Pear Therapeutics director outlines challenges of regulated software design

The company has plans to work on new, streamlined design systems for the future.
By Laura Lovett
03:17 pm
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Figuring out the best user experience can be a tricky process for any platform. But its particularly important in digital therapeutics, which some view as a disruptor to traditional pharmaceuticals. 

Unlike medical drug makers, digital therapeutics companies have UX design to consider during the development of their products, Madhavi Jagdish, director of product designer at Pear Therapeutics, said at Mad*Pow's HXD 2019 in Boston. 

In 2017 the Boston-based company landed a De Novo FDA clearance for reSET, a digital therapeutic for substance abuse, and became the first software-only digital therapeutic cleared by the FDA with claims to improve clinical outcomes in a disease. This was followed by the clearance of reSET-O, a digital therapeutic to treat opioid use disorder, in December. 

“The brain is really powerful. We can do a lot with cognitive behavioral therapy [CBT] and we can give people access to care who have not had access before through prescription digital therapeutics,” Jagdish said during a Tuesday session.

But despite the launch of two of its products, the company continues to grapple with design question about process, patient feedback and user diversity. 

“Our work [at] Pear is not just about designing individual apps, but also to design a system or an engine to make sure that we can make changes to these apps and make new apps in the future," Jagdish said.

Pear’s current platforms specialize in CBT, a type of therapy that helps patients become aware of inaccurate or negative thoughts. While several apps on the market also tout CBT approaches, Pear is regulated, creating a specific set of requirements for it to meet. 

“We are designing regulated software, which means we have to define inputs in the user tasks. In the case of design, these are user tasks,” she said, “some of which are critical upfront and then make sure our designs create outputs that make sense for any given input. For example, any user insight we might collect is a design input, for which a corresponding user experience flow and visual design is the output.” 

Getting patient feedback is key to the design process. She said co-design is one technique that the teams has employed in the past. It is especially important since the designers have not gone through the patient experience themselves. 

“We need to talk about patients often because we ourselves do not suffer from these conditions,” Jagdish said. “So we might think they have certain goals that are much, much loftier than the ones they actually have to function on a daily basis.”

Unlike traditional drugs, in digital therapeutics stakeholders are able to get immediate access to real-life feedback, which can help with future development. 

“Our products are fundamentally different than drugs because we know everything about every patients that use our products,” she said. “We can push self-reports to clinicians We can measure efficiency in the real world, not just in a clinical trial.”

She gave the example of a therapeutic designed for people with schizophrenia. The users said they liked the ability to add skills to their toolbox. However, looking at the data, the design team found that patients rarely retrieve the skills from the toolbox. This data challenged the team to think about the feedback and how to integrate real-life evidence into the design of the future. 

While Pear has designed each of the digital therapeutics individually, Jagdish said that in the future the company would like to make it more streamlined.

“Making regulated prescription digital therapeutics is complicated. There are lots of moving parts but you don’t have to reinvent the wheel. We are doing this by having very robust design systems,” Jagdish said. “Right now each product has its own dedicated design system. But our big goal this year is to really go one level higher and componentize flows and mechanisms of action that can be leveraged across new products we build.”

But she reminded audience members that this technology is still new in the grand scheme of things, and as time goes by the industry will continue to shore up its design process. 

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