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.

The foundation for safe and effective use begins with exploratory research and spans the entire development process.

Explore

Understand the challenges faced by patients, caregivers, and healthcare providers.

Document

Our method closely follows FDA regulations assessing risk through identification of use errors with guidance from HCPs.

Design

Know where you stand and get the insight you need to focus future development efforts or to document achievement of objectives.

Test

Gather data necessary to ensure the best possible outcomes in upcoming validation testing.

Validate

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 enginnering 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.

9

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.

9

Injection site

Participants select their preferred injection site prior to placing an injection pad.

9

Supplies match actual use

Provide gloves, alcohol swabs, hand sanitizer, cotton balls, trash can, sharps container, etc.

9

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.

9

Refrigeration

Cold storage affects viscosity and handling and should be incorporated into protocols.

9

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

We manage recruitment for difficult-to-find populations alongside trusted recruiting and facility partners, ensuring that the unique needs and aspects of each recruit are addressed and planned for.

Bold Insight

Creates screener

Obtains screener approval

Manages recruiter, facilities, and other logistics (e.g., IRB if needed)
Provides regular updates to client
Notifies HCP if participant says or does anything of concern during study

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

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CASE STUDIES

CASE STUDIES

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Refine iterative design process to improve pharmaceutical instructions for use (IFU)
Refine iterative design process to improve pharmaceutical instructions for use (IFU)

A pharmaceutical company needed to evaluate the effectiveness of their instructions for use for a new product.

Improve usability and identify behavioral use of mobile app for at-risk patients
Improve usability and identify behavioral use of mobile app for at-risk patients

A pharmaceutical company needed to test usability of an app for patients facing a serious medical condition.

Identify speech detection algorithms through voice sampling for global healthcare solutions
Identify speech detection algorithms through voice sampling for global healthcare solutions

A global healthcare company sought to improve speech detection algorithms used by health care professionals (HCPs) to access patient information.

Improve usability of mobile app for MS patients
Improve usability of mobile app for MS patients

A developer of digital health self-assessment tools sought usability testing for an innovative smartphone app designed to help healthcare professionals and patients better understand MS.

Evaluate desirability of digital therapy concept
Evaluate desirability of digital therapy concept

A pharmaceutical company wanted to understand if potential functionalities of a digital therapy met user needs.

Evaluate acceptability of dental device cleaning procedure and instructional materials
Evaluate acceptability of dental device cleaning procedure and instructional materials

A manufacturer of personal care products sought to assess the ability of users to follow cleaning and disinfection protocols in a clinical setting.

Identify infusion pump training requirements for new user population
Identify infusion pump training requirements for new user population

A pharmaceutical company planned to make an existing infusion pump available to a new patient population.

Evaluate design of new infusion pump carrying accessory
Evaluate design of new infusion pump carrying accessory

A pharmaceutical manufacturer sought to improve the design and usability of a currently available pump carrying accessory.

Understand diabetes patient use and management with connected devices
Understand diabetes patient use and management with connected devices

A pharmaceutical company sought to understand how people with diabetes use technology to manage their disease.

Design research program for new drug delivery system
Design research program for new drug delivery system

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.

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