Product and Process Development for Health and Life Sciences

We offer human factors engineering consulting and software to help customers innovate and improve usability of medical products*.

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Closing the human factors gap for product development

Product development and R&D professionals require clear, cost-effective paths forward when developing medical products. They need a discovery process that supports designing innovative, user-centered and software-intensive devices. Companies need to apply human factors engineering (HFE) in their product development processes to enhance usability and reduce the risk of use errors. However, they lack the HFE expertise required for innovative and compliant product development.

Accelerate medical product development

Leverage our HFE expertise and software.

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Leverage our HFE expertise for product innovation and safety

Mitigate use error risks

Identify potential use-related issues early in the product design phase.

Reduce costly redesigns

Confidently deliver a usable product, reduce recalls and build user trust.

Meet regulator expectations

Fulfill HFE regulatory requirements for seamless market access.

Our offerings help customers with user centered and compliant innovation

Human Factors Engineering and Usability Consulting

Our Human Factors Research & Design team provides HFE and usability support, including user research and analysis, design, usability testing and training*.

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Optimal Product Usability Suite (OPUS™)

OPUS is our HFE software as a service (SaaS) platform that delivers regulatory guidance, project planning, training, tools and templates for medical product designers and developers*.

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Stages

Our Stages software enables customers to streamline their software-driven medical product development processes, reduce development timeframes and minimize the risk of noncompliance.

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Meet our expert

“We help our customers develop user-centered and safe medical devices that deliver positive user experience and comply with global regulations.”

Allison Strochlic

Senior Research Director, Human Factors Research & Design

Related product and process development resources

Understanding Human Factors Engineering in Medical Products

Access to best practices can help guide major human factors engineering stages of a development effort.

Risk Analysis for Design and Innovation

Our experts present use-related risk analysis as a powerful tool for creative thinking throughout the medical product design process.

Nuubo^® System: Innovating Wearable Cardiac Monitoring

Learn how our Human Factors Research & Design team helped Nuubo^® with Instructions for Use (IFU) expert review, HF validation test protocol development, pre-HF validation testing, HF validation testing and electrode performance evaluations.

Key Benefits of Usability Testing in Medical Devices

Our white paper explains how usability testing can bolster medical device product development and help meet regulatory requirements.

Enabling safety, compliance and sustainability for health and life sciences innovators

Our safety science expertise and software enable industry innovators to streamline market access, manage cybersecurity risks, build a compliant workforce, enhance supplier risk management and strengthen ESG management capabilities, helping them develop safer and compliant medical products and systems. Download our brochure to learn more.

Health and life sciences brochure

HLS brochure introduces UL Solutions' offerings for the Health and Life Sciences (HLS) industry. It showcases five key solution pillars—Market Access, Cybersecurity, Workforce Training & Competence, Supply Chain Resilience, and ESG stewardship—each addressing critical industry challenges and our value proposition. Designed for awareness and consideration stages, this brochure targets Medtech innovators, medical device manufacturers, and HLS decision makers. Ideal for digital campaigns, sales enablement, and industry events.

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Accelerate medical product development

Leverage our HFE expertise and software.

Related Health and Life Sciences market access offerings

Testing and Certification for Health and Life Sciences

Regulatory Readiness and Compliance for Health and Life Sciences

Comprehensive offerings for the Health and Life Sciences industry

Market Access for Health and Life Sciences

Cybersecurity for Health and Life Sciences

Workforce Training and Competence for Health and Life Sciences

Supply Chain Resilience for Health and Life Sciences

ESG Stewardship for Health and Life Sciences

* Within UL Solutions we provide a broad portfolio of offerings to all the medical device industries. This includes certification, Approved/Notified Body and consultancy services. In order to protect and prevent any conflict of interest, perception of conflict of interest and protection of both our brand and our customers brand, we have processes in place to identify and manage any potential conflicts of interest and maintain impartiality. UL Solutions is unable to provide consultancy services to EU MDD, MDR, IVDD or IVDR Notified Body, UKCA MD Approved Body or MDSAP Customers.