Workshop 9 - Trends & Challenges in the Medical Device Industry


Susan Leonard
QUARA Consulting, Scotland

Marion Lepmets
SoftComply, Estonia

Alastair Walker
Lorit Consultancy, Scotland (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.

It is possible to submit short statements (for presentation and workshop discussions) continuously directly to This email address is being protected from spambots. You need JavaScript enabled to view it.

Important Information

Thematic Paper Topics

  • MDR/IVDR Case Studies
  • The future on IEC 82304-1
  • FDA CMMI – Case for Quality
  • MDR Class I to Class IIa changes  – a users point of view
  • Usability in the medical device sector
  • Cybersecurity in the medical device sector
  • AI in healthcare

Submission Dates

12.04.2019 First Thematic Paper Submission
10.05.2019 Review by International Programme Committee and Notification of Acceptance
21.06.2019 Camera Ready Version of Paper for Book
16.08.2019 Early Registration Deadline (All presenters must register, otherwise the contribution is deselected)
13.09.2019 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.

How to submit

Please follow the following steps for submitting a paper:

  • Your thematic topic paper should comprise 10-12 pages.
  • Your paper has to be conform to the Springer CCIS format which is the same as the Lecture Notes in Computer Science (LNCS) format (please see the author guidelines of Springer)
  • The paper has to be uploaded to the EuroAsiaSPI² conference website (see below).
  • Authors of accepted papers will be asked to write a final paper of 10 to maximum 12 pages and to prepare a 20 minutes PowerPoint presentation.
  • The final paper has to be uploaded to the EuroAsiaSPI² conference website again.
  • Papers shall reference the SPI Manifesto (find relationships to values and principles or propose new values and principles to be added).

Note: To publish the paper in the proceedings the authors have to sign a copyright form and at least one of the authors has to present the paper at the conference. The paper will be published in printed form and electronically and therefore we need all source files.

Please read first the author submission guide. More...

Also see "Thematic Paper Submission for one of the 10 workshop communities" for more information

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).