First RegOps Days conference!

What was only a dream last August, has now became a real RegOps Days conference and community. With RegOps, we share an interest in integrating regulation activities into DevOps practices. It all started during a discussion over a pizza with Tommi Mikkonen. We talked about the state of regulatory work in today's fast pacing DevOps practicing organisations. Our first thought was to cover the topic with a guest lecture at Helsinki University, but we soon realised that that was not a good forum to approach this topic. The exposure to regulatory work is quite limited among students. The idea of having a conference was born! It would provide a venue where researchers and practitioners could meet. There, they can exchange ideas and experiences about their areas of expertise. Things were getting serious. We reached out to our friends at Osaango, and Marjukka Niinioja jumped in to help.

So here we are: February 13th in Tiedekulma at RegOps Days Helsinki 2020. Roughly 50 participants representing more that 20 organisations with an interest in regulated medical device software development. Needless to say, excitement was high. Over the course of the morning we listened to four engaging presentations.

The first talk was held by Mauri Honkanen from Avaa. He explored the thin line that separates wellness and medical applications. Medical regulations cast a much larger shadow as they influence expectations and decision making beyond their intended target. Next, I've talked about the challenges caused by using agile development in regulated environments. A practical way to reduce these challenges is to perform RegOps during pull requests. The timing enables compliance officers to be in sync with the rest of the development team. The coffee break and the cinnamon buns gave the energy boost for the next two talks. Risto Kaikkoinen described Solita's journey into becoming a medical device manufacturer. He gave practical advice on how an experienced software organization handles regulations. The last presentation was by Ilari Richardt from Terveystalo. He described the challenges his organization faces developing in parallel several regulated products.

The conference concluded with a lively panel discussion focused around the following topics:

• The importance of RegOps
• The biggest challenges hindering RegOps adoption
• The relations of medical regulatory practices with other regulated industries
• The need for having a community of practice around RegOps

Besides these topics, we explored the role of academia in fulfilling these needs. Universities need to step up and prepare the students for a new workplace governed by regulations. The discipline required to develop regulated software products is the rule rather than the exception. Understanding that behind regulatory activities are best practices is of upmost importance. The acquired skills are applicable across many application domains, making them more valuable.

The recent evolutions in artificial intelligence and machine learning were also touched. Their use raises interesting questions from a regulatory perspective. Datasets play an important role for the development of new algorithms and models. What is their origin? How do they change over time? The consensus was that new regulatory practices will emerge to cover data lifecycle. Someone even suggested the term DataOps.

While the panelists gave interesting insights into these topics, the real heroes were the participants. They asked questions and engaged into lively conversations. The distance between the stage and the audience disappeared. This created a meetup-like vibe to the whole event.

Last but not least, an event like this does not happen without help from our emerging community. Big thanks to Citrus for supporting us at the beginning of this journey. Nice to have them as first RegOps Days event sponsor. Techie Stories filmed the talks and the panel discussion. The videos allows us to reach the community members that were not able to join us this time.

Looking forward, the feedback from this event participants looks solid. RegOps discussions will continue in community events like meet-ups. Their scope might cover other regulation intensive industries such as finance or automotive. Keep an eye on the RegOps website for upcoming events and register for our newsletter.