Key Takeaways:
- Inclusive design is designing something that is usable and a good user experience for the broadest possible spectrum of people.
- The transition change from a disposable to a reusable insulin pen from AstraZeneca was a sustainability decision turned inclusivity project.
- Adding in sustainability can never sacrifice user experience or safety.
When Lucy Baldwin took the stage at Pharmapack to speak about inclusive design in healthcare, one message stood out: safe isn’t the same as usable, and usable isn’t the same as equitable.
Baldwin, who leads research and design strategy at Ensera Design (part of the wider manufacturing group, Ensera), works at the intersection of product development, user experience, and healthcare innovation. Her team ensures that products in the healthcare space meet the needs of the people who rely on them every day. A big part of that is designing for inclusion.
“Inclusive design is about creating products that deliver a good user experience for the broadest possible spectrum of people,” Baldwin explains.
Historically, medical devices have been developed and approved under regulatory frameworks that rely heavily on the concept of “substantial equivalence” — proving a new device is comparable to one already on the market. But that benchmark doesn’t guarantee the original device was designed with diverse users in mind.
“It means that it was tested on a population of people, but it doesn't mean that that population of people represented the needs of the people that actually use the device,” says Baldwin.
For example, when designing for people living with diabetes, it’s not enough to consider insulin delivery alone, says Baldwin. Designers must also account for physical or cognitive characteristics such as neuropathy, vision loss, reduced dexterity, or cognitive load. “The question becomes; how can we design to make their experience just as great as someone who's got 20/20 vision?”
When Sustainability Drives Change
One project Baldwin highlighted involved transitioning a diabetes therapy from a disposable prefilled autoinjector to a reusable platform with replaceable insulin vials. The shift, driven by AstraZeneca, was rooted in sustainability goals, but quickly developed into an inclusivity project, because the move introduced a new challenge: behavior change.
“Patients accustomed to a disposable, single-format device were now expected to adapt to a reusable system with multiple components,” says Baldwin. “That’s where inclusive packaging design became essential.”
The solution centered on maintaining a familiar design language. Packaging structure, opening mechanisms, tamper seals, color cues, and component placement were intentionally designed to echo the previous format. While the internal system changed, the external cues were there to reduce cognitive friction.
“The transition itself was significant,” Baldwin says. “Our job was to make it feel intuitive.”
Beyond the Lab: Research in Real Life
To make it feel intuitive, the team conducted usability testing to get the package right. Traditional usability testing often takes place in controlled environments — observation rooms with one-way mirrors, structured tasks, and scripted interactions. These studies are critical for regulatory approval and safety validation.
“What it doesn't give you is any context into that person's life beyond the room that they've come into for the day,” says Baldwin.
To better understand real-world behaviors, Baldwin’s team conducted remote diary studies using a digital platform that allowed participants to record videos and answer prompts in their own homes. The insights were revealing.
Medication wasn’t stored in pristine cabinets. It sat next to chopping boards and half-prepared meals. Refrigerators were crowded with multiple therapies. Patients managed vitamins, supplements, and prescriptions simultaneously. Storage, retrieval, identification, and disposal were all part of the lived experience.
“Medical devices do not exist in sterile vacuums, they exist in kitchens, bedrooms, and busy households… we saw people with chopping boards out, a dirty knife and onions being chopped, and right next to it is the insulin vial about to be loaded,” explains Baldwin.
And unlike consumer goods, medical devices aren’t optional.
“Patients don’t choose to use insulin pens — they need them. That changes the equation,” Baldwin says.
Balancing Sustainability and User Experience
While the original goal of the AstraZeneca pen was to reduce material usage and improve the product’s sustainability, the ultimate goal for Baldwin and her team was to design a device that did not take away from the user experience.
“If we’re going to make something more sustainable,” Baldwin notes, “it has to be just as good as what people are already using, or better.”
In fact, she says poor usability can undermine sustainability altogether. If a product is difficult to use, confusing to store, or frustrating to maintain, it may be discarded prematurely or misused, creating waste rather than reducing it.
“Sustainability cannot come at the cost of dignity, safety, or ease of use, especially for patients already navigating life-changing diagnoses,” says Baldwin.
Redefining Risk
When discussing device development, Baldwin talks about reducing risk and emphasizes that “risk” extends far beyond regulatory approval.
“There are lots of dimensions of risk,” she says. “One is user safety, making sure something is safe and understood. Another is user experience- something can be safe but still challenging or unpleasant to use. At the moment, devices still get recalled because they've endangered someone's life. So diligent research and understanding the population is critical.”
But there is also experiential risk. A device may be technically safe but still compromise independence or dignity. Baldwin points to a concept developed by the Royal National Institute of Blind People (RNIB): a pregnancy test designed to be read independently by blind users. A standard pregnancy test is safe for a blind person to use but the results could not be read independently. The redesigned concept addressed privacy and autonomy, elevating the user experience.
“Inclusive design asks a different question,” Baldwin says. “Not just ‘Can they use it safely?’ but ‘Can they use it in the way they want to?’”
As populations age and independence becomes an increasingly important design consideration, those questions grow more urgent.
But as Baldwin explains, risk also exists at the manufacturing stage.
“Will the design behave the way we think it will when manufactured?”
In the example of the autoinjector project, the team proposed a new packaging material. To ensure performance under real-world pressures like transportation, storage, and handling, the team combined physical prototyping with finite element analysis (FEA), digitally simulating stress conditions before scaling production.
This approach reduced the risk of late-stage failures, minimized costly redesigns, and helped ensure the packaging would behave as intended at volume.
“That allowed us to reduce risk in design to manufacture and make sure there wouldn't be problems once in production. And that's critical when you're scaling to large volumes,” says Baldwin.
As regulatory pressures evolve, sustainability targets accelerate, and patient expectations rise, the medical device industry faces a pivotal moment. Inclusive design offers a structured way to meet those intersecting demands. By grounding development in real-world context, broad user representation, and rigorous validation, companies can reduce a variety of risk while delivering more equitable experiences.
