Workshop 9 - Trends & Challenges in the Medical Device Industry


Armin Riess
BBraun, Germany

Fergal Mc Caffery
Dundalk Institute of Technology, Ireland

Marion Lepmets
SoftComply, Estonia

Alastair Walker
Lorit Consultancy, Scottland (UK)


Trends & Challenges in the Medical Device Industry


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

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.

We are looking for a mix of industrial and academic papers. Please submit your paper
by the 6th April for inclusion in EuroSPI conference proceedings.

Workshop Program 5.9.2018

09.00 - 10.30

A Software Process Improvement Roadmap for IEC 62304: an Expert Review
Ceara Treacy of Dundalk Institute of Technology, Ireland

EU Medical Device Regulation
Armin Riess B.Braun, Germany

Verification of the Effectiveness of Risk Management in the Medical Device Industry
Szabolcs Agai & Alastair Walker Lorit Consultancy, Scottland


10.30 - 11.00

Coffee Break

11.00 - 12.30

Medical SPICE
Markus Manleitner, Germany

Capability Counts - The New FDA Strategy
Morten Korsaa, Jorn Johansen, Whitebox, Denmark

How to be Agile in a Regulated World? Processes for Scaled Agility
Peter Pedross, PEDCO, Switzerland


14.00 - 15.30

Interactive Workshop

Summarise findings of the 3 team exercises. Focus on process improvement and the it’s pros and cons
in the medical device sector

15.30 - 16.00

Coffee Break

16.00 - 17.00

Interactive Workshop Continues

Summarise findings of the 3 team exercises. Focus on process improvement and the it’s pros and cons
in the medical device sector


Important Information

Thematic Paper Topics

  • Challenges of medical device industry and best practices from the community.
  • Support to overcome the fear of the new standards ISO 62304, 60601 and MDR.
  • How to strengthen medical products against safety vulnerabilities and/or cybersecurity threats?
  • How can assessment models such as Medical/MDev SPICE, CMMI help us in achieving better products?
  • additional models, norms, experiences

Submission Dates

06.04.2018 First Thematic Paper Submission
30.04.2018 Review by International Programme Committee and Notification of Acceptance
12.06.2018 Camera Ready Version of Paper for Book
31.07.2018 Early Registration Deadline (All presenters must register, otherwise the contribution is deselected)
30.08.2018 Upload of Powerpoint Conference Presentation

SPRINGER Book Series

EuroAsiaSPI² is publishing an annual SPRINGER book and the EuroSPI books show a total of 150000 (one hunded fifty thousand) chapter downloads. The workshop papers will form a chapter for this thematic topic in the SPRINGER book.

Additional Information

Key Contributors

The goal of this workshop community is to share experiences with the implementation of the different medical device industry norms, to discuss new upcoming norms, and also to present and discuss experiences with the usage of new technologies (e.g. programmable chips, intelligent sensors, etc.). Also the use of assessment models in medical device industry will be be discussed.

BBraun as a major medical industry company, Dundalk Institute of Technology as a research organisations , Softcomply and Lorit Consultancy as experienced consulting companies in the medical device industry area are moderating the workshop.

Interactive Workshop Approach

Focus of interest and main questions discussed during the workshop will be:
  • Best practices to implement medical device industry norms
  • Best practices for system and software architecture including the required safety aspects
  • Best practices with assessment models and improvement programs
  • Best practices with the application of new design issues / patterns (programmable chips, intelligent sensors, Internet of THings connections, etc.)
  • How would an existing organisation adapt to the new technologies
  • How would an existing organisation adapt to the requied standards
  • Is there a list of influence and success factors / criteria

Each presentation will be discussed towards these main topics of interest. A panel discussion at the end shall come up with a summary of the solutions presented and with new research topics to focus on to solve this integrated approach (work for next year to meet at next EuroAsiaSPI² and share again).

History (starting with 2018)