Strategic technology
leadership for
life sciences & healthcare
Fractional CTO services delivering 25+ years of AI/ML, regulatory compliance, and cloud architecture expertise — without the overhead of a full-time executive.
Executive-level technology
guidance, precisely when you need it
AI/ML & Predictive Analytics
Build production-ready AI/ML pipelines for speech biomarkers, infection prediction, and clinical decision support across 22 languages.
FDA & HIPAA Compliance
Navigate FDA breakthrough device designation, 510(k) submissions, HIPAA/HITECH frameworks, and SaMD validation with proven expertise.
Product & Engineering Leadership
Reduce time-to-market by 45% through agile transformation, CI/CD implementation, and high-performing team architecture.
Cloud & SaaS Architecture
Design multi-tenant, HIPAA-compliant platforms on AWS/Azure serving 30+ global clinical trials and 97% of U.S. healthcare market.
Clinical Data Integration
Integrate 15+ disparate healthcare sources, build FHIR/HL7 pipelines, and create real-time analytics for clinical operations.
Strategic Growth & Fundraising
Architect platforms that secure Series A funding ($10M+), achieve breakthrough designations, and drive 25%+ revenue growth.
Deep domain expertise across life
sciences and healthcare
Clinical Trials & Research
CTMS platforms, speech biomarkers for ALS/Alzheimer's, and 30+ global trial deployments in 22 languages
Digital Therapeutics (DTx)
FDA-compliant SaMD platforms for mental health, remote patient monitoring, and ambulatory care analytics
AI/ML Health Analytics
Predictive models for infection prevention, cognitive biomarkers, and real-time clinical decision support
Pharma Patient Engagement
Patient recruitment/retention platforms serving 700+ sites across 71 countries with HIPAA-secure infrastructure
Healthcare Data Integration
Multi-source integration (15+ national datasets), geospatial analytics, and population health platforms
Health System Planning
Demand/supply forecasting, EHR interoperability (FHIR/HL7), and secure multi-tenant analytics portals
Proven outcomes across
health tech's hardest problems
FDA Breakthrough Device & AI Speech Biomarkers
Architected the AI/ML platform for speech-based cognitive biomarkers targeting Alzheimer's and ALS. Led technology through FDA Breakthrough Device designation and positioned the company for acquisition by Linus Health.
Clinical Trial Platform & Investor-Ready Architecture
Built a HIPAA-compliant, multi-tenant SaaS platform supporting 30+ international clinical trials across 22 languages. Architected for Series A due diligence — securing $10M+ in funding.
Global Patient Engagement & Retention Platform
Designed and delivered a pharma patient recruitment and retention platform deployed across 700+ clinical sites in 71 countries, integrating 15+ national healthcare datasets and FHIR/HL7 pipelines.
Healthcare Analytics Serving Near-Universal US Coverage
Led cloud architecture and data platform strategy for analytics products reaching 97% of the U.S. healthcare market — spanning health systems, payers, and pharmaceutical clients.
A flexible engagement model built
around your needs
Discovery
01We start with a deep-dive into your organization — understanding your technology landscape, team capabilities, regulatory context, and business objectives.
Strategy
02Together, we define a pragmatic technology roadmap that balances innovation with compliance, speed with quality, and ambition with resources.
Execution
03I embed with your team as a hands-on technology leader — making decisions, unblocking teams, and driving delivery alongside your people.
Scale
04As your organization grows, we build the processes, hire the right leaders, and create the systems that let you scale confidently.
Chris Middleton —
Your Fractional CTO
I've architected FDA-compliant AI platforms, secured breakthrough device designations, led acquisitions, and built clinical analytics serving 97% of the U.S. healthcare market. Now I bring that same strategic and technical depth to your organization — on your timeline.
Whether you need interim leadership during a search, pre-Series A technical validation, regulatory strategy for a 510(k) submission, or hands-on architecture for a SaaS platform — Scaled Objects delivers CTO-level expertise without the full-time commitment.
- • Direct access to Chris Middleton — 25+ years as CTO across Aural Analytics (acquired by Linus Health), Avalon Metrics, Pivotal Analytics, and Omnicom Group
- • Proven track record: FDA breakthrough device designation, $10M+ Series A funding, 45% faster time-to-market, 25%+ revenue growth
- • Hands-on technical execution across AI/ML, cloud architecture (AWS/Azure), regulatory compliance, and HIPAA-secure SaaS platforms
- • Global scale expertise: 30+ international clinical trials, 22 languages, partnerships with Michael J Fox Foundation, MGH, BI
Common questions about
fractional CTO services
What is a fractional CTO for healthcare?
A fractional CTO for healthcare is an experienced technology executive who provides CTO-level strategic leadership on a part-time or project basis — specializing in regulatory compliance (HIPAA, FDA), AI/ML strategy, cloud architecture, and clinical platform development — without the cost of a full-time hire ($250K–$500K/year). Scaled Objects provides this service with 25+ years of health tech experience.
How is Scaled Objects different from a technology consulting firm?
Unlike consulting firms that send rotating teams of generalists, Scaled Objects gives you direct access to Chris Middleton — a CTO with a proven track record including FDA breakthrough device designation, $10M+ Series A funding secured, 30+ international clinical trials, and a successful acquisition (Aural Analytics, acquired by Linus Health). You get one experienced executive who embeds with your team, not a billable-hours consulting model.
Can a fractional CTO help with FDA regulatory submissions and SaMD compliance?
Yes. Scaled Objects has direct, hands-on experience navigating FDA breakthrough device designation, 510(k) submissions, SaMD (Software as a Medical Device) validation, 21 CFR Part 11, HIPAA/HITECH frameworks, and GDPR. This is a rare differentiator — most fractional CTOs lack direct FDA regulatory experience at this depth.
What types of healthcare companies benefit most from fractional CTO services?
Fractional CTO services are ideal for: life sciences and digital health startups preparing for Series A fundraising; healthcare companies needing interim technology leadership during a CTO search; medical device or SaMD companies navigating FDA submissions; pharma and CROs building clinical trial technology; and health systems modernizing data infrastructure with FHIR/HL7 integration.
Does Scaled Objects work with companies outside of the Washington DC area?
Yes. While Scaled Objects is headquartered in Alexandria, VA, Chris Middleton works with healthcare and life sciences organizations across the United States and internationally. Previous engagements include 30+ global clinical trials across 22 languages and patient engagement platforms spanning 71 countries and 700+ sites.
Let's discuss your
technology needs
Whether you need strategic guidance for a fundraise, hands-on architecture for a clinical platform, or interim leadership during a transition — let's talk.