Case studies

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Connected medical system

A pharmaceutical manufacturer wanted to use an existing connected system mobile app with a pediatric population.

Challenge

The FDA requested verification that the app would work with this new pediatric patient population.

The initial study was to identify major showstoppers (if any) and if using the existing mobile app was possible with these patients.

Approach

We were to uncover any environmental, scenario, and logistic considerations that are different for the user group.

We simulated at-home environments in a lab setting, including a mock living room, bedroom, and bathroom.

Our preliminary research revealed that working with pediatrics with this particular diagnosis required a heightened level of moderator sensitivity as the patient may not be aware of their diagnosis.

Outcome

We learned our simulated in-home setup supported data collection; patients and caregivers adapted well to the simulated environments.

We also learned to include a kitchen in future studies as there was a tendency for patients and/or caregivers to utilize these areas when prepping the medication.

Next-gen osteoarthritis

A pharmaceutical manufacturer was exploring next generation improvements for currently available medication to treat osteoarthritis in the knee.

Challenge

The current medication requires patients to receive multiple injections in the knee for a full dose.

The manufacturer had three goals for this project: to better understand and improve the current routine of doctors that administer this drug, to gather feedback on using the drug for osteoarthritis of the ankle, and to receive feedback on a prototype syringe design.

Approach

We observed current practices by visiting orthopedic surgeons’ offices and gathered feedback on their current routines, thoughts on injecting into ankles, and possible dosage reductions. HCPs were asked to perform a simulated injection and provide feedback for future development.

The sessions concluded with the HCPs administering a simulated injection with a prototype syringe into a model of a knee and providing high-level directional feedback for future development.

Outcome

We provided HCP feedback on the possibility of dosage reduction, shared design recommendations on improving stability of the prototype syringe, and offered positive feedback on the possibility of utilizing current drugs for new applications.

Acceptability of new drug formulation and device

A pharmaceutical manufacturer was simultaneously developing a liquid formulation for a drug (currently only available as a pill), as well as a new delivery device to administer this liquid formulation.

Challenge

The manufacturer wanted to evaluate the usability and acceptability of the new formulation and prototype device and gather insights for further development.

 

Approach

We conducted one-on-one in-depth interviews with participants currently taking the pill form of the medication. Participants were asked to complete a simulated-use scenario using the prototype device. We obtained feedback on ease of use, physical attributes, need for instructions, and overall acceptability of the device. We also captured participant data around the new liquid formulation, including appearance, taste, and color.

Outcome

While the device was relatively easy to use, feedback about the acceptability and usefulness of the device for daily use was largely negative. Participants nearly unanimously cited the size of the device as a major deterrent (especially as it related to portability, storage, disposal, etc.) and were also hesitant about the potential taste of the medication. Due to these issues, it was not recommended that development of the device be pursued for this medication unless substantial changes were made. 

Human factors training course designed for FDA

The FDA reached out to the Human Factors and Ergonomics Society (HFES) to assemble a team of experts.

Challenge

The objective was to provide a training course for the Division of Medication Error Prevention and Analysis (DMEPA) from the Center for Drug Evaluation and Research (CDER) that would offer deeper knowledge of and appreciation for the scientific roots of human factors (HF) research and user-centered design.

Approach

Three experts were chosen by HFES to design and deliver the two-day training, including Korey Johnson (Bold Insight), Dr. Anthony Andre, and Michael Wiklund. The team covered topics ranging from the history and origin of HF as a practice to user-centered design principles.

A series of modules included the science behind HF, such as human perception, cognition, memory, and learning, as well as best practices in root cause analysis and dealing with the biases associated with subjective data.

Outcome

The team provided the FDA with the scientific underpinnings of HF – on one hand to amplify instances where requests for additional research are warranted, and on the other hand to provide the scientific context for when that additional research may not be warranted.

Human factors training course designed for medical device team

A global medical device manufacturer wanted to promote internal awareness of and appreciation for best practices in the application of human factors engineering to medical device development.

