Medical Devices SIG

Objectives

The Medical Devices Special Interest Group (MedDev SIG) was formed in 2025.

We are a group of statisticians with focus or interest in statistical methods for medical devices development and post-market follow-up. The objectives of our SIG are:

  • Analyse the diversity of regulatory requirements across the globe and the medical device landscape.
  • Develop/improve algorithms better reflecting
    • multiplicity of devices,
    • procedural influence,
    • high timing variability, &
    • diversity of endpoints.
  • Raise the awareness for statistical challenges in medical devices trials within the industry and a broader audience.

Who we are

NameCompany/Institution
Bruno BoulangerArlenda
Ana Rita ChernyshovaTerumo
Rada DakovicMerz Aesthetics
Martin FahyJena Valve
Emilie GérardBrain & Mind
Wilmar IglVeranex
Michael Mader (Chair)Nobel Biocare
Arnaud MonseurEsylos
Julia SaperiaMHRA
Erica SecchettinUniversity of Verona
Tao XuRoche
Zoe WelshAbbott Diabetes Care

How to get in touch

For further information, or to join the MedDev SIG, please contact our Chair:

Michael Mader (Nobel Biocare) michael.mader@envistaco.com.

Recent SIG Activities

  1. Emilie Gérard, Wilmar Igl, Martin Fahy, Michael Mader (2026). Agenda of the novel Special Interest Group for Medical Devices:  Finding similarity within the diversity of Medical Devices, Annual Conference of Statisticians in the Pharmaceutical Industry 2026 (PSI2026), June 15 to 17, Belfast, Northern Ireland.
    Poster: Finding similarity within the diversity of Medical Devices - PSI 2026 Conference
  2. Michael Mader, Emilie Gérard, Wilmar Igl, Martin Fahy, Rada Dakovic (2026). Omnipresent but exotic? Statistical concepts for medical device trials. EFSPI Regulatory Statistics Workshop 2026 (EFSPI2026). August 19 to 20, 2026, Basel, Switzerland.
    Poster: Omnipresent but exotic? Statistical concepts for medical device trials - EFSPI 2026
  3. [Preliminary] Wilmar Igl, Emilie Gérard, Martin Fahy, Michael Mader for the SIG Medical Devices (2026). Agenda of the novel Special Interest Group for Medical Devices: Finding Similarity within the Diversity of Medical Devices. Annual Conference of the International Society for Clinical Biostatistics (ISCB2026), September 27 to October 1, 2026, Freiburg, Germany.
    Poster:

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