UTSAAH Laboratory

Universal Technology Solutions for Accessible and Affordable Healthcare Laboratory



Design of BioMedical Devices and Systems (2:1)


Medical Device Classification, Bioethics and Privacy, Biocompatibility and Sterilization Techniques, Design of Clinical Trials, Design Control & Regulatory Requirements. Introduction to specific medical technologies: Biopotentials measurement (EMG, EOG, ECG, EEG), Medical Diagnostics (In-vitro diagnostics), Medical Diagnostics (Imaging), Minimally Invasive Devices, Surgical Tools and Implants, Medical Records and Telemedicine.

The course will include guest lectures by healthcare professionals giving exposure to unmet needs in the healthcare technologies and systems.

Reference Books:

  • Paul H. King, Richard C. Fries, Arthur T. Johnson, Design of Biomedical Devices and Systems, Third Edition, ISBN 9781466569133
  • John G. Webster (ed), Medical Instrumentation: Application and Design, 2007
  • Peter J. Ogrodnik, Medical Device Design: Innovation from Concept to Market, Academic Press Inc; 1 edition (2012), ISBN-10: 0123919428
  • Stefanos Zenios , Josh Makower , Paul Yock , Todd J. Brinton , Uday N. Kumar , Lyn Denend , Thomas M. Krummel, Biodesign: The Process of Innovating Medical Technologies, Cambridge University Press; 1 edition (2009), ISBN-10: 0521517427


  • Lectures: Tuseday 10-12am
  • Lab/Discussion session: Wednesdays 2-4 pm

Lecture Notes:

  • Available in MS-Teams


It is preferred that assignments are submitted in hand written format.


Course project will involve designing a product/device for real world problem taken from our clinical contacts. See list of Design Briefs for projects this year.

Project work will be evaluated individually evaluated but is done in teams of up to 3.

Other Online Resources:

Mayo Clinic  Health Information Pages

Pubmed – Biomedical Research Papers

Stanford Bioesign

Draft Indian Medical Device Rules 2016

GOI Medical Device Rules Notification (Jan2017 -English)

Newly Classified Medical Devices by CDSCO/GoI (June 2017)

Medical Device Classification as per EU MDD