Challenge

The objective was to better understand the importance of integrating human factors into the earlier stages of their development process. To accomplish this, our team designed a full-day training, split into two modules.

Approach

In the first module, our team provided a broad overview of how feedback from end users should be leveraged early and often during product development, and how that feedback should be integrated into use specifications, task analyses, risk analyses, etc. as well as the overall human factors plan.

In the second module, our team worked collaboratively with stakeholders to apply those best practices to their current products in development and talking through how to implement practical solutions.

Outcome

Stakeholders walked away with tangible next steps to ensure their current products under development were receiving adequate human factors attention.

Risk assessment for surgical equipment

A medical manufacturer had US-approved surgical equipment, but its current design was not working for some international markets.

Challenge

International markets required the system to be smaller and more compact, but still maintain the necessary functionality. With the new changes, the manufacturer wanted to conduct testing in the US to get FDA approval, which would facilitate approval in international markets.

Approach

We tested the redesigned device with a surgical team trained on the current system.

This included in-person testing in an outpatient clinic, in the surgical team’s environment. We evaluated system setup, tool programming, and use during a simulated surgery.

Outcome

We evaluated and updated their Risk Assessment (uFMEA), aligning with previously submitted documents, while identifying new risks and user paths for the redesigned equipment.

Clinical workflows & packaging design

A manufacturer of surgical and delivery devices needed to better understand use cases around the deployment of their crash cart products in typical clinical environments.

Challenge

The manufacturer wanted to develop new packaging and labeling that would better support clinical teams from a storage and retrieval perspective, as well as a safe and effective use perspective.

Approach

We conducted interviews with SMEs from the manufacturer’s organization, as well as contextual inquiries with clinical teams in the field to understand known opportunities for improvement and current challenges.

We used these insights to create a number of simulated use scenarios and conducted lab-based research to refine and prioritize design opportunities.

Outcome

We provided our client with redesigned packaging and labeling for several products based on what we learned from the clinical workflows associated with crash cart deployments. Many of the design changes significantly mitigated use-related risks.

Clinical workflows & packaging design

A manufacturer of surgical and delivery devices needed to better understand use cases around the deployment of their crash cart products in typical clinical environments.

Challenge

The manufacturer wanted to develop new packaging and labeling that would better support clinical teams from a storage and retrieval perspective, as well as a safe and effective use perspective.

Approach

We conducted interviews with SMEs from the manufacturer’s organization, as well as contextual inquiries with clinical teams in the field to understand known opportunities for improvement and current challenges.

We used these insights to create a number of simulated use scenarios and conducted lab-based research to refine and prioritize design opportunities.

Outcome

We provided our client with redesigned packaging and labeling for several products based on what we learned from the clinical workflows associated with crash cart deployments. Many of the design changes significantly mitigated use-related risks.

Surgical mesh implantation procedure

A manufacturer of surgical products had developed a new surgical mesh that provided various advancements in clinical outcomes, but also came with necessary adjustments to implantation procedure.

Challenge

The manufacturer needed to assess the impacts of these adjustments to surgical teams’ ability to implant the mesh safely and effectively, and tailor the packaging and labeling to clearly communicate the need for the adjustments.

Approach

We recruited representative members of surgical teams to conduct simulated implantations in porcine subjects at a simulation lab managed by a local hospital.

Multiple researchers observed the simulated implantations to capture the surgical team dynamics and interactions with the revised implantation procedures.

Outcome

We provided our client with redesigned packaging and labeling for their surgical mesh product that clearly communicated the necessary procedural adjustments.

With the revised packaging and labeling, residual use-related risks were reduced to acceptable levels.

Connected medical system: program of research

A pharmaceutical manufacturer is developing an updated version of an existing, in-market system to help patients with medication adherence. As a connected medical system, both the existing product and new product have an accompanying mobile application.

Challenge

The manufacturer continues to make improvements to the existing mobile app, while also designing the next generation of the product.

