J.S. Held Acquires Shechter & Everett to Expand Forensic Accounting Capabilities for Family Law Disputes in Florida
Read MoreOur healthcare human factors and medical device experts utilize deep understanding of human behavior and cognition and apply scientific usability principles to help clients design and develop products that are safe and effective.
We assist clients to ensure products are aligned with Food & Drug Administration (FDA) guidance, help achieve 510(k) clearance and pre-market approval (PMA), and support in meeting expectations of the De Novo pathway.
As trusted healthcare and medical device human factors partners, we collaborate with leading healthcare and life sciences organizations to deliver support at every stage of the product lifecycle. We are engaged by leading medical device, cosmetics, pharmaceutical, and healthcare technology organizations for our deep expertise in applying human factors principles to complex product development. We provide clients—including healthcare and life science companies, manufacturers, law firms, and government agencies—with evidence-based usability insights, risk mitigation strategies, and actionable data sets that inform design decisions, enhance user safety, and support successful regulatory submissions.
Our human factors consultants help clients meet regulatory expectations, improve product usability, and support healthcare and medical device performance. The benefits of our research services include:
In addition to performance and regulatory benefits, our healthcare human factors expertise helps support long-term product success and legal protection. We leverage extensive experience in healthcare-related litigation to inform our research methodologies and align product experiences with user and market expectations. Advantages of this comprehensive approach include:
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.
Unlike academic or generalist user experience (UX) teams, our experts bring direct human factors experience in product-related and product failure litigation support. We serve as expert witnesses in medical device and healthcare service cases, leveraging extensive litigation insight to inform defensible research methods from the outset of the product development lifecycle.
Our litigation-focused expertise shapes how our experts design and document human factors studies, ensuring our findings stand up to scientific scrutiny and meet the evidentiary standards required in high-stakes product liability cases. Whether conducting failure analysis, reviewing interface design, or preparing materials for legal review, we provide healthcare clients with critical understanding of human factors risks associated with their products and services, grounded in both scientific and legal precedent.
Our human factors experts support medical device manufacturers and healthcare organizations in meeting FDA human factors requirements throughout the product lifecycle. We assist with planning, conducting, and documenting usability studies that align with FDA guidance for validation testing and risk-based design.
Our team works with clients to develop human factors documentation that meets the expectations of reviewers across PMA, 510(k), and De Novo pathways. With extensive experience across a wide range of medical devices, we can help clients reduce submission delays and strengthen their regulatory filings.
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