Injection and drug delivery devices

Plan realistic simulated-use environments to capture the data needed to improve outcomes for your users

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. 

healthcare and med device research & design engagements

med device, pharma, and medtech companies

years of injection device research experience

%

of our healthcare projects

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:

5Are you using a placebo or live drug?
5Do you need refrigerated storage?
5What type of injection pad should be used?
5Does the research team have needle safety training?
5Is there a first aid kit in the test room?

We partner with you to understand possible areas of interest including:

5Injection site and angle
5Drug volume and viscosity
5Plunger or flange design
5Storage and packaging design
5Dose and drug differentiation
5Design of instructions for use

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).

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.
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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.
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Injection site

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

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Supplies match actual use

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

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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.

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Refrigeration

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

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Prescribing scenario

For patients, providing context by simulating a prescribing scenario encourages realistic behavior.

5 tips to mitigate use-related risk for pre-filled syringes and other injection devices

With years of experience conducting human factors research with injection devices, we wanted to share some data-driven insights to those involved in the product development for these devices. We have pulled together five research and design tips to mitigate use-related risk for injection devices.

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