For my work life, 2016 was a year of transitions and contrasts.

I began 2016 working on a crowdsourced comic book translation platform with a team spread across three continents, as many primary languages, and non-overlapping work hours to boot. I ended it on a focused team from multiple industries, spread across a mere single coast of the U.S., working on a software platform for orchestrating cell therapy cancer treatments.

Country vs industry culture

Led refreshingly by a majority female executive team, we’re a mix of medical devices and consumer software, pharmaceuticals and healthcare, nonprofits and consumer startups. This team’s cultural contrasts have come not from our countries of origin but from our industry backgrounds, and have led to many fruitful discussions of process and mindset. And the premise of helping to cure cancer, besides being an unfair line to pull out at startup networking events, has proven to have a powerful focusing effect when debating product decisions.

Consumer software to health tech

Some aspects of this work is familiar, such as the enterprise-like dynamic of having customers who are distinct from end users. Others are anticipated. Our users are more challenging to access than walking down to the local coffee shop; it’s hard to do guerrilla testing with hospital staff.

One surprise was shifting away from an emphasis on quantitative user analytics. When our users are a constrained number of largely mandated staff, attrition flows and A/B testing stop having the same relevance.

And at a fundamental level, there were comforting aspects of designing digital products for consumers. “At the end of the day, no one will die,” was a reassuring reminder during periods of stressful work. That line is no longer true.

Enter Regulation

The tech startup mindset of “Move fast and break things” is not acceptable. Our balanced team of Lean product design & management, and Agile (specifically XP) engineering, meets waterfall regulatory requirements written by a large bureaucracy. The regulations, while arguably byzantine in many of their specifics, are driven by a shared motivation to prevent harm to patients. Lean-Agile processes, born out of generations of startups learning to iterate efficiently towards well-tested solutions, incorporate the latest thinking on how to avoid waste and reduce risk.

Our challenge has been to negotiate between the goals of regulation and the practicalities of agile processes. We’ve made strides towards automating away many of the busywork requirements, but it’s an ongoing tension.

Onward

It’s been a fascinating year joining a new team, learning about regulation, and generally acclimating to health tech. I look forward to sharing more stories of my experience in each of those areas.