What LUTO Research does

LUTO Research (legal name: Luto Research Limited) is a UK-headquartered healthcare communications and usability testing firm founded in 2004 as the Leeds University Testing Organisation, originating from the University of Leeds. The company writes, designs, and tests clear health communications — including Patient Information Leaflets (PILs), Instructions for Use (IFUs), Participant Information Sheets and Informed Consent Forms for clinical trials, EU Clinical Trial Lay Summaries, and Risk Management / REMS materials — and validates their readability through iterative user testing with lay participants, patients, and healthcare professionals. Its proprietary 'Audience Design Step' (ADS) methodology and ISO 9001 accredited Readability User Testing underpin the service, alongside hybrid usability testing for medical devices, eye tracking, heuristic evaluation, and expert usability review. The firm operates physical usability testing labs in Broughton near Skipton (UK headquarters), Basel (Switzerland), and Chicago (USA), enabling multi-jurisdictional participant recruitment and regulatory submission support for clients in the EU and US.

LUTO serves global pharmaceutical companies, medical device manufacturers, regulators, charities, government bodies, and healthcare providers (named references include Forte Medical and Macmillan Cancer Support). Revenue is generated through project-based professional services engagements priced on a quote basis per scope, with services spanning content writing, design enhancement, user testing with full ISO 9001 documented reports, recruitment of representative patient panels, and additive modules such as eye tracking and heuristic evaluation. An associated sub-brand, iC Display, extends into digital storytelling, signage, motion graphics, and web/app development for visual content applications. Marketing is largely sales-led with industry visibility through the CEO's roles with the British Medical Association Patient Information Awards and the Patient Information Forum.

The firm is privately held with one disclosed external capital event: a £250,000 investment from NPIF – FW Capital in July 2021 to support Covid-19 recovery and global expansion. The senior leadership team is led by Chief Executive Wayne Middleton (appointed April 2015), with founder Professor Theo Raynor serving as Co-Founder & Academic Advisor. The team comprises information design specialists, graphic designers, writers, medical information experts, nurses, pharmacists, psychologists, project managers, interviewers, and academics.

Name

LUTO Research

Legal name

Luto Research Limited

Website

https://luto.co.uk

Company type

Private

Founded year

2004

Operating status

Operating

Headcount range

11–50 employees

Short description

LUTO Research is a UK-based healthcare communications and usability testing firm that writes, designs, and user-tests Patient Information Leaflets, Instructions for Use, clinical trial materials, and lay summaries for pharmaceutical, medical device, regulator, and charity clients across the UK, Switzerland, and the US.

Ownership category

akta.pro rank

Product category

Healthcare Communications Services

NAICS

Scientific Research and Development Services (5417), Research and Development in the Physical, Engineering, and Life Sciences (54171), Other Scientific and Technical Consulting Services (541690), Professional, Scientific, and Technical Services (54)

SIC

Services-Commercial Physical & Biological Research (8731), Services-Testing Laboratories (8734), Services-Health Services (8000)

akta.pro primary industry

Medical Affairs, Scientific Communications & HEOR FSP (HLAGAOAG)

akta.pro secondary industries

Medical Writing & Clinical Documentation FSP (HLAGAOAC), Medical Affairs Scientific Communications (MSL Support/Scientific Response) (HLAGALAF)

Keywords

• Healthcare communications
• Usability testing
• Readability testing
• Patient information leaflets
• Medical device IFUs

Headquarters

HQ city

Leeds

HQ country

United Kingdom

HQ region

Europe

Offices3 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Healthcare Communications Services: Professional services for creating, designing, and testing health communications including Patient Information Leaflets, Instructions for Use, clinical trial materials, lay summaries, and risk management documentation. Services are tailored to regulatory requirements in EU and US markets.

Pricing tiers

Go-to-market motion2 records

Distribution channels1 record

Marketing channels5 records

Core offering

LUTO Research designs, writes, and tests healthcare communications for pharmaceutical companies, medical device manufacturers, regulators, and charities. Services include the development and usability/readability testing of Patient Information Leaflets (PILs), Instructions for Use (IFUs), clinical trial materials (Participant Information Sheets, Informed Consent Forms, lay summaries), and risk management documentation. All materials are tested with real patients, carers, and healthcare professionals to ensure regulatory compliance and patient understanding.

Product overview

LUTO Research operates as a healthcare communications company offering a unified portfolio of user testing and information design services. The core offering centers on Usability Testing and Readability User Testing services, supported by specialized testing methodologies (Eye Tracking, Heuristic Evaluation, Expert Usability Review). The Create suite includes Instructions for Use (IFU), Patient Information Leaflets, Clinical Trial documentation (Informed Consent Forms and Lay Summaries), and Risk Management materials. Creative Services are delivered through the iC Display sub-brand offering digital signage and motion graphics. All services are delivered through usability facilities in Yorkshire (UK), Basel (Switzerland), and Chicago (USA), with human-centered testing approaches involving real patients, carers, and healthcare professionals.

