Medical device research
We primarily work in healthcare, where we have experience across hundreds of products, in diverse environments. We have a highly specialized medical device and digital research practice—exceeding most consultancies in experience and scalability.
We partner with you to reach validation at any stage.
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Understand the challenges faced by patients, caregivers, and healthcare providers.
Define use-related risks and the human factors plan to address those risks
Identify design improvements to address identified use-related challenges
Gather data necessary to ensure safe and effective use can be validated
Assess if the user can safely and effectively perform critical tasks for intended use in the expected use environment.
%
of our work is in medical device and digital health working in-situ and lab environments
years of combined experience applying human factors engineering to medical device development
Healthcare and medical device research and design engagements our team has planned, managed, and executed in the past 5 years
Explore our areas of expertise
Part of our DNA
Our experience with medical devices and related products
Digital assets & connected devices
- Digital therapeutics
- Patient support applications
- Websites & desktop software
- Clinical decision support systems
- Remote patient monitoring and management
Packaging, labeling & IFU
- Clinical applications
- Connected devices
- Injection devices
- Infusion pumps
- Oral therapies
Injection devices
- Form factor considerations
- Clinical and home use
- Needle safety devices
- Connected devices
- On-device labeling
Pumps, diagnostics & more
- Infusion pumps
- Surgical devices
- Clinical diagnostics
- Robotic surgery systems
- Patient & caregiver diagnostics
Injection and drug delivery devices
We have extensive experience conducting research with a wide range of injection and drug delivery devices. Attention to logistics, thoughtful product and research study design, and iterative user testing of designs can help mitigate user-related risk with these devices.
med device, pharma, and medtech companies
%
of our healthcare projects
years of injection device research experience
Considerations for injection and drug delivery devices
Clinical and home use
In clinical settings, delivery device design must account for variable workflows. Most often for home use, untrained use cases must be accounted for.
Form-factor design
Form factor of injection devices can be critical to safe and effective use, particularly when dexterity and/or hand dysfunction are of concern for home use cases.
Medication delivery and training
Create clarity around injection hold times and any necessary reconstitution procedures.
Instructions for Use
Even when the instructions for use are not the primary focus of research, they play an important role and should be developed along with the delivery device itself.
Regulatory guidance
Beyond general guidance on application of HFE, specific industry guidance from FDA governs various aspects of development for combination products, needle safety devices, and SaMD just to name a few.
We work with your team to account for all research logistics and answer all simulated use environment-related questions like:
- Are you using a placebo or live drug?
- Do you need refrigerated storage?
- What type of injection pad should be used?
- Does the research team have needle safety training?
- Is there a first aid kit in the test room?
We partner with you to understand possible areas of interest including:
- Injection site and angle
- Drug volume and viscosity
- Plunger or flange design
- Storage and packaging design
- Dose and drug differentiation
- Design of instructions for use
We incorporate multiple strategies to encourage natural use behavior for simulated drug delivery. Each user group operates a device in different settings, requiring different environments to put them in their natural state during testing.
Realistic injection locations
Manikins can be used as patients for caregivers and HCPs. Injection pads should be used for patients, which they can place on their thigh, arm, or abdomen depending on their current practice or expectation based on instructional materials.
Injection site
Participants select their preferred injection site prior to placing an injection pad.
Supplies match actual use
Provide gloves, alcohol swabs, hand sanitizer, cotton balls, trash can, sharps container, etc.
Provide context
Deepen understanding of realistic scenario, e.g., ask HCPs to imagine a patient is in the waiting room or to prepare an injection as they would in their office.
Refrigeration
Cold storage affects viscosity and handling and should be incorporated into protocols.
Prescribing scenario
For patients, providing context by simulating a prescribing scenario encourages realistic behavior.
Training
If training is required, consider decay timing and clinical vs. layperson training differences.
Available resources in a real-world scenario (e.g., help line, tutorial videos) should be available upon request.
When conducting research with injection devices, we emphasize needle safety regardless of training to prevent accidental needle sticks.
For most injection devices, untrained use should be assessed during both formative and summative evaluations.
Package design and testing
Clearly communicate
Primary (e.g, tray), and secondary (e.g, box) packaging, as well as Quick Start guides and IFUs, collectively communicate device functionality.
Test early and often
Iterative testing can inform layout, design, and language of packaging. Conducting this testing early in the development process is recommended.
Differentiate design
Packaging is important to dose and drug differentiation, particularly in the pharmacy. Elements such as use of color, shape, and text, should be tested to ensure that differentiation errors are minimized.
Validate
At minimum, new packaging and labeling designs should be validated with respect to differentiation. Even minor changes can impact potential for medication errors.
Pharmacy sim-lab
Ensure fidelity of the test environment by incorporating stocked shelves, pharmacy bags, prescription labels, and even testing with dyads (both techs & PharmDs).
