Peter Pedross, Sept. 17th, Zürich  It was my first time to attend the EuroAsia SPI² (European Systems Software and Service Process Improvement and Innovation). The conference took place this year in the beautiful City Bilbao in Spain. As I was also a speaker in the ‘SPI in Medical Device Industry’, I would like to summarize my personal impressions with this small blog entry.

As described on the EuroSPI² website, the conference presents and discusses results from systems, software, and services process improvement and innovation (SPI) projects in industry and research, focusing on the gained benefits and the criteria for success. This year’s event was the 19th of a series of conferences to which international researchers and professionals contribute their lessons learned and share their knowledge as they work towards the next higher level of software management professionalism. It was nice to get a printed proceeding of all papers (published by Springer), this is something that I don’t see so many times and it also continues a long history of publications.

When I arrived, I was impressed by the location, which was in the Bizkaia Technology Park close to Bilbao and the airport. There was a friendly welcome and people from all over Europe (Turkey, Italy, Austria, Irland, Germany …. to Scottland); this Tecno Park also hosts the European Software Institute (ESI). The conference holds thematic workshops on three days as well as international keynotes, a research stream, and presentations from leading industry and leading research institutes, and a joint paper award with the SW Division of the American Society of Quality. Workshop communities are moderated by leading research and industry. To my impression, the program and the concurrent workshops/sessions was a really good mix of academic research and real-world status reports (for example about ‘Managing Traceability’ e.g. from Bosch, Continental and many others).

Each thematic workshop covers specific thematic topics:

  1. Gamification of SPI
  2. SPI in Industry 4.0
  3. Best Practices in Implementing Traceability
  4. Good and Bad Practices in Improvement
  5. Functional Safety and Cybersecurity
  6. SPI and Agile and Lean
  7. International Standards and Norms
  8. Team Skills Accessibility, and Diversity
  9. SPI in Medical Device Industry
  10. Empowering the Future Infrastructure (Automotive Industry, GEAR 2030 & DRIVES)

I was participating at the SPI iMedicalal Device Industry under the Lead by Dr. Marion Lepmets, SoftComply (Pic on the right, with Peter Pedross from PEDCO). There were several speaches in the morning, followed by a lively discussion at the workshop in the afternoon.

Trends & Challenges in the Medical Device Industry

Here’s the summary of this workshop: There are many challenges facing medical device manufacturers nowadays and these include the introduction of the medical device regulation (MDR) in the EU, the increasing demands to combat cybersecurity and always a hot topic – how to keep abreast of the very complex medical device regulatory landscape.
In this workshop we want to invite contributions on topics that include but are not limited to the implications of the MDR and regulatory compliance; medical device safety & risk management; cybersecurity; usability; and best practices for successfully implementing IEC 60601 and IEC 62304 in medical device development projects.
Contributions on whether there is a route to introducing a SPICE model in the medical device sector and would medical device manufacturers welcome such a process improvement model, are also invited.

Speakers (topics) were:

  • Ceara Treacy of Dundalk Institute of Technology, Ireland (A Software Process Improvement Roadmap for IEC 62304: an Expert Review)
  • Armin Riess B.Braun, Germany (A Software Process Improvement Roadmap for IEC 62304: an Expert Review)
  • Szabolcs Agai & Alastair Walker Lorit Consultancy, Scottland  (A Software Process Improvement Roadmap for IEC 62304: an Expert Review)
  • Markus Manleitner, Germany (Medical SPICE)
  • Morten Korsaa, Jorn Johansen, Whitebox, Denmark (Capability Counts – The New FDA Strategy)
  • Peter Pedross, PEDCO, Switzerland (How to be Agile in a Regulated World? Processes for Scaled Agility)

As I provided some input on my topic ‘How to be Agile in a Regulated World? Processes for Scaled Agility ‘, I was able to give and to receive a lot of good information (if you are interested about my slides, you can write me an email at For example, I learned about interesting aspects and its implications of the brand new Medical SPICE, as well as how new EU Medcial Device Regulation is reflected at B.Braun (Germany) or about a process improvement roadmap for IEC 62304. With this new knowledge, I was able to enlarge my understanding of how to built the best agile processes for the medical device development. The interactive workshops helped a lot to dive into some specific details.

There were also some very interesting key notes, especially the one from Thomas Muer, Sony Interactive Entertainment. Thomas talked about their successful journey on how to apply scaled agile processes (SAFe) for their world wide distributed development team of the famous playstation.

Over all, a very interesting smaller conference with a family-like atmosphere at a great location. It was also nice to visit the Guggenheim Museum, to take a lovely boat ride on the nervion-river and have a wonderful dinner with all participant in on of the best restaurants of Bilbao.

I will join again next year to the conference in Edinburgh, Scottland!

If you want to meet us at a conference, we will be (presentation and/or booth) at the following conferences: