What Sage Research & Design does

Sage Research & Design is a privately-held, founder-led human factors engineering and UX research consulting firm headquartered in Boulder, Colorado, founded in 1997 by Shannon Halgren, PhD (formerly of Apple/Claris and Macromedia). The firm operates with a team of 1-10 employees, including PhD-level researchers, a licensed physician (MD, Karolinska Institutet), and senior consultants with prior human factors roles at NASA/Lockheed, Canon, Sun Microsystems, and Pacific Bell. Its four core service lines are Medical Human Factors (FDA and IEC 62366 HF activities, validation testing, gap analysis, design audit), Medical Device Risk Management (ISO 14971 compliant risk files), Healthcare Patient and Clinician Experience (in-context research for hospitals and health systems), and Usability/User Experience (user-centered design, usability testing, journey mapping, heuristic evaluation). The firm serves medical device companies requiring 510(k) and De Novo HF submissions, healthcare facilities, and consumer/enterprise technology companies.

The firm's underlying technology is methodological rather than productized: deep expertise in FDA 2016 Human Factors Guidance, IEC 62366-1/62366-2, ISO 14971, and EU MDR requirements, applied through qualitative and quantitative human-subjects research. Notable capabilities include Use-Related Risk Analysis (URRA), HF validation study protocol development with FDA pre-submission support, formative and summative usability testing, and instructional documentation/IFU design. No software products, AI/ML systems, APIs, or proprietary datasets are disclosed; the offering is purely human-delivered professional services. Delivery is direct-to-enterprise through quote-based engagements, offered as full-service partnerships or à la carte support.

Revenue mechanics are project-based professional services with non-public pricing. The customer base spans recognizable enterprise logos across both healthcare technology (ResApp Diagnostics, Ascom, LiveProcess, Hach, Bolder Surgical, Eximis Surgical) and consumer/enterprise technology (Google, Oculus, Dell, Netflix, Indeed, SolarWinds, Facebook, eBay, IBM, Intel, Lockheed). Marketing relies on educational content (blog/insights), webinars, conference presentations (HFES), and community engagement through two co-hosted meetup groups totaling 350+ members. The firm has no disclosed funding, parent company, acquisitions, or geographic offices beyond its Boulder headquarters, and operates nationally and internationally from that single location.

Name

Sage Research & Design

Legal name

Sage Research & Design, LLC

Website

https://sage-research.com

Company type

Private

Founded year

1997

Operating status

Operating

Headcount range

1–10 employees

Short description

Sage Research & Design is a Boulder, CO-based human factors engineering and UX research consulting firm founded in 1997, serving medical device companies, healthcare facilities, and technology firms requiring FDA/IEC 62366 submissions, ISO 14971 risk management, and usability validation services.

Ownership category

akta.pro rank

Product category

Human Factors Engineering Consulting

NAICS

Other Scientific and Technical Consulting Services (54169), Management Consulting Services (54161), Other Specialized Design Services (54149)

SIC

Services-Management Consulting Services (8742), Services-Engineering Services (8711)

akta.pro primary industry

Industry & Sector Research (Syndicated/Custom) (BPAHALAE)

Keywords

• Human factors engineering
• Medical device consulting
• FDA submission support
• Usability testing services
• Risk management consulting

Headquarters

HQ city

Boulder

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Marketing or Sales, Technology or R&D, Infrastructure

Revenue model

1. Human Factors Engineering Consulting: Professional consulting services for medical device companies including HF process audits, use-related risk analysis, formative and validation usability testing, HF documentation preparation, and FDA submission support. Services offered as full packages or à la carte.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels5 records

Core offering

Sage Research & Design provides Human Factors Engineering and User Experience (UX) research consulting services to medical device manufacturers, healthcare facilities, and technology companies. Their core offerings include FDA and IEC-62366 Human Factors activities and documentation for medical device submissions, ISO-14971 compliant risk management, healthcare facility UX research, and general User-Centered Design and usability testing for consumer and enterprise products. Services are delivered as full-service partnerships or à la carte support tailored to client team, timeline, and budget.

Product overview

Sage Research & Design is a human factors engineering and UX research consulting firm offering four core service offerings: Medical Human Factors (FDA & IEC-62366 HF activities and documentation), Medical Device Risk Management (ISO-14971 compliant risk management), Healthcare Patient + Clinician Experience (healthcare facility UX), and Usability + User Experience (User-Centered Design and UX Research). The company provides end-to-end consulting services from early design through FDA/EU regulatory submissions, including formative testing, validation testing, heuristic evaluations, use error analyses, and UI design. Their team brings over 30 years of combined experience working with complex OR devices, OTC wearables, and various healthcare technology products.

Differentiator

Problem solved

Functional benefit

Products and services

• Medical Human Factors Human Factors engineering services for medical device manufacturers covering FDA and IEC-62366 HF activities and documentation, gap analysis, design audit, and end-to-end HF support for medical device approval submissions.
• Medical Device Risk Management ISO-14971 compliant risk management services that ensure the safety of medical products through comprehensive risk management files and procedures.
• Healthcare Patient + Clinician Experience User experience services that help healthcare facilities perform better for patients, clinicians, support staff, and executives through human-centered design research and usability testing.
• Usability + User Experience User-Centered Design and UX Research services that propel products and services to new heights through expert research and design methodologies, including usability testing, journey mapping, heuristic evaluations, and expert reviews.

Quantifiable outcome

• 95% of 510k Human Factors reviews have HF deficiencies - proper HF process can help avoid these deficiencies
• +2 more outcomes

Named customers14 records

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

One partnership is on record.

• TensenticcoreStrategic or Co-development Partner · 1 January 2014Co-host of Medical Technology UX/HF Meetup group in Boulder, CO. Partnership started in 2014 when the meetup was established to connect with other UX/HF professionals in healthcare. The meetup has grown to over 350 members and 35+ meetings.

Scale indicators3 records

Recent moves5 records

Expansion highlights4 records

Direct peers

• Worrell: Medical device design and development consultancy with human factors and usability engineering capabilities. Direct peer offering comparable HF and design services to medtech clients, though with broader industrial design scope.
• Design Science: Independent human factors and usability engineering consultancy specializing in medical device design, FDA submissions, and IEC 62366 compliance. Direct peer to Sage with comparable medical device HF focus and a similar boutique consulting model serving medtech clients.
• Core Human Factors: Human factors engineering consulting firm specializing in medical device usability and FDA submissions. Direct peer with similar boutique model and regulatory specialization serving medtech and healthcare clients.
• UserWise: Human factors engineering consulting firm focused on medical device FDA submissions and usability validation. Direct peer offering similar services to medical device manufacturers with comparable regulatory expertise and boutique operating model.
• Bold Insight: UX and human factors research consultancy providing user research, usability testing, and regulatory compliance support. Direct peer with overlapping services in UX research and HF validation for medical devices and consumer health products.
• HS Design: Medical device product development firm providing design, engineering, and human factors services. Direct peer with similar focus on medtech clients and comparable HF expertise, though operating at slightly larger scale.

Broad incumbents

• National Center for Human Factors in Healthcare (MedStar Health): Research center within MedStar Health focused on patient safety, health IT usability, and human factors in healthcare. Broader institutional player with overlapping HF expertise, but embedded in an academic health system rather than commercial consulting.
• Ximedica: Medical device development firm offering design, engineering, and human factors services across the full product lifecycle. Broader incumbent with overlapping HF capabilities but operates at significantly larger scale across end-to-end device development.
• NAMSA: Global medical device testing, regulatory, and consulting firm offering clinical and laboratory services with HF capabilities. Broader incumbent providing HF as part of a larger CRO service bundle, serving many of the same medical device clients as Sage.
• UL Research Institutes (Human Factors): Safety science organization with human factors research and testing capabilities serving medical device, consumer product, and industrial clients. Broader incumbent with overlapping HF expertise, operating across a much larger standards-and-testing portfolio.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks5 records

Key highlights7 records

Customer concentration

• Xx.com/sage_research

Revenue estimate

Valuation estimate

Number of profiles

Profiles15 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Sage Research & Design