent requirements of HIPAA and the FDA.
Key Challenges
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01
Regulatory Complexity : Navigating the FDA's requirements for SaMD, including quality management systems (QMS), risk analysis, and technical documentation.
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Speed to Market : The need to build and validate an MVP within 9-12 months to meet investor milestones.
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03
Interoperability : Ensuring the platform could integrate with various hospital Picture Archiving and Communication Systems (PACS).
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Talent Gap : Inability to hire a full-time, experienced team of SaMD developers, MLOps engineers, and compliance experts quickly enough.
Our Solution
CIS engaged with AuraVision using a combination of our AI/ML Rapid-Prototype Pod and our Healthcare Interoperability Pod. We acted as their full-stack engineering and compliance partner.
Compliance-First Architecture : We designed a HIPAA-compliant cloud architecture on AWS, using services like S3 for encrypted DICOM storage, a secure VPC, and robust IAM policies. We also established a lightweight QMS compliant with ISO 13485.
Agile MVP Development : Our team developed the core platform in agile sprints, focusing on a web-based DICOM viewer, user management, and an API for the AI model.
MLOps Implementation : We built a scalable MLOps pipeline to manage AuraVision's AI model, enabling versioning, performance monitoring, and the auditable logs required for FDA review.
Interoperability Engine : Our specialists built a flexible integration engine using the DICOM standard to ensure the platform could receive studies from different hospital PACS.
Implementation & Execution
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Discovery & Scoping
A 2-week sprint to define the MVP scope, technical architecture, and regulatory strategy.
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Agile Sprints
Bi-weekly sprints with daily stand-ups and regular demos to ensure alignment and rapid feedback.
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Dedicated POD
A cross-functional team of 6 experts was assigned: a Project Manager, a Solutions Architect, two Full-Stack Developers, one DevOps/MLOps Engineer, and one QA/RA Specialist.
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Regulatory Documentation
We worked alongside the founders to co-author key sections of their FDA pre-submission package.
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Security Audits
Conducted internal penetration testing and vulnerability scanning prior to deployment.
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Staged Rollout
Deployed the platform to a pilot group of friendly radiologists for user acceptance testing and feedback.
Positive Outcome
1. Successful MVP Launch
A feature-complete, secure, and compliant MVP was delivered in just under 9 months, on schedule and on budget.
2. Investor Confidence
The successful MVP delivery was a key factor in AuraVision closing their $25M Series A funding round.
3. Positive FDA Feedback
The company had a successful pre-submission meeting with the FDA, which praised the quality of their technical documentation and risk management plan.
4. Reduced Time to Market
AuraVision estimates that partnering with CIS saved them at least 6-8 months of development time compared to hiring an in-house team from scratch.
Why Choose Us
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Verifiable Process Maturity
Our structured approach to SaMD development was key.
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Fortress-Grade Security
The HIPAA-compliant architecture was foundational.
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Deep Domain Fluency
We understood SaMD, DICOM, and the clinical workflow.
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100% In-House Experts
The dedicated POD worked as a single, cohesive unit.
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AI-Accelerated Delivery
Our POD model and frameworks were built for speed.
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Global Delivery, Local Touch
Seamless communication with the US-based founders.
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Radical Transparency
Shared Jira boards and daily stand-ups built trust.
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Full IP Ownership
AuraVision owns 100% of their groundbreaking platform.
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Proven Partner to Leaders
We empowered a startup to compete with established players.
Conclusion
By providing a full-service engineering and compliance team in a flexible POD model, CIS enabled AuraVision to overcome the typical hurdles faced by MedTech startups. We didn't just write code; we provided the strategic partnership, process discipline, and specialized expertise needed to turn a brilliant idea into a compliant, market-ready medical device.