Differentiator

Problem solved

Functional benefit

Products and services

• Usability Testing Hands-on usability testing service for medical device Instructions for Use (IFU) and other healthcare communications, using hybrid methodology combining User and Usability Testing techniques. Offered as formative testing during development or summative validation, conducted in dedicated usability labs.
• Readability User Testing Readability testing for Patient Information Leaflets (PILs) and Instructions for Use (IFUs) across the EU and US markets, conducted under ISO 9001 accredited methodology. For pharmaceutical companies and medical device manufacturers needing to demonstrate readability and user comprehension.
• Instructions for Use (IFU) Development Development of clear and understandable Instructions for Use (IFUs), instruction manuals, and packaging for medical devices. Includes human factors service to test IFUs with iterative, formative development process involving users at key stages. For medical device manufacturers needing regulatory-compliant IFU materials.
• Patient Information Leaflets (PILs) Enhancement of Package Leaflet clarity and readability using the proprietary Audience Design Step methodology, ensuring regulatory compliance with EU QRD template requirements. Includes writing, design enhancement, readability testing, and bridging services. For pharmaceutical companies.
• Clinical Trials - Informed Consent Forms Production, redesign, refinement and alignment of Participant Information Sheets (PIS) and Informed Consent Forms (ICF) for clinical trials. Brings together patient information experience, information design principles and User Testing methodology. For pharmaceutical companies and clinical trial sponsors.
• Clinical Trial Lay Summaries Turning clinical study reports into lay-friendly summaries per EU Clinical Trials Regulation No. 536/2014. Includes writing, enhancing existing summaries, template creation, graphic design, and User Testing. Services include development, user engagement, lay person review, and bespoke training. For pharmaceutical companies and clinical trial sponsors.
• Risk Management Documentation Production of Risk Management information for clinical trials, training packages, and teaching tools. Includes redesign of RMP lay summaries and Risk Evaluation and Mitigation Strategy (REMS) program materials including medication guides, training tools, and educational materials. For pharmaceutical companies.
• User Engagement Research User-centered research approach using various tools and techniques to gather insight from patients, carers and health professionals. Services include recruitment, surveys, telephone interviews, 1-to-1 interviews, focus groups and workshops. For pharmaceutical, medical device, and healthcare clients needing patient insights.
• iC Display (Creative Services) Digital storytelling and digital signage service creating high-impact visual content. Includes motion graphics, signage and wayfinding, digital screens and CMS, web and app development, and brand strategy services. For clients needing creative digital content production.

Quantifiable outcome

• Better informed clinical trial participants make better treatment decisions and demonstrate improved adherence
• +1 more outcomes

Named customers2 records

Segments4 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Scale indicators2 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• Clariness: Clariness is a clinical trial patient engagement and recruitment company producing study information, patient-facing materials, and usability-tested study communications for pharma sponsors. It is a direct peer to Luto as both focus on enhancing participant-facing clinical trial documents through patient-centred design and testing.
• Healthwise: Healthwise is a US non-profit producing patient education materials with rigorous readability and plain-language standards. It is comparable to Luto as both specialise in evidence-based, plain-language patient communications and readability testing, though Healthwise focuses on consumer-facing content while Luto serves pharma and medical device clients.
• BBK Worldwide: BBK Worldwide is a clinical trial patient recruitment and engagement firm offering study materials, informed consent design, and patient-facing communications. It is a direct peer to Luto because both produce patient information sheets, ICFs, and trial lay materials, and compete for similar pharma trial operations budgets.

Broad incumbents

• ICON plc: ICON plc is a global CRO offering clinical trial services across all phases. It is comparable as a potential competitor for pharma trial-communications budgets, though ICON's primary focus is clinical operations and biometrics rather than the readability/user testing niche where Luto specialises.
• Langland: Langland is a UK-based health communications agency providing advertising, medical communications, and patient engagement services to pharma. It is comparable to Luto as both serve the same pharma client base with regulated health-communications deliverables, but Langland operates at much larger scale across creative, medical education, and advertising rather than specialising in usability/readability testing.
• McCann Health: McCann Health is a large global health communications network offering advertising, medical communications, and patient engagement. It is comparable because both compete for pharma health-communications budgets, but McCann operates a broad portfolio across many disciplines whereas Luto is a specialist in usability and readability testing of patient materials.
• ERT (Clario): Clario (formerly ERT) is a clinical trial technology and endpoint services provider offering eCOA, imaging, and patient-centric trial solutions including instructions and training materials. It is comparable because both support clinical trial patient-facing materials, though Clario operates a broader technology platform rather than specialising in usability testing.
• Real Chemistry: Real Chemistry is a healthcare marketing and communications firm offering advertising, medical affairs, and patient engagement services to pharma and biotech. It is comparable to Luto because both produce regulated patient and clinical trial communications, though Real Chemistry operates at far larger scale with a broad service portfolio.

Emerging players

• Dudnyk: Dudnyk is a specialty healthcare agency focused on biotech and rare disease communications. It is comparable because both serve pharma clients producing patient-facing communications including clinical trial and disease-education materials, though Dudnyk emphasises brand strategy while Luto specialises in user testing and readability.

Others

• Veeva Systems: Veeva Systems provides cloud software for life sciences including medical affairs, regulatory, and clinical operations. It is comparable to Luto only as a thematically adjacent technology provider serving regulated communications workflows in pharma — not a direct competitor, but Veeva's growing medical communications modules could eventually overlap with Luto's content workstreams.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

• Xx.com/LutoResearch
• LinkedInlinkedin.com/company/luto

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles10 records

Funding overview

Funding rounds1 record

Investors1 record

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 LUTO Research