These two streams of research (improving the existing app and designing the new system) eventually intersect during the release of the new product.

Throughout this research, the goals are to evaluate the new system for safety, effectiveness, and unforeseen use risks, think through touchpoints and pain points of updated releases to ensure this is accounted for in the new system, consider alternate designs to make both versions of the system more usable and understood, and bridge patients to the new app (training, integration).

Approach

To reach this specialized patient population, we’ve tested in multiple locations across the country, both in English- and Spanish-speaking in-lab sessions. We also have an on-staff RN to advise on considerations during testing for this protected patient population to make sure we are approaching testing scenarios and environments in a way that participants will understand and respond well to.

One part of the research required clinician-assisted training to simulate real-world training of the system.

Outcome

The research for the next-generation system resulted in recommendations to ensure there is a seamless set-up process that prompt less questions and fears of using the system, less outreach to call centers, and to drive accompanying mobile app use.

We’ve made design recommendations for the system packaging that included improved imagery, layout, terminology, sentence structure, labeling, and fonts. We also continue to uncover considerations as users are introduced to the new system.

Electronic health record

An innovative healthcare solutions company sought to test the usability of their electronic health record (EHR) mobile application.

Challenge

Our team was tasked with evaluating the usability and utility of an electronic health record mobile application. The goal was to evaluate the usability of the current user interface and to provide evidence of utility of this application.

Approach

The study was conducted at a hospital where nurses were asked to perform tasks typically executed on an EHR under simulated conditions. The nurses then provided feedback on a post-test questionnaire for qualitative and quantitative data.

Outcome

The rates of success on tasks identified strengths and weaknesses in the application. We were able to identify areas of confusion and inefficiency and offer interface design recommendations that would improve navigation and efficiency.

HCP desktop & mobile portal usability

A pharmaceutical manufacturer wanted to improve the usability and usefulness of an existing HCP portal for a desktop and design a new mobile app version of the portal.

Challenge

The manufacturer presented a multi-phased research plan that included two teams of researchers working independently on the two portal apps.

The goals of the desktop app research were to evaluate account registration performance, usability, and new feature integration.

The goal for the mobile app research was proof of concept, including how well the data was presented and understood, user interaction, and usefulness of the content.

Approach

Both studies conducted one-on-one, in-lab usability sessions with three different groups of specialized HCPs using prototypes of the portal.

The team discovered that the session time was not long enough to collect the desired data, and refocused testing to adjust the protocol and moderators guide to cover all of the manufacturer's objectives.

Outcome

We made key design recommendations to improve the understanding how information is presented, how to interact with the content, improve the terminology to make it more useful, and improve the usability and utility of the portals (both on mobile and desktop).

Website & mobile usability

A global biotechnology company wanted to assess the usefulness and usability of its informational website designed for clinicians.

Challenge

The goal of this study was to determine if clinicians found the website, which consolidated content from various news sources, trustworthy and easy to use.

Approach

We conducted 90-min interviews with specialty health care providers. Participants interacted with a clickable prototype of both the desktop and mobile websites.

Participants found the site usable but terminology used, lack of context, and trust of news sources impacted usefulness.

Outcome

We were able to identify simple fixes that could dramatically improve usefulness and mitigate the issues around credibility.

Pediatric medical injection kit validation

A pharmaceutical company required a validation study to determine if the preparation and administration of an injection kit requiring the reconstitution of a pediatric medication was safe and effective.

Challenge

Our client asked us to determine if nurses could prepare an injection device and reconstitute the drug for a clinical trial.

We executed every stage of the project from protocol writing to recruitment of a hard-to-recruit population (clinical trial pediatric nurses) to writing the validation report.

Approach

The validation study included HCP training, done by our on-staff RN to demonstrate techniques, a 24-hour decay, and a 60-min validation session, during which participants had to prepare and administer two doses of the kit.

Outcome

We evaluated and updated their Risk Assessment (uFMEA), aligning with previously submitted documents, while identifying new risks and user paths for the redesigned equipment.

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