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OnShape view of the HALŌ showing the reusable upper section and disposable lower section

HALŌ

*Bringing subcutaneous large-volume drug delivery out of the clinic and into a wearable.

Key Skills: Design Research Human Factors Need Finding Design Thinking
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Living with Regular Infusions

Around the world, hundreds of millions of people are living with chronic diseases that require regular intravenous (IV) or subcutaneous infusions.  Even ignoring complications of these drugs, the infusion process is burdensome to patients;

  • Depending on healthcare professionals to administer the treatment makes the patient’s health less private,
  • Commuting to a clinic can be extremely challenging, especially for patients who live in healthcare deserts, and
  • Regular infusions require patients to miss work, family events, or other important commitments for the sake of their health.

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Solution Space: Wearables

Large-volume on-body delivery systems (OBDSs), wearable medical devices capable of administering large volumes (up to 10 mL) of liquid drugs over long durations (up to 6 hours) aim to relieve many of the challenges of traditional drug infusions.

However, even as more OBDS products (like the YpsoDose®, Neulasta® Onpro®, and enFuse® pictured to the right) enter the market, they suffer from several key issues:

  1. Most are single-use, requiring careful disposal due to their hypodermic needles inside, and leading to significant sustainability concerns.
  2. Many have limited drug reservoir capacities (< 10 mL).
  3. Even with significant instruction from healthcare providers, users are uncomfortable administering their own infusions.
Photo of live usage of the 3-lead ECG system

Ypsodose® [cred: ondrugdelivery.com]

Photo of live usage of the 3-lead ECG system

enFuse® [cred: enableinjections.com]

Photo of live usage of the 3-lead ECG system

Neulasta® Onpro® [cred: neulasta.com]

The Solution: HALŌ

Read the full HALŌ design research case study here.

The HALŌ is an eco-driven, partly-reusable large-volume dosing solution. More importantly, it’s built from the bottom up with lived user experiences in mind.

Screenshot of tolerance analysis table (Excel or Word document)

The HALŌ prioritizes simplicity in its user interaction, with just a three-state slider and an ergonomic, one-handed twistable ring for adjusting the administration rate and status.

Dark-background CAD render (e.g., green tinted OnShape view)

One of the most unsettling aspects of clinic-based infusions is the lack of visibility into the process. The HALŌ addresses this by providing a clear window into the drug reservoir and a simple LED indicator (powered by a 650 mAh CR2450 battery) to show the user the current status of their infusion.

Screenshot of tolerance analysis table (Excel or Word document)

The HALŌ is designed to be worn on the upper arm, with a low-profile form factor (7 cm diameter, 3.4 cm height) that can be easily concealed under clothing.

Dark-background CAD render (e.g., green tinted OnShape view)
Photo of live usage of the 3-lead ECG system

Cross section of the HALŌ; plunger in green, elastomer dome for needle deployment in grey.

Photo of live usage of the 3-lead ECG system

The upper section of the HALŌ is reusable and battery-powered, and contains all of the electronics necessary to control the infusion. The lower section is disposable and contains the drug reservoir and hypodermic needle.

My Contributions

Complete Physical Product Design

After each round of user interviews, I added and modified HALŌ geometry to depict the device in its truest form. This included using OnShape CAD to sculpt each component and visualize relative sizing of important parts, like the 25-gauge hypodermic needle.

Dark-background CAD render (e.g., green tinted OnShape view)

Interview Guide Preparation

I wrote interview guides that gathered invaluable knowledge from healthcare professionals and patients while valuing them as people, not just research subjects.

Dark-background CAD render (e.g., green tinted OnShape view)

User/Design Research Interviews

I conducted several interviews each with four different users to gather ideas, feedback, and opinions throughout the entire design process.

Screenshot of tolerance analysis table (Excel or Word document)

Translating User Experiences into Design Decisions

User Statement
Research Trend
How Might We…
Design Element
"Yeah, I don’t have many complaints other than that I wish [the drug] wasn’t necessary."
Patients only want to think about the treatment, not the process.
…take “patients don’t want to think about the process” to the extreme?
Three-state LED ring indicating idle, active, and complete infusion status.
"I went through three sets of instructions as well as a video online to figuring things out."
There is no right answer to how SDD should look, but there are wrong ones.
…use a device tutorial to increase the accessibility of the SDD process?
Single-handed twist-ring activation requiring no clinical setup step.
"One time, I saw a little air bubble through the window and I freaked out."
The positive parts of the process are far more consistent than the negative parts.
…add to the existing customizability of self-injection devices?
Low-profile upper-arm form factor (7 cm diameter) concealable under clothing.
"I use an old Tupperware to store the old needles. I would definitely be more worried about throwing stuff out if I had little kids, though."
The features patients care most about give the device a place in their lives, and have little to do with drug delivery.
…allow the device to be easily usable in unusual settings?
Separable disposable lower cartridge isolating the needle for safe removal.