Research Collective
Pioneering Human Factors Engineering for Safer Medical Devices

In the world of medical device development, prioritizing safety, usability, and efficiency is crucial for enhancing patient care and streamlining healthcare operations. Yet, traditional medical device designs often lack standardization and can have complex interfaces, increasing the risk of errors and reducing overall usability.

A leader in addressing these challenges is Research Collective, a company specializing in human factors engineering. With a dedicated focus on user capabilities and limitations, the firm helps medical device manufacturers create products that are usable, desirable, and most importantly, safe. By understanding user needs, analyzing product usability, and conducting rigorous testing, the company provides practical improvements that lead to safer and more efficient medical products.

“Our aim is to make it easy for the user to do the right thing and make it impossible for the user to do the wrong thing,” explains Russell J. Branaghan, PhD, President and Co-Founder. “Whereas making a product complicated is easy, making it easy can be complicated. That is the real challenge.”

Enhancing Usability, Reducing Risk

The company’s approach is both comprehensive and practical, grounded in real-world feedback. By studying users—whether they are doctors, nurses, caregivers, or patients—in their natural environments, they gather detailed data on how products perform in everyday settings. This enables manufacturers to identify strengths, weaknesses, and opportunities for improvement long before a product is submitted to a regulatory agency or reaches the market.

To evaluate a product’s ease of use and potential safety risks, Research Collective conducts rigorous usability testing. Their team observes users interacting with devices to complete real-world tasks, tracking success rates, errors, and unexpected challenges. This data-driven approach ensures that products not only meet regulatory standards but also excel in real-life scenarios.

In fact, Research Collective conducts well over one hundred of these projects, working with more than 1,500 usability test participants each year. From the initial prototypes to the final product, the firm employs a proactive testing approach to address usability issues as early as possible. Formative usability testing is used to refine designs iteratively. When the team believes a product is sufficiently polished, they conduct a formal validation test to simulate real-world usage scenarios. Insights gathered from these tests are then applied to further refine the product, ensuring it meets all safety and regulatory requirements.

Specialized Focus in Human Factors

What sets the organization apart is its exclusive commitment to human factors engineering. Rather than offering a broad range of services, Research Collective dedicates itself entirely to this specialized field, partnering with experts in industrial design, engineering, marketing, and more. This focus enables them to improve device design through an extensive understanding of user capabilities and limitations.

“Our goal is to design products that build on users’ strengths while addressing their weaknesses,” Branaghan notes. “By understanding these aspects early in the design process, we can prevent information overload and minimize unnecessary distractions, such as excessive alerts or complex instructions.”

Our aim is to make it easy for the user to do the right thing and make it impossible for the user to do the wrong thing

Ensuring Compliance and Preventing Recalls

Research Collective plays a crucial role in helping companies navigate the complex landscape of regulatory requirements and industry standards, reducing the risk of costly recalls, halted sales, and potential legal disputes. The firm works closely with partners to strategically implement and comply with key human factors standards and guidance, including those set by the FDA, IEC, MHRA, AAMI, and other regulatory bodies.

Recognizing that each medical product has its unique challenges, the team tailors its approach to meet the specific needs of each partner. From early design phases to final product release, they provide comprehensive support to ensure that every aspect of the product meets the stringent requirements necessary for market entry. Their expertise in regulatory strategy and human factors integration ensures that products not only meet but exceed the standards set by global regulatory agencies.

Additionally, the team’s deep understanding of international standards allows them to guide clients through the varied and often challenging regulatory landscapes across different markets. They assist companies in complying with FDA human factors guidance in the U.S., while also ensuring they meet IEC standards for global distribution, MHRA requirements for the UK market, and AAMI standards for high-quality medical device performance.

Broad Expertise Across Medical Product Categories

Research Collective brings specialized expertise to a wide range of medical products, supporting the design, usability, and safety of devices across multiple categories.

Their portfolio includes diagnostics (such as imaging systems and biosensors), drug delivery (including injection devices and syringes), monitoring (like glucose meters and patient monitors), electronic medicine (covering telemedicine platforms and wearable devices), cardiac devices (such as pacemakers and artificial organs), and therapy assistance (like assistive walking devices and pain treatment).
One notable project involved designing an artificial heart to address the critical shortage of donor organs. The team played a key role in developing an intuitive alarm communication system, ensuring that patients could confidently and quickly respond to critical alerts, such as overheating, by providing clear instructions for replacing the pump. This innovation allowed patients and caregivers to manage emergencies effectively, ensuring safe and reliable usage of this life-saving device.

State-of-the-Art Usability Lab

Supporting their services is a state-of-the-art usability lab in Phoenix, Arizona. This facility features customizable research spaces with one-way observation windows and advanced AV systems, making it ideal for usability testing, interviews, and participatory design. Flexible setups replicate various real-world environments, such as living rooms, exam rooms, or surgical suites, to ensure realistic testing conditions.

Their expertise extends to participant recruiting, where they excel at connecting researchers with the right participants for each study. From the general population to patients with specific conditions, healthcare providers, and specialists, the team ensures that the most relevant voices are included. The firm’s recruiting capabilities encompass a wide range of needs, from common conditions like asthma and diabetes to rare diseases such as Guillain-Barré syndrome, and even extend to professionals like interventional radiologists and robotic-assisted surgeons.

Training Classes and Workshops

To further their mission, Research Collective offers customized training classes and workshops that sharpen skills and deepen understanding in human factors and research. Their courses cover key topics, including human factors for healthcare design, regulatory requirements, cognitive ergonomics, and practical research methodologies like usability testing, contextual inquiry, task analysis, and effective interviewing techniques. Each workshop is tailored to meet the specific needs of a team or product, providing hands-on learning experiences that deliver practical, applicable knowledge.