
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.
Explore

%
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
Bold Insight’s Korey Johnson shares ways to boost patient confidence through device design with HIT Consultant
This week, Korey Johnson, Managing Partner of Bold Insight, was featured in the healthcare technology-focused digital media platform, HIT Consultant. In his article, How to Improve Patient Confidence When Rolling Out New Medical Technology, Johnson highlights key...
Bold Insight’s Korey Johnson featured in MedTech Intelligence
This week, Korey Johnson, Managing Partner of Bold Insight, contributed to the online journal MedTech Intelligence with his article, How to Boost Patient Confidence Through Medical Device Design. Johnson details several tactical design approaches that can help medtech...
CASE STUDIES