JK: To me, no. I am probably the furthest thing from a traditional tester you will find though. I did meet some testers who didn't like the process. They liked to create a new release in a test case system, copy their last test plan, change a few details and regression test off of scripted test cases without much thought. They felt like it was too much work, and resisted the process because it wasn't easy and because it required thought. I also found some of my agile testing purist colleagues who complained about the extra documentation and having to break the rules of Scrum to make it work. We were pragmatists though and figured our way through it trying to keep the spirit of Scrum alive while working in a regulated system. I found the FDA-mandated approach to be in line with how I tend to work anyway (just with more overhead), so it was nice to plug in my risk assessment into our internal auditors work and collaborate. However, the stakes are much higher, and there was a higher process and documentation burden, which could get tiresome at times. You want to move on and work on the new phone or tablet that came out, but you have to spend a couple of days buttoning up docs.
You have this extra part of your release that depends on oversight from a regulatory body (and we worked in several countries, so we had several) and that changes the pace of a release as opposed to a non-regulated environment. You don't get to move on as quickly, and if you fail your audit, or you get a pass with strict orders to fix some areas of weakness, you will spend more time with existing products.
The difficult part was the high stakes of what you are doing. You feel a tremendous amount of responsibility because this software affects people's lives. The flip side of that is you know you are working on something that can really help people, not like some get rich quick social networking mobile app scheme. Not that there's anything wrong with sexy startups trying to make a lot of money, but you feel you are helping humanity by contributing to health technology. That is a great feeling.
The hardest part for me personally was dealing with test data for certain kinds of scans. For some, I just saw a body, and I was interested in the pathologies. For others, it was a person, and I felt disturbed. I couldn't test mammography scans very much; I found it very upsetting when I saw the pathologies in the scans. I kept thinking that it was someone's wife, mother, sister, or aunt. It was also difficult to work on some of the tests when a family member was going through a health scare at the same time. I didn't count on the emotional or visceral impact some of the work would have on us—to look at scans of sick people all day. We scheduled time on other duties to mix things up in part to help deal with the emotional toll this could sometimes have.
Read more in the continuation of this interview: Government Regulation and Medical Apps: An Interview with Jonathan Kohl.