Medical Device & Healthcare Human Factors Consulting

We utilize deep understanding of human behavior and cognition to guide the development of medical devices and healthcare services that are safe, effective, usable, useful, and conform with Food & Drug Administration (FDA) guidance.

Our experts provide support at every stage of the medical device lifecycle, from ideation and early-stage research through formal validation/summative testing and regulatory submissions. We have been engaged by some of the largest, most influential companies in healthcare, cosmetics, and pharmaceuticals, and leverage that extensive experience to provide specialized expertise to healthcare and life sciences organizations, medical device manufacturers, law firms, and government clients alike.

Our Services for Healthcare & Life Science Companies

Advanced Data Analysis & Synthesis
Cognitive Workload Assessment
Competitive Analysis & Benchmarking
Contextual Inquiry
Ethnographic Research
Eye Tracking & Pupillometry
Formative & Generative Research
Gap Analyses

Health & Safety Risk Assessments
Heuristic Evaluations
Human Factors Engineering Usability Engineering (HFE/UE) Reports for Regulatory Submissions - PMA, 510(k) & De Novo
Instructions for Use (IFU) Testing & Design
Interviews & Focus Groups
Literature Review
Motion Capture & IMUs
Participatory Design

Physiological Data Recording & Analysis - EEG, EKG, EMG
Safety Data Sheet (SDS) Authoring & Development
Survey & Questionnaire Design & Analysis
Task & Workflow Analyses
Use-Related Risk Analyses (URRAs)
Validation & Summative Testing
Warnings Comprehension Testing & Design

Benefits of Human Factors in Healthcare & Life Sciences

J.S. Held’s User Research Lab (URL) is the premier scientific user research and human factors consultancy, combining decades of experience across different industries and leveraging methodologies from basic science. Our refined human factors research approach provides extensive benefits to healthcare and life sciences clients, including:

Enhanced FDA Application & Clearance Process
Our human factors experts help clients mitigate the 90% initial FDA rejection rate by performing human factors conform with FDA’s expectations.
Attenuated Physician Strain Reduction
Proper workflow, usability, and ergonomics can reduce fatigue, both physical and mental, and improve physician performance and well-being.
Medical Error Reduction
Human factors engineering reduces the opportunity for medical errors, helping to save patient lives, cost, physician time, and brand reputation.
Branding & Reputation Enhancement
A favorable user/patient experience weighs heavily into a brand’s reputation in the market. This, in turn, is a key factor for patient and customer loyalty, talent acquisition and retention, future partnerships, and strategic growth strategies.
Developing Competitive Advantage
A positive, differentiated user/patient experience provides a competitive for healthcare and life sciences companies, creating defensive moats that protect market share and profits from competitors.
Legal Defensibility
Our experts leverage insight from product failure and product-related litigation engagements to devise research methods that are legally defensible and hold up to scientific scrutiny. We develop a complete design history file including diligent human factors research, fortifying manufacturers against design defect and failure to warn claims.

Our Healthcare Human Factors Expertise

Healthcare products and services are undergoing a radical increase in complexity, combined with continued struggles to manage usability, cognitive and physical workload, and interleaved workflows. Concurrently, patients are now more demanding consumers, increasingly expecting an enhanced, forward-thinking user experience in lockstep with the other products and services they interact with.

In order to respond to these challenges, our experts are academically trained in foundational scientific research and leverage deep industry experience with various clients and products, spanning sectors. We perform university-grade research regarding healthcare products and services, but operate on faster timelines and understand the need to generate actionable insights that translate directly into project-related decisions.

Further, unlike many university research teams, UX researchers, and human factors practitioners, we possess real-world human factors litigation support experience, and have served as expert witnesses in healthcare products and services litigation. This allows our team to leverage insights from previous product failure and product-related litigation to devise advanced research methods that are legally defensible and will stand up to scientific scrutiny.

RELATED SERVICE AREAS Click the icon to view the directory

Human Factors Consulting

Human Factors Litigation Support

User Experience Research Laboratories (URL)

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Healthcare Human Factors

INDUSTRY INSIGHTS

Keep up with the latest research and announcements from our team.

J.S. Held

Headquarters

50 Jericho Quadrangle
Suite 117
Jericho, N.Y. 11753
+1 516 621 2900
[email protected]

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Subsidiary Firms

Contract Administration Associates, a J.S. Held Company

DBSConsult, a J.S. Held Company

JS Held Malaysia Sdn. Bhd. | Registration No. 202001033278 (1389599-P)

J.S. Held Engineering Services PLLC

J.S. Held Singapore Pte. Ltd. | Registration No. 202032700W

J.S. Held UK Limited

J.S. Held India Private Limited

Ocean Tomo, a part of J.S. Held

California Architecture & Engineering services are provided by J.S. Held Engineering and Architecture, Inc., a wholly owned subsidiary of J.S. Held LLC

Areas of Expertise

Technical & Scientific

Strategic Advisory

Financial Investigations, Valuation & Risk

Digital & Data

Insights

White Papers & Research Reports

Perspectives

Educational Seminars & Events

Markets Served

Consumer Products & Services

Industrial & Manufacturing

Insurance

Private Equity

Real Estate

Retail, Restaurant & Hospitality

Technology, Media & Telecommunications

Transportation Infrastructure

About J.S. Held

Service Organization Control (SOC) 2 Type II

J.S. Held, its affiliates and subsidiaries are not certified public accounting firm(s) and do not provide audit, attest, or any other public accounting services. J.S. Held is not a law firm and does not provide legal advice. Securities offered through PM Securities, LLC, d/b/a Phoenix IB, a part of J.S. Held, member FINRA/ SIPC or Ocean Tomo Investment Group, LLC, a part of J.S. Held, member FINRA/ SIPC. All rights reserved.

Member FINRA | SIPC