Recruiting
In addition to working with patients, our team has extensive experience interviewing and observing healthcare professionals and others who support patient care and disease management. Our team has managed HF studies ranging in size and complexity, up to samples of more than 250 participants, representing thousands of face-to-face hours, both in lab & home environments.
Example HCP populations with which we have conducted research:
Example patient populations with which we have conducted research:
- Anesthesiologists
- Cardiologists
- Caregivers
- Critical Care Doctors
- Medical Assistants
- Neurologists
- Nurses
- Nutritionists
- Ophthalmologists
- Opticians
- Pharmacists
- Primary Care Physicians
- Psychiatrists
- Social Workers
- Surgeons
Example patient populations with which we have conducted research:
Example patient populations with which we have conducted research:
- Alzheimer’s
- Amblyopia
- Ankylosing Spondylitis
- Bipolar Disorder
- Cancer
- Crohn’s
- Diabetes
- Hemophilia
- Major Depressive Disorder
- Meibomian Gland Dysfunction
- Migraine
- Parkinson’s
- Psoriasis
- Rheumatoid Arthritis
- Schizophrenia
Forging partnerships to tackle difficult recruits
Bold Insight
Obtains screener approval
Clinical trial recruiter / private practice
Central test facility
Prior to fieldwork, our clinical trail recruiter or private practice partner screens potential participants and backup participants through existing database and outreach. They then schedule qualified participants and provides updates.
During fieldwork, they coordinate transportation of participant (and caregiver) to/from central test facility, if needed. They can also provide onsite HCP to conduct participant assessment prior to session and post-session assessment prior to dismissal.
After fieldwork, our partners update the database with participation information and sources participants for future studies based on need.
Our central facility partners can check ID prior to session, disburse compensation and dismisses participants.
Medical device insights
CASE STUDIES
3 crucial aspects of submitting a successful human factors engineering package to the FDA
Have a mid-development question about medtech regulation? Chances are – no matter the size or scale of the manufacturer you work for – you probably can’t just pick up the phone and ask the FDA for an answer. Most often, the process is instead slow and bureaucratic,...
Bold Insight sponsors 2023 HFES Healthcare Symposium
This month, members from Bold Insight will attend the Human Factors and Ergonomics Society (HFES) 2023 Healthcare Symposium in Orlando, Florida. This symposium will bring together human factors (HF) experts, pharmaceutical and medical device companies, biomedical...
CASE STUDIES
A pharmaceutical manufacturer was interested in obtaining empirical data and user feedback regarding the usability of a medication delivery system, including the devices, labeling, and IFU.
A pharmaceutical manufacturer was interested in collecting data to inform the development of a large-volume autoinjector and its accompanying IFU and labeling.
A healthcare company wanted to identify existing workflows of their laboratory equipment across global markets and determine opportunities for usability improvement.
A pharmaceutical manufacturer required a validation study to determine if an autoinjector and its related materials were safe and effective.
A wearable technology company wanted to understand the current telehealth landscape in hopes of identifying unexpected insights about the future of telehealth, particularly in the age of COVID-19.
A pharmaceutical company asked us to test the design preferences and usability of a mobile application designed as a 6-week treatment programme to help patients manage their depression
A medical device manufacturer asked us to evaluate the use of their haematology analysers in different settings and identify opportunities for improvement.
A medical device manufacturer asked us to evaluate the usability of a home monitoring device for individuals with pacemakers and defibrillators and explore ways to improve the product according to user needs and preferences.
A pharmaceutical company needed to evaluate the effectiveness of their instructions for use for a new product.
A pharmaceutical company needed to evaluate the effectiveness of their instructions for use for a new product.
A pharmaceutical manufacturer was exploring next generation improvements for currently available medication to treat osteoarthritis in the knee.
A pharmaceutical manufacturer wanted to use an existing connected system mobile app with a pediatric population.
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.
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.
An innovative healthcare solutions company sought to test the usability of their electronic health record (EHR) mobile application.
A global biotechnology company wanted to assess the usefulness and usability of its informational website designed for clinicians.
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.
A medical manufacturer had US-approved surgical equipment, but the current design was not working for some international markets.
The FDA reached out to the Human Factors and Ergonomics Society (HFES) to assemble a team of experts to provide a training course for the Division of Medication Error Prevention and Analysis (DMEPA) from the Center for Drug Evaluation and Research (CDER).
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.
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.
A pharmaceutical manufacturer sought to explore the ideal customer journey for a new connected wearable medication delivery system.
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.
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.
A medical device manufacturer sought to evaluate the usability and safety of the patch pump and training with potential patients and healthcare providers.
A pharmaceutical manufacturer wanted to eliminate selection errors due to similar packaging.
This multi-study program of research used a combination of early iterative design studies and later formative studies to refine all elements of the drug delivery system.
A pharmaceutical company sought to understand how people with diabetes use technology to manage their disease.
A pharmaceutical manufacturer sought to improve the design and usability of a currently available pump carrying accessory.
A pharmaceutical company planned to make an existing infusion pump available to a new patient population.
